The information in this prospectus is not complete and may be changed. We may not sell these securities until the Securities and Exchange Commission declares our registration statement effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction or state where the offer or sale is not permitted.

following the closing of the business combination (the requirements set forth in clause (A) or (B), “Milestone 2”); and (3) 2,500,000 shares of PubCo Common Stock if Clene completes a randomized placebo-controlled study for treatment of COVID-19 which results in a statistically significant finding of clinical efficacy within twelve (12) months after the closing of the Business Combination. If Milestone 1 is not achieved but Milestone 2 is achieved, the Clene stockholders will receive a catchup issuance equal to the shares issued upon satisfaction of Milestone 1.

Furthermore, immediately prior to the closing of the Business Combination, Tottenham shall cancel and forfeit an aggregate of 750,000 insider shares owned by its current officers and directors and the Sponsor (collectively, the “initial shareholders”) for no additional consideration. The initial shareholders instead may be entitled to receive earn-out shares as follows: (1) 375,000 shares of PubCo Common Stock upon satisfaction of the requirements of Milestone 1; and (2) another 375,000 shares of PubCo Common Stock upon satisfaction of the requirements of Milestone 2. If Milestone 1 is not achieved but Milestone 2 is achieved, the initial shareholders shall receive a catchup issuance equal to the shares granted upon satisfaction of the requirements of Milestone 1.

At the Extraordinary General Meeting, Tottenham shareholders will be asked to consider and vote upon the following proposals:

1.      approval of the Reincorporation Merger, which we refer to as the “Reincorporation Merger Proposal” or “Proposal No. 1;”

2.      approval of the Acquisition Merger, which we refer to as the “Acquisition Merger Proposal” or “Proposal No. 2;”

3.      approval of PubCo’s Incentive Plan, which we refer to as the “Incentive Plan Proposal” or “Proposal No. 3.” A copy of the Incentive Plan is attached to the accompanying proxy statement as Annex C;

4.       approval of PubCo’s 2020 Employee Stock Purchase Plan, which we refer to as the “ESPP Plan Proposal” or “Proposal No. 4.” A copy of the ESPP Plan is attached to the accompanying proxy statement as Annex D;

5.      approval to adjourn the Extraordinary General Meeting under certain circumstances, which is more fully described in the accompanying proxy statement/consent solicitation/prospectus, which we refer to as the “Adjournment Proposal” or “Proposal No. 5” and, together with the Reincorporation Merger Proposal, the Acquisition Merger Proposal, the Incentive Plan Proposal, and the ESPP Plan Proposal, the “Proposals.”

If the Tottenham shareholders approve the Reincorporation Merger Proposal and the Acquisition Merger Proposal immediately prior to the consummation of the Business Combination, all outstanding units, including the Private Units (as defined below) of Tottenham (each of which consists of one TOTA Ordinary Share, one TOTA Right and one TOTA Warrant) (the “TOTA Units”) will separate into their individual components of TOTA Ordinary Shares, TOTA Rights and TOTA Warrants and will cease separate existence and trading. Upon the consummation of the Business Combination, the current equity holdings of the Tottenham shareholders shall be exchanged as follows:

(i)     Each Tottenham’s ordinary share, par value $0.0001 per share (“TOTA Ordinary Shares”), issued and outstanding immediately prior to the effective time of the Reincorporation Merger (other than any redeemed shares and any Dissenting Shares (as defined herein)), will automatically be cancelled and cease to exist and for each TOTA Ordinary Share, PubCo shall issue to each Tottenham shareholder (other than Dissenting Shareholders (as hereinafter defined) and Tottenham shareholders who exercise their redemption rights in connection with the Business Combination) one validly issued share of PubCo Common Stock, which, unless explicitly stated herein, shall be fully paid;

(ii)    Each TOTA Ordinary Share, issued and outstanding immediately prior to the closing held by each holder of TOTA Ordinary Shares who has validly exercised such holder’s right to dissent from the Reincorporation Merger in accordance with Section 179 of the BVI Business Companies Act, 2004, as amended (the “BVI BC Act”) (a “Dissenting Shareholder”), and who has not effectively withdrawn its right to such dissent (collectively, the “Dissenting Shares”) will be cancelled in exchange for the right to receive payment resulting from the procedure in Section 179 of the BVI BC Act and such Dissenting Shareholder shall not be entitled to receive any shares of the PubCo Common Stock to be issued in connection with the Reincorporation Merger;

(iii)   Each warrant to purchase one half of one TOTA Ordinary Share (“TOTA Warrant”) issued and outstanding immediately prior to effective time of the Reincorporation Merger will convert into a warrant to purchase one-half of one share of PubCo Common Stock (each, a “PubCo Warrant”) (or equivalent portion thereof). The PubCo Warrants will have substantially the same terms and conditions as set forth in the TOTA Warrants; and

(iv)   The holders of Tottenham’s rights (exchangeable into one-tenth of one TOTA Ordinary Share) (collectively, the “TOTA Rights”) issued and outstanding immediately prior to the effective time of the Reincorporation Merger will receive one-tenth (1/10) of one share of PubCo Common Stock in exchange for the cancellation of each TOTA Right; provided, however, that no fractional shares will be issued and all fractional shares will be rounded to the nearest whole share.

It is anticipated that, upon consummation of the Business Combination, Tottenham’s existing shareholders, including the initial shareholders, will own approximately [•]% of the issued PubCo Common Stock, and Clene’s current stockholders will own of approximately [•]% of the issued PubCo Common Stock. These relative percentages assume that (i) none of Tottenham’s existing public shareholders exercise their redemption rights or dissenter rights, as discussed herein; (ii) there is no exercise or conversion of PubCo Warrants; (iii) 750,000 insider shares have been cancelled and forfeited; and (iv) the Notes (defined below) have been converted into TOTA Ordinary Shares at the price of $10.00 per share immediately before the closing. If any of Tottenham’s existing public shareholders exercise their redemption rights or dissenter rights, the anticipated percentage ownership of Tottenham’s existing shareholders will be reduced. You should read “Summary of the Proxy Statement/Consent Solicitation Statement/Prospectus — The Business Combination and the Merger Agreement” and “Unaudited Pro Forma Condensed Combined Financial Statements” for further information.

The TOTA Units, TOTA Ordinary Shares, TOTA Rights and TOTA Warrants are currently listed on the NASDAQ Capital Market under the symbols “TOTAU,” “TOTA,” “TOTAR” and “TOTAW,” respectively. PubCo intends to apply to list the PubCo Common Stock and PubCo Warrants on the NASDAQ Stock Market under the symbols “CLNN” and “CLNNW,” respectively, in connection with the closing of the Business Combination. Tottenham cannot assure you that the PubCo Common Stock and PubCo Warrants will be approved for listing on NASDAQ.

Investing in PubCo securities involves a high degree of risk. See “Risk Factors” beginning on page 17 for a discussion of information that should be considered in connection with an investment in PubCo securities.

As of [•], 2020, there was approximately $[•] in Tottenham’s trust account. On [•], 2020, the last sale price of TOTA Ordinary Shares was $[•].

Pursuant to Tottenham’s second amended and restated memorandum and articles of association, Tottenham is providing its public shareholders with the opportunity to redeem all or a portion of their TOTA Ordinary Shares at a per-share price, payable in cash, equal to the aggregate amount then on deposit in Tottenham’s trust account as of two business days prior to the consummation of the Business Combination, including interest, less taxes payable, divided by the number of then outstanding TOTA Ordinary Shares that were sold as part of the TOTA Units in Tottenham’s initial public offering (“IPO”), subject to the limitations described herein. Tottenham estimates that the per-share price at which public shares may be redeemed from cash held in the trust account will be approximately $[•] at the time of the Extraordinary General Meeting. Tottenham’s public shareholders may elect to redeem their shares even if they vote for the Reincorporation Merger or do not vote at all. Tottenham has no specified maximum redemption threshold under Tottenham’s memorandum and articles of association. It is a condition to closing under the Merger Agreement, however, that PubCo shall receive not less than $30,000,000 of cash (from the trust account or raised in private placements) that is available for distribution upon the consummation of the Business Combination. If redemptions by Tottenham public shareholders cause Tottenham to be unable to meet this closing condition, then Clene will not be required to consummate the Business Combination, although it may, in its sole discretion, waive this condition. In the event that Tottenham waives this condition, Tottenham does not intend to seek additional shareholder approval or to extend the time period in which its public shareholders can exercise their redemption rights. Holders of outstanding TOTA Warrants and TOTA Rights do not have redemption rights in connection with the Business Combination.

Tottenham is providing this proxy statement/consent solicitation statement/prospectus and accompanying proxy card to its shareholders in connection with the solicitation of proxies to be voted at the Extraordinary General Meeting and at any adjournments or postponements of the Extraordinary General Meeting. Norwich Investment Limited (“Sponsor”) and other initial shareholders, which own approximately [36.79]% of TOTA Ordinary Shares as of the record date, has agreed to vote their TOTA Ordinary Shares in favor of the Reincorporation Merger Proposal and the Acquisition Merger Proposal, which transactions comprise the Business Combination, and intend to vote for the Incentive Plan Proposal and the Adjournment Proposal, although there is no agreement in place with respect to voting on those proposals.

Each shareholder’s vote is very important. Whether or not you plan to attend the Extraordinary General Meeting in person, please submit your proxy card without delay. Tottenham’s shareholders may revoke proxies at any time before they are voted at the meeting. Voting by proxy will not prevent a shareholder from voting in person if such shareholder subsequently chooses to attend the Extraordinary General Meeting. If you are a holder of record and you attend the Extraordinary General Meeting and wish to vote in person, you may withdraw your proxy and vote in person. Assuming that a quorum is present, attending the Extraordinary General Meeting either in person or by proxy and abstaining from voting will have the same effect as voting against all the Proposals, and broker non-votes will have no effect on any of the Proposals.

If you sign, date and return your proxy card without indicating how you wish to vote, your proxy will be voted in favor of each of the Proposals presented at the Extraordinary General Meeting. If you fail to return your proxy card or fail to instruct your bank, broker or other nominee how to vote, and do not attend the Extraordinary General Meeting in person, the effect will be that your shares will not be counted for purposes of determining whether a quorum is present at the Extraordinary General Meeting and, if a quorum is present, will have the effect of a vote against all the Proposals (except the Adjournment Proposal) and no effect on the Adjournment Proposal. If you are a shareholder of record and you attend the Extraordinary General Meeting and wish to vote in person, you may withdraw your proxy and vote in person.

We encourage you to read this proxy statement/consent solicitation statement/prospectus carefully. In particular, you should review the matters discussed under the caption “Risk Factors” beginning on page 17.

Tottenham board of directors has unanimously approved the Merger Agreement and the Plans of Merger, and unanimously recommends that Tottenham shareholders vote “FOR” approval of each of the Proposals. When you consider Tottenham board of director’s recommendation of these Proposals, you should keep in mind that Tottenham’s directors and officers have interests in the Business Combination that may conflict or differ from your interests as a shareholder. See “Proposal No. 2 The Acquisition Merger Proposal — Interests of Certain Persons in the Business Combination.”

On behalf of the Tottenham board of directors, I thank you for your support and we look forward to the successful consummation of the Business Combination.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of the securities to be issued in the Business Combination or otherwise, or passed upon the adequacy or accuracy of this proxy statement/consent solicitation statement/prospectus. Any representation to the contrary is a criminal offense.

Clene Nanomedicine, Inc.
6550 South Millrock Drive, Suite G50
Salt Lake City, Utah 84121

NOTICE OF SOLICITATION OF WRITTEN CONSENT

To Stockholders of Clene Nanomedicine, Inc.:

Your consent is being solicited with regards to a proposed merger between Clene Nanomedicine, Inc. (“Clene”) and Tottenham Acquisition I Limited (“Tottenham”). Tottenham is a British Virgin Islands company incorporated as a blank check company for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination with one or more businesses or entities. Pursuant to a merger agreement, dated as of September 1, 2020 (the “Merger Agreement”), the proposed merger will be effected in two steps: (i) subject to the approval and adoption of the Merger Agreement by the shareholders of Tottenham, Tottenham will reincorporate to the state of Delaware by merging with and into Chelsea Worldwide Inc., a Delaware corporation and wholly owned subsidiary of Tottenham (“PubCo”), with PubCo remaining as the surviving publicly traded entity (the “Reincorporation Merger”); (ii) immediately after the Reincorporation Merger, Creative Worldwide Inc. (“Merger Sub”), a Delaware corporation and wholly owned subsidiary of PubCo, will be merged with and into Clene, resulting in Clene being a wholly owned subsidiary of PubCo (the “Acquisition Merger”). The Merger Agreement is by and among Clene, Tottenham, PubCo and Merger Sub.

This proxy statement/consent solicitation statement/prospectus is being delivered to you on behalf of the Clene board of directors to request that holders of Clene common stock or preferred stock as of the record date of [•], 2020 execute and return written consents to adopt and approve the proposed Merger Agreement.

This proxy statement/consent solicitation statement/prospectus describes the proposed merger and the actions to be taken in connection with the merger and provides additional information about the parties involved. Please give this information your careful attention. A copy of the Merger Agreement is attached as Annex A to this proxy statement/consent solicitation statement/prospectus.

A summary of the appraisal rights that may be available to you is described in “Appraisal Rights.” Please note that if you wish to exercise appraisal rights you must not sign and return a written consent adopting the Merger Agreement. However, so long as you do not return a consent form at all, it is not necessary to affirmatively vote against or disapprove the merger. In addition, you must take all other steps necessary to perfect your appraisal rights.

The Clene board of directors has considered the merger and the terms of the Merger Agreement and has unanimously determined that the merger and the Merger Agreement are advisable, fair to and in the best interests of Clene and its stockholders and recommends that Clene stockholders adopt the Merger Agreement by submitting a written consent.

Please complete, date and sign the written consent furnished with this proxy statement/consent solicitation statement/prospectus and return it promptly to Clene by one of the means described in “Clene’s Solicitation of Written Consents.”

HOW TO OBTAIN ADDITIONAL INFORMATION

If you would like to receive additional information or if you want additional copies of this document, agreements contained in the appendices or any other documents filed by Tottenham with the Securities and Exchange Commission, such information is available without charge upon written or oral request. Please contact our proxy solicitor, at:

Advantage Proxy
P.O. Box 13581
Des Moines, WA 98198
Toll Free: 877-870-8565
Collect: 206-870-8565
Email: KSmith@advantageproxy.com

If you would like to request documents, please do so no later than [•], 2020 to receive them before the Extraordinary General Meeting. Please be sure to include your complete name and address in your request. Please see “Where You Can Find More Information” to find out where you can find more information about Tottenham, PubCo and Clene. You should rely only on the information contained in this proxy statement/consent solicitation statement/prospectus in deciding how to vote on the Business Combination. Neither Tottenham, PubCo nor Clene has authorized anyone to give any information or to make any representations other than those contained in this proxy statement/consent solicitation statement/prospectus. Do not rely upon any information or representations made outside of this proxy statement/consent solicitation statement/prospectus. The information contained in this proxy statement/consent solicitation statement/prospectus may change after the date of this proxy statement/consent solicitation statement/prospectus. Do not assume after the date of this proxy statement/consent solicitation statement/prospectus that the information contained in this proxy statement/consent solicitation statement/prospectus is still correct.

USE OF CERTAIN TERMS

Unless otherwise stated in this proxy statement/consent solicitation statement/prospectus:

•        “Chardan” refers to Chardan Capital Markets, LLC.

•        “Closing Date” refers to the date on which the Business Combination is consummated.

•        “Exchange Act” refers to the Securities Exchange Act of 1934, as amended.

•        “HKD” refers to the legal currency of Hong Kong.

•        “IPO” refers to the initial public offering of 4,600,000 units (including 600,000 units after Chardan exercised its over-allotment option) of Tottenham consummated on August 6, 2018.

•        “LifeSci” refers to LifeSci Capital LLC.

•        “Loeb” refers to Loeb & Loeb LLP.

•        “LOI” refers to a letter of intent.

•        “Merger Agreement” refers to the merger agreement between Tottenham, PubCo, Merger Sub and Clene, and Fortis Advisors LLC, a Delaware limited liability company as the representative of Clene’s shareholders.

•        “Plan of Merger” refers to a plan of merger by and among Tottenham and PubCo.

•        “Sponsor” refers to Norwich Investment Limited.

•        “US Dollars,” “$,” and “USD$” refers to the legal currency of the United States.

•        “U.S. GAAP” refers to accounting principles generally accepted in the United States.

•        “VWAP” refers to, for any security as of any date(s), the dollar volume-weighted average price for such security on the principal securities exchange or securities market on which such security is then traded during normal trading hours of such exchange or market, as reported by Bloomberg through its “HP” function (set to weighted average) or, if the foregoing does not apply, the dollar volume-weighted average price of such security in the over-the-counter market on the electronic bulletin board for such security during normal trading hours of such market, as reported by Bloomberg, or, if no dollar volume-weighted average price is reported for such security by Bloomberg for such hours, the average of the highest closing bid price and the lowest closing ask price of any of the market makers for such security as reported by OTC Markets Group Inc. If the VWAP cannot be calculated for such security on such date(s) on any of the foregoing bases, the VWAP of such security on such date(s) shall be the fair market value as determined reasonably and in good faith by a majority of the disinterested directors of the board of directors (or equivalent governing body) of the applicable issuer. All such determinations shall be appropriately adjusted for any stock or share dividend, stock split or share subdivision, stock combination or share consolidation, recapitalization or other similar transaction during such period.

Tottenham Acquisition I Limited
Unit 902, Lucky Building
39-41 Wellington Street
Central, Hong Kong
(852) 3998-4852

NOTICE OF EXTRAORDINARY GENERAL MEETING OF SHAREHOLDERS
TO BE HELD ON             , 2020

TO THE SHAREHOLDERS OF TOTTENHAM ACQUISITION I LIMITED:

NOTICE IS HEREBY GIVEN that an Extraordinary General Meeting of shareholders of Tottenham Acquisition I Limited, a British Virgin Islands company (“Tottenham”), will be held on             , 2020 at 10:00 AM Hong Kong Time as a teleconference using the following dial-in information:

The Extraordinary General Meeting will be held for the following purposes:

I.       To approve the merger of Tottenham with and into PubCo, its wholly owned Delaware subsidiary, with PubCo surviving the merger. The merger will change Tottenham’s place of incorporation from British Virgin Islands to Delaware. We refer to the merger as the Reincorporation Merger. This proposal is referred to as the Reincorporation Merger Proposal or Proposal No. 1. Holders of TOTA Ordinary Shares as of record date are entitled to vote on this proposal.

II.     To approve the authorization for PubCo’s board of directors to complete the merger of Merger Sub into Clene, resulting Clene becoming a wholly owned subsidiary of PubCo. We refer to the merger as the Acquisition Merger. This proposal is referred to as the Acquisition Merger Proposal or Proposal No. 2. Holders of TOTA Ordinary Shares as of record date are entitled to vote on this proposal.

III.    To approve the Incentive Plan, which we refer to as the Incentive Plan Proposal or Proposal No. 3. Holders of TOTA Ordinary Shares as of record date are entitled to vote on this proposal.

IV.     To approve the ESPP Plan, which we refer to as the ESPP Plan Proposal or Proposal No. 4. Holders of TOTA Ordinary Shares as of record date are entitled to vote on this proposal.

V.      To approve the adjournment of the Extraordinary General Meeting in the event Tottenham does not receive the requisite shareholder vote to approve any of the above Proposals. This proposal is called the Adjournment Proposal or Proposal No. 5.

All of the proposals set forth above are sometimes collectively referred to herein as the “Proposals.” The Reincorporation Merger Proposal and the Acquisition Merger Proposal are dependent upon each other. It is important for you to note that in the event that either of the Reincorporation Merger Proposal or the Acquisition Merger Proposal is not approved, then Tottenham will not consummate the Business Combination. In the absence of shareholder approval for a further extension, if Tottenham does not consummate the Business Combination and fails to complete an initial business combination by November 6, 2020, Tottenham will be required to dissolve and liquidate.

As of [•], 2020, there were [3,710,386] TOTA Ordinary Shares issued and outstanding and entitled to vote. Only Tottenham shareholders who hold shares of record as of the close of business on [•], 2020 are entitled to vote at the Extraordinary General Meeting or any adjournment of the Extraordinary General Meeting. This proxy statement/consent solicitation statement/prospectus is first being mailed to Tottenham shareholders on or about [•], 2020. Approval of the Reincorporation Proposal and the Acquisition Proposal will require the affirmative vote of 65% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof. Approval of the Incentive Plan Proposal and the Adjournment Proposal will require the affirmative vote of 50% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof. Assuming that a quorum is present, attending the Extraordinary General Meeting either in person or by proxy and abstaining from voting will have the same effect as voting against the Proposals and failing to instruct your bank, brokerage firm or nominee to attend and vote your shares will have no effect on any of the Proposals.

Holders of TOTA Ordinary Shares will be entitled to dissenter rights under the BVI BC Act in connection with the Reincorporation Merger. In accordance with Section 179 of the BVI BC Act, a holder of TOTA Ordinary Shares is entitled to payment of the fair value of all of its shares upon validly dissenting from the Reincorporation Merger. Holders of TOTA Ordinary Shares may only dissent in respect of all shares that they hold in Tottenham. Upon a holder of TOTA Ordinary Shares validly exercising its entitlement under Section 179 of the BVI BC Act, such Dissenting Shareholder ceases to have any rights (including redemption rights) of a shareholder of Tottenham except the right to be paid the fair value of its TOTA Ordinary Shares.

A holder of TOTA Ordinary Shares who desires to exercise its entitlement to payment of the fair value of all of its TOTA Ordinary Shares is required to give us written objection to the Reincorporation Merger before the Extraordinary General Meeting or before the vote on the Reincorporation Merger Proposal at the Extraordinary General Meeting. Within 20 days immediately following the date on which the approval of Tottenham shareholders is obtained at the Extraordinary General Meeting (or any adjourned meeting), Tottenham shall give written notice of the approval to each Tottenham shareholder who gave a valid written objection to the Reincorporation Merger, except for those Tottenham shareholders who after giving the written objection subsequently voted to approve the Reincorporation Merger Proposal at the Extraordinary General Meeting (or any adjourned meeting). Any such holder of TOTA Ordinary Shares who elects to dissent is required, within 20 days immediately following the date on which the notice of approval by Tottenham referred to above is given, to give Tottenham a written notice of its decision to elect to dissent, stating: (a) its name and address; (b) the number of TOTA Ordinary Shares in respect of which it dissents; and (c) a demand for payment of the fair value of its TOTA Ordinary Shares. On the effective date of the Reincorporation Merger, a Dissenting Shareholder shall have its TOTA Ordinary Shares automatically cancelled in exchange for the right to receive payment resulting from the procedure in Section 179 of the BVI BC Act and a Dissenting Shareholder shall not be entitled to receive PubCo Common Stock pursuant to the Reincorporation Merger.

A Tottenham shareholder who elects to dissent under Section 179 of the BVI BC Act and validly exercises its entitlement to payment of the fair value of the TOTA Ordinary Shares it holds following the procedures set forth above will not be entitled to have its TOTA Ordinary Shares redeemed. If a Tottenham shareholder has elected to have its TOTA Ordinary Shares redeemed but later elects to dissent, upon receipt of the written notice of such a Tottenham shareholder’s decision to elect to dissent, Tottenham shall instruct its transfer agent to return the TOTA Ordinary Shares (physically or electronically) delivered to the transfer agent in connection with such Tottenham shareholder’s demand for redemption to the Tottenham shareholder.

Whether or not you plan to attend the Extraordinary General Meeting in person, please submit your proxy card without delay to Advantage Proxy not later than the time appointed for the Extraordinary General Meeting or adjourned meeting. Voting by proxy will not prevent you from voting your shares in person if you subsequently choose to attend the Extraordinary General Meeting. If you fail to return your proxy card and do not attend the meeting in person, the effect will be that your shares will not be counted for purposes of determining whether a quorum is present at the Extraordinary General Meeting. You may revoke a proxy at any time before it is voted at the Extraordinary General Meeting by executing and returning a proxy card dated later than the previous one, by attending the Extraordinary General Meeting in person and casting your vote by ballot or by submitting a written revocation to Advantage Proxy, P.O. Box 13581, Des Moines, WA 98198 Attention: Karen Smith, Telephone: 877-870-8565, that is received by proxy solicitor before we take the vote at the Extraordinary General Meeting. If you hold your shares through a bank or brokerage firm, you should follow the instructions of your bank or brokerage firm regarding revocation of proxies.

Tottenham board of directors unanimously recommends that you vote “FOR” approval of each of the Proposals.

•        the possibility that the COVID-19 pandemic, or another major disease, disrupts Clene’s business;

•        litigation and regulatory enforcement risks, including the diversion of management time and attention and the additional costs and demands on Clene’s resources; and

•        the risks that the consummation of the Business Combination is substantially delayed or does not occur.

Should one or more of these risks or uncertainties materialize, or should any of the assumptions made by the management of Tottenham, Clene and PubCo prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.

All subsequent written and oral forward-looking statements concerning the Business Combination or other matters addressed in this proxy statement/consent solicitation statement/prospectus and attributable to Clene, Tottenham, PubCo or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this proxy statement/consent solicitation statement/prospectus. Except to the extent required by applicable law or regulation, PubCo, Clene and Tottenham undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this proxy statement/consent solicitation statement/prospectus or to reflect the occurrence of unanticipated events.

QUESTIONS AND ANSWERS ABOUT THE BUSINESS COMBINATION, THE EXTRAORDINARY GENERAL MEETING AND THE CONSENT SOLICITATION

Questions and Answers About the Merger

Q:     Why are Tottenham and Clene proposing to enter into the Business Combination?

A:    Tottenham is a blank check company formed specifically as a vehicle to effect a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, recapitalization or similar business combination with one or more businesses. In the course of Tottenham’s search for a Business Combination partner, Tottenham investigated the potential acquisition of many entities in various industries, including Clene, and concluded that Clene was the best candidate for a Business Combination with Tottenham. For more details on Tottenham’s search for a Business Combination partner and the board’s reasons for selecting Clene as Tottenham’s Business Combination partner, see “Proposal No. 2 The Acquisition Merger Proposal — Background of the Business Combination” and “Proposal No. 2 The Acquisition Merger Proposal — Tottenham’s Board of Director’s Reasons for Approving the Business Combination” included in this proxy statement/prospectus.

Q:     What is the purpose of this document?

A:    Tottenham and Clene are proposing to consummate the Business Combination. The Business Combination consists of the Reincorporation Merger and the Acquisition Merger, each of which is described in this proxy statement/consent solicitation statement/prospectus. In addition, the Merger Agreement and the Plan of Merger are attached to this proxy statement/consent solicitation statement/prospectus as Annex A, and is incorporated into this proxy statement/consent solicitation statement/prospectus by reference. This proxy statement/consent solicitation statement/prospectus contains important information about the proposed Business Combination and the other matters to be acted upon at the Extraordinary General Meeting or consented to by the Clene stockholders, as applicable. You are encouraged to carefully read this proxy statement/consent solicitation statement/prospectus, including “Risk Factors” and all the annexes hereto.

Approval of the Reincorporation Merger and the Acquisition Merger will each require the affirmative vote of 65% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof. Approval of the Incentive Plan Proposal and the Adjournment Proposal will each require the affirmative vote of 50% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof.

Approval of the Merger Agreement will require the affirmative consent of a majority of the issued and outstanding common stock and preferred stock of Clene, on an as-converted basis. Approval of the Merger Agreement also requires the affirmative consent of the holders of a majority of the holders of shares of Series B, Series C and Series D preferred stock, each voting as a separate class, and the approval of the “Lead Investor” as defined in Clene’s Series D Preferred Stock Purchase Agreement.

Q.     Are any of the proposals conditioned on one another?

A:     Yes, the Reincorporation Merger Proposal and the Acquisition Merger Proposal are dependent upon each other. It is important for you to note that in the event that either of the Reincorporation Merger Proposal or the Acquisition Merger Proposal is not approved, Tottenham will not consummate the Business Combination. In the absence of shareholder approval for a further extension, if Tottenham does not consummate the Business Combination and fails to complete an initial business combination by November 6, 2020, Tottenham will be required to dissolve and liquidate. Adoption of the Adjournment Proposal is not conditioned upon the adoption of any of the other Proposals.

The matters for which the consent of the stockholders of Clene are being sought are not conditioned on one another.

Q:     When is the Business Combination expected to occur?

A:     Assuming the requisite shareholder approvals are received, Tottenham expects that the Business Combination will occur as soon as practicable following the Extraordinary General Meeting and no later than November 6, 2020, but only after PubCo holds a statutory meeting of shareholders, which is expected to be held [10] days after the date of this proxy statement/consent solicitation statement/prospectus.

Q:     Who will manage PubCo?

A:     The current management team of Clene, including Rob Etherington, who currently serves as Chief Executive Officer, will serve in the same roles at PubCo following the consummation of the Business Combination. For more information on PubCo’s current and anticipated management, see “PubCo’s Directors and Executive Officers after the Business Combination” in this proxy statement/consent solicitation statement/prospectus.

Q:     What happens if the Business Combination is not consummated?

A:     If the Business Combination is not consummated, Tottenham may seek another suitable business combination. In the absence of shareholder approval for a further extension, if Tottenham does not consummate a business combination by November 6, 2020, then pursuant to Article 28 of its second amended and restated memorandum and articles of association, Tottenham’s officers must take all actions necessary in accordance with the BVI BC Act to dissolve and liquidate Tottenham as soon as reasonably practicable. Following dissolution, Tottenham will no longer exist as a company. In any liquidation, the funds held in the trust account, plus any interest earned thereon (net of taxes payable), together with any remaining out-of-trust net assets will be distributed pro-rata to holders of TOTA Ordinary Shares who acquired such shares in Tottenham’s IPO or in the aftermarket. The estimated consideration that each TOTA Ordinary Share would be paid at liquidation would be approximately $[•] per share for shareholders based on amounts on deposit in the trust account as of [•], 2020. The closing price of TOTA Ordinary Shares on Nasdaq as of [•], 2020 was $[•]. The Sponsor and other initial shareholders waived the right to any liquidation distribution with respect to any TOTA Ordinary Shares held by them.

If the Business Combination is not consummated, Clene will continue operating as a private company.

Q:     What happens to the funds deposited in the trust account following the Business Combination?

A:     Following the closing of the Business Combination, holders of TOTA Ordinary Shares exercising redemption rights will receive their per share redemption price out of the funds in the trust account. The balance of the funds will be released to PubCo and utilized to fund working capital needs of PubCo. As of [•], 2020, there was approximately $[•] in Tottenham’s trust account. Tottenham estimates that approximately $[•] per outstanding share issued in Tottenham’s IPO will be paid to the public investors exercising their redemption rights. Any funds remaining in the trust account after such uses will be used for future working capital and other corporate purposes of the combined entity.

Q:     Do any of Tottenham’s directors or officers have interests that may conflict with the interests of Tottenham’s shareholders with respect to the Business Combination?

A:    Tottenham’s directors and officers may have interests in the Business Combination that are different from your interests as a shareholder. In February 2018, Tottenham issued an aggregate of 1,150,000 ordinary shares to our initial shareholders including the Sponsor, which we refer to herein as “insider shares,” for an aggregate purchase price of $25,000. Simultaneously with the closing of the IPO, Tottenham consummated a private placement of 215,000 units (the “Private Units”) at a price of $10.00 per Private Unit. Immediately prior to the closing of the Business Combination, an aggregate 750,000 shares owned by our initial shareholders will be cancelled and forfeited for no additional consideration. In exchange, our initial shareholders will be entitled to receive up to 750,000 shares of PubCo Common Stock upon PubCo’s satisfaction of Milestone 1 and Milestone 2 after the closing. Furthermore, the Sponsor will be repaid at closing for the loans extended to Tottenham since its IPO, among which $2,485,000 will be paid in the form of PubCo Common Stock at a per share price of $10.00. In the absence

of shareholder approval for a further extension, if Tottenham does not consummate the Business Combination by November 6, 2020, Tottenham will be required to dissolve and liquidate and the securities held by our initial shareholders, including the Sponsor, will be worthless because the initial shareholders have agreed to waive their rights to any liquidation distributions.

The exercise of Tottenham’s directors’ and officers’ discretion in agreeing to changes or waivers in the terms of the Business Combination may result in a conflict of interest when determining whether such changes or waivers are appropriate and in Tottenham shareholders’ best interests.

Questions and Answers About the Extraordinary General Meeting for Tottenham’s Shareholders

Q:     What is being voted on at the Extraordinary General Meeting?

A:     Below are the Proposals that the Tottenham’s shareholders are being asked to vote on:

•        The Reincorporation Merger Proposal to approve the Reincorporation Merger;

•        The Acquisition Merger Proposal to approve the Acquisition Merger;

•        The Incentive Plan Proposal to approve PubCo’s Incentive Plan;

•        The ESPP Plan Proposal to approve PubCo’s ESPP Plan; and

•        The Adjournment Proposal to approve the adjournment of the Extraordinary General Meeting in the event Tottenham does not receive the requisite shareholder vote to approve the above Proposals.

Approval of the Reincorporation Proposal and the Acquisition Proposal will require the affirmative vote of 65% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof. Approval of the Incentive Plan Proposal and the Adjournment Proposal will require the affirmative vote of 50% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof. As of the record date, [1,365,000] shares held by the initial shareholders, or approximately [36.79]% of the outstanding TOTA Ordinary Shares, would be voted in favor of each of the Proposals.

Q:     When and where is the Extraordinary General Meeting?

A:     The Extraordinary General Meeting will take place on [•], 2020, at [•] a.m., Hong Kong Time. Due to the COVID-19 pandemic, Tottenham will be holding its Extraordinary General Meeting as a teleconference using the following dial-in information:

Q:     Who may vote at the Extraordinary General Meeting?

A:     Only holders of record of TOTA Ordinary Shares as of the close of business on [•], 2020 (the record date) may vote at the Extraordinary General Meeting. As of [•], 2020, there were [3,710,386] TOTA Ordinary Shares outstanding and entitled to vote. Please see “The Extraordinary General Meeting — Record Date; Who is Entitled to Vote” for further information.

Q:     What is the quorum requirement for the Extraordinary General Meeting?

A:     TOTA shareholders representing a majority of the shares of capital stock issued and outstanding as of the record date and entitled to vote at the Extraordinary General Meeting must be present in person or represented by proxy in order to hold the Extraordinary General Meeting and conduct business. This is called a quorum. TOTA Ordinary Shares will be counted for purposes of determining if there is a quorum if the shareholder (i) is present and entitled to vote at the meeting, or (ii) has properly submitted a proxy card or voting instructions through a broker, bank or custodian. In the absence of a quorum, the Extraordinary General Meeting will be adjourned to the next business day at the same time and place or to such other time and place as the directors may determine.

Q:     What vote is required to approve the Proposals?

A:     Approval of the Reincorporation Proposal and the Acquisition Proposal will require the affirmative vote of 65% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof and approval of the Incentive Plan Proposal and the Adjournment Proposal will require the affirmative vote of 50% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof. Attending the Extraordinary General Meeting either in person or by proxy and abstaining from voting will have the same effect as voting “AGAINST” the Proposals and failing to instruct your bank, brokerage firm or nominee to attend and vote your shares will have no effect on any of the Proposals.

Q:     How will the initial shareholders vote?

A:     Tottenham’s initial shareholders, who as of the record date, owned [1,365,000] TOTA Ordinary Shares, or approximately [36.79]% of the issued and outstanding TOTA Ordinary Shares, have agreed to vote their respective shares acquired by them prior to the IPO in favor of the Reincorporation Merger Proposal, Acquisition Merger Proposal and other related proposals. The initial shareholders have also agreed that they will vote any shares they purchase in the open market in or after the IPO in favor of each of the Proposals.

Q:     What do I need to do now?

A:     We urge you to read carefully and consider the information contained in this proxy statement/consent solicitation statement/prospectus, including the annexes, and consider how the Business Combination will affect you as a Tottenham shareholder. You should vote as soon as possible in accordance with the instructions provided in this proxy statement/consent solicitation statement/prospectus and on the enclosed proxy card.

Q:     Do I need to attend the Extraordinary General Meeting to vote my shares?

A:     No. You are invited to attend the Extraordinary General Meeting to vote on the Proposals described in this proxy statement/consent solicitation statement/prospectus. However, you do not need to attend the Extraordinary General Meeting to vote your TOTA Ordinary Shares. Instead, you may submit your proxy by signing, dating and returning the applicable enclosed proxy card in the pre-addressed postage paid envelope. Your vote is important. Tottenham encourages you to vote as soon as possible after carefully reading this proxy statement/consent solicitation statement/prospectus.

Q:     Am I required to vote against the Reincorporation Merger and the Acquisition Merger Proposal in order to have my TOTA Ordinary Shares redeemed?

A:     No. You are not required to vote against the Reincorporation Merger Proposal and the Acquisition Merger Proposal in order to have the right to demand that Tottenham redeem your TOTA Ordinary Shares for cash equal to your pro rata share of the aggregate amount then on deposit in the trust account (including interest earned on your pro rata portion of the trust account, net of taxes payable) before payment of deferred underwriting commissions. These redemption rights in respect of the TOTA Ordinary Shares are sometimes referred to herein as “redemption rights.” If the Business Combination is not completed, holders of TOTA Ordinary Shares electing to exercise their redemption rights will not be entitled to receive such payments and their TOTA Ordinary Shares will be returned to them.

Q:     How do TOTA shareholders exercise their redemption rights?

A:     If you are a public shareholder and you seek to have your shares redeemed, you must (i) demand, no later than 5:00 p.m., eastern time on [•], 2020 (two business days before the Extraordinary General Meeting), that Tottenham redeem your shares for cash, and (ii) submit your request in writing to Tottenham’s transfer agent, at the address listed at the end of this section and deliver your shares to Tottenham’s transfer agent (physically, or electronically using the DWAC (Deposit/Withdrawal At Custodian) system) at least two business days prior to the vote at the Extraordinary General Meeting.

Any corrected or changed written demand of redemption rights must be received by Tottenham’s transfer agent two business days prior to the Extraordinary General Meeting. No demand for redemption will be honored unless the holder’s shares have been delivered (either physically or electronically) to the transfer agent at least two business days prior to the vote at the Extraordinary General Meeting.

Public shareholders may seek to have their shares redeemed regardless of whether they vote for or against the Business Combination and whether or not they are holders of TOTA Ordinary Shares as of the record date. Any public shareholder who holds TOTA Ordinary Shares on or before [•], 2020 (two business days before the Extraordinary General Meeting) will have the right to demand that his, her or its shares be redeemed for a pro rata share of the aggregate amount then on deposit in the trust account, less any taxes then due but not yet paid, at the consummation of the Business Combination. If you have questions regarding the certification of your position or delivery of your shares, please contact:

Continental Stock Transfer & Trust Company
One State Street Plaza, 30th Floor
New York, NY 10004
Attn: Mark Zimkind
E-mail: mzimkind@continentalstock.com

A Tottenham shareholder who elects to dissent under Section 179 of the BVI BC Act and validly exercises its entitlement to payment of the fair value of the TOTA Ordinary Shares it holds will not be entitled to have its TOTA Ordinary Shares redeemed.

Q:     How can I vote?

A:     If you were a holder of record of TOTA Ordinary Shares on [•], 2020, the record date for the Extraordinary General Meeting, you may vote with respect to the Proposals in person at the Extraordinary General Meeting, or by submitting a proxy by mail so that it is received prior to 10:00 a.m. Hong Kong Time on [•], 2020, in accordance with the instructions provided to you under “The Extraordinary General Meeting.” If you hold your shares in “street name,” which means your shares are held of record by a broker, bank or other nominee, your broker or bank or other nominee may provide voting instructions (including any telephone or Internet voting instructions). You should contact your broker, bank or nominee in advance to ensure that votes related to the shares you beneficially own will be properly counted. In this regard, you must provide the record holder of your shares with instructions on how to vote your shares or, if you wish to attend the Extraordinary General Meeting and vote in person, obtain a proxy from your broker, bank or nominee.

Q:     If my shares are held in “street name” by my bank, brokerage firm or nominee, will they automatically vote my shares for me?

A:     No. Under Nasdaq rules, your broker, bank or nominee cannot vote your TOTA Ordinary Shares with respect to non-discretionary matters unless you provide instructions on how to vote in accordance with the information and procedures provided to you by your broker, bank or nominee. Tottenham believes the Proposals are non-discretionary and, therefore, your broker, bank or nominee cannot vote your TOTA Ordinary Shares without your instruction. Broker non-votes will not be considered present for the purposes of establishing a quorum and will have no effect on the Proposals. If you do not provide instructions with your proxy, your bank, broker or other nominee may submit a proxy card expressly indicating that it is NOT voting your TOTA Ordinary Shares; this indication that a bank, broker or nominee is not voting your TOTA Ordinary Shares is referred to as a “broker non-vote.” Your bank, broker or other nominee can vote your TOTA Ordinary Shares only if you provide instructions on how to vote. You should instruct your broker to vote your TOTA Ordinary Shares in accordance with directions you provide.

Q:     What if I abstain from voting or fail to instruct my bank, brokerage firm or nominee?

A:     Tottenham will count a properly executed proxy marked “ABSTAIN” with respect to a particular Proposal as present for the purposes of determining whether a quorum is present at the Extraordinary General Meeting of Tottenham shareholders. For purposes of approval, an abstention on any Proposals will have the same effect as a vote “AGAINST” such Proposal.

Q:     May I seek statutory dissenter rights with respect to my TOTA shares?

A:     Yes. Dissenter rights are available to holders of TOTA Ordinary Shares in connection with the Reincorporation Merger. Upon a holder of TOTA Ordinary Shares validly exercising its entitlement under Section 179 of the BVI BC Act, such Dissenting Shareholder ceases to have any rights (including the redemption rights) of a shareholder of Tottenham except the right to be paid the fair value of its TOTA Ordinary Shares.

In accordance with Section 179 of the BVI BC Act, a holder of TOTA Ordinary Shares is entitled to payment of the fair value of all of its shares upon validly dissenting from the Reincorporation Merger. Holders of TOTA Ordinary Shares may only dissent in respect of all shares that they hold in Tottenham. A holder of TOTA Ordinary Shares who desires to exercise their entitlement to payment of the fair value of all of its shares is required to give to Tottenham written objection to the Reincorporation Merger before the Extraordinary General Meeting or before the vote on the Reincorporation Merger Proposal at the Extraordinary General Meeting.

Within 20 days immediately following the date on which the approval of Tottenham shareholders is obtained at the Extraordinary General Meeting (or any adjourned meeting), Tottenham shall give written notice of the approval to each Tottenham shareholder who gave a valid written objection to the Reincorporation Merger, except for those Tottenham shareholders who after giving the written objection, subsequently voted to approve the Reincorporation Merger Proposal at the Extraordinary General Meeting (or any adjourned meeting). Any such holder of TOTA Ordinary Shares who elects to dissent is required, within 20 days immediately following the date on which the notice of approval by Tottenham referred to above is given, to give Tottenham a written notice of its decision to elect to dissent, stating: (a) its name and address; (b) the number of TOTA Ordinary Shares in respect of which it dissents; and (c) a demand for payment of the fair value of its shares. On the closing date, a Dissenting Shareholder shall have its TOTA Ordinary Shares automatically cancelled in exchange for the right to receive payment resulting from the procedure in Section 179 of the BVI BC Act and such Dissenting Shareholder shall not be entitled to receive PubCo Common Stock pursuant to the Reincorporation Merger.

A Tottenham shareholder who elects to dissent under Section 179 of the BVI BC Act and validly exercises its entitlement to payment of the fair value of the TOTA Ordinary Shares it holds following the procedures set forth above will not be entitled to have its TOTA Ordinary Shares redeemed. If a Tottenham shareholder has elected to have its TOTA Ordinary Shares redeemed but later elects to dissent, upon receipt of the written notice of such a Tottenham shareholder’s decision to elect to dissent, Tottenham shall instruct its transfer agent to return the TOTA Ordinary Shares (physically or electronically) delivered to the transfer agent in connection with such Tottenham shareholder’s demand for redemption to the Tottenham shareholder.

For additional information, please see “The Extraordinary General Meeting — Dissenter Rights.” Tottenham shareholders who elect redemption rights will receive their cash payment in respect of their redeemed TOTA Ordinary Shares earlier than shareholders who exercise dissenter rights.

Q:     What happens if I sell my TOTA Ordinary Shares before the Extraordinary General Meeting?

A:     The record date for the Extraordinary General Meeting is earlier than the date that the Business Combination is expected to be consummated. If you transfer your TOTA Ordinary Shares after the record date, but before the Extraordinary General Meeting, unless the transferee obtains from you a proxy to vote those shares, you would retain your right to vote at the Extraordinary General Meeting. However, you would not be entitled to receive any shares of PubCo Common Stock following the consummation of the Business Combination because only Tottenham shareholders at the time of the consummation of the Business Combination will be entitled to receive PubCo Common Stock in connection with the Business Combination.

Q:     Will I experience dilution as a result of the Business Combination?

A:     Prior to the Business Combination, the Tottenham shareholders who hold shares issued in the IPO own, after redemption in April, 2020, approximately [63.21]% of Tottenham’s issued and outstanding ordinary shares. After giving effect to the Business Combination and to (i) the issuance of the 54,254,055 shares of PubCo Common Stock in the Acquisition Merger; (ii) the issuance of up to [4,191,886] shares of PubCo Common Stock to the Tottenham shareholders in connection with the Reincorporation Merger (assuming there are no Tottenham shareholders who exercise their redemption rights and an aggregate of 481,500 shares are issued

upon conversion of the TOTA Rights, including private rights); (iii) assuming no exercise of the PubCo Warrants; (iv) the issuance of [248,500] shares of PubCo Common Stock upon conversion of the Notes issued to the Sponsor; (v) the cancellation and forfeiture of 750,000 insider shares pursuant to the Merger Agreement; (vi) an aggregate of 3,000,000 shares are issued at the closing of the Business Combination through private placements (“PIPE Shares”), Tottenham’s current public shareholders will own approximately [4.60]% of PubCo.

Q:     Are Clene’s stockholders required to approve the Acquisition Merger?

A:     Yes. Clene’s stockholders’ approval of the Acquisition Merger and Merger Agreement is required to consummate the Business Combination. In the event that the Acquisition Merger and the Merger Agreement fail to be authorized or approved by Clene’s stockholders and such breach has not been cured within fifteen (15) days following the receipt by Clene of a notice describing such breach, Tottenham can terminate the Merger Agreement at its sole discretion. Clene’s stockholders are not required to approve the Reincorporation Merger Proposal.

Q:     Is the consummation of the Business Combination subject to any conditions?

A:     Yes. The obligations of each of Tottenham, Clene, Merger Sub and PubCo to consummate the Business Combination are subject to conditions, as more fully described in “Summary of the Proxy Statement/Consent Solicitation Statement/Prospectus — The Business Combination and the Merger Agreement” in this proxy statement/consent solicitation statement/prospectus.

Q:     Can I change my vote after I have mailed my proxy card?

A:     Yes. You may change your vote at any time before your proxy is voted at the Extraordinary General Meeting. You may revoke your proxy by executing and returning a proxy card dated later than the previous one, or by attending the Extraordinary General Meeting in person and casting your vote by hand or by ballot (as applicable) or by submitting a written revocation stating that you would like to revoke your proxy that our proxy solicitor receives prior to the Extraordinary General Meeting. If you hold your TOTA Ordinary Shares through a bank, brokerage firm or nominee, you should follow the instructions of your bank, brokerage firm or nominee regarding the revocation of proxies. If you are a record holder, you should send any notice of revocation or your completed new proxy card, as the case may be, to:

Advantage Proxy
P.O. Box 13581
Des Moines, WA 98198
Toll Free: 877-870-8565
Collect: 206-870-8565
Email: KSmith@advantageproxy.com

Q:     Should I send in my share certificates now?

A:     Yes. Tottenham’s shareholders who intend to have their shares redeemed should send their certificates or tender their shares electronically no later than two business days before the Extraordinary General Meeting. Please see “The Extraordinary General Meeting — Redemption Rights” for the procedures to be followed if you wish to redeem your ordinary shares for cash.

Q:     What are the U.S. federal income tax consequences of exercising my redemption rights?

A:     In the event that a U.S. Holder elects to redeem its TOTA Ordinary Shares for cash, the treatment of the transaction for U.S. federal income tax purposes will depend on whether the redemption qualifies as sale or exchange of the TOTA Ordinary Shares under Section 302 of the Internal Revenue Code (the “Code”) or is treated as a distribution under Section 301 of the Code and whether TOTA would be characterized as a passive foreign investment company (“PFIC”). If the redemption qualifies as a sale or exchange of the TOTA Ordinary Shares, the U.S. Holder will be treated as recognizing capital gain or loss equal to the difference between the amount realized on the redemption and such U.S. Holder’s adjusted tax basis in the TOTA Ordinary Shares surrendered in such redemption transaction. Any such capital gain or loss generally will be long-term capital gain or loss if the U.S. Holder’s holding period for the TOTA Ordinary Shares redeemed exceeds one year.

Long-term capital gains recognized by non-corporate U.S. Holders will be eligible to be taxed at reduced rates. The deductibility of capital losses is subject to limitations. See “Material U.S. Federal Income Tax Consequences — U.S. Holders — Certain U.S. Federal Income Tax Consequences to U.S. Holders of Tottenham Securities of Exercising Redemption Rights” and “Material U.S. Federal Income Tax Consequences — U.S. Holders — U.S. Federal Income Tax Consequences of the Reincorporation Merger to U.S. Holders of Tottenham Securities — Passive Foreign Investment Company Status” for a more detailed discussion of the U.S. federal income tax consequences of a U.S. Holder electing to redeem its TOTA Ordinary Shares for cash, including with respect to TOTA’s potential PFIC status and certain tax implications thereof.

Q:     Will holders of TOTA Ordinary Shares, TOTA Rights or TOTA Warrants be subject to U.S. federal income tax on the PubCo Common Stock or PubCo Warrants received in the Reincorporation Merger?

A:     As discussed more fully under “Material U.S. Federal Income Tax Consequences of the Business Combination,” the Reincorporation Merger should qualify as a “reorganization” within the meaning of Section 368(a)(1)(F) of the Code. However, the provisions of the Code that govern reorganizations are complex, and due to the absence of direct guidance on the application of Section 368(a)(1)(F) to a merger of a corporation holding only investment-type assets such as Tottenham, the qualification of the Reincorporation Merger as an “reorganization” within the meaning of Section 368(a)(1)(F) of the Code is not entirely clear. If the Reincorporation Merger so qualifies, then a U.S. Holder (as defined below) will be subject to Section 367(b) of the Code and, as a result:

•        a U.S. Holder whose TOTA Ordinary Shares have a fair market value of less than $50,000 on the date of the Reincorporation Merger and who on the date of the Reincorporation Merger owns (actually and constructively) less than 10% of the total combined voting power of all classes of Tottenham stock entitled to vote and less than 10% of the total value of all classes of Tottenham stock will generally not recognize any gain or loss and will generally not be required to include any part of Tottenham’s earnings in income pursuant to the Reincorporation Merger;

•        a U.S. Holder whose TOTA Ordinary Shares have a fair market value of $50,000 or more on the date of the Reincorporation Merger, but who on the date of the Reincorporation Merger owns (actually and constructively) less than 10% of the total combined voting power of all classes of Tottenham stock entitled to vote and less than 10% of the total value of all classes of Tottenham stock will generally recognize gain (but not loss) on the exchange of TOTA Ordinary Shares for PubCo Common Stock pursuant to the Reincorporation Merger. As an alternative to recognizing gain, such U.S. Holders may file an election to include in income as a dividend the “all earnings and profits amounts,” (as defined in Treasury Regulation Section 1.367(b)-2(d)) attributable to their TOTA Ordinary Shares, provided certain other requirements are satisfied. Any U.S. Holder that is a corporation may, under certain circumstances, effectively be exempt from taxation on a portion or all of the deemed dividend pursuant to Section 245A of the Code. Tottenham does not expect to have significant cumulative earnings and profits on the date of the Reincorporation Merger; and

•        a U.S. Holder who on the date of the Reincorporation Merger owns (actually and constructively) 10% or more of the total combined voting power of all classes of Tottenham stock entitled to vote or 10% or more of the total value of all classes of Tottenham stock will generally be required to include in income as a dividend the “all earnings and profits amount,” (as defined in Treasury Regulation Section 1.367(b)-2(d))) attributable to its TOTA Ordinary Shares, provided certain other requirements are satisfied. Tottenham does not expect to have significant cumulative earnings and profits on the date of the Reincorporation Merger.

Furthermore, even if the Reincorporation Merger qualifies as a “reorganization” within the meaning of Section 368(a)(1)(F) of the Code, a U.S. Holder of Tottenham securities may, in certain circumstances, still recognize gain (but not loss) upon the exchange of its Tottenham securities for PubCo securities pursuant to the Reincorporation Merger under the “passive foreign investment company,” or PFIC, rules of the Code equal to the excess, if any, of the fair market value of PubCo securities received in the Reincorporation Merger and the U.S. Holder’s adjusted tax basis in the corresponding Tottenham securities surrendered in exchange therefor. The tax on any such gain so recognized would be imposed at the rate applicable to ordinary income and an interest charge would apply. For a more complete discussion of the potential application of the PFIC rules to U.S. Holders as a result of the Reincorporation Merger, see the discussion in the section titled “Material U.S. Federal Income Tax Consequences of the Business Combination — U.S. Holders — U.S. Federal Income Tax Consequences of the Reincorporation Merger to U.S. Holders of Tottenham Securities — Passive Foreign Investment Company Status.”

If the Reincorporation Merger does not qualify as a reorganization, then a U.S. Holder that exchanges its Tottenham securities for PubCo securities will recognize gain or loss equal to the difference between (i) the sum of the fair market value of the PubCo Common Stock and PubCo Warrants received and (ii) the U.S. Holder’s adjusted tax basis in the TOTA Ordinary Shares, TOTA Rights, and TOTA Warrants exchanged.

For a more detailed discussion of certain U.S. federal income tax consequences of the Reincorporation Merger and the Business Combination, see “Material U.S. Federal Income Tax Consequences” in this proxy statement/consent solicitation statement/prospectus. Holders should consult their own tax advisors to determine the tax consequences to them (including the application and effect of any state, local or other income and other tax laws) of the Business Combination.

Q:     Who can help answer my questions?

A:     If you have questions about the Proposals or if you need additional copies of this proxy statement/consent solicitation statement/prospectus or the enclosed proxy card you should contact Tottenham’s proxy solicitor at:

Advantage Proxy
P.O. Box 13581
Des Moines, WA 98198
Toll Free: 877-870-8565
Collect: 206-870-8565
Email: KSmith@advantageproxy.com

You may also obtain additional information about Tottenham from documents filed with the SEC by following the instructions in “Where You Can Find More Information.”

Questions and Answers About the Clene Consent Solicitation

Q.     What is consent being sought for?

A:     Stockholders of Clene are being asked to vote on the adoption and approval of the proposed Merger Agreement.

Approval of the Merger Agreement will require the affirmative consent of a majority of the issued and outstanding common stock and preferred stock of Clene, on an as-converted basis. Approval of the Merger Agreement also requires the affirmative consent of the holders of a majority of shares of each of Series B, Series C and Series D preferred stock, including the Series D lead investor.

At the time of entry into the Merger Agreement, United Technologies and General Resonance entered into shareholder support agreements with Tottenham agreeing to vote approximately 34.2% of the issued and outstanding capital stock for the transaction after the registration statement of which this joint proxy statement/consent solicitation statement/prospectus forms a part is declared effective by the SEC.

Q.     Who is entitled to give a written consent for Clene?

A:     The Clene board of directors has set [•], 2020 as the record date (the “Clene record date”) for determining Clene stockholders entitled to sign and deliver written consents with respect to this consent solicitation. Holders of outstanding shares of Clene common stock or preferred stock as of the close of business on the Clene record date will be entitled to give a consent using the form of written consent furnished with this proxy statement/consent solicitation statement/prospectus.

Q.     What will Clene stockholders receive in the merger?

A:     If the Merger Agreement is approved and the merger is completed, at the effective time, shares of Clene common stock and preferred stock issued and outstanding immediately prior to the effective time of the merger (other than shares owned by Clene as treasury stock or dissenting shares) collectively will convert into the right to receive newly issued shares of PubCo Common Stock (the “Closing Payment Shares”) equal to (a) an aggregate equity value of $542,540,558.06 (plus the net proceeds (if any) from any new equity investment received by Clene between the date of the Merger Agreement and the closing date of the business combination), divided by (b) a per share value equal to the lesser of (i) $10.00 per share or (ii) Tottenham’s cash-in-trust value per share on the

trading date prior to the closing of the business combination. However, no fractional shares of PubCo Common Stock will be paid. Under the Merger Agreement, 5% of the Closing Payment Shares to be issued will be held in escrow for a period of 6 months after the closing to satisfy indemnification obligations, if any. In addition to the Closing Payment Shares, Clene shareholders as of immediately prior to the closing are also entitled to receive up to 8,333,333 earn-out shares (the “Earnout Shares”), subject to PubCo achieving certain share price thresholds prior to certain future dates or meeting certain Covid-19 clinical trial targets, in each case as described in the Merger Agreement.

Q:     Will Clene common stockholders and preferred stockholders receive different considerations in the merger?

A:     No. Each share of Clene common stock and each share of Clene preferred stock will receive the same per share merger consideration, equal to the Closing Payment Shares divided by the total number of shares of outstanding Clene common stock and preferred stock immediately prior to the closing (5% of which will be subject to escrow as described above) plus the Earnout Shares (if any) divided by the total number of shares of outstanding Clene common stock and preferred stock immediately prior to the closing. Based on the total number of outstanding Clene common stock and preferred stock of approximately 390,530,162 as of the date of this proxy statement/consent solicitation statement/prospectus, each share of Clene capital stock will be entitled to receive 0.1389 shares of PubCo common stock (0.0069 share of which will be subject to escrow as described above), plus approximately 0.02134 Earnout Shares (subject to achievement of the earnout milestones described above).

Q.     Do any of Clene’s directors or officers have interests in the merger that may differ from or be in addition to the interests of Clene stockholders?

A:     Clene’s executive officers and certain non-employee directors may have interests in the merger that are different from, or in addition to, the interests of Clene generally. The Clene board of directors was aware of and considered these interests to the extent such interests existed at the time, among other matters, in approving the merger agreement and in recommending that the merger agreement be approved by the stockholders of Clene.

Q.     How can I return my written consent?

If you hold shares of Clene common stock or preferred stock as of the close of business on the Clene record date then you will receive an email from one of Clene’s attorneys, Meg Krivanec, requesting that you sign and submit the written stockholder consent via DocuSign. If you wish to submit your consent, you must promptly complete the DocuSign request. If you have any questions regarding the DocuSign processes or experience any difficulties, you should reach out to Meg Krivanec via email at meg.krivanec@stoel.com. Clene does not intend to hold a stockholders’ meeting to consider the Clene Merger Proposal, and, unless Clene decides to hold a stockholders’ meeting for such purposes, you will be unable to vote in person by attending a stockholders’ meeting.

Q.     What is the deadline for returning my written consent?

A:     The Clene board of directors has set [•], on [•], 2020 as the targeted final date for the receipt of written consents (the “target date”).

Q.     What choices do I have with respect to the proposed merger?

A:     With respect to the shares of Clene common stock and preferred stock that you hold, you may execute a written consent to approve the proposed Merger Agreement. If you fail to execute and return your written consent, or otherwise withhold your written consent, it has the same effect as voting against the proposed Merger Agreement.

Q.     Can I dissent and require appraisal of my shares?

A:     If you are a Clene stockholder who does not approve the merger by delivering a written consent adopting the merger agreement, you will, by complying with Section 262 of the General Corporation Law of the State of Delaware (the “DGCL”), be entitled to appraisal rights. Section 262 of the DGCL is attached to this proxy statement/consent solicitation statement/prospectus as Annex E. Failure to follow the procedures specified under Section 262 of the DGCL may result in the loss or waiver of appraisal rights under Delaware law. Delaware law

requires that, among other things, you send a written demand for appraisal to Clene after receiving a notice that appraisal rights are available to you, which notice will be sent to non-consenting Clene stockholders in the future. This proxy statement/consent solicitation statement/prospectus is not intended to constitute such a notice. Do not send in your demand before the date of such notice because any demand for appraisal made prior to your receipt of such notice may not be effective to perfect your rights. See “Clene’s Solicitation of Written Consent — Appraisal Rights” beginning on page 89 of this proxy statement/consent solicitation statement/prospectus.

Q:     Will U.S. Holders of Clene common stock or Clene warrants be subject to U.S. federal income tax on the PubCo Common Stock or PubCo Warrants received in the Acquisition Merger?

A:     As discussed more fully under “Material U.S. Federal Income Tax Consequences of the Business Combination,” it is intended that the Acquisition Merger qualify as a “reorganization” within the meaning of Section 368(a). Clene’s obligation to effect the Acquisition Merger is conditioned on its receipt of an opinion from its tax counsel, Kirkland & Ellis LLP, to that effect. The opinion will be based on certain assumptions and representations as to factual matters from Clene, Tottenham, PubCo and Merger Sub, as well as certain covenants by those parties. In addition, the opinion is based on current law and cannot be relied upon if current law changes with retroactive effect. The opinion of counsel is not binding upon the Internal Revenue Service (the “IRS”) or the courts, and there can be no assurance that the IRS or a court will not take a contrary position. Clene and Tottenham do not intend to request a ruling from the IRS regarding any aspects of the U.S. federal income tax consequences of the Acquisition Merger. Subject to the qualifications and limitations set forth in “Material U.S. Federal Income Tax Consequences of the Business Combination — U.S. Holders — U.S. Federal Income Tax Consequences of the Acquisition Merger to U.S. Holders of Clene Securities,” if the Acquisition Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Code, U.S. Holders of Clene common stock or Clene Warrants will generally not recognize any gain or loss as a result of the Acquisition Merger. For more information on the material U.S. federal income tax consequences of the Acquisition Merger to U.S. Holders of Clene common stock or Clene warrants, see “Material U.S. Federal Income Tax Consequences of the Business Combination — U.S. Holders — U.S. Federal Income Tax Consequences of the Acquisition Merger to U.S. Holders of Clene Securities” in this proxy statement/consent solicitation statement/prospectus. Holders should consult their own tax advisors to determine the tax consequences to them (including the application and effect of any state, local or other income and other tax laws) of the Business Combination.

Q:     Should Clene stockholders send in their stock certificates now?

A:     No. Clene stockholders, whether they hold common stock or preferred stock, SHOULD NOT send in any stock certificates now. If the merger agreement is adopted and the merger is consummated, transmittal materials, with instructions for their completion, will be provided under separate cover to Clene stockholders who hold physical stock certificates and the stock certificates should be sent at that time in accordance with such instructions.

Q:     Whom should I contact if I have any questions about the consent solicitation?

A:     If you have any questions about the merger or how to return your written consent or letter of transmittal, or if you need additional copies of this proxy statement/consent solicitation statement/prospectus or a replacement written consent or letter of transmittal, you should contact Rob Etherington, at rob@clene.com.

DELIVERY OF DOCUMENTS TO Tottenham’s shareholders

Pursuant to the rules of the SEC, Tottenham and vendors that it employs to deliver communications to its shareholders are permitted to deliver to two or more shareholders sharing the same address a single copy of this proxy statement/consent solicitation statement/prospectus, unless Tottenham has received contrary instructions from one or more of such shareholders. Upon written or oral request, Tottenham will deliver a separate copy of this proxy statement/consent solicitation statement/prospectus to any shareholder at a shared address to which a single copy of this proxy statement/consent solicitation statement/prospectus was delivered and who wishes to receive separate copies in the future. Shareholders receiving multiple copies of the proxy statement may likewise request that Tottenham deliver single copies of this proxy statement/consent solicitation statement/prospectus in the future. Stockholders may notify Tottenham of their requests by contacting Advantage Proxy as follows:

Advantage Proxy
P.O. Box 13581
Des Moines, WA 98198
Toll Free: 877-870-8565
Collect: 206-870-8565
Email: KSmith@advantageproxy.com

Clene’s history of recurring losses and anticipated expenditures raise substantial doubt about its ability to continue as a going concern. Clene’s ability to continue as a going concern requires that it obtain sufficient funding to finance its operations.

As of June 30, 2020, Clene had cash and cash equivalents totaling $6.9 million and an accumulated deficit of $79.3 million. During the six months ended June 30, 2020, Clene incurred a net loss totaling $9.7 million, and used cash in operating activities totaling $5.4 million. Clene expects to continue to incur losses and use cash in operating activities in 2020 and for the foreseeable future. Clene’s ability to continue as a going concern requires that it obtain sufficient funding to finance its operations until its drug candidates began generating sufficient revenue. Subsequent to June 30, 2020, Clene issued additional convertible notes, which, along with those already outstanding, converted into Series D Preferred Stock, and Series D Preferred Stock for cash. Clene does not expect that the cash and cash equivalents on hand as of June 30, 2020, plus cash raised of $36.3 million, net of issuance costs, will be sufficient to fund its operations for a period extending beyond twelve months from the date the consolidated financial statements are available to be issued. For details, please see “Management’s Discussion and Analysis of Financial Condition and Results of Operations of Clene.” In addition, Clene cannot assure you that its plans to raise capital or to consummate the Business Combination will be successful. These factors, among others, raise substantial doubt about Clene’s ability to continue as a going concern. The financial statements contained elsewhere in this prospectus do not include any adjustments that might result from our inability to consummate this offering or our inability to continue as a going concern.

Clene has a limited operating history, which may make it difficult to evaluate Clene’s current business and predict Clene’s future performance.

Clene is a biopharmaceutical company formed in December 2012 focusing on the discovery and development of innovative drugs for the treatment of neurological diseases and other disorders. Clene’s limited operating history, particularly in light of the rapidly evolving nanocrystal therapies field, may make it difficult to evaluate its current business and predict its future performance.

As a relatively new business, Clene has not yet demonstrated an ability to manufacture drugs at a commercial scale, or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful commercialization. Clene has not had any product approved for commercial sale and has not generated any revenue from product sales. Consequently, any assessment you make about Clene’s current business or future success or viability may not be as accurate as they could be if Clene had a longer operating history and had been able to reduce some of the uncertainties as set out above. Further, Clene’s limited financial track record, without any revenue yet from Clene’s expected future principal business, may be of limited reference value for your assessment of Clene’s business.

Clene may encounter difficulties in managing its growth and expanding its operations successfully.

As it seeks to advance its drug candidates through clinical trials, Clene will need to expand its development, regulatory, compliance, manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for Clene. As its operations expand, Clene expects that it will need to manage additional relationships with various strategic partners, suppliers and other third parties. Future growth will impose significant added responsibilities on members of management. Clene’s future financial performance and Clene’s ability to commercialize Clene’s drug candidates and to compete effectively will depend, in part, on Clene’s ability to manage any future growth effectively. To that end, Clene must be able to manage its development efforts and clinical trials effectively and hire, train and integrate additional management, administrative, and sales and marketing personnel. Clene may not be able to accomplish these tasks, and Clene’s failure to accomplish any of them could prevent it from successful growth and could harm its future business, financial condition and operating results.

Changes in government regulation or in practices relating to the pharmaceutical and biotechnology industries, including potential healthcare reform, could decrease the need for Clene’s drug candidates, and make it more difficult to obtain regulatory approvals for Clene’s drug candidates and commercialize them.

In recent years, the U.S. Congress, the President, executive branch agencies, and state legislatures have considered various types of healthcare reform to control growing healthcare costs. Similar reform movements have occurred in parts of Europe and Asia. Healthcare reform legislation could also increase the costs of drug development and commercialization that could limit the profits to be made from the development of new drugs.

This could adversely affect R&D expenditures by pharmaceutical and biotechnology companies, which could in turn decrease the business opportunities available to Clene in the U.S. and other countries. Clene is unable to predict what reform proposals will be adopted in the future, if any.

If Clene, or any CRO Clene may engage, fails to comply with environmental, health and safety laws and regulations, Clene could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of Clene’s business.

Clene and its third parties, such as Clene’s contract research organizations, or CROs, are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment, and disposal of hazardous materials and wastes. In addition, Clene’s planned construction projects can only be put into operation after certain regulatory procedures have been completed with the relevant administrative authorities in charge of environmental protection, health and safety. Clene’s operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Clene’s operations also may produce hazardous waste products at some future time. Clene generally contracts with third parties for the disposal of these materials and wastes. Clene cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from Clene’s use of hazardous materials, Clene could be held liable for any resulting damages, and any liability could exceed Clene’s resources.

Although Clene maintains workers’ compensation insurance to cover the costs and expenses Clene may incur due to injuries to its employees resulting from the use of or exposure to hazardous materials, this insurance may not provide adequate coverage against potential liabilities. Clene does not maintain insurance for environmental liability or toxic tort claims that may be asserted against it in connection with its storage, use or disposal of biological or hazardous materials.

In addition, the environmental, health and safety laws and regulations applicable to Clene and its third parties may change and impose stricter requirements in the future. As a result, Clene may be required to incur substantial costs to comply with future environmental, health and safety laws and regulations. These current or future laws and regulations may impair Clene’s research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Clene’s internal computer systems, or those used by any CRO or other contractors or consultants Clene may engage, may fail or suffer security breaches.

Despite the implementation of security measures, Clene’s internal computer systems and those of Clene’s CROs and other contractors and consultants are vulnerable to damage from computer viruses and unauthorized access. Although, to Clene’s knowledge, it has not experienced any material system failure or security breach to date, if such an event were to occur and cause interruptions in Clene’s operations, it could result in a material disruption of Clene’s development programs and business operations.

In the ordinary course of its business, Clene collects and stores sensitive data, including, among other things, legally protected patient health information, personally identifiable information about Clene’s employees, intellectual property, and proprietary business information. Clene manages and maintains its applications and data utilizing on-site systems and outsourced vendors. These applications and data encompass a wide variety of business-critical information including research and development information, commercial information, and business and financial information. Because information systems, networks and other technologies are critical to many of Clene’s operating activities, shutdowns or service disruptions at Clene or the vendors that provide information systems, networks or other services to Clene pose increasing risks. Such disruptions may be caused by events such as computer hacking, phishing attacks, ransomware, dissemination of computer viruses, worms and other destructive or disruptive software, denial of service attacks and other malicious activity, as well as power outages, natural disasters (including extreme weather), terrorist attacks or other similar events. Such events could have an adverse impact on Clene and its business, including loss of data and damage to equipment and data. In addition, system redundancy may be ineffective or inadequate, and Clene’s disaster recovery planning may not be sufficient to cover all eventualities. Significant events could result in a disruption of Clene’s operations, damage to Clene’s reputation or a loss of revenues. In addition, Clene may not have adequate insurance coverage to compensate for any losses associated with such events.

Clene could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in its information systems and networks and those of Clene’s vendors, including personal information of Clene’s employees and patients, and company and vendor confidential data. In addition, outside parties may attempt to penetrate Clene’s systems or those of Clene’s vendors or fraudulently induce Clene’s personnel or the personnel of Clene’s vendors to disclose sensitive information in order to gain access to Clene’s data and/or systems. Like other companies, Clene has on occasion experienced, and will continue to experience, threats to its data and systems, including malicious codes and viruses, phishing and other cyber-attacks. The number and complexity of these threats continue to increase over time. If a material breach of Clene’s information technology systems or those of Clene’s vendors occurs, the market perception of the effectiveness of Clene’s security measures could be harmed and Clene’s reputation and credibility could be damaged. Clene could be required to expend significant amounts of money and other resources to repair or replace information systems or networks.

In addition, Clene could be subject to regulatory actions and/or claims made by individuals and/or groups in private litigations involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices. Although Clene develops and maintains systems and controls designed to prevent these events from occurring, and Clene has a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated. Moreover, despite Clene’s efforts, the possibility of these events occurring cannot be eliminated entirely. As Clene outsources more of its information systems to vendors, engages in more electronic transactions with payers and patients and relies more on cloud-based information systems, the related security risks will increase and Clene will need to expend additional resources to protect its technology and information systems.

Clene manufactures all of its drugs itself, and intends to manufacture most, if not all, of any approved drugs itself as well.

Clene currently has manufacturing facilities in the U.S. and may build additional manufacturing facilities in other markets to expand its manufacturing capacity. These facilities may encounter unanticipated delays and expenses due to a number of factors, including regulatory requirements. If construction, regulatory evaluation, and/or approval of Clene’s new facilities is delayed, Clene may not be able to manufacture sufficient quantities of its drug candidates, if approved, which would limit Clene’s development and commercialization activities and its opportunities for growth. Cost overruns associated with constructing or maintaining Clene’s facilities could require Clene to raise additional funds from other sources.

Much of the equipment used in Clene’s manufacturing process was developed and built by Clene, and it would be difficult or even impossible to purchase or create suitable replacements in a short period of time. Further, for much of this equipment Clene has an insufficient amount of or no spare parts available. Were certain equipment, some of which is critical to the production of Clene’s drug candidates, to become damaged, lost, or otherwise unusable, Clene would have to construct new parts, which could take a considerable time, causing a temporary halt to at least a portion of its production operations in the meantime. Further, Clene is constantly seeking to further fine-tune and develop its advanced manufacturing techniques and process controls to fully utilize its facilities. Advances in manufacturing techniques may render Clene’s facilities and equipment inadequate, in which case Clene may lose competitive advantage.

To produce Clene’s drug candidates in the quantities that it believes will be required to meet anticipated market demand, if approved, Clene will need to increase or “scale up” the production process by a significant factor over current levels of production. A significant part of the scaling up process will include seeking for ways to increase the automation and semi-automation of Clene’s production process, which will require additional research and development, investment, potential new regulatory approvals, and cooperation with third-parties, some of which may not be successful. If Clene is unable or delayed in scaling up, or if the cost of doing so is not economically feasible for Clene, Clene may not be able to produce its approved drug candidates in a sufficient quantity to meet future demand.

Delays in completing and receiving regulatory approvals for Clene’s manufacturing facilities, could delay its development plans or commercialization efforts.

Clene’s manufacturing facilities will be subject to ongoing, periodic inspection by various regulatory authorities, including the U.S. Food and Drug Administration (“FDA”), European Medicines Agency (“EMA”), China’s National Medical Products Administration (“NMPA”), Health Canada, and the Australian Therapeutics Goods Administration (“TGA”) or other comparable regulatory agencies to ensure compliance with good manufacturing practices (“GMP”). Clene’s failure to follow and document its adherence to such GMP or other regulatory requirements may lead to significant delays in the availability of products for clinical or, in the future, commercial use, and may result in the termination of or a hold on a clinical trial, or may delay or prevent filing or approval of marketing applications for Clene’s drug candidates or the commercialization of its drugs, if approved. Clene also may encounter problems with the following:

•        achieving adequate or clinical-grade materials that meet FDA, EMA, NMPA, Health Canada, TGA or other comparable regulatory agency standards or specifications with consistent and acceptable production yield and costs;

•        shortages of qualified personnel, raw materials or key contractors; and

•        ongoing compliance with GMP and other requirements of the FDA, EMA, NMPA, TGA or other comparable regulatory agencies.

Failure to comply with applicable regulations could also result in sanctions being imposed on Clene, including fines, injunctions, civil penalties, a requirement to suspend or put on hold one or more of Clene’s clinical trials, failure of regulatory authorities to grant marketing approval of Clene’s drug candidates, delays, suspension or withdrawal of approvals, supply disruptions, license revocation, seizures, or recalls of Clene’s drug candidates, operating restrictions and civil or criminal prosecutions, any of which could harm Clene’s business.

Damage to, destruction of or interruption of production at Clene’s manufacturing facilities would negatively affect its business and prospects.

If Clene’s manufacturing facilities or the equipment in them is damaged or destroyed, Clene may not be able to quickly or inexpensively replace its manufacturing capacity or replace it at all. In the event of a temporary or protracted loss of the facilities or equipment, Clene might not be able to transfer manufacturing to a third party. Even if Clene could transfer manufacturing to a third party, the shift would likely be expensive and time-consuming, particularly since the new facility would need to comply with the necessary regulatory requirements and Clene would need regulatory agency approval before selling any of Clene’s future approved drugs manufactured at that new facility. Such an event could delay Clene’s clinical trials or reduce Clene’s product sales if and when Clene is able to commercialize one or more of its drug candidates. Any interruption in manufacturing operations at Clene’s manufacturing facilities could result in its inability to satisfy the demands of its clinical trials or commercialization. Any disruption that impedes Clene’s ability to manufacture its drugs in a timely manner could materially harm its business, financial condition and operating results.

Currently, Clene maintains insurance coverage against damage to its property and equipment in amounts Clene believes are reasonable. However, Clene’s insurance coverage may not reimburse Clene, or may not be sufficient to reimburse Clene, for any expenses or losses it may suffer. Clene may be unable to meet the requirements for its drugs if there were a catastrophic event or failure of its manufacturing facilities or processes.

Clene’s future success depends on its ability to retain key executives and to attract, train, retain and motivate qualified and highly skilled personnel.

Clene is highly dependent on Mark Mortenson, its co-founder and chief science officer, Rob Etherington, CEO, President and a Director, and the other principal members of its management and scientific teams. Although Clene has formal employment agreements with select executive officers, these agreements do not prevent Clene’s executives from terminating their employment with Clene at any time. Clene does not maintain “key person” insurance for any of its executives or other employees. The loss of the services of any of these persons could impede the achievement of Clene’s research, development and commercialization objectives.

Recruiting and retaining qualified scientific, technical, clinical, and manufacturing and sales and marketing personnel in the future will also be critical to Clene’s success. In addition, Clene relies on consultants and advisors, including scientific and clinical advisors, to assist Clene in formulating Clene’s discovery, clinical development, operations, and commercialization strategy. The loss of the services of Clene’s executive officers or other key employees and consultants could impede the achievement of Clene’s research, development, and commercialization objectives and seriously harm Clene’s ability to successfully implement its business strategy.

Clene benefits from certain tax and financial incentives, the expiration of or changes to which could adversely affect Clene’s profitability.

Clene benefits from certain tax treatments, as well as tax concessions in relation to Clene’s research and development costs. Clene receives income treatment through the R&D tax credits in the United States, Australia, and the state of Maryland. In the United States, the R&D credit is used to offset federal employment taxes on Clene’s United States payroll. In Australia, Clene receives a refundable tax offset of 43.5% of R&D deductions. In Maryland, Clene receives the Basic Research and Development Tax credit of 3% of eligible R&D expenses. Clene also receives a tax exemption in Maryland for state personal property and sales tax, as well as the Maryland enterprise zone hiring and job creation tax credits.

In addition, current or future tax treatments, tax concessions, tax allowances and financial incentives applicable to Clene may be changed, terminated, or otherwise become unavailable due to many factors, including changes in government policy or administrative decisions by the relevant government authorities. Due to potential changes in government policies, Clene cannot be certain of the level of government grants Clene will receive in the future. Clene’s post-tax profitability and cash flows may be adversely affected as a result of one or more of these or other factors.

Clene’s financial position and operations may be adversely affected by the COVID-19 outbreak.

An outbreak of the respiratory illness COVID-19 caused by a strain of novel coronavirus, SARS-Cov-2, has spread worldwide, causing many governments to implement measures to slow the spread of the outbreak through quarantines, strict travel restrictions, heightened border scrutiny, and other measures. The outbreak and government measures taken in response have had a significant impact, both direct and indirect, on businesses and commerce. The future progression of the outbreak and its effects on Clene’s business and operations are uncertain.

Clene and its clinical research organizations (“CROs”) and clinical sites may experience disruptions in supply of drug candidates and/or procuring items that are essential for its research and development activities, including raw materials used in the manufacturing of its drug candidates, medical and laboratory supplies used in its clinical trials or preclinical studies or animals that are used for preclinical testing, in each case, for which there may be shortages because of ongoing efforts to address the outbreak. Any disruption in the supply chain from the recent COVID-19 outbreak, or any potential future outbreak could have a material adverse impact on our clinical trial plans and business operations.

Additionally, Clene has enrolled, and will seek to enroll, patients in its clinical trials at sites located in many areas affected by COVID-19 and, as a result, its trials may be impacted. In addition, even if sites are actively recruiting, Clene may face difficulties recruiting or retaining patients in its ongoing and planned clinical trials if patients are affected by the virus or are fearful of visiting or traveling to clinical trial sites because of the outbreak. Prolonged delays or closure to enrollment in Clene’s trials or patient discontinuations could have a material adverse impact on its clinical trial plans and timelines.

The response to the COVID-19 pandemic may redirect resources with respect to regulatory and intellectual property matters in a way that would adversely impact Clene’s ability to progress regulatory approvals and protect its intellectual property. In addition, Clene may face impediments to regulatory meetings and approvals due to measures intended to limit in-person interactions.

Any negative impact that the COVID-19 outbreak has on the ability of Clene’s suppliers to provide materials for Clene’s drug candidates or on recruiting or retaining patients in its clinical trials or its ability to collect patient data could cause costly delays to clinical trial activities, which could adversely affect Clene’s ability to obtain regulatory approval for and to commercialize its drug candidates, increase its operating expenses, and have a material adverse effect on Clene’s financial results.

The COVID-19 pandemic has significantly impacted economies worldwide, which could result in adverse effects on Clene’s business and operations. Clene cannot be certain what the overall impact of the COVID-19 pandemic will be on its business. It has the potential to adversely affect Clene’s business, financial condition, results of operations, and prospects.

Clene will incur increased costs as a result of operating as a public company, and its management will be required to devote substantial time to new compliance initiatives.

As a public company, and particularly after it is no longer an emerging growth company, Clene will incur significant legal, accounting and other expenses that it did not incur as a private company. In addition, the Sarbanes-Oxley Act of 2002 and rules subsequently implemented by the SEC and the Nasdaq Global Market have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Clene’s management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase Clene’s legal and financial compliance costs and will make some activities more time-consuming and costly. For example, Clene expects that these rules and regulations may make it more difficult and more expensive for Clene to obtain director and officer liability insurance.

Clene has identified material weaknesses in its internal control over financial reporting. If Clene fails to remediate the material weakness, or if it experiences additional material weaknesses in the future or otherwise fails to maintain an effective system of internal controls in the future, it may not be able to accurately or timely report its financial condition or results of operations, which may adversely affect investor confidence in Clene and, as a result, the value of its common stock.

Effective internal control over financial reporting is necessary for Clene to provide reliable financial reports and, together with adequate disclosure controls and procedures, is designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause Clene to fail to meet its reporting obligations. In addition, any testing by Clene, as and when required, conducted in connection with Section 404 of the Sarbanes-Oxley Act, or Section 404, or any subsequent testing by Clene’s independent registered public accounting firm, as and when required, may reveal deficiencies in Clene’s internal control over financial reporting that are deemed to be significant deficiencies or material weaknesses or that may require prospective or retroactive changes to its financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in Clene’s reported financial information, which could have a negative effect on the trading price of its common stock.

In connection with the audit of Clene’s financial statements as of and for the year ended December 31, 2019, 2018 and 2017 Clene’s management identified material weaknesses in its internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. The material weaknesses identified relate to the fact that Clene did not design and maintain an effective control environment commensurate with its financial reporting requirements, including (a) lack of a sufficient number of trained professionals with an appropriate level of accounting knowledge, training and experience to appropriately analyze, record and disclose accounting matters timely and accurately, and (b) lack of structures, reporting lines and appropriate authorities and responsibilities to achieve financial reporting objectives. This deficiency in Clene’s control environment contributed to the following additional deficiencies in Clene’s internal control over financial reporting:

•        Clene did not design and maintain formal accounting policies, procedures and controls to achieve complete, accurate and timely financial accounting, reporting and disclosures, including controls over the preparation and review of account reconciliations and journal entries;

•        Clene did not design and maintain effective controls over segregation of duties related to manual journal entries. Specifically, certain personnel have the ability to both prepare and post manual journal entries without an independent review by someone without the ability to prepare and post manual journal entries;

•        Clene did not design and maintain formal accounting policies, processes and controls to analyze, account for and disclose complex transactions. Specifically, Clene did not design and maintain controls to analyze, account for and disclose warrants to purchase preferred stock and convertible promissory notes with embedded derivatives, including ensuring complete and accurate data was used in the valuations; and

•        Clene did not design and maintain effective controls over certain information technology general controls for IT systems that are relevant to the preparation of the financial statements. Specifically, Clene did not design and maintain: (a) user access controls to ensure appropriate segregation of duties and that adequately restrict user and privileged access to financial applications, programs, and data to appropriate personnel of Clene, (b) program change management controls to ensure that IT program and data changes affecting financial IT applications and underlying accounting records are identified, tested, authorized and implemented appropriately, (c) computer operations controls to ensure that data backups are authorized and monitored, and (d) testing and approval controls for program development to ensure that new software development is aligned with business and IT requirements.

The control deficiencies described above resulted in the misstatement of Clene’s redeemable convertible preferred stock warrant liability, accrued liabilities, general and administrative expenses, Australian research and development credit, and amounts and classification within our statement of cash flows and related financial disclosures, which led to a restatement of our 2017 financial statements. Additionally, each of the control deficiencies described above could result in a misstatement of one or more account balances or disclosures that would result in a material misstatement to the annual or interim consolidated financial statements that would not be prevented or detected. Accordingly, Clene’s management has determined that each of the control deficiencies described above constitute a material weakness.

Although Clene has begun to implement measures to address the material weaknesses, the implementation of these measures may not fully address the material weaknesses and deficiencies in its internal control over financial reporting, and it cannot conclude that it has been fully remedied. Further, in the future Clene may determine that it has additional material weaknesses. Clene’s failure to remediate the material weaknesses or failure to identify and address any other material weaknesses or control deficiencies could result in inaccuracies in its financial statements and could also impair its ability to comply with applicable financial reporting requirements and related regulatory filings on a timely basis, which could cause investors to lose confidence in its reported financial information, which may result in volatility in and a decline in the market price of PubCo securities.

Pursuant to Section 404, after the Business Combination, Clene, as the surviving entity, will be required to furnish a report by its management on the effectiveness of Clene’s internal control over financial reporting, including an attestation report on internal control over financial reporting issued by its independent registered public accounting firm. However, while Clene remains an emerging growth company, Clene will not be required to include an attestation report on internal control over financial reporting issued by its independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, Clene will be engaged in a process to document and evaluate its internal control over financial reporting, which is both costly and challenging. In this regard, Clene will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite its efforts, there is a risk that neither Clene nor its independent registered public accounting firm will be able to conclude within the prescribed timeframe that Clene’s internal control over financial reporting is effective as required by Section 404. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of Clene’s financial statements.

Clene’s drug candidates are the first metallic nanocrystals in development for potential direct therapeutic effect, and, if approved, would constitute a new therapeutic class, and there is significant uncertainty associated with Clene’s drug candidates and their viability as a commercial product.

Metallic nanocrystal therapeutic candidates, such as Clene’s lead product, CNM-Au8, are considered emerging and novel investigational products for the potential treatment of neurological diseases and other disorders. Clene is developing CNM-Au8 for the treatment of neurological disorders such as MS, ALS, and PD through remyelination and/or neuroprotection mechanisms related to catalysis of certain biological reactions. There are currently no approved remyelination therapies and the evidence for an effect of neuroprotection treatments on these indications is thus far limited. Since there is limited clinical trial data and precedent for the development of nanocrystal therapies that promote

remyelination and neuroprotection to treat these indications, there is a substantial risk that the design or outcomes of Clene’s clinical trials will not be satisfactory to support regulatory approval. In addition, there are generally limited or no regulatory precedents concerning metallic nanocrystal drug marketing authorization, or a regulatory framework to appropriately differentiate approved nanocrystal product labeling. Clene’s lead metallic nanocrystal drug candidate, CNM-Au8, contains nanocrystals made entirely of high purity gold alone. It is unclear how regulatory authorities will identify or classify the active moiety of CNM-Au8, including whether it is classified as a new chemical entity or comparable designation. The inability to obtain sufficiently differentiated active moiety classification from gold generically could potential limit CNM-Au8 and Clene’s drug candidates from ever achieving profitability.

Moreover, the mechanisms of action for nanocrystal therapies are not thoroughly understood, and adverse events or side effects may be observed in clinical studies and reported by medical practitioners in connection with patient usage in the future. If those adverse events or side effects prove significant, they may hamper the ability of Clene’s drug candidates to pass through clinical trials or they may outweigh the benefits that patients derive from using Clene’s drug candidates, both of which could potentially prevent Clene’s drug candidates from ever achieving profitability.

Clene’s drug candidates are not metabolized and may accumulate in the body following long-term usage, making the long-term effects of taking Clene’s drug candidates for substantial periods of time uncertain. While all of the current toxicology studies of Clene’s drug candidates have resulted in no-adverse-effect levels as the date of this prospectus, Clene has not completed reproductive or carcinogenicity studies, which Clene is required to complete in the future. Any negative results from these studies could materially and adversely affect Clene’s business, results of operations, financial condition and prospects.

Moreover, the results of clinical trials for nanocrystal therapies could reveal a high and unacceptable severity and prevalence of undesirable side effects. Any such side effects could adversely impact Clene’s ability to obtain regulatory approvals. For example, the FDA, NMPA, TGA, EMA or other comparable authorities could order Clene to suspend or terminate its studies or to cease further clinical development of or deny approval of Clene’s drug candidates. In addition, any adverse drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete trials or may result in potential product liability claims. Any of these occurrences may harm Clene’s business, financial condition and prospects significantly.

Clene has not previously obtained any regulatory approval for a drug candidate and Clene may be unable to obtain, or may be delayed in obtaining regulatory approval for any of Clene’s drug candidates.

Clene’s business is substantially dependent on Clene’s ability to complete the development of, obtain regulatory approval for and successfully commercialize drug candidates in a timely manner. Clene cannot commercialize drug candidates without obtaining regulatory approval to market each drug from the FDA, NMPA, Health Canada, TGA, EMA and other comparable regulatory authorities. The time required to obtain approval from regulatory authorities is unpredictable but typically takes years following the commencement of pre-clinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a drug candidate’s clinical development and may vary among jurisdictions.

Clene’s drug candidates could fail to receive regulatory approval for many reasons, including:

•        failure to begin or complete clinical trials due to disagreements with regulatory authorities;

•        failure to begin or complete clinical trials due to inability to recruit sufficient numbers of study participants;

•        failure to demonstrate that a drug candidate is safe and effective or is safe, pure and potent for its proposed indication;

•        failure of clinical trial results to meet the level of statistical significance required for approval;

•        data integrity issues related to Clene’s clinical trials;

•        disagreement with Clene’s interpretation of data from preclinical studies or clinical trials;

•        changes in approval policies or regulations that render Clene’s preclinical and clinical data insufficient for approval or require Clene to amend Clene’s clinical trial protocols;

•        regulatory requests for additional analysis, reports, data, nonclinical studies and clinical trials, or questions regarding interpretations of data and results and the emergence of new information regarding Clene’s drug candidates;

•        insufficient data from the clinical trials of Clene’s drug candidates to obtain regulatory approval;

•        failure by Clene or its investigators to conduct a clinical trial in accordance with regulatory requirements or Clene’s clinical trial protocols; and

•        clinical sites, investigators or other participants in Clene’s clinical trials deviating from a trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial.

The FDA, NMPA, TGA, EMA or a comparable regulatory authority may require more information, including additional preclinical or clinical data, to support approval, which may delay or prevent approval and Clene’s commercialization plans, or Clene may decide to abandon the development program.

New or unexpected adverse events, or changes in regulatory requirements and guidance may also occur, and Clene may need to amend clinical trial protocols submitted to applicable regulatory authorities to reflect these changes. Amendments may require Clene to resubmit clinical trial protocols to institutional review boards (“IRBs”) or human research ethics committees (“HREC”) for re-examination, which may impact the costs, timing or successful completion of a clinical trial.

If Clene experiences delays in the completion of, or the termination of, a clinical trial of any of Clene’s drug candidates, the commercial prospects of that drug candidate will be harmed, and Clene’s ability to generate product sales revenues from any of those drug candidates will be delayed. In addition, any delays in completing Clene’s clinical trials will increase Clene’s costs, slow down Clene’s drug candidate development and approval process, and jeopardize Clene’s ability to commence product sales and generate related revenues for that product. Any of these occurrences may harm Clene’s business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of Clene’s drug candidates.

Clene may not be able to successfully identify, discover, develop or in-license new drug candidates.

Clene cannot guarantee that Clene will be successful in identifying potential drug candidates for clinical development for a number of reasons. For example, Clene’s research methodology may be unsuccessful in identifying potential drug candidates or those Clene identify may be shown to have harmful side effects or other characteristics that make them unmarketable or unlikely to receive regulatory approval. Clene has devoted significant resources to discovery efforts through Clene’s proprietary electro-crystal-chemistry drug development platform, and Clene cannot guarantee that Clene will be successful in identifying additional potential drug candidates, or that Clene will be able to successfully identify and in-license new drug candidates with high potential from other parties.

Research programs to pursue the development of Clene’s drug candidates for additional indications and to identify new drug candidates and drug targets require substantial technical, financial, and human resources. Clene’s research programs may initially show promise in identifying potential indications and/or drug candidates, yet fail to yield results for clinical development for a number of reasons, including:

•        the research methodology used may not be successful in identifying potential indications, and/or drug candidates;

•        potential drug candidates may, after further study, be shown to have harmful adverse effects or other characteristics that indicate they are unlikely to be effective drugs; or

•        it may take greater human and financial resources to identify additional therapeutic opportunities for Clene’s drug candidates or to develop suitable potential drug candidates through internal research programs than Clene will possess, thereby limiting Clene’s ability to diversify and expand Clene’s drug portfolio.

Accordingly, there is no assurance that Clene will ever be able to identify additional therapeutic opportunities for Clene’s drug candidates or to develop suitable potential drug candidates through internal research programs, which could materially and adversely affect Clene’s future growth and prospects. Clene may focus Clene’s efforts and resources on potential drug candidates or other potential programs that ultimately prove to be unsuccessful.

Pre-clinical and clinical development of drug candidates involves a lengthy and expensive process with an uncertain outcome, and Clene is unable to predict if or when Clene will successfully develop or commercialize any of Clene’s drug candidates.

There is a risk of failure for each of Clene’s drug candidates. It is difficult to predict when or if any of Clene’s drug candidates will prove effective and safe in humans or will receive regulatory approval. Before obtaining regulatory approval from regulatory authorities for the sale of any of Clene’s drug candidates, Clene must complete pre-clinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of Clene’s drug candidates in humans. Clene’s internal discovery programs for some of Clene’s drug candidates are at an early stage of development and will require significant investment and regulatory approvals prior to commercialization. Clene is not permitted to market or promote any of Clene’s drug candidates until Clene receives regulatory approval from the FDA, NMPA, TGA, EMA or comparable regulatory authorities, and Clene may never receive such regulatory approval for any of Clene’s drug candidates.

Clene could encounter regulatory delays if a clinical trial is suspended or terminated by Clene or, as applicable, by the institutional review boards or the ethics committees of the institutions in which such trials are being conducted, by the data safety monitoring board, which is an independent group of experts that is formed to monitor clinical trials while ongoing, or by the FDA, NMPA, TGA, EMA or other regulatory authorities. Such authorities may impose a suspension or termination due to a number of factors, including: a failure to conduct the clinical trial in accordance with regulatory requirements or the applicable clinical protocols, inspection of the clinical trial operations or trial site by the FDA, NMPA, TGA, EMA or other regulatory authorities that results in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions, or lack of adequate funding to continue the clinical trial. Many of the factors that cause a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of Clene’s drug candidates. Further, the FDA, NMPA, TGA, EMA or other regulatory authorities may disagree with Clene’s clinical trial design or Clene’s interpretation of data from clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for Clene’s clinical trials.

Pre-clinical studies and clinical trials are expensive, difficult to design and implement, and can take many years to complete. Moreover, pre-clinical and clinical data are often susceptible to varying interpretations and analysis, and many companies that have believed their drug candidates performed satisfactorily in pre-clinical studies and clinical trials have nonetheless failed to obtain regulatory approval of their drug candidates. Future clinical trials of Clene’s drug candidates may not be successful.

Commencement of clinical trials is subject to finalizing the trial design based on ongoing discussions with the FDA, NMPA, TGA, EMA and/or other regulatory authorities. The FDA, NMPA, TGA, EMA and other regulatory authorities could change their position on the acceptability of trial designs or clinical endpoints, which could require Clene to complete additional clinical trials or impose approval conditions that Clene does not currently expect. Successful completion of Clene’s clinical trials is a prerequisite to submitting an NDA (or analogous filing) to the FDA, NMPA, TGA, EMA and/or other regulatory authorities for each drug candidate and, consequently, the ultimate approval and commercial marketing of Clene’s drug candidates. Clene does not know whether the clinical trials for Clene’s drug candidates will be completed on schedule, if at all.

Results of earlier clinical trials may not be predictive of results of later-stage clinical trials.

The results of pre-clinical studies and early clinical trials of Clene’s drug candidates may not be predictive of the results of later-stage clinical trials. Drug candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through pre-clinical studies and initial clinical trials. Future clinical trial results may not be favorable for these and other reasons.

In some cases, there can be significant variability in the safety and/or efficacy results between different trials of the same drug candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, including genetic differences, patient adherence to the dosing regimen, and the rate of dropout among clinical trial participants. As drug candidates are developed through pre-clinical to early- to late-stage clinical trials towards approval and commercialization, it is customary that various aspects of the development program, such as manufacturing and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these

intended objectives. In the case of any trials Clene conducts, results may differ from earlier trials due to the larger number of clinical trial sites and additional countries and languages involved in such trials. Any of these changes could make the results of planned clinical trials or other future clinical trials Clene may initiate less predictable and could cause Clene’s drug candidates to perform differently, which could delay completion of clinical trials, delay approval of Clene’s drug candidates, and/or jeopardize Clene’s ability to commence commercialization of Clene’s drug candidates.

Clinical trials of Clene’s drug candidates may fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, or may not otherwise produce positive results, which may cause Clene to incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of Clene’s drug candidates.

Before obtaining regulatory approval for the sale of Clene’s drug candidates, Clene must conduct extensive clinical trials to demonstrate the safety and efficacy of Clene’s drug candidates in humans. Clene may experience numerous unexpected events during, or as a result of, clinical trials that could delay or prevent Clene from receiving regulatory approval or commercializing Clene’s drug candidates, including:

•        regulators, IRBs, or HRECs may not authorize Clene or Clene’s investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

•        Clene’s inability to reach agreements on acceptable terms with prospective clinical research organizations (“CROs”), clinical trial vendors, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•        manufacturing issues, including problems with manufacturing, supply quality, compliance with GMP, or obtaining from third parties sufficient quantities of a drug candidate for use in a clinical trial;

•        clinical trials of Clene’s drug candidates may produce negative or inconclusive results, and Clene may decide, or regulators may require Clene, to conduct additional clinical trials or abandon drug development programs;

•        the number of patients required for clinical trials of Clene’s drug candidates may be larger than Clene anticipate;

•        Clene’s third-party contractors, including clinical investigators, may fail to comply with regulatory requirements or meet their contractual obligations to Clene in a timely manner, or at all;

•        Clene may not investigate, may not be able to license, or may be unable to properly conduct companion diagnostic tests to identify patients who are likely to benefit from treatment with Clene’s drug candidates;

•        Clene might have to suspend or terminate clinical trials of Clene’s drug candidates for various reasons, including a finding of a lack of clinical response or other unexpected characteristics or a finding that participants are being exposed to unacceptable health risks;

•        regulators, IRBs or HRECs may require that Clene or Clene’s investigators suspend or terminate clinical research or not rely on the results of clinical research for various reasons, including non-compliance with regulatory requirements;

•        the cost of clinical trials of Clene’s drug candidates may be greater than Clene anticipates;

•        the supply or quality of Clene’s drug candidates or other materials necessary to conduct clinical trials of Clene’s drug candidates may be insufficient or inadequate; and

•        Clene’s drug candidates may have undesirable side effects or unexpected characteristics, causing Clene or Clene’s investigators, regulators, institutional review boards or ethics committees to suspend or terminate the clinical trials, or reports may arise from pre-clinical studies or clinical trials of other therapies that raise safety or efficacy concerns about Clene’s drug candidates.

If Clene is required to conduct additional clinical trials or other testing of Clene’s drug candidates beyond those that Clene currently contemplates, if Clene is unable to successfully complete clinical trials of Clene’s drug candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if they raise safety

concerns, Clene may (i) be delayed in obtaining regulatory approval for its drug candidates; (ii) not obtain regulatory approval at all; (iii) obtain approval for indications that are not as broad as intended; (iv) have the drug removed from the market after obtaining regulatory approval; (v) be subject to additional post-marketing testing requirements; (vi) be subject to restrictions on how the drug is distributed or used; or (vii) be unable to obtain reimbursement for use of the drug.

Significant clinical trial delays may also increase Clene’s development costs and could shorten any periods during which Clene has the exclusive right to commercialize Clene’s drug candidates or allow Clene’s competitors to bring drugs to market before Clene does. This could impair Clene’s ability to commercialize Clene’s drug candidates and may harm Clene’s business and results of operations.

If Clene encounters difficulties enrolling patients in clinical trials, clinical trials of Clene’s drug candidates may be delayed or otherwise adversely affected.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on Clene’s ability to enroll a sufficient number of patients who remain in the trial until its conclusion. Clene may experience difficulties in patient enrollment in its clinical trials for a variety of reasons, including:

•        the size and nature of the patient population;

•        the design of the trial, including the patient eligibility criteria defined in the protocol;

•        the size of the study population required for analysis of the trial’s primary endpoints;

•        the proximity of patients to trial sites;

•        Clene’s ability to recruit clinical trial investigators with the appropriate competencies and experience;

•        competing clinical trials for similar therapies or other new therapeutics;

•        clinicians’ and patients’ perceptions as to the potential advantages and side effects of the drug candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications Clene is investigating;

•        Clene’s ability to obtain and maintain patient consents;

•        the risk that patients enrolled in clinical trials will not complete a clinical trial; and

•        the availability of approved therapies that are similar in mechanism to Clene’s drug candidates.

Failure of Clene’s timely completion of clinical trials would delay the approval and commercialization of Clene’s drug candidates, impair the commercial performance of its drug candidates, and consequently harm Clene’s business and results of operations.

If Clene is not able to obtain, or experiences delays in obtaining, required regulatory approvals, Clene will not be able to commercialize Clene’s drug candidates, and Clene’s ability to generate revenue will be materially impaired.

Before obtaining regulatory approvals for the commercial sale of any drug candidate for a target indication, Clene must demonstrate in preclinical studies and well-controlled clinical trials, and, with respect to approval in the U.S., to the satisfaction of the FDA, that the drug candidate is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls are adequate. In addition to preclinical and clinical data, the New Drug Application (“NDA”) must include significant information regarding the chemistry, manufacturing, and controls for the drug candidate. Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and approval may not be obtained. After Clene submits an NDA to the FDA, the FDA decides whether to accept or reject the submission for filing. Clene cannot be certain that any submissions will be accepted for filing and review by the FDA.

Clene has not yet demonstrated an ability to file for or receive regulatory approval for its drug candidates. For example, Clene does not have experience in preparing the required materials for regulatory submission or navigating the regulatory approval process. As a result, Clene’s ability to successfully submit an NDA and obtain regulatory approval for its drug candidates may involve more inherent risk, take longer, and cost more than it would if Clene were a company with experience in obtaining regulatory approvals.

Regulatory authorities outside of the U.S., such as the NMPA and EMA, also have requirements for approval of drugs for commercial sale with which Clene must comply prior to marketing in those areas. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of Clene’s drug candidates. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and obtaining regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation, and additional administrative review periods. Seeking non-U.S. regulatory approval could require additional nonclinical studies or clinical trials, which could be costly and time consuming. The non-U.S. regulatory approval process may include all of the risks associated with obtaining FDA approval. For all of these reasons, Clene may not obtain non-U.S. regulatory approvals on a timely basis, if at all.

The process to develop, obtain regulatory approval for and commercialize drug candidates is long, complex and costly both inside and outside the United States, and approval is never guaranteed. Even if Clene’s drug candidates were to successfully obtain approval from the regulatory authorities, any approval might significantly limit the approved indications for use, or require that precautions, contraindications or warnings be included on the product labeling, or require expensive and time-consuming post-approval clinical trials or surveillance as conditions of approval. Following any approval for commercial sale of Clene’s drug candidates, certain changes to the drug, such as changes in manufacturing processes and additional labeling claims, may be subject to additional review and approval by the FDA, NMPA, TGA, EMA and comparable regulatory authorities. Also, regulatory approval for any of Clene’s drug candidates may be withdrawn. If Clene is unable to obtain regulatory approval for its drug candidates in one or more jurisdictions, or any approval contains significant limitations, Clene’s target market will be reduced and Clene’s ability to realize the full market potential of its drug candidates will be harmed. Furthermore, Clene may not be able to obtain sufficient funding or generate sufficient revenue and cash flows to continue the development of any other drug candidate in the future.

Favorable designations may not be granted, or if granted, be withdrawn later, for any of Clene’s drug candidates, and may not lead to faster development or regulatory review or approval.

Clene does not currently have Fast Track Designation or, Breakthrough Therapy Designation, but may seek one or more of such designations in the future.

If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical need for that condition, the drug sponsor may apply for FDA Fast Track Designation. The FDA has broad discretion whether or not to grant this designation. Even if Clene believes a particular drug candidate is eligible for this designation, Clene cannot assure you that the FDA would decide to grant it. Even if Clene does receive Fast Track Designation, Clene may not experience a development, review or approval process faster than conventional FDA procedures. The FDA may withdraw a Fast Track Designation if it believes that the designation is no longer supported by data from Clene’s clinical development program. Many drugs that have received Fast Track Designation have failed to obtain approval from the FDA.

A Breakthrough Therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs that have been designated as Breakthrough Therapies, interaction and communication between the FDA and the sponsor can help to identify the most efficient path for development.

Designation as a Breakthrough Therapy is within the discretion of the FDA. Accordingly, even if Clene believes, after completing early clinical trials, that one of Clene’s drug candidates meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead decide not to grant that designation. In any event, the receipt of a Breakthrough Therapy Designation for a drug candidate may not result in a faster development, review or approval process compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of Clene’s drug candidates qualify as Breakthrough Therapies, the FDA may later decide that such drug candidates no longer meet the conditions for qualification.

The U.S. FDA granted orphan drug development status to Clene’s lead drug candidate, CNM-Au8, for the treatment of ALS in May 2019. Regulatory authorities in some jurisdictions, including the U.S. and the European Union, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act,

the FDA may designate a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a disease with a patient population of fewer than 200,000 individuals in the U.S., or that affects more than 200,000 individuals in the U.S. and for which there is no reasonable expectation that costs of research and development of the product for the indication can be recovered by sales of the product in the U.S. Generally, if a drug with an orphan drug designation subsequently receives the first regulatory approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the FDA or EMA, from approving another marketing application for the same drug for the same indication during the period of exclusivity. The applicable period is seven years in the United States and 10 years in the European Union. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

Although Clene has obtained orphan drug exclusivity for CNM-Au8 for the treatment of ALS in the U.S., and may obtain the same exclusivity for other drug candidates or indication, that exclusivity may not effectively protect the drug candidate from competition because different drugs can be approved for the same condition and the same drugs can be approved for a different condition but used off-label for any orphan indication Clene may obtain. Even after an orphan drug is approved, the FDA can subsequently approve a drug that is otherwise the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective, or makes a major contribution to patient care.

Any of Clene’s future approved drug candidates will be subject to ongoing or additional regulatory obligations and continued regulatory review, which may result in significant additional expense and Clene may be subject to penalties if Clene fails to comply with regulatory requirements or experiences unanticipated problems with Clene’s drug candidates.

Any of Clene’s future approved drug candidates will be subject to ongoing or additional regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the U.S. and requirements of comparable regulatory authorities in European Union, China, Australia and other markets.

Manufacturers and manufacturers’ facilities are required to comply with extensive FDA, NMPA, TGA, EMA and other comparable regulatory authority requirements ensuring that quality control and manufacturing procedures conform to GMP. As such, Clene will be subject to continual review and inspections to assess compliance with GMP and adherence to commitments made in any NDA, other marketing application, and previous responses to any inspection observations if Clene were to build manufacturing facilities in the future. Accordingly, Clene and others with whom Clene work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, and quality control.

Any approvals that Clene receives for Clene’s drug candidates may be subject to limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, which could adversely affect the drug’s commercial potential or contain requirements for potentially costly post-marketing testing and surveillance to monitor the safety and efficacy of the drug candidate. The FDA, NMPA, TGA, EMA or a comparable regulatory authority may also require a risk evaluation mitigation strategy program as a condition of approval of Clene’s drug candidates or following approval. In addition, if the FDA, NMPA, TGA, EMA or a comparable regulatory authority approves Clene’s drug candidates, Clene will have to comply with requirements, including, for example, submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with GMP and good clinical practice GCP, for any clinical trials that Clene conducts post-approval.

The FDA and other regulatory authorities strictly regulate the marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for their approved indications and for use in accordance with the provisions of the approved label. The FDA, NMPA, TGA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

Even if Clene is able to commercialize any approved drug candidates, the drugs may become subject to national or other third-party reimbursement practices or unfavorable pricing regulations, which could harm Clene’s business.

The regulations that govern regulatory approvals, pricing and reimbursement for new therapeutic products vary widely from country to country. In Europe, Canada, Australia, China, and some markets outside China, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, Clene might obtain regulatory approval for a drug in a particular country, but then be subject to price regulations that delay Clene’s commercial launch of the drug and negatively impact its revenues.

Clene’s ability to commercialize any approved drug candidates successfully also will depend in part on the extent to which reimbursement for these drugs and related treatments will be available from government health administration authorities, private health insurers, and other organizations.

A primary trend in the global healthcare industry is cost containment. Government authorities and these third-party payers have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

In the U.S., no uniform policy of coverage and reimbursement for drugs exists among third-party payers. As a result, obtaining coverage and reimbursement approval of a drug from a government or other third-party payer is a time-consuming and costly process that could require Clene to provide to each payer supporting scientific, clinical, and cost-effectiveness data for the use of Clene’s future approved drugs on a payer-by-payer basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if Clene obtains coverage for a given drug, the resulting reimbursement rates might not be adequate for Clene to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party payers may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of Clene’s future approved drug candidates. Patients are unlikely to use any of Clene’s future approved drugs unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of the drug. Because some of Clene’s drug candidates may have a higher cost of goods than conventional small molecule therapies, and may require long-term follow-up evaluations, the risk that coverage and reimbursement rates may be inadequate for Clene to achieve profitability may be greater.

Increasingly, third-party payers are requiring that companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Clene cannot assure that reimbursement will be available for any approved drug candidate that Clene commercializes and, if reimbursement is available, what the level of reimbursement will be. Reimbursement may impact the demand for, or the price of, any approved drug candidate that Clene commercializes. If reimbursement is not available or is available only to limited levels, Clene may not be able to successfully commercialize any drug candidate that it successfully develops.

There may be significant delays in obtaining reimbursement for approved drug candidates, and coverage may be more limited than the purposes for which the drug candidates are approved by the FDA, NMPA, TGA, EMA or other comparable regulatory authorities. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers Clene’s costs, including research, development, manufacture, sale and distribution. Interim payments for new drugs, if applicable, may also not be sufficient to cover Clene’s costs and may not be made permanent. Payment rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on payments allowed for lower cost drugs that are already reimbursed, and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payers and by any future weakening of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the U.S. Clene’s inability to promptly obtain coverage and profitable payment rates from both government-funded and private payers for any future approved drug candidates and any new drugs that Clene develops could have a material adverse effect on Clene’s business, operating results and overall financial condition.

Clene intends to seek approval alone or in conjunction with partners to market Clene’s drug candidates in the U.S., China, European Union, Australia, Canada, and other jurisdictions. In China, Australia, Canada, and the European Union, the pricing of drugs is subject to governmental control, and it can take considerable time after obtaining marketing regulatory approval to get the future approved drugs reimbursed. Market acceptance and sales of any of Clene’s future approved drug candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payers for drugs and may be affected by existing and future healthcare reform measures.

Clene’s drug candidates approved in the future may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success and the market opportunity for the drug candidate may be smaller than Clene estimates.

Clene’s future approved drug candidates may fail to gain sufficient market acceptance by physicians, patients, third-party payers and others in the medical community. For example, current multiple sclerosis treatments are well established in the medical community, and physicians may continue to rely on these treatments to the exclusion of Clene’s drug candidates that are in clinical trials for the same or similar indications. In addition, physicians, patients, and third-party payers may prefer other novel products to Clene’s. If Clene’s drug candidates do not achieve an adequate level of acceptance, Clene may not generate significant product sales revenues and Clene may not become profitable. The degree of market acceptance of Clene’s drug candidates, if approved for commercial sale, will depend on a number of factors, including:

•        the clinical indications for which Clene’s drug candidates are approved;

•        whether physicians, hospitals, treatment centers and patients consider Clene’s drug candidates as a safe and effective treatment;

•        the potential and perceived advantages of Clene’s drug candidates over alternative treatments;

•        the prevalence and severity of any side effects;

•        product labeling or product insert requirements of regulatory authorities;

•        limitations or warnings contained in the labeling approved by regulatory authorities;

•        the timing of market introduction of Clene’s drug candidates as well as competitive drugs;

•        the cost of treatment in relation to alternative treatments;

•        the availability of adequate coverage, reimbursement and pricing by third-party payers and government authorities;

•        the willingness of patients to pay out-of-pocket in the absence of coverage and reimbursement by third-party payers and government authorities; and

•        the effectiveness of Clene’s sales and marketing efforts.

If any approved drug candidates that Clene commercializes fail to achieve market acceptance among physicians, patients, hospitals, treatment centers or others in the medical community, Clene will not be able to generate significant revenue. Even if Clene’s future approved drug candidates achieve market acceptance, Clene may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than Clene’s drug candidates, are more cost-effective or render Clene’s drug candidates obsolete.

If Clene’s drug candidates cause, or are perceived to cause, undesirable side effects, it can result in delays or failure to receive regulatory approval or limitations on the commercial profile of an approved label.

Undesirable side effects caused by Clene’s drug candidates could cause either Clene or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, NMPA, TGA, EMA or other regulatory authorities. If the results of the ongoing clinical trials of Clene’s drug candidates reveal a high and unacceptable severity and prevalence of undesirable side effects, the clinical trials of Clene’s drug candidates could be suspended or terminated and the FDA, NMPA, TGA, EMA or comparable regulatory authorities could order Clene to cease further development of or deny approval of Clene’s drug candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the clinical trial or result in potential product liability claims. Any of these occurrences may harm Clene’s business, financial condition and prospects significantly.

Clinical trials assess a sample of the potential patient population. With a limited number of patients and a limited duration of exposure, rare and severe side effects of Clene’s drug candidates may only be uncovered with a significantly larger number of patients exposed to the drug candidates. If Clene’s drug candidates receive regulatory approval and Clene or others discover undesirable side effects caused by such drugs (or any other similar drugs) or that such drug candidates are less effective than previously believed, a number of potentially significant negative consequences could result, including:

•        the FDA, NMPA, TGA, EMA or other comparable regulatory authorities may withdraw or limit their approval of such drug candidates;

•        the FDA, NMPA, TGA, EMA or other comparable regulatory authorities may require the addition of labeling statements, such as a “boxed” warning or a contra-indication;

•        Clene may be required to create a medication guide outlining the risks of such side effects for distribution to patients;

•        Clene may be required to change the way such drug candidates are distributed or administered, conduct additional clinical trials or change the labeling of Clene’s drug candidates;

•        the FDA, NMPA, TGA, EMA or other comparable regulatory authorities may require the development of risk evaluation and mitigation strategies and plans to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools;

•        Clene may be subject to regulatory investigations and government enforcement actions;

•        Clene may decide to remove such drug candidates from the marketplace;

•        Clene could be sued and held liable for injury caused to individuals exposed to or taking Clene’s drug s; and

•        Clene’s reputation may suffer.

Any of these events could prevent Clene from achieving or maintaining market acceptance of the affected drug candidates and could substantially increase the costs of commercializing Clene’s drugs, if approved, and significantly impact Clene’s ability to successfully commercialize Clene’s drugs and generate revenue.

Adverse drug reactions and negative results from off-label use of Clene’s products could materially harm Clene’s business reputation, product brand name, financial condition and expose Clene to liability.

Products distributed or sold in the pharmaceutical market may be subject to off-label drug use. Off-label drug use is prescribing a product for an indication, patient population, dosage strength or frequency, or other condition of use that is not in accordance with regulatory approved usage and labeling. Even though the FDA, NMPA, TGA, EMA and other comparable regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label use, there remains the risk that Clene’s products are subject to off-label drug use and is prescribed in a patient population or dosage that has not been approved by competent authorities. Off-label use of Clene’s products may be less effective or entirely ineffective and may cause adverse drug reactions. Any of these occurrences can create negative publicity and significantly harm Clene’s business reputation, product brand name, commercial operations, and financial condition, including Clene’s share price. These occurrences may also expose Clene to liability and cause, or lead to, a delay in the progress of Clene’s clinical trials and may also ultimately result in failure to obtain regulatory approval for Clene’s drug candidates.

As a company, Clene has no experience in launching and marketing drugs. If Clene is unable to develop sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements or arrangements with third parties, Clene may not be successful in commercializing any drugs and generate drug candidate sales revenue.

Clene has not yet demonstrated an ability to launch and commercialize any of Clene’s drug candidates. As a result, Clene’s ability to successfully commercialize any approved drugs may involve more inherent risk, take longer, and cost more than it would if Clene were a company with prior experience launching and marketing drugs.

Clene will have to compete with other pharmaceutical and biopharmaceutical companies to recruit, hire, train and retain marketing and sales personnel. Clene must either develop internal sales, marketing, and commercial distribution capabilities for any or all of its approved drugs or pursue collaborative arrangements regarding the sales and marketing of its approved drugs. However, there can be no assurance that Clene will be able to develop such distribution capabilities or establish or maintain such collaborative arrangements, or if Clene are able to do so, that they will have effective sales forces. Any revenue Clene receives will depend upon the efforts of such third parties. Clene would have little or no control over the marketing and sales efforts of such third parties, and Clene’s revenue from product sales may be lower than if Clene had commercialized its approved drugs by itself. Clene also faces competition in its search for third parties to assist it with the sales and marketing efforts for its approved drugs.

As a result, Clene may not be able to generate product sales revenue.

Clene faces substantial competition from other pharmaceutical and biotechnology companies, and Clene’s operating results may suffer if Clene fails to compete effectively.

The development and commercialization of new drugs is highly competitive. Clene faces competition from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell drugs or are pursuing the development of drugs for the treatment of neurological diseases and other disorders for which Clene is commercializing its drugs or developing its drug candidates. Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing, and commercialization.

Clene’s commercial opportunity could be reduced or eliminated if its competitors develop and commercialize drugs that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than any drugs that Clene commercializes or may develop. Clene’s competitors may also obtain approval from the FDA, NMPA, TGA, EMA or other comparable regulatory authorities for their drugs more rapidly than Clene may obtain approval for its drugs, which could result in Clene’s competitors establishing a strong market position before Clene is able to enter the market and/or could slow Clene’s regulatory approval.

Many of the companies against which Clene is competing or against which Clene may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved drugs than Clene does. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of Clene’s competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with Clene in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, Clene’s programs.

Clene may be subject, directly or indirectly, to applicable anti-kickback, false claims laws, physician payment transparency laws, fraud and abuse laws or similar healthcare and security laws and regulations in the U.S. and other jurisdictions, which could expose Clene to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and others play a primary role in the recommendation and prescription of any products for which Clene obtains regulatory approval. If Clene obtains FDA approval for any of its drug candidates and begins commercializing those drugs in the U.S., Clene’s operations may be subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician payment sunshine laws and regulations. These laws may impact, among other things, Clene’s proposed sales, marketing, and education programs. In addition, Clene may be subject to patient privacy regulation by both the federal government and the states in which Clene conducts its business.

Additionally, Clene is subject to state and non-U.S. equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply to healthcare services reimbursed by any source, not just governmental payers, including private insurers. In addition, some states have passed laws that require pharmaceutical companies to comply with the April 2003 Office of Inspector General Compliance Program Guidance

for Pharmaceutical Manufacturers and/or other voluntary industry codes of conduct. Several states also impose other marketing restrictions or require pharmaceutical companies to make marketing or price disclosures to the state. There are ambiguities as to what is required to comply with these state requirements, and if Clene fails to comply with applicable state law requirements, Clene could be subject to penalties.

Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including penalties, fines and/or exclusion or suspension from federal and state healthcare programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions on behalf of the U.S. government under the federal False Claims Act as well as under the false claims laws of several states.

Neither the U.S. government nor the U.S. courts have provided definitive guidance on limitations to potential liability under the fraud and abuse laws as they may apply to Clene’s business. Law enforcement authorities are increasingly focused on enforcing these laws, often using new and creative legal theories, and it is possible that some of Clene’s practices may be challenged under these laws. Efforts to ensure that Clene’s business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Regardless of the compliance efforts, it is possible that governmental authorities will conclude that Clene’s business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against Clene, defending against such actions, even if successful, would distract the company and key personnel from its core mission and impose potentially significant costs. If Clene is not successful in defending itself or asserting Clene’s rights, those actions could have a significant impact on Clene’s business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid, and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of Clene’s operations, any of which could adversely affect Clene’s ability to operate its business and its results of operations. In addition, the approval and commercialization of any of Clene’s approved drugs outside the U.S. will also likely subject Clene to non-U.S. equivalents of the healthcare laws mentioned above, among other non-U.S. laws, as well as the U.S. Foreign Corrupt Practices Act (FCPA).

If any of the physicians or other providers or entities with whom Clene expects to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs, which may also adversely affect Clene’s business.

Any failure to perform proper quality control and quality assurance would have a material adverse effect on Clene’s business and financial results.

The manufacturing of Clene’s drug candidates and future approved drugs is subject to applicable laws, regulations, and GMP. These regulations govern manufacturing processes and procedures, including record keeping and the implementation and operation of quality management systems to control and assure the quality of investigational products and products approved for sale. Clene applies stringent quality controls at each stage of its production process to comply with these requirements. Clene performs extensive tests throughout the manufacturing processes to ensure the safety and effectiveness of its drug candidates. Clene may, however, detect instances in which an unreleased product was produced without adherence to its manufacturing procedures or the raw material used in Clene’s production process was not collected to store in accordance with the GMP or other regulations, resulting in a determination that the implicated products should be destroyed.

In addition, if Clene fails to comply with relevant quality control requirements under laws and GMP, Clene could experience a disruption in the supply of Clene’s products, which could delay or prevent further sales of such products, which could have a material adverse effect on Clene’s business and financial results.

In addition, quality issues may arise during scale-up activities. If Clene is unable to successfully ensure consistent and high quality of its products during large-volume production, the sales of its products may not be able to be promoted, which could have a material adverse effect on its business and financial results.

Clene may explore the licensing of commercialization rights or other forms of collaboration worldwide, which will expose Clene to additional risks.

Non-U.S. markets are an important component of Clene’s growth strategy. Clene initially intends to focus on opportunities in the U.S., European Union, Canada, Australia, Japan, and China, in particular. If Clene fails to obtain licenses or enter into collaboration arrangements with third parties in these or other markets, or if these parties are not

successful, Clene’s revenue-generating growth potential will be adversely affected. Moreover, international business relationships subject Clene to additional risks that may materially adversely affect its ability to attain or sustain profitable operations, including:

•        efforts to enter into collaboration or licensing arrangements with third parties in connection with Clene’s international sales, marketing, and distribution efforts may increase Clene’s expenses or divert its management’s attention from the acquisition or development of its drug candidates;

•        difficulty of effective enforcement of contractual provisions in local jurisdictions;

•        differing regulatory requirements for drug approvals and marketing internationally;

•        changes in a specific market’s political and cultural climate or economic condition;

•        potential third-party patent rights or potentially reduced protection for intellectual property rights;

•        unexpected changes in tariffs, trade barriers, and regulatory requirements;

•        economic weakness, including inflation;

•        compliance with tax, employment, immigration, and labor laws for employees traveling abroad;

•        the effects of applicable non-U.S. tax structures and potentially adverse tax consequences;

•        currency fluctuations, which could result in increased operating expenses and reduced revenue;

•        production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

•        workforce uncertainty and labor unrest;

•        failure of Clene’s employees and contracted third parties to comply with Office of Foreign Asset Control rules and regulations and the Foreign Corrupt Practices Act; and

•        business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods, hurricanes, and fires.

These and other risks may materially and adversely affect Clene’s ability to attain or sustain revenue from international markets.

Illegal and/or parallel imports and counterfeit pharmaceutical products may reduce demand for Clene’s future approved drug candidates and could have a negative impact on Clene’s reputation and business.

The importation, whether authorized by governmental policy or illegally, of competing products from countries where government price controls or other market dynamics result in lower prices may adversely affect the demand for Clene’s future approved drugs and, in turn, may adversely affect Clene’s sales and profitability where Clene commercializes its products. Unapproved foreign imports of prescription drugs are illegal under the current laws of the U.S., China, European Union, Australia and other jurisdictions. However, illegal imports may continue to occur or even increase as the ability of patients to obtain these lower priced imports continues to grow. Furthermore, cross-border imports from lower-priced markets (parallel imports) into higher-priced markets could harm sales of Clene’s future approved drugs and exert commercial pressure on pricing within one or more markets. In addition, competent government authorities may expand consumers’ ability to import lower priced versions of Clene’s future approved products or competing products from outside the countries where Clene operates. Any future legislation or regulations that increase consumer access to lower priced medicines from outside the countries where Clene operates could have a material adverse effect on Clene’s business.

Certain products distributed or sold in the pharmaceutical market may be manufactured without proper licenses or approvals, or are fraudulently mislabeled with respect to their content or manufacturers. These products are generally referred to as counterfeit pharmaceutical products. The counterfeit pharmaceutical product control and enforcement system, particularly in developing markets such as China, may be inadequate to discourage or eliminate the manufacturing and sale of counterfeit pharmaceutical products imitating Clene’s products. Since counterfeit pharmaceutical products in many cases have very similar appearances compared with the authentic pharmaceutical

products but are generally sold at lower prices, counterfeits of Clene’s products can quickly erode the demand for Clene’s future approved drugs. Clene’s reputation and business could suffer harm as a result of counterfeit pharmaceutical products sold under Clene’s or Clene’s collaborators’ brand name(s). In addition, theft of inventory at warehouses, plants or while in-transit, which are not properly stored and which are sold through unauthorized channels, could adversely impact patient safety, as well as Clene’s reputation and business.

Clene relies on third parties to conduct its preclinical studies and clinical trials and Clene must work effectively with collaborators to develop its drug candidates. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, Clene may not be able to obtain regulatory approval for or commercialize its drug candidates and Clene’s business could be substantially harmed.

Clene has relied upon and plans to continue to rely upon third-party CROs and third-party vendors to monitor, collect samples, analyze samples, report data, and manage data for Clene’s ongoing preclinical and clinical programs. Clene relies on these parties for execution of its preclinical studies and clinical trials, and controls only certain aspects of their activities. Nevertheless, Clene is responsible for ensuring that each of Clene’s studies is conducted in accordance with the applicable protocol, legal and regulatory requirements, and scientific standards, and Clene’s reliance on the CROs does not relieve Clene of its regulatory responsibilities. Clene, its CROs and third-party vendors supporting its clinical programs, and its clinical investigators, are required to comply with GCPs, which are regulations and guidelines enforced by the FDA, NMPA, TGA, EMA, and other comparable regulatory authorities for all of Clene’s drugs in clinical development. If Clene or any of Clene’s CROs or clinical investigators fails to comply with applicable GCPs, the clinical data generated in Clene’s clinical trials may be deemed unreliable and the FDA, NMPA, TGA, EMA or comparable regulatory authorities may require Clene to perform additional clinical trials before approving Clene’s marketing applications. In addition, Clene’s pivotal clinical trials must be conducted with product produced under GMP. Clene’s failure to comply with these regulations may require it to repeat clinical trials, which would delay the regulatory approval process.

If any of Clene’s relationships with these third-parties terminates, Clene may not be able to enter into arrangements with alternative CROs or vendors, or to do so on commercially reasonable terms. In addition, Clene’s CROs are not Clene’s employees, and except for remedies available to Clene under its agreements with such CROs, Clene cannot control whether or not they devote sufficient time and resources to Clene’s ongoing clinical and nonclinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they or Clene’s clinical investigators obtain is compromised due to the failure to adhere to Clene’s clinical protocols, regulatory requirements, or for other reasons, Clene’s clinical trials may be extended, delayed or terminated and Clene may not be able to obtain regulatory approval for or successfully commercialize its drug candidates. As a result, Clene’s results of operations and the commercial prospects for Clene’s approved drugs would be harmed, its costs could increase and its ability to generate revenues could be delayed.

Switching or adding additional CROs involves additional cost and delays, which can materially influence Clene’s ability to meet its desired clinical development timelines. There can be no assurance that Clene will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse effect on Clene’s business, financial condition and prospects.

Clene’s future revenues are dependent on its ability to work effectively with collaborators to develop its drug candidates, including to obtain regulatory approval. Clene’s arrangements with collaborators will be critical to successfully bringing products to market and commercializing them. Clene relies on collaborators in various respects, including to undertake research and development programs, conduct clinical trials, manage or assist with the regulatory filings and approval process, and to assist with Clene’s commercialization efforts. Clene does not control its collaborators; therefore, Clene cannot ensure that these third parties will adequately and timely perform all of their obligations to Clene. If they fail to complete the remaining studies successfully, or at all, it could delay, adversely affect or prevent regulatory approval. Clene cannot guarantee the satisfactory performance of any of its collaborators and if any of Clene’s collaborators breach or terminate their agreements with Clene, Clene may not be able to successfully commercialize the licensed product which could materially and adversely affect Clene’s business, financial condition, cash flows and results of operations.

Clene’s third-party CROs and third-party vendors may also be impacted by the COVID-19 outbreak. See “— Clene’s financial position and operations may be adversely affected by the COVID-19 outbreak.”

Clene has entered into research collaborations and may form or seek collaborations or strategic alliances or enter into licensing arrangements in the future, and Clene may not realize the benefits of such collaborations, alliances, or licensing arrangements.

Clene may form or seek strategic alliances, create joint ventures or collaborations, or enter into licensing arrangements with third parties that Clene believes will complement or augment its development and commercialization efforts with respect to its drug candidates and any future drug candidates that it may develop. Any of these relationships may require Clene to incur non-recurring and other charges, increase Clene’s near and long-term expenditures, issue securities that dilute its existing shareholders, or disrupt its management and business.

Clene has entered into collaborative research arrangements with some of the world’s leading academic institutions and research centers and are working with key scientists in the field of central nervous system disorders.

Clene faces significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, Clene may not be successful in its efforts to establish a strategic partnership or other alternative arrangements for its drug candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view Clene’s drug candidates as having the requisite potential to demonstrate safety and efficacy or commercial viability. If and when Clene collaborates with a third party for development and commercialization of a drug candidate, Clene can expect to relinquish some or all of the control over the future success of that drug candidate to the third party. For any drug candidates that Clene may seek to in-license from third parties, Clene may face significant competition from other pharmaceutical or biotechnology companies with greater resources or capabilities than Clene, and any agreement that Clene does enter may not result in the anticipated benefits.

Further, collaborations involving Clene’s drugs are subject to numerous risks, which may include the following:

•        collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;

•        collaborators may not pursue development and commercialization of Clene’s drug candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive drugs, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;

•        collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a drug candidate, repeat or conduct new clinical trials, or require a new formulation of a drug candidate for clinical testing;

•        collaborators could independently develop, or develop with third parties, drugs that compete directly or indirectly with Clene’s drugs;

•        a collaborator with marketing and distribution rights to one or more drugs may not commit sufficient resources to their marketing and distribution;

•        collaborators may not properly develop, maintain, or defend Clene’s intellectual property rights or may use Clene’s intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate Clene’s intellectual property or proprietary information or expose Clene to potential liability;

•        disputes may arise between Clene and a collaborator that cause the delay or termination of the research, development, or commercialization of Clene’s drug candidates, or that result in costly litigation or arbitration that diverts management attention and resources;

•        collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development, or commercialization of the applicable drug candidates; and

•        collaborators may own or co-own intellectual property covering Clene’s drugs that results from Clene’s collaborating with them, and in such cases, Clene would not have the exclusive right to commercialize such intellectual property.

As a result, Clene may not be able to realize the benefit of current or future research collaborations, strategic partnerships, or the potential licensing of third-party drugs if Clene is unable to successfully integrate such products with its existing operations and company culture, which could delay Clene’s timelines or otherwise adversely affect Clene’s business. Clene also cannot be certain that, following a strategic transaction or license, Clene will achieve the revenue or specific net income that justifies such transaction. If Clene is unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, Clene may have to curtail the development of a drug candidate, reduce or delay its development program or one or more of its other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase its expenditures and undertake development or commercialization activities at its own expense. If Clene elects to fund and undertake development or commercialization activities on its own, it may need to obtain additional expertise and additional capital, which may not be available to Clene on acceptable terms or at all. If Clene fails to enter into collaborations and does not have sufficient funds or expertise to undertake the necessary development and commercialization activities, Clene may not be able to further develop its drug candidates or bring them to market and generate product sales revenue, which would harm Clene’s business prospects, financial condition and results of operations.

Clene’s business depends on the use of raw materials, and a decrease in the supply, or an increase in the cost of these raw materials could materially and adversely affect Clene’s business, financial condition and results of operations.

In order to manufacture its products, Clene must obtain sufficient quantities of high-quality raw materials at commercially acceptable prices and in a timely manner. Certain critical raw materials, such as wires made of high-purity gold and other transition elements, are available from a limited number of suppliers in the market. As a result, any disruption in production or inability of Clene’s suppliers to produce adequate quantities to meet Clene’s needs could impair Clene’s ability to operate its business on a day-to-day basis and to continue its research and development of future drug candidates. Moreover, Clene expects its demand for such materials to increase as it expands business scale and commercializes its products, and Clene cannot guarantee that current suppliers have the capacity to meet Clene’s demand. Clene is also exposed to the risk of increased material costs, which Clene may not be able to pass on to customers and as a result, could lower its profitability. In addition, although Clene has implemented quality inspection procedures on such materials before they are used in Clene’s manufacturing processes and also requires its suppliers to maintain high quality standards, Clene cannot guarantee that it will be able to secure sufficient quantities of raw materials at high quality standards, nor detect all quality issues in the supplies Clene uses. For example, should the highly purified water that we utilize be compromised in any way, it could render entire batches unusable or, depending on the nature of the impurity, potentially dangerous to patients. Clene cannot assure you that these third parties will be able to maintain and renew all licenses, permits, and approvals necessary for their operations or comply with all applicable laws and regulations. Failure to do so by them may lead to interruption in their business operations, which in turn may result in shortage of the raw materials utilized by Clene. If Clene is unable to obtain qualified raw materials and the quality of its products suffer as a result, Clene may have to delay clinical trials and regulatory filings, recall its products, be subject to product liability claims, fail to comply with continuing regulatory requirements, and incur significant costs to rectify such issue, which may have a material and adverse effect on Clene’s business, financial condition and results of operations.

If Clene is unable to obtain and maintain sufficient patent protection for its drug candidates through intellectual property rights, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties could develop and commercialize products similar or identical to Clene’s products, and Clene’s ability to commercialize its approved drugs successfully may be adversely affected.

Clene’s success depends in large part on its ability to protect its proprietary technology, drug candidates in clinical studies, and approved drugs on market (if approved) from competition by obtaining, maintaining and enforcing its intellectual property rights, including patent rights. Clene seeks to protect the drug candidates and technology that it considers commercially important by filing patent applications in most important commercial markets, including the U.S., the People’s Republic of China (“PRC”), Europe, Canada, Japan, Korea, and other countries, relying on trade secrets or pharmaceutical regulatory protection or employing a combination of these methods. However, the patent prosecution process is expensive, time-consuming and complex, and Clene may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that Clene will fail to identify patentable aspects of its research and development output before it is too late to obtain patent protection. As a result, Clene may not be able to prevent competitors from developing and commercializing competitive drugs in all such fields and territories.

Patents may be invalidated and patent applications may not be granted for a number of reasons, including known or unknown prior art, deficiencies in the patent application or the lack of novelty of the underlying invention or technology. Although Clene enters into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of its research and development output, such as its employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and any other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing Clene’s ability to seek patent protection. In addition, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the U.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases, not at all. Therefore, Clene cannot be certain that it was the first to make the inventions claimed in its patents or pending patent applications or that it was the first to file for patent protection of such inventions. Furthermore, the PRC, EPO, and the U.S. have adopted the “first-to-file” system under which whoever first files a patent application will be awarded the patent if all other patentability requirements are met. Under the first-to-file system, third parties may be granted a patent relating to a technology which Clene invented.

The coverage sought by the claims in a patent application can be significantly reduced before the patent is issued, and the scope of the claims can be reinterpreted after issuance. Even if patent applications Clene licenses or owns currently or in the future issue as patents, they may not issue in a form that will provide Clene with any meaningful protection, prevent competitors or other third parties from competing with Clene, or otherwise provide Clene with any competitive advantage. In addition, the patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability and commercial value of Clene’s patent rights are highly uncertain.

The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and Clene’s patents may be challenged in the courts or patent offices in any country. Clene may be subject to a third-party preissuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, or become involved in opposition, derivation, revocation, re-examination, post-grant and inter partes review, or interference proceedings or similar proceedings in foreign jurisdictions challenging Clene’s patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, Clene’s patent rights, allow third parties to commercialize Clene’s technology or approved drugs and compete directly with Clene without payment, or result in Clene’s inability to manufacture or commercialize drug candidates and approved drugs without infringing, misappropriating or otherwise violating third-party patent rights. Moreover, Clene may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge the priority of Clene’s invention or other features of patentability of Clene’s patents and patent applications. Such challenges may result in loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated, or held unenforceable, which could limit Clene’s ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of Clene’s technology and drug candidates. Such proceedings also may result in substantial costs and require significant time from Clene’s scientists and management, even if the eventual outcome is favorable to Clene. Consequently, Clene does not know whether any of its technology or drug candidates will be protectable or remain protected by valid and enforceable patents. Clene’s competitors or other third parties may be able to circumvent its patents by developing similar or alternative technologies or products in a non-infringing manner.

Furthermore, although various extensions may be available, the life of a patent and the protection it affords, is limited. For example, approved therapies may face competition from generic medications after the related patents have expired, or if they are challenged and invalidated even before their expiry. Manufacturers of generic drugs may challenge the scope, validity or enforceability of Clene’s patents in court, and Clene may not be successful in enforcing or defending those intellectual property rights and, as a result, may not be able to develop or market the relevant product exclusively, which would have a material adverse effect on any potential sales of that product. The issued patents and pending patent applications, if issued, for Clene’s drug candidates are expected to expire on various dates as described in [“Business — Intellectual Property”] of this prospectus. Upon the expiration of Clene’s issued patents or patents that may issue from Clene’s pending patent applications, Clene will not be able to assert such patent rights against potential competitors and Clene’s business and results of operations may be adversely affected.

Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such drug candidates might expire before or shortly after such drugs are commercialized. As a result, Clene’s patents and patent applications may not provide it with sufficient rights to exclude others from

commercializing products similar or identical to Clene’s products. Moreover, some of Clene’s patents and patent applications may in the future be co-owned with third parties. If Clene is unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including Clene’s competitors, and Clene’s competitors could market competing products and technology. In addition, Clene may need the cooperation of any such co-owners of Clene’s patents in order to enforce such patents against third parties, and such cooperation may not be provided to Clene. Any of the foregoing could have a material adverse effect on Clene’s competitive position, business, financial conditions, results of operations and prospects.

Clene may not be able to protect Clene’s intellectual property rights throughout the world or prevent unfair competition by third parties.

Filing, prosecuting, maintaining, and defending patents on drug candidates in all countries throughout the world could be prohibitively expensive for Clene, and Clene’s intellectual property rights in some non-U.S. countries can have a different scope and strength than do those in the U.S. In addition, the laws of certain non-U.S. countries do not protect intellectual property rights to the same extent as the laws of the U.S. Consequently, Clene may not be able to prevent third parties from practicing Clene’s inventions in all countries outside the U.S., or from selling or importing drugs made using Clene’s inventions in and into the U.S. or non-U.S. jurisdictions. Competitors may use Clene’s technologies in jurisdictions where Clene has not obtained patent protection to develop their own drugs and further, may export otherwise infringing drugs to non-U.S. jurisdictions where Clene has patent protection, but where enforcement rights are not as strong as those in the U.S. These drugs may compete with Clene’s future approved drugs and Clene’s patent rights or other intellectual property rights may not be effective or adequate to prevent them from competing.

Clene may become involved in lawsuits to protect or enforce Clene’s intellectual property, which could be expensive, time consuming and unsuccessful. Clene’s patent rights relating to Clene’s drugs could be found invalid or unenforceable if challenged in court or before the U.S. Patent and Trademark Office or comparable non-U.S. authority.

Competitors may infringe Clene’s patent rights or misappropriate or otherwise violate Clene’s intellectual property rights. To counter infringement or unauthorized use, litigation may be necessary in the future to enforce or defend Clene’s intellectual property rights, protect its trade secrets or determine the validity and scope of its own intellectual property rights or the proprietary rights of others. Enforcement or defense of intellectual property rights can be expensive and time consuming. Any claims that Clene asserts against perceived infringers could also provoke these parties to assert counterclaims against Clene alleging that Clene infringes their intellectual property rights. Many of Clene’s current and potential competitors have the ability to dedicate substantially greater resources to enforce and/or defend their intellectual property rights than Clene can. Accordingly, despite Clene’s efforts, Clene may not be able to prevent third parties from infringing upon or misappropriating Clene’s intellectual property. An adverse result in any litigation proceeding could put Clene’s patents, as well as any patents that may issue in the future from Clene’s pending patent applications, at risk of being invalidated, held unenforceable or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Clene’s confidential information could be compromised by disclosure during this type of litigation.

In patent litigation in the U.S., defendant counterclaims in district courts or in the patent trademark and appeal board (PTAB) alleging invalidity or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include ex parte re-examination, inter partes review, post-grant review, derivation and equivalent proceedings in non-U.S. jurisdictions, such as opposition proceedings. Such proceedings could result in revocation or amendment to Clene’s patents in such a way that they no longer cover and protect Clene’s drug candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity of Clene’s patents, for example, Clene cannot be certain that there is no invalidating prior art of which Clene, Clene’s patent counsel, and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, Clene would lose at least part, and perhaps all, of the patent protection on Clene’s drug candidates. Such a loss of patent protection could have a material adverse impact on Clene’s business.

Clene may not be able to prevent misappropriation of Clene’s trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the U.S. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Clene’s confidential information could be compromised by disclosure during this type of litigation.

If Clene is sued for infringing the intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay Clene from developing or commercializing Clene’s drug candidates.

Clene’s commercial success depends in part on Clene’s avoiding infringement of the patents and other intellectual property rights of third parties. Clene is aware of other issued patents belonging to third parties that exist in fields in which Clene is developing its drug candidates. There may also be third-party patents or patent applications of which Clene is currently unaware, and given the dynamic area in which Clene operates, additional patents are likely to be issued that relate to some aspects of Clene’s business. There is a substantial amount of litigation and other claims and proceedings involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries generally. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that Clene’s drug candidates may give rise to claims of infringement of the patent rights of others.

Third parties may assert that Clene is using technology in violation of their patent or other proprietary rights. Defense of these claims, regardless of their merit, could involve substantial litigation expense and divert Clene’s technical personnel, management personnel, or both from their normal responsibilities. If third parties bring successful claims against Clene for infringement of their intellectual property rights, Clene may be subject to injunctive or other equitable relief, which could prevent Clene from developing and commercializing one or more of its drug candidates. Clene may also have to pay substantial damages, including treble damages and attorneys’ fees in the case of willful infringement, or redesign Clene’s infringing drug candidates, which may be impossible or require substantial time and cost. In the event of an adverse result in any such litigation, or even in the absence of litigation, Clene may need to obtain licenses from third parties to advance its research or allow commercialization of its drug candidates. Any such license might not be available on reasonable terms or at all. In the event that Clene are unable to obtain such a license, Clene would be unable to further develop and commercialize one or more of its drug candidates, which could harm its business significantly. Clene may also elect to enter into license agreements in order to settle patent infringement claims or to resolve disputes prior to litigation, and any such license agreements may require Clene to pay royalties and other fees that could significantly harm its business.

Intellectual property litigation may lead to unfavorable publicity that harms Clene’s reputation and increases Clene’s operating losses, causing the market price of Clene’s common stock to decline.

During the course of any intellectual property litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the market price of the ordinary shares. Such litigation or proceedings could substantially increase Clene’s operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. Clene may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of Clene’s competitors may be able to sustain the costs of such litigation or proceedings more effectively than Clene can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on Clene’s ability to compete in the marketplace.

Obtaining and maintaining Clene’s patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and Clene’s patent protection could be reduced or eliminated for noncompliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and most foreign jurisdictions either annually or in several stages over the lifetime of the patent. The USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. Although an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the

Clene may be subject to claims that Clene’s employees have wrongfully used or disclosed the alleged trade secrets of their former employers.

Many of Clene’s employees, including Clene’s senior management, were previously employed at other biotechnology or pharmaceutical companies, including Clene’s competitors or potential competitors. Some of these employees, including each member of Clene’s senior management, executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment. Although Clene tries to ensure that its employees do not use the proprietary information or know-how of others in their work for Clene, Clene may be subject to claims that Clene or these employees have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. Clene is not aware of any threatened or pending claims related to these matters or concerning the agreements with Clene’s senior management, but in the future litigation may be necessary to defend against such claims. If Clene fails in defending any such claims, in addition to paying monetary damages, Clene may lose valuable intellectual property rights, or personnel. Even if Clene is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

Intellectual property rights do not necessarily protect Clene from all potential threats to Clene’s competitive advantages.

The degree of future protection afforded by Clene’s intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect Clene’s business, or permit Clene to maintain its competitive advantage. The following examples are illustrative:

•        others may be able to make compounds that are similar to Clene’s drug candidates but that are not covered by the claims of the patents that Clene own or may in the future exclusively license;

•        Clene might not have been the first to make the inventions covered by the issued patents or pending patent applications that it owns or may in the future exclusively license, which could result in the patent applications not issuing or being invalidated after issuing;

•        Clene might not have been the first to file patent applications covering certain of its inventions, which could prevent the issuance of the patent applications or cause them to be invalidated after issuance;

•        others may independently develop similar or alternative technologies or duplicate any of Clene’s technologies without infringing Clene’s intellectual property rights;

•        it is possible that Clene’s pending patent applications will not lead to issued patents;

•        issued patents that Clene owns or have exclusively licensed may not provide it with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by its competitors;

•        Clene may obtain patents for certain drug candidates many years before it receives NDA approval for these drugs, and because patents have a limited life, which may begin to run prior to the commercial sale of the related drugs, limiting the commercial value of Clene’s patents;

•        Clene’s competitors might conduct research and development activities in countries where Clene does not have patent rights and then use the information learned from such activities to develop competitive drugs for commercialization in Clene’s major markets;

•        Clene may fail to develop additional proprietary technologies that are patentable;

•        Clene may fail to apply for or obtain adequate intellectual property protection in all the jurisdictions in which it operates; and

•        the patents of others may have an adverse effect on Clene’s business, for example by preventing Clene from commercializing one or more of its drug candidates for one or more indications.

Any of the aforementioned threats to Clene’s competitive advantage could have a material adverse effect on Clene’s business.

Risks Relating to Tottenham’s Business

Tottenham will be forced to liquidate the trust account if it cannot consummate a business combination by November 6, 2020, Tottenham’s public shareholders will receive $10.00 per share and the rights will expire worthless.

In the absence of shareholder approval for a further extension, if Tottenham is unable to complete a business combination by November 6, 2020, and is forced to liquidate, the per-share liquidation distribution will be $10.00, plus interest earned on amounts held in trust that have not been used to pay for taxes. Furthermore, there will be no distribution with respect to the TOTA Rights, which will expire worthless as a result of Tottenham’s failure to complete a business combination.

You must tender your TOTA Ordinary Shares in order to validly seek redemption at the Extraordinary General Meeting.

In connection with tendering your shares for redemption, you must elect either to physically tender your share certificates to Tottenham’s transfer agent by two (2) business days before the Extraordinary General Meeting, or deliver your TOTA Ordinary Shares to the transfer agent electronically using The Depository Trust Company’s DWAC System, which election would likely be determined based on the manner in which you hold your ordinary shares. The requirement for physical or electronic delivery by two (2) business days before the Extraordinary General Meeting ensures that a redeeming holder’s election to redeem is irrevocable once the Business Combination is consummated. Any failure to observe these procedures will result in your loss of redemption rights in connection with the vote on the Business Combination.

A Tottenham shareholder who elects to dissent under Section 179 of the BVI BC Act and validly exercises its entitlement to payment of the fair value of the TOTA Ordinary Shares it holds following the procedures set forth above will not be entitled to have its TOTA Ordinary Shares redeemed. If a Tottenham shareholder has elected to have its TOTA Ordinary Shares redeemed but later elects to dissent, upon receipt of the written notice of such a Tottenham shareholder’s decision to elect to dissent, Tottenham shall instruct its transfer agent to return the TOTA Ordinary Shares (physically or electronically) delivered to the transfer agent in connection with such Tottenham shareholder’s demand for redemption to the Tottenham shareholder.

If third parties bring claims against Tottenham, the proceeds held in trust could be reduced and the per-share liquidation price received by Tottenham’s shareholders may be less than $10.00.

Tottenham’s placing of funds in trust may not protect those funds from third party claims against Tottenham. Although Tottenham has received from many of the vendors, service providers (other than its independent accountants) and prospective target businesses with which it does business executed agreements waiving any right, title, interest or claim of any kind in or to any monies held in the trust account for the benefit of Tottenham’s public shareholders, they may still seek recourse against the trust account. Additionally, a court may not uphold the validity of such agreements. Accordingly, the proceeds held in trust could be subject to claims which could take priority over those of Tottenham’s public shareholders. If Tottenham liquidates the trust account before the completion of a business combination and distributes the proceeds held therein to its public shareholders, the Sponsor has contractually agreed that it will be liable to ensure that the proceeds in Tottenham’s trust account are not reduced by the claims of target businesses or claims of vendors or other entities that are owed money by us for services rendered or contracted for or products sold to us, but only if such a vendor or prospective target business does not execute such a waiver. However, Tottenham cannot assure you that they will be able to meet such obligation. Therefore, the per-share distribution from the trust account for our shareholders may be less than $10.00 due to such claims.

Additionally, if Tottenham is forced to file a bankruptcy case or an involuntary bankruptcy case is filed against it which is not dismissed, the proceeds held in the trust account could be subject to applicable bankruptcy law, and may be included in Tottenham’s bankruptcy estate and subject to the claims of third parties with priority over the claims of its shareholders. To the extent any bankruptcy claims deplete the trust account, Tottenham may not be able to return $10.00 to Tottenham’s public shareholders.

Any distributions received by Tottenham’s shareholders could be viewed as an unlawful payment if it was proved that immediately following the date on which the distribution was made, Tottenham was unable to pay its debts as they fell due in the ordinary course of business and the value of its assets does not exceed its liabilities.

Tottenham’s second amended and restated memorandum and articles of association provides that it will continue in existence only until November 6, 2020. In the absence of shareholder approval for a further extension, if Tottenham is unable to consummate a transaction within the required time period, upon notice from Tottenham, the trustee of the trust account will distribute the amount in its trust account to its public shareholders. Concurrently, Tottenham shall pay, or reserve for payment, from funds not held in trust, its liabilities and obligations, although Tottenham cannot assure you that there will be sufficient funds for such purpose. If there are insufficient funds held outside the trust account for such purpose, our Sponsor agreed that, if it liquidates prior to the consummation of a business combination, it will be liable to ensure that the proceeds in the trust account are not reduced by the claims of target businesses or claims of vendors or other entities that are owed money by Tottenham for services rendered or contracted for or products sold to it, but only if such a vendor or prospective target business does not execute such a waiver. However, we cannot assure you that the liquidator will not determine that he or she requires additional time to evaluate creditors’ claims (particularly if there is uncertainty over the validity or extent of the claims of any creditors). We also cannot assure you that a creditor or shareholder will not file a petition with the British Virgin Islands court which, if successful, may result in our liquidation being subject to the supervision of that court. Such events might delay distribution of some or all of Tottenham’s assets to its public shareholders.

Thereafter, Tottenham’s sole business purpose will be to voluntarily liquidate and dissolve in accordance with British Virgin Islands law. In such a situation under British Virgin Islands law, a liquidator would be appointed and, subject to the terms of the required plan of liquidation, the liquidator would give at least 21 days’ notice to creditors of his intention to make a distribution by notifying known creditors (if any) and by placing a public advertisement in the appropriate newspaper in the British Virgin Islands. However, in practice the procedure to be followed by the liquidator will be subject to the terms of the plan of liquidation and the memorandum and articles of association of the company and the mentioned notice may not necessarily delay the distribution of assets particularly if the liquidator is satisfied that no creditors would be adversely affected as a consequence of a distribution before this time period has expired. In practice, as soon as the affairs of the company are fully-wound up, the liquidator would normally lay a final report and accounts before a final general meeting. Upon completion of a voluntary liquidation, the liquidator must file a statement that the liquidation has been completed with the Registrar of Corporate Affairs in the British Virgin Islands (the “Registrar”) and thereafter the company will be dissolved on the date of the certificate issued by the Registrar. It is Tottenham’s intention to liquidate the trust account to its public shareholders as soon as reasonably possible and the initial shareholders have agreed to take any such action necessary to liquidate the trust account and to dissolve the company as soon as reasonably practicable if Tottenham does not complete a business combination within the required time period. Pursuant to Tottenham’s second amended and restated memorandum and articles of association, in the absence of shareholder approval for a further extension, failure to consummate a business combination by November 6, 2020 will trigger an automatic winding up of the company.

If at any time the voluntary liquidator of a company in voluntary liquidation is of the opinion that the company is insolvent (that is to say, either the value of the company’s liabilities exceeds, or will exceed, its assets or, the company is, or will be, unable to pay its debts as they fall due), he shall forthwith send a written notice to the British Virgin Islands Official Receiver in the approved form. The voluntary liquidator shall then call a meeting of creditors of the company to be held within twenty-one days of the date of the aforesaid notice to the Official Receiver. The said creditors’ meeting shall be treated as if it were the first meeting of the creditors of a company called under section 179 of the Insolvency Act, 2003 of the British Virgin Islands (as the same may be amended from time to time, “Insolvency Act”) by a liquidator appointed by the members of a company and sections 179 and 180 of the Insolvency Act shall apply to the calling and holding of such a meeting.

Where a voluntary liquidator is not an eligible licensed insolvency practitioner with respect to the company, the Official Receiver may apply to the British Virgin Islands High Court ex parte for the appointment of himself or an eligible licensed insolvency practitioner as the liquidator of the company and the court may make the appointment subject to such conditions as it considers appropriate. From the time that a voluntary liquidator appointed first becomes aware that the company is not, or will not be, able to pay its debts he shall conduct the liquidation as if he had been appointed liquidator under the Insolvency Act. The Insolvency Act will apply to the liquidation of the company subject to such

modifications as are appropriate and the liquidation of the company shall be deemed to have commenced on the date of the appointment of the voluntary liquidator. If Tottenham is deemed insolvent, then there are also circumstances where prior payments made to shareholders or other parties may be deemed to be a “voidable transaction” for the purposes of the Insolvency Act if it was proved that immediately following the date on which the distribution was made, Tottenham was unable to pay its debts as they fall due in the ordinary course of business. A voidable transaction would be, for these purposes, payments made as “unfair preferences” or “transactions at an undervalue.” Where a payment was a risk of being a voidable transaction, a liquidator appointed over an insolvent company could apply to the British Virgin Islands court for an order, inter alia, for the transaction to be set aside as a voidable transaction in whole or in part. Furthermore, Tottenham’s board of directors may be viewed as having breached its fiduciary duties to Tottenham or Tottenham’s creditors and/or may have acted in bad faith, thereby exposing itself and our company to claims, by paying public shareholders from the trust account prior to addressing the claims of creditors. Tottenham cannot assure you that claims will not be brought against Tottenham for these reasons.

If Tottenham is forced to enter into an insolvent liquidation, any distributions received by Tottenham shareholders could be viewed as an unlawful payment if it was proved that immediately following the date on which the distribution was made, Tottenham was unable to pay its debts as they fall due in the ordinary course of business. As a result, a liquidator could seek to recover all amounts received by Tottenham shareholders. Furthermore, Tottenham board of directors may be viewed as having breached its fiduciary duties to its creditors and/or may have acted in bad faith, and thereby exposing itself and Tottenham to claims of damages, by paying public shareholders from the trust account prior to addressing the claims of creditors. Tottenham cannot assure you that claims will not be brought against it for these reasons.

If Tottenham’s due diligence investigation of Clene was inadequate, then Tottenham shareholders following the Business Combination could lose some or all of their investment.

Even though Tottenham conducted a due diligence investigation of Clene, it cannot be sure that this diligence uncovered all material issues that may be present inside Clene or its business, or that it would be possible to uncover all material issues through a customary amount of due diligence, or that factors outside of Clene and its business and outside of its control will not later arise.

All of Tottenham’s officers and directors own TOTA Ordinary Shares, TOTA Warrants and TOTA Rights and will not participate in liquidation distributions and, therefore, they may have a conflict of interest in determining whether the Business Combination is appropriate.

All of Tottenham’s officers and directors collectively own an aggregate of [135,000] TOTA Ordinary Shares. Such individuals/entities have waived their rights to redeem these shares (including shares underlying the units), or to receive distributions with respect to these shares upon the liquidation of the trust account if Tottenham is unable to consummate a business combination. Accordingly, the TOTA Ordinary Shares purchased by our officers and directors will be worthless if Tottenham does not consummate a business combination. Based on a market price of $[•] per TOTA Ordinary Share, $[•] per TOTA Warrant, $[•] per TOTA Right, and $[•] per TOTA Unit on [•], 2020, the aggregate value of these shares, warrants, rights and units was approximately $[•]. The TOTA Ordinary Shares acquired prior to the IPO, as well as the TOTA Units will be worthless if Tottenham does not consummate a business combination. Consequently, our directors’ and officers’ discretion in identifying and selecting Clene as a suitable target business may result in a conflict of interest when determining whether the terms, conditions and timing of the Business Combination are appropriate and in Tottenham shareholders’ best interest.

Tottenham is requiring shareholders who wish to redeem their shares in connection with the Business Combination to comply with specific requirements for redemption that may make it more difficult for them to exercise their redemption rights prior to the deadline for exercising their rights.

Tottenham is requiring public shareholders who wish to redeem their ordinary shares to either tender their certificates to Tottenham’s transfer agent or deliver their shares to the transfer agent electronically using the Depository Trust Company’s, or DTC, DWAC System two (2) business days before the Extraordinary General Meeting. In order to obtain a physical certificate, a shareholder’s broker and/or clearing broker, DTC and Tottenham’s transfer agent will

need to act to facilitate this request. It is Tottenham’s understanding that shareholders should generally allot at least two weeks to obtain physical certificates from the transfer agent. However, because Tottenham does not have any control over this process or over the brokers or DTC, it may take significantly longer than two weeks to obtain a physical share certificate. While Tottenham has been advised that it takes a short time to deliver shares through the DWAC System, Tottenham cannot assure you of this fact. Accordingly, if it takes longer than Tottenham anticipates for shareholders to deliver their shares, shareholders who wish to redeem may be unable to meet the deadline for exercising their redemption rights and thus may be unable to redeem their ordinary shares.

Tottenham will require its public shareholders who wish to redeem their ordinary shares in connection with the Business Combination to comply with specific requirements for redemption described above, such redeeming shareholders may be unable to sell their securities when they wish to in the event that the Business Combination is not consummated.

If Tottenham requires public shareholders who wish to redeem their ordinary shares in connection with the proposed Business Combination to comply with specific requirements for redemption as described above and the Business Combination is not consummated, Tottenham will promptly return such certificates to its public shareholders. Accordingly, investors who attempted to redeem their ordinary shares in such a circumstance will be unable to sell their securities after the failed acquisition until Tottenham has returned their securities to them. The market price for Tottenham’s ordinary shares may decline during this time and you may not be able to sell your securities when you wish to, even while other shareholders that did not seek redemption may be able to sell their securities.

The initial shareholders, including the officers and directors, control a substantial interest in Tottenham and thus may influence certain actions requiring a shareholder vote.

Tottenham’s initial shareholders, including the officers and directors, collectively own approximately [36.79]% of its issued and outstanding ordinary shares. However, if a significant number of Tottenham shareholders vote, or indicate an intention to vote, against the Business Combination, Tottenham’s initial shareholders or the affiliates, could make such purchases in the open market or in private transactions in order to influence the vote. Tottenham’s initial shareholders or the affiliates have agreed to vote any shares they own in favor of the Business Combination.

If the current Tottenham’s security holders exercise their registration rights with respect to their securities, it may have an adverse effect on the market price of PubCo’s securities.

Tottenham’s initial shareholders are entitled to make a demand that it registers the resale of their insider shares at any time commencing three months prior to the date on which their shares may be released from escrow. Additionally, our initial shareholders, including Sponsor, are entitled to demand that we register the resale of the shares underlying the Private Units and private rights and any securities our initial shareholders, officers, directors or their affiliates may be issued in payment of working capital loans made to us at any time upon or after we consummate a business combination. If such persons exercise their registration rights with respect to all of their securities, then there will be an additional [636,500] shares of PubCo Common Stock eligible for trading in the public market. The presence of these additional shares of common stock trading in the public market may have an adverse effect on the market price of PubCo Common Stock after the consummation of the Business Combination.

Tottenham will not obtain an opinion from an unaffiliated third party as to the fairness of the Business Combination to its shareholders.

Tottenham is not required to obtain an opinion from an unaffiliated third party that the price it is paying is fair to its public shareholders from a financial point of view. Although Tottenham’s board of directors did not receive a valuation report from any third party agency, Chardan has informed Tottenham’s management that its initial review of Clene is positive. Tottenham has conducted its own due diligence and calculations and has engaged in comprehensive discussions with Clene. Based on these efforts, Tottenham believes the valuation offered by Clene is favorable to Tottenham and its shareholders. Tottenham’s board of directors believes that because of the background of its directors, it was qualified to conclude that Clene’s fair market value was at least 80% of Tottenham’s net assets. Therefore, Tottenham’s board of directors did not obtain a fairness opinion to assist it in its determination and Tottenham’s board of directors may be incorrect in its assessment of the Business Combination and Tottenham public shareholders must rely solely on the judgment of Tottenham’s board of directors.

Tottenham’s directors and officers may have certain conflicts in determining to recommend the acquisition of Clene, since certain of their interests, and certain interests of their affiliates and associates, are different from, or in addition to, your interests as a shareholder.

Tottenham’s management and directors have interests in and arising from the Business Combination that are different from, or in addition to, your interests as a shareholder, which could result in a real or perceived conflict of interest. These interests include the fact that certain of the Tottenham’s securities owned by Tottenham’s management and directors, or their affiliates and associates, would become worthless if the Business Combination is not approved and Tottenham otherwise fails to consummate a Business Combination prior to its liquidation.

Tottenham will incur significant transaction costs in connection with transactions contemplated by the Merger Agreement.

Tottenham will incur significant transaction costs in connection with the Business Combination. If the Business Combination is not consummated, Tottenham may not have sufficient funds to seek an alternative business combination and may be forced to voluntarily liquidate and subsequently dissolve.

Risks Relating to the Business Combination

Tottenham and Clene have incurred and expect to incur significant costs associated with the Business Combination. Whether or not the Business Combination is completed, the incurrence of these costs will reduce the amount of cash available to be used for other corporate purposes by Tottenham if the Business Combination is completed or by Tottenham if the Business Combination is not completed.

Tottenham and Clene expect to incur significant costs associated with the Business Combination. Whether or not the Business Combination is completed, Tottenham expects to incur approximately $1,000,000 in expenses. These expenses will reduce the amount of cash available to be used for other corporate purposes by Tottenham if the Business Combination is completed or by Tottenham if the Business Combination is not completed.

In the event that a significant number of TOTA Ordinary Shares are redeemed, the PubCo Common Stock may become less liquid following the Business Combination.

If a significant number of TOTA Ordinary Shares are redeemed, PubCo may be left with a significantly smaller number of stockholders. As a result, trading in the shares of PubCo following the Business Combination may be limited and your ability to sell your shares in the market could be adversely affected.

Tottenham may waive one or more of the conditions to the Business Combination without resoliciting Tottenham shareholder approval for the Business Combination.

Tottenham may agree to waive, in whole or in part, some of the conditions to its obligations to complete the Business Combination, to the extent permitted by applicable laws. The Tottenham board of directors will evaluate the materiality of any waiver to determine whether amendment of this proxy statement/consent solicitation statement/prospectus and resolicitation of proxies is warranted. In some instances, if Tottenham board of directors determines that a waiver is not sufficiently material to warrant resolicitation of Tottenham shareholders, Tottenham has the discretion to complete the Business Combination without seeking further shareholder approval . For example, it is a condition to Tottenham’s obligations to close the Business Combination that there be no restraining order, injunction or other order restricting Clene’s conduct of its business, however, if Tottenham board of directors determines that any such order or injunction is not material to the business of Clene, then Tottenham board of directors may elect to waive that condition and close the Business Combination.

The grant and future exercise of registration rights may adversely affect the market price of PubCo’s securities upon consummation of the Business Combination.

Pursuant to the registration rights agreement to be entered into in connection with the Business Combination and which is described elsewhere in this proxy statement/consent solicitation statement/prospectus, certain stockholders can demand that PubCo register their registrable securities under certain circumstances and will also have piggyback

registration rights for these securities in connection with certain registrations of securities that PubCo undertakes. Following the consummation of the Business Combination, PubCo intends to file and maintain an effective registration statement under the Securities Act covering such securities.

The registration of these securities will permit the public resale of such securities. The registration and availability of such a significant number of securities for trading in the public market may have an adverse effect on the market price of PubCo Common Stock post-Business Combination.

There will be a substantial number of PubCo Common Stock available for sale in the future that may adversely affect the market price of PubCo Common Stock.

PubCo may issue such number of shares as may be approved by its stockholders and authorized by its directors, in accordance with the terms of PubCo’s first amended and restated certificate of incorporation (the “Certificate of Incorporation”). Clene will use its commercially reasonable efforts to cause its stockholders who will own more than 1% of the issued and outstanding PubCo Common Stock immediately after the closing to enter into Lock-Up Agreements that extend for six (6) months after closing. In addition, 400,000 shares of PubCo Common Stock held by our initial shareholders that are currently in an escrow account will be released and available for sale as early as six months from the date of the Business Combination, provided that 50% of such shares will be released on the date on which the closing price of the shares equals or exceeds $12.50 per share (as adjusted for share splits, share dividends, reorganizations and recapitalizations) for any 20 trading days within any 30-trading day period commencing after the initial Business Combination. The availability of such a significant number of securities for trading in the public market, after the expiration of these restricted periods, may have an adverse effect on the market price of PubCo Common Stock.

Regulatory approvals may not be received, may take longer than expected or may impose conditions that are not presently anticipated or cannot be met.

Before the transactions contemplated by the Merger Agreement can be completed, approval must be obtained under the HSR Act. In deciding whether to grant antitrust clearance, the relevant governmental authorities will consider a variety of factors, including the effect of the merger on competition within their relevant jurisdiction. The terms and conditions of the approvals that are granted may impose requirements, limitations or costs, or place restrictions on the conduct of Clene’s business following completion of the Business Combination. The requirements, limitations or costs imposed by the relevant governmental authorities could delay the closing of the merger or diminish the anticipated benefits of the merger. Additionally, the completion of the merger is conditioned on the absence of certain orders, injunctions or decrees by any court or regulatory authority of competent jurisdiction that would prohibit or make illegal the completion of the merger. Tottenham and Clene believe that the merger should not raise significant regulatory concerns and that Tottenham and Clene will be able to obtain all requisite regulatory approvals in a timely manner. However, Tottenham and Clene cannot be certain when or if regulatory approvals will be obtained or, if obtained, the conditions that may imposed. In addition, neither Tottenham nor Clene can provide assurance that any such conditions, terms, obligations or restrictions will not result in delay.

Tottenham shareholders will experience immediate dilution as a consequence of the issuance of PubCo Common Stock as consideration in the Business Combination. Having a minority share position may reduce the influence that Tottenham’s current shareholders have on the management of Tottenham.

After the Business Combination, assuming (i) no redemptions of Tottenham’s shares or Dissenting Shares, (ii) no exercise of the PubCo Warrants, and (iii) 3,000,000 PIPE Shares issued, Tottenham’s current public shareholders will own approximately 4.6% of PubCo, Tottenham’s initial shareholders will own approximately 1.5% of PubCo, holders of the PIPE Shares will own approximately 4.9% of PubCo, and Clene stockholders will own approximately 89.0% of PubCo. Assuming redemption by holders of [1,560,484] Tottenham’s outstanding ordinary shares, which assumes the maximum redemption of Tottenham ordinary shares after giving effect to payments to redeeming stockholders, Tottenham’s current public shareholders will own approximately 2.1% of PubCo, Tottenham’s initial shareholders will own approximately 1.5% of PubCo, holders of the PIPE Shares will own approximately 5.0% of PubCo, and Clene stockholders will own approximately 91.3% of PubCo. The minority position of the former Tottenham’s shareholders will give them limited influence over the management and operations of the post-Business Combination company.

Risks Relating to PubCo

Provisions in PubCo’s amended and restated certificate of incorporation and amended and restated bylaws that will be in effect upon the consummation of the Business Combination could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of PubCo’s common stock.

Provisions in PubCo’s amended and restated certificate of incorporation and amended and restated bylaws that will be in effect upon the consummation of the Business Combination may discourage, delay or prevent a merger, acquisition or other change in control of Pubco that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of PubCo’s common stock, thereby depressing the market price of PubCo’s common stock. Such provisions including the following:

•        a classified board of directors with three-year staggered terms, which could delay the ability of stockholders to change the membership of a majority of PubCo’s board of directors;

•        the ability of PubCo’s board of directors to issue shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;

•        the requirement for the affirmative vote of holders of at least 66 2/3% of the voting power of all of the then-outstanding shares of the voting stock, voting together as a single class, to amend the provisions of our amended and restated certificate of incorporation or PubCo’s amended and restated bylaws, which may inhibit the ability of an acquiror to effect such amendments to facilitate an unsolicited takeover attempt;

•        the exclusive right of PubCo’s board of directors to elect a director to fill a vacancy created by the expansion of PubCo’s board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on PubCo’s board of directors; and

•        the requirement that a special meeting of stockholders may be called only by the board of directors of PubCo, the chairman of the board of directors of PubCo or the Chief Executive Officer of PubCo, which could delay the ability of PubCo’s stockholders to force consideration of a proposal or to take action, including the removal of directors.

These and other provisions in PubCo’s amended and restated certificate of incorporation and amended and restated bylaws that will become effective upon consummation of the Business Combination could make it more difficult for stockholders or potential acquirors to obtain control of PubCo’s board of directors or initiate actions that are opposed by PubCo’s then-current board of directors, including delay or impede a merger, tender offer or proxy contest involving PubCo. The existence of these provisions could negatively affect the price of PubCo’s common stock and limit opportunities for you to realize value in a corporate transaction.

The Business Combination may be a taxable event for U.S. Holders of TOTA Ordinary Shares, TOTA Warrants, and TOTA Rights.

Subject to the limitations and qualifications described in “Material U.S. Federal Income Tax Consequences of the Business Combination,” including the application of the PFIC rules and Section 367(b) of the Code, the Reincorporation Merger should qualify as a “reorganization” within the meaning of Section 368(a)(1)(F) of the Code If the Reincorporation Merger qualifies as a “reorganization” within the meaning of Section 368(a)(1)(F) of the Code, a U.S. Holder of Tottenham securities may still recognize gain (but not loss) or be required to include the “all earnings and profits amount” upon the exchange of its Tottenham securities for PubCo securities pursuant to the Reincorporation Merger under Section 367(b) of the Code.

In addition, if the Reincorporation Merger does not qualify as a “reorganization” within the meaning of Section 368(a)(1)(F) of the Code, then a U.S. Holder that exchanges its TOTA Ordinary Shares, TOTA Rights, or TOTA Warrants for the consideration under the Business Combination will recognize gain or loss equal to the difference between (i) the sum of the fair market value of the PubCo Common Stock and PubCo Warrants received and (ii) the U.S. Holder’s adjusted tax basis in the TOTA Ordinary Shares, TOTA Rights, and TOTA Warrants exchanged therefor.

Notwithstanding the foregoing, U.S. Holders of TOTA Ordinary Shares, TOTA Warrants, and TOTA Rights may be subject to adverse U.S. federal income tax consequences under the passive foreign investment company regime. Please see “Material U.S. Federal Income Tax Consequences of the Business Combination — U.S. Holders — U.S. Federal Income Tax Consequences of the Reincorporation Merger to U.S. Holders of Tottenham Securities — Passive Foreign Investment Company Status” for a more detailed discussion with respect to Tottenham’s potential PFIC status and certain tax implications thereof.

Tottenham may be or may have been a PFIC during a U.S. Holder’s holding period.

If Tottenham is a PFIC or has been a PFIC during a U.S. Holder’s holding period, such U.S. Holder may be subject to certain adverse U.S. federal income tax consequences as a result of the Reincorporation Merger. There is no assurance that Tottenham is not currently or has not been a PFIC during a U.S. Holder’s holding period. If (a) Tottenham has been a PFIC for any taxable year during the holding period of a U.S. Holder (and a U.S. Holder of TOTA Ordinary Shares, TOTA Rights, or TOTA Warrants has not made certain elections with respect to its TOTA Ordinary Shares, TOTA Rights, or TOTA Warrants), and (b) PubCo is not a PFIC in the taxable year of the Reincorporation Merger, such U.S. Holder would likely recognize gain (but not loss if the Reincorporation Merger qualifies as a “reorganization” within the meaning of Section 368(a)(1)(F) of the Code) upon the exchange of TOTA Ordinary Shares, TOTA Rights, and TOTA Warrants, as applicable, for PubCo Common Stock or PubCo Warrants pursuant to the Reincorporation Merger. Please see “Material U.S. Federal Income Tax Consequences of the Business Combination — U.S. Holders — U.S. Federal Income Tax Consequences of the Reincorporation Merger to U.S. Holders of Tottenham Securities — Passive Foreign Investment Company Status” for a more detailed discussion with respect to TOTA’s potential PFIC status and certain tax implications thereof.

If the Acquisition Merger does not qualify as a reorganization under Section 368(a) of the Code, U.S. Holders of Clene common stock and Clene warrants may be required to pay substantial U.S. federal income taxes.

Clene’s obligation to effect the Acquisition Merger is conditioned on its receipt of an opinion from its tax counsel, Kirkland & Ellis LLP, to the effect that, for U.S. federal income tax purposes, the Acquisition Merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. The opinion will be based on certain assumptions and representations as to factual matters from Clene, Tottenham, PubCo and Merger Sub, as well as certain covenants by those parties. In addition, the opinion is based on current law and cannot be relied upon if current law changes with retroactive effect. The opinion of counsel is not binding upon the Internal Revenue Service (the “IRS”) or the courts, and there can be no assurance that the IRS or a court will not take a contrary position. Clene and Tottenham do not intend to request a ruling from the IRS regarding any aspects of the U.S. federal income tax consequences of the Acquisition Merger. If the Acquisition Merger does not qualify as a “reorganization” within the meaning of Section 368(a) of the Code, then a U.S. Holder that exchanges its Clene common stock or Clene warrants for PubCo Common Stock or PubCo Warrants, as applicable, may recognize gain in connection with the Acquisition Merger and may be subject to substantial U.S. federal income taxes. For more information on the material U.S. federal income tax consequences of the Acquisition Merger to U.S. Holders of Clene securities, see “Material U.S. Federal Income Tax Consequences of the Business Combination — U.S. Holders — U.S. Federal Income Tax Consequences of the Acquisition Merger to U.S. Holders of Clene Securities.”

THE EXTRAORDINARY GENERAL MEETING OF TOTTENHAM SHAREHOLDERS

General

We are furnishing this proxy statement/consent solicitation statement/prospectus to Tottenham shareholders as part of the solicitation of proxies by Tottenham board of directors for use at the Extraordinary General Meeting to be held on [•], 2020 and at any adjournment or postponement thereof. This proxy statement/consent solicitation statement/prospectus is first being furnished to our shareholders on or about [•], 2020 in connection with the vote on the Reincorporation Merger Proposal, the Acquisition Merger Proposal, the Incentive Plan Proposal and the Adjournment Proposal. This document provides you with the information you need to know to be able to vote or instruct your vote to be cast at the Extraordinary General Meeting.

Date, Time and Place

The Extraordinary General Meeting will be held on [•], 2020 at [•] a.m. Hong Kong Time, or such other date, time and place to which such meeting may be adjourned or postponed. Due to the COVID-19 pandemic, Tottenham will be holding the Extraordinary General Meeting as a teleconference using the following dial-in information:

Purpose of the Extraordinary General Meeting

At the Extraordinary General Meeting, we are asking holders of TOTA Ordinary Shares to approve the following Proposals:

•        The Reincorporation Merger Proposal to approve the Reincorporation Merger;

•        The Acquisition Merger Proposal to approve the Acquisition Merger;

•        The Incentive Plan Proposal to approve PubCo’s Incentive Plan;

•        The ESPP Plan Proposal to approve PubCo’s ESPP Plan; and

•        The Adjournment Proposal to approve the adjournment of the Extraordinary General Meeting in the event Tottenham does not receive the requisite shareholder vote to approve the above Proposals.

Recommendation of Tottenham’s Board of Directors

Tottenham board of directors:

•        has determined that each of the Reincorporation Merger Proposal, the Acquisition Merger Proposal, the Incentive Plan Proposal and the Adjournment Proposal, are fair to, and in the best interests of, Tottenham and its shareholders;

•        has approved the Reincorporation Merger Proposal, the Acquisition Merger Proposal, the Incentive Plan Proposal and the Adjournment Proposal; and

•        recommends that Tottenham shareholders vote “FOR” each of the Reincorporation Merger Proposal, the Acquisition Merger Proposal, the Incentive Plan Proposal and the Adjournment Proposal.

Tottenham board of directors have interests that may be different from or in addition to your interests as a shareholder. See “Proposal No. 2 The Acquisition Merger Proposal — Interests of Certain Persons in the Business Combination” in this proxy statement/consent solicitation statement/prospectus for further information.

Record Date; Who is Entitled to Vote

We have fixed the close of business on [•], 2020, as the record date for determining those Tottenham shareholders entitled to notice of and to vote at the Extraordinary General Meeting. As of the close of business on [•], 2020, there were [3,710,386] TOTA Ordinary Shares outstanding and entitled to vote. Each holder of TOTA Ordinary Shares is entitled to one vote per share on each of the Proposals.

As of [•], 2020, the initial shareholders collectively own and is entitled to vote [1,365,000] TOTA Ordinary Shares, or approximately [36.79]% of Tottenham’s issued and outstanding ordinary shares. With respect to the Business Combination, they have agreed to vote their TOTA Ordinary Shares acquired by them in favor of the Reincorporation Proposal and the Acquisition Merger Proposal. The Sponsor has indicated that it intends to vote its shares, as applicable, “FOR” the other Proposals, although there is no agreement in place with respect to the other Proposals.

Quorum and Required Vote for the Proposals

A quorum of Tottenham shareholders is necessary to hold a valid meeting. A quorum will be present at the Extraordinary General Meeting if a majority of the shares of capital stock issued and outstanding as of the record date and entitled to vote at the Extraordinary General Meeting is represented in person or by proxy. A Tottenham holder present in person or by proxy and abstaining from voting at the Extraordinary General Meeting will count as present for the purposes of establishing a quorum but broker non-votes will not.

Approval of the Reincorporation Proposal and the Acquisition Proposal will require the affirmative vote of 65% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof. Approval of the Incentive Plan Proposal, the ESPP Plan Proposal and the Adjournment Proposal will require the affirmative vote of 50% of the issued and outstanding TOTA Ordinary Shares present and entitled to vote at the Extraordinary General Meeting or any adjournment thereof. Attending the Extraordinary General Meeting either in person or by proxy and abstaining from voting will have the same effect as voting against all the Proposals and, assuming a quorum is present, broker non-votes will have no effect on the voting on Proposals.

Voting Your Shares

Each TOTA Ordinary Share that you own in your name entitles you to one vote for each Proposal on which such shares are entitled to vote at the Extraordinary General Meeting. Your proxy card shows the number of TOTA Ordinary Shares that you own.

There are two ways to ensure that your TOTA Ordinary Shares are voted at the Extraordinary General Meeting:

•        You can cause your shares to be voted by signing and returning the enclosed proxy card. If you submit your proxy card, your “proxy,” whose name is listed on the proxy card, will vote your shares as you instruct on the proxy card. If you sign and return the proxy card but do not give instructions on how to vote your shares, your shares will be voted, as recommended by Tottenham board of directors, “FOR” the adoption of the Reincorporation Merger Proposal, the Acquisition Merger Proposal, the Incentive Plan Proposal and the Adjournment Proposal. Votes received after a matter has been voted upon at the Extraordinary General Meeting will not be counted.

•        You can attend the Extraordinary General Meeting and vote in person. We will give you a ballot when you arrive. However, if your shares are held in the name of your broker, bank or another nominee, you must get a proxy from the broker, bank or other nominee. That is the only way we can be sure that the broker, bank or nominee has not already voted your shares.

IF YOU RETURN YOUR PROXY CARD WITHOUT AN INDICATION OF HOW YOU WISH TO VOTE, YOUR SHARES WILL BE VOTED IN FAVOR OF THE REINCORPORATION MERGER PROPOSAL AND THE ACQUISITION MERGER PROPOSAL (AS WELL AS THE OTHER PROPOSALS). IN ORDER TO REDEEM YOUR SHARES, YOU MUST TENDER YOUR SHARES TO OUR TRANSFER AGENT AT LEAST TWO BUSINESS DAYS PRIOR TO THE EXTRAORDINARY GENERAL MEETING. YOU MAY TENDER YOUR SHARES FOR REDEMPTION BY EITHER DELIVERING YOUR SHARE CERTIFICATE TO THE TRANSFER AGENT OR BY DELIVERING YOUR SHARES ELECTRONICALLY USING THE DEPOSITORY TRUST COMPANY’S DWAC SYSTEM. IF THE BUSINESS COMBINATION IS NOT COMPLETED, THEN THESE TENDERED SHARES WILL NOT BE REDEEMED FOR CASH AND WILL BE RETURNED TO THE APPLICABLE SHAREHOLDER. IF YOU HOLD THE SHARES IN STREET NAME, YOU WILL NEED TO INSTRUCT THE ACCOUNT EXECUTIVE AT YOUR BROKER OR BANK TO WITHDRAW THE SHARES FROM YOUR ACCOUNT IN ORDER TO EXERCISE YOUR REDEMPTION RIGHTS.

Revoking Your Proxy

If you give a proxy, you may revoke it at any time before it is exercised by doing any one of the following:

•        you may send another proxy card with a later date;

•        if you are a record holder, you may notify our proxy solicitor, Advantage Proxy, in writing before the Extraordinary General Meeting that you have revoked your proxy; or

•        you may attend the Extraordinary General Meeting, revoke your proxy, and vote in person, as indicated above.

Who Can Answer Your Questions About Voting Your Shares

If you have any questions about how to vote or direct a vote in respect of your ordinary shares, you may call Advantage Proxy, our proxy solicitor, at 877-970-8565.

No Additional Matters May Be Presented at the Extraordinary General Meeting

This Extraordinary General Meeting has been called only to consider the approval of the Proposals.

Redemption Rights

Pursuant to Tottenham’s second amended and restated memorandum and articles of association, a holder of TOTA Ordinary Shares has the right to have its public shares redeemed for cash equal to its pro rata share of the trust account (net of taxes payable) in connection with the Business Combination.

If you are a public shareholder and you seek to have your shares redeemed, you must (i) demand, no later than 5:00 p.m., Eastern Time on [•], 2020 (two (2) business days before the Extraordinary General Meeting), that Tottenham redeem your shares into cash; and (ii) submit your request in writing to Tottenham’s transfer agent, at the address listed at the end of this section and deliver your shares to Tottenham’s transfer agent physically or electronically using the DWAC system at least two (2) business days prior to the vote at the Extraordinary General Meeting. In order to validly request redemption, you must either make a request for redemption on the proxy card or separately send a request in writing to Tottenham’s transfer agent. The proxy card or separate request must be signed by the applicable shareholder in order to validly request redemption. A shareholder is not required to submit a proxy card or vote in order to validly exercise redemption rights.

You may tender the TOTA Ordinary Shares for which you are electing redemption by two (2) business days before the Extraordinary General Meeting by either:

•        Delivering certificates representing Tottenham’s ordinary shares to Tottenham’s transfer agent, or

•        Delivering the TOTA Ordinary Shares electronically through the DWAC system.

Tottenham shareholders will be entitled to redeem their TOTA Ordinary Shares for a full pro rata share of the trust account (currently anticipated to be no less than approximately $[•] per share) net of taxes payable.

Any corrected or changed written demand of redemption rights must be received by Tottenham’s transfer agent two (2) business days prior to the Extraordinary General Meeting. No demand for redemption will be honored unless the holder’s shares have been delivered (either physically or electronically) to the transfer agent at least two (2) business days prior to the vote at the Extraordinary General Meeting.

Public shareholders may seek to have their shares redeemed regardless of whether they vote for or against the Business Combination and whether or not they are holders of TOTA Ordinary Shares as of the record date. Any public shareholder who holds TOTA Ordinary Shares on or before [•], 2020 (two (2) business days before the Extraordinary General Meeting) will have the right to demand that his, her or its shares be redeemed for a pro rata share of the aggregate amount then on deposit in the trust account, less any taxes then due but not yet paid, at the consummation of the Business Combination.

In connection with tendering your shares for redemption, you must elect either to physically tender your share certificates to Tottenham’s transfer agent or deliver your shares to the transfer agent electronically using The Depository Trust Company’s DWAC System, in each case, two (2) business days before the Extraordinary General Meeting.

Through the DWAC system, this electronic delivery process can be accomplished by contacting your broker and requesting delivery of your shares through the DWAC system. Delivering shares physically may take significantly longer. In order to obtain a physical share certificate, a shareholder’s broker and/or clearing broker, DTC, and Tottenham’s transfer agent will need to act together to facilitate this request. There is a nominal cost associated with the above-referenced tendering process and the act of certificating the shares or delivering them through the DWAC system. The transfer agent will typically charge the tendering broker $45 and the broker would determine whether or not to pass this cost on to the redeeming holder. It is Tottenham’s understanding that Tottenham shareholders should generally allot at least two weeks to obtain physical certificates from the transfer agent. Tottenham does not have any control over this process or over the brokers or DTC, and it may take longer than two weeks to obtain a physical share certificate. Tottenham shareholders who request physical share certificates and wish to redeem may be unable to meet the deadline for tendering their shares before exercising their redemption rights and thus will be unable to redeem their shares.

In the event that a shareholder tenders its shares and decides prior to the consummation of the Business Combination that it does not want to redeem its shares, the shareholder may withdraw the tender. In the event that a shareholder tenders shares and the Business Combination is not completed, these shares will not be redeemed for cash and the physical certificates representing these shares will be returned to the shareholder promptly following the determination that the Business Combination will not be consummated. Tottenham anticipates that a shareholder who tenders shares for redemption in connection with the vote to approve the Business Combination would receive payment of the redemption price for such shares soon after the completion of the Business Combination.

If properly demanded by Tottenham public shareholders, Tottenham will redeem each share into a pro rata portion of the funds available in the trust account, calculated as of two business days prior to the anticipated consummation of the Business Combination. As of the record date, this would amount to approximately $[•] per share. If you exercise your redemption rights, you will be exchanging your TOTA Ordinary Shares for cash and will no longer own the shares. In the absence of shareholder approval for a further extension, if Tottenham is unable to complete the Business Combination by November 6, 2020, it will liquidate and dissolve and public shareholders would be entitled to receive approximately $[•] per share upon such liquidation.

The Business Combination will not be consummated if the holders of [•] or more of Tottenham’s ordinary shares exercise their redemption rights.

Holders of outstanding TOTA Units must separate the underlying TOTA Ordinary Shares, TOTA Warrants and TOTA Rights prior to exercising redemption rights with respect to the TOTA Ordinary Shares. If TOTA Units are registered in a holder’s own name, the holder must deliver the certificate for its TOTA Units to the transfer agent with written instructions to separate the TOTA Units into their individual component parts. This must be completed far enough in advance to permit the mailing of the certificates back to the holder so that the holder may then exercise his, her or its redemption rights upon the separation of the TOTA Ordinary Shares from the TOTA Units.

If a broker, dealer, commercial bank, trust company or other nominee holds TOTA Units for an individual or entity (such individual or entity, the “beneficial owner”), the beneficial owner must instruct such nominee to separate the beneficial owner’s TOTA Units into their individual component parts. The beneficial owner’s nominee must send written instructions by facsimile to the transfer agent. Such written instructions must include the number of TOTA Units to be separated and the nominee holding such TOTA Units. The beneficial owner’s nominee must also initiate electronically, using DTC’s DWAC system, a withdrawal of the relevant TOTA Units and a deposit of an equal number of TOTA Ordinary Shares, TOTA Warrants and TOTA Rights. This must be completed far enough in advance to permit the nominee to exercise the beneficial owner’s redemption rights upon the separation of the TOTA Ordinary Shares from the TOTA Units. While this is typically done electronically the same business day, beneficial owners should allow at least one full business day to accomplish the separation. If beneficial owners fail to cause their TOTA Ordinary Shares to be separated in a timely manner, they will likely not be able to exercise their redemption rights.

If you have questions regarding the certification of your position or delivery of your shares, please contact:

Continental Stock Transfer & Trust Company
One State Street Plaza, 30th Floor
New York, NY 10004
Attn: Mark Zimkind
E-mail: mzimkind@continentalstock.com

Tendering Ordinary Shares Certificates in connection with Redemption Rights

Tottenham is requiring Tottenham public shareholders seeking to exercise their redemption rights, whether they are record holders or hold their shares in “street name,” to either tender their certificates to Tottenham’s transfer agent, or to deliver their shares to the transfer agent electronically using Depository Trust Company’s DWAC System, at the holder’s option at least two (2) business days prior to the Extraordinary General Meeting. There is a nominal cost associated with the above-referenced tendering process and the act of certificating the shares or delivering them through the DWAC System. The transfer agent will typically charge the tendering broker $45.00 and it would be up to the broker whether to pass this cost on to the redeeming holder. However, this fee would be incurred regardless of whether Tottenham requires holders seeking to exercise redemption rights to tender their ordinary shares. The need to deliver ordinary shares is a requirement of exercising redemption rights regardless of the timing of when such delivery must be effectuated.

Any request for redemption, once made, may be withdrawn at any time up to two business days immediately preceding the Extraordinary General Meeting. Furthermore, if a shareholder delivered his certificate for redemption and subsequently decided, at any time up to two business days immediately preceding the Extraordinary General Meeting, not to elect redemption, he may simply request that the transfer agent return the certificate (physically or electronically).

A redemption payment will only be made in the event that the proposed Business Combination is consummated. If the proposed Business Combination is not completed for any reason, then public shareholders who exercised their redemption rights would not be entitled to receive the redemption payment. In such case, Tottenham will promptly return the share certificates to the public shareholder.

Dissenter Rights

In accordance with Section 179 of the BVI BC Act, a holder of TOTA Ordinary Shares is entitled to payment of the fair value of all of its shares upon validly dissenting from the Reincorporation Merger. Holders of TOTA Ordinary Shares may only dissent in respect of all shares that they hold in Tottenham.

Upon a holder of TOTA Ordinary Shares validly exercising its entitlement under Section 179 of the BVI BC Act, such Dissenting Shareholder ceases to have any rights (including the redemption rights) of a shareholder of Tottenham except the right to be paid the fair value of its TOTA Ordinary Shares.

A holder of TOTA Ordinary Shares who desires to exercise its entitlement to payment of the fair value of all of its shares is required to give to Tottenham written objection to the Reincorporation Merger before the Extraordinary General Meeting or before the vote on the Reincorporation Merger Proposal at the Extraordinary General Meeting.

Within 20 days immediately following the date on which the approval of Tottenham shareholders is obtained at the Extraordinary General Meeting (or any adjourned meeting), Tottenham shall give written notice of the approval to each Tottenham shareholder who gave a valid written objection to the Reincorporation Merger, except for those Tottenham shareholders who after giving the written objection, subsequently voted to approve the Reincorporation Merger Proposal at the Extraordinary General Meeting (or any adjourned meeting). Any such holder of TOTA Ordinary Shares who elects to dissent is required, within 20 days immediately following the date on which the notice of approval by Tottenham referred to above is given, to give Tottenham a written notice of its decision to elect to dissent, stating: (a) its name and address; (b) the number of TOTA Ordinary Shares in respect of which it dissents; and (c) a demand for payment of the fair value of its shares. On the effective date, a Dissenting Shareholder shall have its TOTA Ordinary Shares automatically cancelled in exchange for the right to receive payment resulting from the procedure in Section 179 of the BVI BC Act and such Dissenting Shareholder shall not be entitled to receive PubCo Common Stock pursuant to the Reincorporation Merger.

A Tottenham shareholder who elects to dissent under Section 179 of the BVI BC Act and validly exercises its entitlement to payment of the fair value of the TOTA Ordinary Shares it holds following the procedures set forth above will not be entitled to have its TOTA Ordinary Shares redeemed. If a Tottenham shareholder has elected to have its TOTA Ordinary Shares redeemed but later elects to dissent, upon receipt of the written notice of such a Tottenham shareholder’s decision to elect to dissent, Tottenham shall instruct its transfer agent to return the TOTA Ordinary Shares (physically or electronically) delivered to the transfer agent in connection with such Tottenham shareholder’s demand for redemption to the Tottenham shareholder.

Holders of outstanding TOTA Units must separate the underlying TOTA Ordinary Shares, TOTA Warrants and TOTA Rights prior to objecting to the Reincorporation Merger and exercising their dissenter rights under Section 179 of the BVI BC Act. If TOTA Units are registered in a holder’s own name, the holder must deliver the certificate for its TOTA Units to Continental with written instructions to separate the TOTA Units into their individual component parts. This must be completed far enough in advance to permit the mailing of the certificates back to the holder so that the holder may object to the Reincorporation Merger and then exercise his, her or its dissenter rights upon the separation of the TOTA Ordinary Shares from the TOTA Units.

If a broker, dealer, commercial bank, trust company or other nominee holds TOTA Units for an individual or entity (such individual or entity, the “beneficial owner”), the beneficial owner must instruct such nominee to separate the beneficial owner’s TOTA Units into their individual component parts. The beneficial owner’s nominee must send written instructions by facsimile to Continental. Such written instructions must include the number of TOTA Units to be separated and the nominee holding such TOTA Units. The beneficial owner’s nominee must also initiate electronically, using DTC’s DWAC system, a withdrawal of the relevant TOTA Units and a deposit of an equal number of TOTA Ordinary Shares, TOTA Warrants and TOTA Rights. This must be completed far enough in advance to permit the mailing of a physical certificate back to the holder so that the holder may object to the Reincorporation Merger and then exercise his, her or its dissenter rights upon the separation of the TOTA Ordinary Shares from the TOTA Units. While this is typically done electronically the same business day, beneficial owners should allow at least one full business day to accomplish the separation. If beneficial owners fail to cause their TOTA Ordinary Shares to be separated in a timely manner, they will likely not be able to object to the Reincorporation Merger and exercise their dissenter rights.

Proxies and Proxy Solicitation Costs

We are soliciting proxies on behalf of Tottenham board of directors. This solicitation is being made by mail but also may be made by telephone or in person. Tottenham and its directors, officers and employees may also solicit proxies in person, by telephone or by other electronic means. Any solicitation made and information provided in such a solicitation will be consistent with the written proxy statement/consent solicitation statement/prospectus and proxy card. Advantage Proxy, a proxy solicitation firm that Tottenham has engaged to assist it in soliciting proxies, will be paid its customary fee and out-of-pocket expenses.

Tottenham will ask banks, brokers and other institutions, nominees and fiduciaries to forward its proxy materials to their principals and to obtain their authority to execute proxies and voting instructions. Tottenham will reimburse them for their reasonable expenses.

If you send in your completed proxy card, you may still vote your shares in person if you revoke your proxy before it is exercised at the Extraordinary General Meeting.

PROPOSAL NO. 1

THE REINCORPORATION MERGER PROPOSAL

The discussion in this proxy statement/consent solicitation statement/prospectus of the Business Combination and the principal terms of the Merger Agreement, is subject to, and is qualified in its entirety by reference to, the Merger Agreement. The full text of the Merger Agreement and the Plan of Merger is attached hereto as Annex A, which is incorporated by reference herein.

Purpose of the Reincorporation Merger Proposal

The purpose of the Reincorporation Merger is to establish a Delaware corporation as the parent entity of Clene. As a result of the Reincorporation Merger, the Tottenham shareholders will no longer be shareholders of Tottenham and (other than the Dissenting Shareholders and the Tottenham shareholders who exercise their redemption rights) will become stockholders of PubCo. The Reincorporation is a condition to consummation of the Business Combination. Clene required that Tottenham redomicile in the state of Delaware in order to enter into the Merger Agreement. Being redomiciled in Delaware will create operation efficiencies for the combined company due to the fact that Clene and its subsidiaries are all located in the United States and a Delaware corporation will provide its stockholders with certain rights not afforded to them by a British Virgin Islands company. The Reincorporation will be completed immediately prior to the Business Combination. As part of the Reincorporation, Tottenham’s corporate name will be that of the surviving company, “Chelsea Worldwide Inc.”

Summary of the Reincorporation Merger

The Merger Agreement was entered into by and among Tottenham, PubCo, Merger Sub, Clene and certain other parties on September 1, 2020. Upon the approval of the Merger Agreement by the Tottenham shareholders and concurrently with the Acquisition Merger, Tottenham will reincorporate to Delaware by merging with and into the PubCo, a Delaware corporation and wholly owned subsidiary of Tottenham. The separate corporate existence of Tottenham will cease and PubCo will continue as the surviving corporation. In connection with the Reincorporation Merger, all outstanding TOTA Units will separate into their individual components of TOTA Ordinary Shares, TOTA Rights and TOTA Warrants and will cease separate existence and trading. Upon the consummation of the Business Combination, the current equity holdings of the Tottenham shareholders shall be exchanged as follows:

(i)     Each TOTA Ordinary Share, issued and outstanding immediately prior to the effective time of the Reincorporation Merger (other than any redeemed shares and Dissenting Shares), will automatically be cancelled and cease to exist and for each TOTA Ordinary Share, PubCo shall issue to each Tottenham shareholder (other than the Dissenting Shareholders and Tottenham shareholders who exercise their redemption rights in connection with the Business Combination) one validly issued share of PubCo Common Stock, which, unless explicitly stated herein, shall be fully paid;

(ii)    each Dissenting Share held by a Dissenting Shareholder (who has not effectively withdrawn its right to such dissent) will be cancelled in exchange for the right to receive payment resulting from the procedure in Section 179 of the BVI BC Act and such Dissenting Shareholders will not be entitled to receive any shares of the PubCo Common Stock to be issued in connection with the Reincorporation Merger;

(iii)   Each TOTA Warrant issued and outstanding immediately prior to effective time of the Reincorporation Merger will convert into a PubCo Warrant to purchase one-half of one share of PubCo Common Stock (or equivalent portion thereof). The PubCo Warrants will have substantially the same terms and conditions as set forth in the TOTA Warrants; and

(iv)   The holders of TOTA Rights issued and outstanding immediately prior to the effective time of the Reincorporation Merger will receive one-tenth (1/10) of one share of PubCo Common Stock in exchange for the cancellation of each TOTA Right; provided, however, that no fractional shares will be issued and all fractional shares will be rounded to the nearest whole share.

Additionally, immediately prior to the exchange listed above, Tottenham shall cancel and forfeit an aggregate of 750,000 insider shares collectively owned by the initial shareholders for no additional consideration.

PubCo’s Amended and Restated Certificate of Incorporation

Shortly before completion of the Business Combination, the amended and restated certificate of incorporation, or the proposed charter, will be adopted by PubCo. By voting in favor the Reincorporation Merger Proposal, you also agree that the combined company will adopt the proposed charter. The following table sets forth a summary of the principal changes proposed to be made between Tottenham’s second amended and restated memorandum and articles of association and the proposed charter. This summary is qualified by reference to the complete text of the proposed charter, a copy of which is attached to this proxy statement/consent solicitation statement/prospectus as Annex B. All shareholders are encouraged to read the proposed charter in its entirety for a complete description of its terms.

Required Vote

Approval of the Reincorporation Merger Proposal requires the affirmative vote of the holders of 65% of the TOTA Ordinary Shares as of the record date represented in person or by proxy at the Extraordinary General Meeting and entitled to vote thereon. Adoption of the Reincorporation Merger Proposal is conditioned upon the adoption of the Acquisition Merger Proposal. It is important for you to note that in the event that either of the Reincorporation Merger Proposal or the Acquisition Merger Proposal is not approved, then Tottenham will not consummate the Business Combination.

Recommendation of Tottenham’s Board of Directors

After careful consideration, Tottenham board of directors determined that the Reincorporation Merger forming part of the Business Combination with Clene is in the best interests of Tottenham and its shareholders. On the basis of the foregoing, Tottenham board of directors has approved and declared advisable the Business Combination with Clene and recommends that you vote or give instructions to vote “FOR” adoption of the Reincorporation Merger Proposal.

Conditions to Closing

General Conditions

Consummation of the transactions herein is conditioned on, among other things, (i) the absence of any order or provisions of any applicable law making the transactions illegal or otherwise preventing the transactions; (ii) Tottenham and Clene receiving approval from their respective shareholders to the transactions, (iii) Tottenham retaining its listing on Nasdaq and the additional listing application for the closing payment shares issued to Clene’s stockholders being approved by Nasdaq; and (iv) the Escrow Agreement as described in the Merger Agreement being entered into and in full force and effect.

Clene’s Conditions to Closing

The obligations of Clene to consummate the transactions contemplated by the Merger Agreement, in addition to the conditions described above, are conditioned upon each of the following, among other things:

•        Purchaser Parties complying with all of their obligations under the Merger Agreement in all material respects;

•        subject to applicable materiality qualifiers, the representations and warranties of Purchaser Parties being true on and as of the closing date of the transactions;

•        all debt owed by Tottenham to the Sponsor shall have been converted into TOTA Ordinary Shares;

•        the net amount of fund in the trust account, together with any net proceeds raised in connection with the mergers contemplated in the Merger Agreement, shall be no less than $30,000,000;

•        the initial shareholders shall have canceled and forfeited, for no additional consideration, 750,000 insider shares;

•        its receipt of an opinion of Kirkland & Ellis LLP providing that the Acquisition Merger will qualify for the reorganization within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended;

•        Tottenham remains listed on Nasdaq and shall not have received any written notice from Nasdaq that it has failed, or would reasonably be expected to fail to meet the Nasdaq listing requirements as of the Closing Date where such notice has not been subsequently withdrawn by Nasdaq or the underlying failure appropriately remedied or satisfied;

•        the additional listing application for the closing payment shares shall have been approved by Nasdaq;

•        Purchaser Parties complying with the reporting requirements under the applicable Securities Act and Exchange Act; and

•        there having been no material adverse effect to Purchaser Parties or Purchaser Parties Material Adverse Effect (COVID-19 Pandemic is excluded herein pursuant to below defnition).

“Purchaser Parties Material Adverse Effect” shall mean a material adverse change or a material adverse effect on the assets, liabilities, condition (financial or otherwise), prospects, business or operations of the Purchaser Parties (and their respective Subsidiaries), taken as a whole, provided, however, that “Purchaser Parties Material Adverse Effect” shall not include or take into account any event, occurrence, fact, condition or change, directly or indirectly, arising out of or attributable to: (i) general economic or political conditions; (ii) conditions generally affecting the industries in which the Purchaser Parties operate; (iii) any changes in financial, banking or securities markets in general, including any disruption thereof and any decline in the price of any security or any market index or any change in prevailing interest rates, or currency exchange rates, monetary policy or fiscal policy; (iv) acts of war (whether or not declared), armed hostilities or terrorism, and any pandemic, epidemics or human health crises, including COVID-19; (v) any action contemplated by this Agreement or any action taken (or omitted to be taken) with the written consent of or at the written request of Clene; (vi) any matter of which the Purchaser Parties are aware on the date hereof; (vii) any changes in applicable Laws or accounting rules (including U.S. GAAP) or the enforcement, implementation or interpretation thereof; (viii) the announcement, pendency or completion of the transactions contemplated by this Agreement, including losses or threatened losses of employees, customers, suppliers, distributors or others having

relationships with the Purchaser Party; (ix) any natural or man-made disaster or acts of God; or (x) any failure by the Purchaser Parties to meet any internal or published projections, forecasts or revenue or earnings predictions (provided that the underlying causes of such failures (subject to the other provisions of this definition) shall not be excluded if not otherwise falling within any of the clauses (i) through (ix) above).

Purchaser Parties’ Conditions to Closing

The obligations of Purchaser Parties to consummate the transactions contemplated by the Merger Agreement, in addition to the conditions described above in the first paragraph of this section, are conditioned upon each of the following, among other things:

•        Clene and its subsidiaries complying with all of the obligations under the Merger Agreement in all material respects;

•        except as would reasonably be expected to have a material adverse effect on Clene, the representations and warranties of Clene and its subsidiaries being true on and as of the closing date of the transactions; and

•        there having been no material adverse effect to Clene’s business or Company Material Adverse Effect (COVID-19 Pandemic is excluded herein pursuant to below definition).

“Company Material Adverse Effect” means a material adverse change or a material adverse effect on the assets, liabilities, condition (financial or otherwise), prospects, business or operations of Clene (and its subsidiaries) and its busienss, taken as a whole, provided, however, that “Company Material Adverse Effect” shall not include or take into account any event, occurrence, fact, condition or change, directly or indirectly, arising out of or attributable to: (i) general economic or political conditions; (ii) conditions generally affecting the industries in which Clene operates; (iii) any changes in financial, banking or securities markets in general, including any disruption thereof and any decline in the price of any security or any market index or any change in prevailing interest rates, or currency exchange rates, monetary policy or fiscal policy; (iv) acts of war (whether or not declared), armed hostilities or terrorism, and any pandemic, epidemics or human health crises, including COVID-19; (v) any action contemplated by this Agreement or any action taken (or omitted to be taken) with the written consent of or at the written request of the Purchaser Parties; (vi) any matter of which Tottenham is aware on the date hereof; (vii) any changes in applicable laws or accounting rules (including U.S. GAAP) or the enforcement, implementation or interpretation thereof; (viii) the announcement, pendency or completion of the transactions contemplated by this Agreement, including losses or threatened losses of employees, customers, suppliers, distributors or others having relationships with Clene; (ix) any natural or man-made disaster or acts of God; or (x) any failure by Clene to meet any internal or published projections, forecasts or revenue or earnings predictions (provided that the underlying causes of such failures (subject to the other provisions of this definition) shall not be excluded if not otherwise falling within any of clauses (i) though (ix) above).

Indemnification

Until the six (6) months anniversary from and after the closing date, Clene’s stockholders will indemnify the PubCo, solely from the Escrow Shares, for any losses incurred or sustained by the PubCo arising from any breach, inaccuracy or nonfulfillment of any of the representations, warranties and covenants of Clene contained herein. The indemnification applies only to amounts (in aggregate) in excess of $1,000,000, and the indemnification obligations are capped at the value of the Escrow Shares. Such indemnification can only be satisfied with the cancellation of shares of PubCo Common Stock.

Termination

The Merger Agreement may be terminated and/or abandoned at any time prior to the closing, whether before or after approval of the proposals being presented to Tottenham’s shareholders , by:

•        mutual consent of Clene and the Purchaser Parties;

•        either Tottenham or Clene, if any legal restraint permanently restraining, enjoining or otherwise prohibiting the transactions contemplated by this Agreement has become final and non-appealable; provided, however, that the right to terminate the Merger Agreement pursuant to this clause shall not be available to a party if the failure by such party or its affiliates to comply with any provision of the Merger Agreement is the principal cause of the legal restraint or the failure of the legal restraint to be lifted;

•        either Tottenham or Clene, if the closing has not occurred by the earlier of (i) the Deadline (as defined in the memorandum and articles of association of Tottenham (as amended) and as extended from time to time in accordance therewith) and (ii) February 6, 2021 (“Outside Closing Date”), provided that no material breach of this Agreement by the party seeking to terminate this Agreement shall have occurred or have been made;

•        Tottenham, if Clene has materially breached any representation, warranty, agreement or covenant contained in the Merger Agreement and such breach (A) would result in the failure to satisfy certain conditions to closing and (B) is incapable of being cured by the Outside Closing Date, or if capable of being cured by the Outside Closing Date, shall not be cured within fifteen (15) days following the receipt by Clene of a notice describing such breach; or

•        Clene, if Tottenham has materially breached any representation, warranty, agreement or covenant contained in the Merger Agreement and such breach (A) would result in the failure to satisfy certain conditions to closing and (B) is incapable of being cured by the Outside Closing Date, or if capable of being cured by the Outside Closing Date, shall not be cured within fifteen (15) days following the receipt by Tottenham a notice describing such breach; and

•        either Tottenham or Clene, if this Agreement or the transactions contemplated hereby fail to be authorized or approved by either Clene or Tottenham shareholders.

In addition to the Agreement, the following agreements have been entered into in connection with the closing of the business combination.

Shareholder Support Agreements

Concurrently with signing the Merger Agreement, Tottenham entered into Shareholder Support Agreements with two of Clene’s stockholders, who collectively own 34.2% of total Clene outstanding shares. These stockholders agree to vote in favor of the Business Combination after the registration statement of which this joint proxy statement/consent solicitation statement/consent solicitation statement/prospectus forms a part is declared effective by the SEC, pursuant to a consent solicitation or at Clene’s stockholders meeting, subject to the terms of such Shareholder Support Agreements.

Initial Shareholders Forfeiture Agreements

Concurrently with signing the Merger Agreement, Tottenham, Clene and the initial shareholders entered into an Initial Shareholders Forfeiture Agreement whereby Tottenham and the initial shareholders will cancel and forfeit an aggregate of 750,000 insider shares of Tottenham owned by the initial shareholders for no additional consideration before the closing of the business combination, and that Tottenham will exchange the Sponsor’s loans to Tottenham into a number of TOTA Ordinary Shares equal to the aggregate amount of the such loans divided by $10.

Escrow Agreement

At the closing of the Business Combination, PubCo, the Stockholders’ Representative of Clene and an escrow agent will enter into an Escrow Agreement pursuant to which PubCo will deposit 2,712,702 of its shares of PubCo Common Stock to secure the indemnification obligations as contemplated by the Merger Agreement.

Lock-Up Agreements

In connection with the transactions, PubCo is expected to enter into Lock-Up Agreements with certain Clene stockholders beneficially owning more than 2.5% of Clene’s common stock prior to the closing (an aggregate of 14,689,742 shares of PubCo Common Stock after closing). The Lock-Up Agreements provide that these Clene stockholder will not, for at the least six (6) months (and in certain cases, up to twelve (12) months) from the closing of the Business Combination and subject to certain exceptions, offer, sell, contract to sell, pledge or otherwise dispose of, directly or indirectly, any of the ordinary shares issued in connection with the Acquisition Merger, enter into a transaction that would have the same effect, or enter into any swap, hedge or other arrangement that transfers, in whole or in part, any of the economic consequences of ownership of such shares, whether any of these transactions are to be

settled by delivery of any such shares, in cash, or otherwise. Such lock-up provisions will not apply to the transfer by gift or court order, or transfers to permitted transferees such as immediate family members or affiliates, provided that any such transferee will also subject to the Lock-Up Agreement.

Registration Rights Agreements

In connection with the Business Combination, PubCo and certain of Clene’s current stockholders are expected to enter into a Registration Rights Agreement to provide for the registration of 31.6 million shares of PubCo common stock being issued to Clene’s stockholders in connection with the transactions. These Clene stockholders will be entitled to (i) make a written demand for registration under the Securities Act of all or part of the their closing payment shares (up to a maximum of two demands in total), and (ii) “piggy-back” registration rights with respect to registration statements filed following the consummation of the Acquisition. Clene will bear the expenses incurred in connection with the filing of any such registration statements.

Interests of Certain Persons in the Business Combination

When you consider the recommendation of Tottenham board of directors in favor of adoption of the Reincorporation Merger Proposal, the Acquisition Merger Proposal and the other related Proposals, you should keep in mind that Tottenham’s directors and officers have interests in the Business Combination that are different from, or in addition to, your interests as a shareholder, including the following:

•        In the absence of shareholder approval for a further extension, if the proposed Business Combination is not completed by November 6, 2020, Tottenham will be required to liquidate. In such event, 1,150,000 TOTA Ordinary Shares held by the initial shareholders, which were acquired prior to the IPO for an aggregate purchase price of $25,000, will be worthless. Such shares had an aggregate market value of approximately $[•] based on the closing price of TOTA Ordinary Shares of $[•] on Nasdaq as of [•], 2020;

•        In the absence of shareholder approval for a further extension, if the proposed Business Combination is not completed by November 6, 2020, 215,000 Private Units purchased by the Sponsor for a total purchase price of $2,150,000, will be worthless. Such Private Units had an aggregate market value of approximately $[•] closing price of TOTA Units of $[•] on Nasdaq as of [•], 2020;

•        As of [•], 2020, Tottenham has $[•] in aggregate principal amount outstanding under the Notes that, pursuant to the Merger Agreement, are convertible into units of Tottenham upon the closing of the Business Combination. In the absence of shareholder approval for a further extension, if the proposed Business Combination is not completed by November 6, 2020, then such loans may not be repaid;

•        The exercise of Tottenham’s directors’ and officers’ discretion in agreeing to changes or waivers in the terms of the transaction may result in a conflict of interest when determining whether such changes or waivers are appropriate and in our shareholders’ best interest; and

•        If the Business Combination with Clene is completed, Clene will designate all members of the board of directors.

Anticipated Accounting Treatment

The Business Combination will be accounted for as a “reverse recapitalization” in accordance with GAAP. Under this method of accounting, Tottenham will be treated as the “acquired” company for financial reporting purposes. This determination is primarily based on the fact that subsequent to the Business Combination, Clene’s stockholders are expected to have a majority of the voting power of the combined company, Clene will comprise all of the ongoing operations of the combined entity, Clene will comprise a majority of the governing body of the combined company, and Clene’s senior management will comprise all of the senior management of the combined company. Accordingly, for accounting purposes, the Business Combination will be treated as the equivalent of Clene issuing shares for the net assets of Tottenham, accompanied by a recapitalization. The net assets of Tottenham will be stated at historical costs. No goodwill or other intangible assets will be recorded. Operations prior to the Business Combination will be those of Clene.

Regulatory Approvals

Completion of the Acquisition Merger is subject to approval under the HSR Act. Other than approval under the HSR Act, the Reincorporation Merger, the Acquisition Merger and the other transactions contemplated by the Merger Agreement are not subject to any additional U.S. federal or state regulatory requirements or approvals, or any regulatory requirements or approvals under the laws of the British Virgin Islands other than the filing of the necessary documents with the Registrar of Corporate Affairs in the British Virgin Islands.

Background of the Business Combination

Promptly after the closing of the IPO on August 6, 2018, Tottenham commenced the process of identifying potential business combination targets. On February 10, 2020, we signed a financial advisory agreement with Chardan, to act as our non-exclusive financial and M&A advisor with respect to a business combination. Tottenham reviewed over 30 candidates in different industries, signed non-disclosure agreements with 15 potential targets and had serious discussion with seven potential targets including Clene. No discussions regarding a potential business combination with any candidates were held prior to Tottenham’s IPO. The following is not intended to be a complete list of all opportunities initially evaluated or explored or discussions held by Tottenham.

•        Target No.1: In September 2018, Tottenham was introduced by a business associate to Target No.1, an e-commerce platform based in China. Tottenham’s team met with the senior management of Target No. 1 and was impressed by their management presentation on the operation and financial performance. Tottenham’s team conducted further due diligence but was not convinced that Target No. 1 would have a viable path for a U.S. listing. Discussions with Target No. 1 were terminated before a letter of intent was executed by the parties.

•        Target No.2: In November 2018, Tottenham was introduced by a business associate to Target No.2, a healthcare and fertility services company based in Australia, where the initial meeting was with the key shareholders and the parties engaged in various discussions on deal structure, valuation and terms of co-operation. In December 2018, Target No.2 and Tottenham discussed with an investment bank and conducted a preliminary analysis on the financial model and valuation. Between January 2019 and February 2019, Tottenham’s team conducted further due diligence and travelled to mainland China and Australia to visit the key locations of Target No. 2. In March 2019, Tottenham’s team worked with Target No.2 to obtain a general consent of key shareholders on the deal structure and a letter of intent was executed between the parties in March 2019. Between April and July 2019, Target No. 2 engaged a big four audit firm to commence audit and during the same period Tottenham’s team worked with the target to prepare the roadshow materials, arrange pre-listing financing, and draft the Merger Agreement. However, by August 2019, progress was severely impacted due to complications and uncertainties surrounding Target No. 2’s restructuring plans. All parties tried but failed to resolve the restructuring issues and decided to stop pursuing the opportunity transaction in September 2019.

•        Target No.3: In December 2019, Tottenham was introduced by a financial advisory firm based in Hong Kong to Target No.3, a plant-based meat alternatives food product solution based in mainland China and incorporated in Hong Kong. Given the success of another plant-based company’s IPO in the U.S., the parties believed that there was tremendous opportunity in the plant-based meat alternatives food sector. Tottenham’s team visited Target No.3 in Shanghai in January 2020 to discuss the SPAC merger structure and timeframe and learn more about the company. From January to February 2020 all parties continued to work on various materials including the investment roadshow PowerPoint, negotiating the deal terms, and discussing process matters relating to tax and the audit. By February 2020, the COVID-19 pandemic began to severely impact China nationwide and the country’s lockdown suspended the audit’s progress. All parties agreed to discontinue discussion due to the uncertainty of the audit timeline and concerns over the financial forecast for year 2020 due to the impact of the pandemic.

•        Target No.4: In February 2020, Tottenham was introduced by Chardan to Target No.4, a gene therapy biotechnology company in the U.S. and Tottenham’s team believed it was a good opportunity. The parties signed a letter of intent in February 2020 and proceeded to pursue investors for a PIPE transaction. By March 2020, the COVID-19 pandemic began to spread in the U.S. causing market volatility and profoundly affecting investment and fund raising opportunities. The uncertainty of securing an investment in such an environment led both parties to decide to cease further discussions.

•        Target No.5: In April 2020, Tottenham was introduced by Chardan to Target No. 5, a U.S. based biotech company focused on the development of dermatology products. Tottenham’s team held initial calls with the senior management team and was impressed by their capabilities and the science backing the research and development. However, the discussions were eventually discontinued because no investor commitment was secured to the parties’ satisfaction.

•        Target No. 6: In April 2020, Tottenham was introduced by a financial advisory firm to Target No. 6, a biotech company based in Switzerland focused on the treatments of neurological disorders. Tottenham’s team reviewed and was impressed by the business, the financial information and potential market opportunities. The parties eventually executed a letter of intent in June 2020, however there was no satisfactory interest gathered from the investment market after and Tottenham’s team decided to stop pursuing the opportunity further.

On May 28, 2020, Mr. Jason Wong, the director of Sponsor was introduced via a conference call arranged by the representatives of Prime Number Capital LLC, to Mr. David Dobkin, managing director at LifeSci Capital (“LifeSci”). In the call LifeSci proposed to Tottenham a potential business combination target with Clene. Following the call, a preliminary company overview was provided to Mr. Jason Wong and Mr. Jason Ma, the chief executive officer of Tottenham.

On May 30, 2020, Tottenham and Clene entered into a non-disclosure agreement.

Following the signing of the non-disclosure agreement, Rob Etherington discussed Tottenham’s interest in Clene with various members of the Clene board of directors. Rob Etherington subsequently kept various members of the Clene board of directors updated on the material terms of the proposed business combination and the status of the transaction.

On June 2, 2020, LifeSci arranged a conference call between Tottenham’s management and representatives from Clene including Mr. Rob Etherington the chief executive officer of Clene, Mr. Shalom Jacobovitz the chairman of Clene’s board of directors, Mr. Robert Glanzman the chief medical officer of Clene, Mr. Mark Mortenson the chief science officer of Clene, Mr. Michael Hotchkin the chief business officer of Clene and Mr. Matt Gardner the chief financial officer of Clene, to discuss Clene’s technical, strategic, commercial and capital-raising plans and the prospects of a business combination with Tottenham.

On June 2, 2020, Clene granted Tottenham access to the data room to evaluate detailed financial, scientific and clinical information concerning Clene, and requested that Tottenham begin preparing an initial term sheet for the proposed deal terms.

On June 11, 2020, Etherington introduced Tottenham’s team Mr. Wong and Mr. Ma.to the managing director of Peace Field Limited, one of the early investors of Clene and who acted as a consultant for Clene from time to time. The parties held an in-person meeting in Hong Kong to discuss the respective businesses operations of Clene and Tottenham and certain of Clene’s strategic plans in Asia.

On June 12, 2020, Tottenham’s management, Clene’s management and LifeSci held an all parties’ conference call to discuss the timeline and the initial terms of the transaction proposed by Tottenham.

On June 23, 2020, a conference call was initiated by LifeSci between the management teams of Tottenham and Clene. The parties discussed and negotiated several terms of Tottenham’s initial proposal, including the pre-money valuation of approximately $500 million, earn-out shares, concurrent private placement size, sponsor shares forfeiture and sponsor debt conversions, among other things. The parties then agreed that these terms should be memorialized in a non-binding LOI regarding the potential business combination.

On July 3, 2020, LifeSci circulated to Tottenham and Clene simutaneously an initial working draft of the LOI agreed to on the June 23 conference call for their review and comment.

On July 8, 2020, Clene responded via email with a revised version of the LOI, which contemplated transaction consideration consisting of public company shares with a value of $500 million plus any new cash proceeds to be raised by Clene, a closing condition that the cash remaining in Tottenham trust account after the redemption together with any proceeds raised in any private placement transaction be at least $30 million, reincorporation of Tottenham in U.S., and registration on a Form S-4 for share consideration issued in the business combination.

On July 10, 2020, Tottenham held an in-person meeting in Hong Kong with a representative of Kirkland & Ellis International LLP (“K&E”), Clene’s legal counsel, to review the terms of the LOI. Following the meeting, Tottenham’s management discussed with its legal counsel at Loeb & Loeb LLP (“Loeb”) and then circulated a revised LOI to Clene. All parties agreed to proceed with the transaction on the basis of the LOI.

On July 15, 2020, Clene’s management, Tottenham’s management, LifeSci and Chardan, and all of their respective legal counsels including K&E, Loeb, Ellenoff Grossman & Schole LLP, and Hunter Taubman Fischer & Li LLC held an organizational kick-off meeting to discuss the transaction overview including the summary of main transaction terms, the preliminary timetable, audit schedule, disclosures, ongoing diligence procedures, and timing of tasks to be undertaken by each party.

Between July 16, 2020and July 24, 2020, Tottenham and Loeb conducted due diligence on Clene.

On July 27, 2020, the same parties that attended the July 15 organizational meeting held a follow-up conference call to discuss the proposed timetable and any questions or outstanding items. Etherington updated the parties on Clene’s series D financing, the banking syndicate research list and an updated high-level investor presentation.

On July 27, 2020, Loeb circulated to K&E an initial draft merger agreement, which included a request that certain Clene shareholders enter into shareholder support agreements. Negotiations of several terms ensued.

On August 4, 2020, K&E circulated to Loeb a revised draft of the merger agreement.

Between August 4, 2020 and August 20, 2020, representatives of Tottenham, Loeb, Clene and K&E had multiple calls to discuss the merger agreement terms, including the treatment of Clene options, post-closing indemnification obligations, and Tottenham’s request that certain Clene shareholders enter into shareholder support agreements. During the course, Loeb and K&E exchange drafts of the merger agreement and other ancillary documents.

On August 21, 2020, Tottenham board of directors held a board meeting to review the transaction with Clene. Tottenham’s management advised its board of directors on the progress of Clene transaction and also shared with the board a near final draft of Merger Agreement, Clene’s audited and unaudited financial statements, and Clene’s investor presentation. After considerable review and discussion, the Merger Agreement and related documents and agreements were unanimously approved by the board of directors, subject to final negotiation and modification, and the board determined to recommend the approval of the Merger Agreement to shareholders. The board also concluded that the fair market value of Clene was equal to at least 80% of the funds held in the Trust Account. In making such determination, Tottenham’s board of directors considered, among other things, the implied valuation of Clene based on the market valuation of comparable companies (as discussed below under “— Clene’s Board of Directors’ Reasons for the Approval of the Business Combination,” the price paid by purchasers of Clene’s Series D preferred stock, and the price to be paid by purchasers in the PIPE.

Also on August 21, 2020, Clene’s board of directors held a meeting to review with Clene’s management and K&E the material terms of the business combination. During this meeting, representatives of K&E provided an overview of directors’ fiduciary duties and the material terms of the transaction. Following discussion, it was the consensus of the Clene board of directors that the proposed business combination was in the best interest of the Clene and Clene’s shareholders, and authorized the Clene’s management and its legal counsel to proceed to finalize the transaction based on the terms presented to the board.

From August 21, 2020 to August 24, 2020, representatives of Clene and Tottenham worked to finalize definitive transaction agreements and related schedules.

On August 24, 2020, Clene’s board of directors executed a unanimous written consent approving the merger agreement, the proposed shareholder support agreements and all transactions contemplated thereby and recommending that the Clene shareholders adopt the merger agreement.

From August 24, 2020 to August 31, 2020, representatives of Clene and Tottenham continued work to address remaining due diligence issues and finalize the Shareholder Support Agreements.

On September 1, 2020, the Merger Agreement, Shareholders Support Agreements and Initial Shareholder Forfeiture Agreement were signed by all parties thereto.

On September 2, 2020, the signing of the Merger Agreement by Tottenham and Clene was announced to the public. On the same day, Tottenham filed a Current Report on Form 8-K relating to the signing of the Merger Agreement.

Tottenham’s Board of Director’s Reasons for Approving the Business Combination

Prior to reaching the decision to approve the Merger Agreement, Tottenham’s board of directors reviewed the results of the business and financial due diligence conducted by its management and third-party legal advisors and discussed the risks of the transaction as well as the valuation considerations, including both information from Clene and other public sources. When considering the Business Combination with Clene, the Tottenham board of directors reviewed the information available, and considered, among other things, the following:

•        Unmet medical need representing huge market opportunity.    Currently, to the knowledge of Tottenham’s board of directors, there are no drugs approved to remyelinate MS lesions which has a big sales potential. In addition, there are no other therapies out there that has shown to decrease the rate of neurodegenerative damage caused by ALS or Parkinson’s Disease, which are another sales opportunity for Clene.

•        Strong intellectual property profile creating high barriers to entry.    Clene has one hundred and one patents approved with another nearly thirty patents pending. Clene also has state of matter claims for Myelin protection, Remyelination, Neuroprotection that will last until 2032 and manufacturing device and process patents that will last beyond 2030. Furthermore, Clene’s approach used to improve bioenergetic processes related to a wide range of neurodegenerative diseases could be revolutionary. This approach would introduce the world’s first nanotherapeutic, with a further advantage being that patients take orally. Replicating competencies in such areas presents a significant barrier for other companies.

•        Clene has a distinguished management team with years of experience in the biotechnology field.    The Clene management team has previously developed and launched medical products. Prior to Clene, chief executive officer Rob Etherington was the chief commercial officer at Actelion Pharmaceuticals, USA division, one of the largest biotech companies in the EU, and which was later purchased by Johnson & Johnson pharmaceuticals. At Actelion US, Etherington led the commercial operations as chair of the US commercial strategic team, and contributed to the launching of five drugs. Chief medical officer Robert Glanzman has held various positions including senior medical director for the medical affairs team in Pfizer, global development team leader for Roche Group, chief medical officer at GeNeuro S.A., assistant clinical professor at Michigan State University. He also received a doctorate in medicine and is certified in neurology. Chief science officer and co-founder Mark Mortenson is a former chief patent counsel responsible for 5500 patents and applications in over 44 countries. He was also a former chief operating officer of research, development and manufacturing for a materials-based company with over 300 employees. Chief business officer Michael Hotchkin led various business developments for Actelion US including leading the commercialization efforts for Actelion’s genetics business unit which resulted in doubling sales of 2 pharmaceutical drugs. He was also responsible for implementing marketing and strategic activities for Actelion globally and in the US. Chief financial officer Matt Gardner was previously a tax director of UPS Freight, a multi-billion dollar Fortune 100 global logistics company. He has also worked at KPMG and Ernst & Young and is a certified public accounting and licensed attorney.

•        Strong fundraising capabilities with strong commitment from existing shareholders.    Clene has successfully raised four rounds of funding including from many high net worth individuals in Series A, United Therapeutics (a publicly traded US public biopharma company) in Series B, strategic healthcare investors and South Korean funds in Series C and from existing shareholders and new investors from Japan and Korea in Series D. Both new and current investors continue to show their support for this transaction. Many have also expressed their intent to not sell their shares during the execution of the business combination and key investors have also already agreed to vote in favor of this merger.

•        Promising clinical results may reflect value inflection points in the coming years.    Clene’s CNM-Au8, an aqueous clean-surfaced faceted nanocrystalline gold, exhibited a favorable safety profile in Phase 1 of studies, and was granted permission by the regulatory bodies in the USA, Canada, and Australia to proceed to Phase 2 and registration clinical trials. In 2019, the first patients were dosed for phase II in MS and ALS. In February 2020, preliminary blinded results presented at a significant Multiple Sclerosis science meeting showed interim blinded efficacy results, up to week 36, from the first 34 enrolled participants.

The data reflect notable median improvements in LCLA and the three remaining modified Multiple Sclerosis Functional Composite (MSFC) sub-scales, including Symbol Digit Modalities Test (cognition), 9-Hole Peg Test (upper extremity function), and Timed 25-foot Walk (gait). Finally, the RESCUE-ALS, a Phase 2 multi-center randomized, double-blind, parallel group, placebo controlled study examining the efficacy, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in participants who are newly symptomatic with ALS (within 24-months of screening or 12-months from diagnosis is almost enrolled. In addition CNM- AG Zn17, a topical gel polymer used for wound healing in infectious diseases, is expected to start human trials in 2021, as well. If one or more of these clinical datasets results in positive results, the potential for Clene to see future commercial successes may be enhanced.

•        Prospects of Clene.    Tottenham’s board reviewed Clene’s business model, financial condition, market needs, profiles of management team, and future growth prospects. Clene has a strong competitive advantage and has made significant progress in its clinical trials showcasing, showing great potential.

•        Other alternatives.    Tottenham’s board also evaluated and assessed other potential acquisition targets. The board and management teams both concluded that Clene represents the current best acquisition target for Tottenham.

•        Terms of the merger agreement.    The board has considered the terms and conditions of the Merger Agreement and the transactions contemplated thereby including the negotiated valuation of $10.00 per share relative to the results of Clene’s financial analysis and potential future valuation.

Chardan Serving as Our Financial Advisor

We retained Chardan as our financial advisor, which also served as the lead underwriter of our IPO in 2018. Chardan is an independent, fully licensed, FINRA-registered, global investment bank and its range of services include capital raising, merger and acquisition advisory, strategic advisory, equity research, corporate access and institutional trading. It is also a bank that underwrites, advises, manages, and sponsors special purpose acquisition companies (“SPACs”). Chardan has been an underwriter in 41 SPAC offerings from January 1, 2016 to August 31, 2020, and also has acted as buyside M&A, capital markets, and financial advisor in 11 closed and announced SPAC business combinations from January 1, 2018 to August 31, 2020. Tottenham’s board mainly considered the following factors during our selection of the financial advisor and finally decided to retain Chardan as its financial advisor: (a) the financial advisor should have extensive M&A transaction experience and be able to offer support during negotiation and deal structuring; (b) the financial advisor should be familiar with the SPAC transaction process and could advise the company on a plan to complete the business combination transaction; and (c) the financial advisor should have extensive experience working with public company clients.

We entered into a financial advisory agreement with Chardan on February 10, 2020, according to which Chardan is engaged to provide us financial advisory services in connection with the identification of and negotiation with potential targets, assistance with due diligence, marketing, financial analysis and investor relations. As Clene was not introduced to Tottenham by Chardan, in the event a Business Combination is consummated and subject to our engagement letter, Tottenham will only be obligated to pay Chardan a fee of $1 million at the closing in cash. Additionally, in the event the Business Combination is consummated involving a Chardan introduced party as investor that is not a holder of Tottenham’s securities before February 10, 2020, the post-closing company will pay to Chardan a financing fee in cash equal to five percent (5%) of the aggregate sale price of Tottenham’s or PubCo’s securities to such investor. Chardan did not provide a fairness or valuation analysis in connection with the transaction with Clene, and no fee has been paid or will be paid to Chardan for any services provided in valuing or determining the fairness of the consideration being paid to Tottenham.

Summary of Clene Financial Analysis

The following is a summary of the material financial analysis prepared by Tottenham’s management and reviewed by Tottenham’s board of directors relating to Clene. The summary set forth below does not purport to be a complete description of the financial analysis performed or factors considered by us nor does the order of the financial analysis described represent the relative importance or weight given to those financial analysis by Tottenham’s board. We may have deemed various assumptions more or less probable than other assumptions, so the reference ranges resulting from any particular portion of the analysis summarized below should not be taken to be our view of the actual value of Clene. Some of the summaries of the financial analysis set forth below include information presented in tabular format. In

order to fully understand the financial analysis, the tables must be read together with the text of each summary, as the tables alone do not constitute a complete description of the financial analysis performed by us. Considering the data in the tables below without considering all financial analysis or factors or the full narrative description of such analysis or factors, including the methodologies and assumptions underlying such analysis or factors, could create a misleading or incomplete view of the processes underlying our financial analysis and Tottenham’s board’s recommendation.

In performing our analysis, we made numerous material assumptions with respect to, among other things, timing of clinical trials, patient enrollment, timing of receipt of regulatory approvals that may be needed, characterization of the product candidates, the timing of, and amounts of, any royalty payments, milestone payments or other payments due to third parties by Clene, the entry by Clene into license or collaboration agreements, market size, commercial efforts, industry performance, general business and economic conditions and numerous other matters, many of which are beyond the control of Tottenham, Clene or any other parties to the Business Combination. None of Clene, Tottenham, or any other person assumes responsibility if future results are materially different from those discussed. Any estimates contained in these analyses are not necessarily indicative of actual values or predictive of future results or values, which may be significantly more or less favorable than as set forth below. In addition, analysis relating to the value of Clene do not purport to be appraisals or reflect the prices at which Clene shares may actually be valued. Accordingly, the assumptions and estimates used in, and the results derived from, the financial analysis are inherently subject to substantial uncertainty. Except as otherwise noted, the following quantitative information, to the extent that it is based on market data, is based on market data as it existed on or before August 14, 2020 and is not necessarily indicative of current market conditions.

Selected Initial Public Offering Market Analysis

Tottenham reviewed financial information of Clene and compared it to corresponding financial information of selected publicly traded companies based on the judgement of the team.

Since none of the selected companies is exactly the same as Clene, Tottenham believed that it was inappropriate to, and therefore did not rely solely on the quantitative results of the selected public company analysis. Accordingly, Tottenham also made qualitative judgments, based on its experience and the judgment of its management team, concerning differences between the operational, business and/or financial characteristics of Clene and the selected companies to provide a context in which to consider the results of the quantitative analysis.

Tottenham considered certain financial and operating data for publicly traded biotechnology and biopharmaceutical companies focused on developing therapies and drugs for treating neurological diseases. The selected companies below are deemed relevant for analysis:

•        Annexon, Inc.

•        Alector, Inc.

•        Cortexyme, Inc.

•        AC Immune SA

Clene’s approach to treat neurodegenerative diseases with the development of Clean-Surfaced Nanocrystals is the first nanotherapeutic in the market. CNM-Au8, their leading asset, are gold atoms organized and held in suspension to treat impaired bioenergetics of damaged cells and support cellular reactions. The technology has a wide range of potential applications and can potentially be used to treat a number of neurological disorders. Since there are no similar applications in the market, the companies selected do not share identical characteristics as Clene. However, just like Clene, all four biotech companies, are currently at similar phases in clinical trials and have not commercialized any of the products yet. Their development stage and their focus on targeting neurodegenerative diseases are some of the many characteristics that were deemed relevant for comparisons. Furthermore, an analysis of selected publicly traded companies is not purely quantitative; rather it involves complex consideration and judgements concerning differences in financial and operating characteristics of the selected companies and other factors that could affect the public trading values of the companies reviewed. Tottenham believed that it was inappropriate to, and therefore did not rely solely on the quantitative results of the selected public company analysis. Accordingly, Tottenham also made qualitative judgments, based on its experience concerning differences between the operational, business and/or financial characteristics of Clene and the selected companies to provide a context in which to consider the results of the quantitative analysis.

The following is the analysis comparing the 30-day moving average price of all four companies between July 6 to August 14, 2020.

Based on the calculations above, Tottenham calculated a range of mean minus 25% and mean plus 25% to indicate the possible scenarios that could occur. The following table shows the mean implied per share equity range value is $14.85.

Tottenham compared these ranges to the proposed $10.00 valuation per share to be paid to shareholders of Clene Shares in the form of newly issues Tottenham shares pursuant to the Merger agreement.

COVID-19 News Impact Analysis

In these unprecedented times, the pandemic has completely disrupted the stock markets. However, the market for biotech companies is among the strongest it has ever been.

Clene’s nanotechnology drug platform is a potential candidate to facilitate mitigating COVID-19. By capitalizing on Clene’s current research and pipeline, Clene is currently launching Phase 2 studies for CNM-ZnAg, an ionic suspension of zinc and silver ions used to treat infectious diseases, including COVID-19. In July 2020, Clene’s representatives confirmed that their COVID-19 program was awaiting Institutional Review Board approval to launch and Clene anticipated beginning human trials in fourth quarter of 2020.

Based on the analysis of specific publicly traded biotechnology companies that Tottenham deemed relevant, Tottenham’s board assumed the changes in stock price is a fair reflection of the companies’ change in valuation, and analysed the stock price data of these companies as a result of plans for the development of COVID-19 vaccines. The selected companies are listed below:

•        BioNTech SE

•        AstraZeneca PLC

•        Moderna Inc.

These companies are not entirely identical to Clene. However, they are all currently conducting research in pursuit of a vaccine based on existing drugs or technology that they have within their pipeline and they are all at similar clinical trial stages. As those companies are all publicly listed, they may have greater resources than Clene has.

The following is a comparison of the stock price before and after the announcement of their plans to develop a COVID-19 drug. Moreover, since all three selected companies have a date of announcement within one month of each other, all growth rates were calculated based on a straight-line percentage change method.

In all three cases, stock prices have increased significantly and, while valuations for vaccines and therapeutics are not identical, it is possible that Clene’s latest valuation may also increase from the development of a potential COVID-19 therapy.

This analysis was prepared by Tottenham’s management based on its judgement. The analysis above should not be deemed determinative of fact and of future results. This analysis reflects the best currently available estimates and judgments, and presents, to the best of management’s knowledge and belief, the expected course of action and the expected future financial performance of Clene.

Required Vote

Approval of the Acquisition Merger Proposal requires the affirmative vote of the holders of 65% of the TOTA Ordinary Shares as of the record date represented in person or by proxy at the Extraordinary General Meeting and entitled to vote thereon. Adoption of the Acquisition Merger Proposal is conditioned upon the adoption of the Reincorporation Merger Proposal. It is important for you to note that in the event that either of the Reincorporation Merger Proposal or the Acquisition Merger Proposal is not approved, then Tottenham will not consummate the Business Combination.

Recommendation of Tottenham’s Board of Directors

After careful consideration, Tottenham board of directors determined that the Acquisition Merger forming part of the Business Combination with Clene is in the best interests of Tottenham and its shareholders. On the basis of the foregoing, Tottenham board of directors has approved and declared advisable the Business Combination with Clene and recommends that you vote or give instructions to vote “FOR” the Acquisition Merger Proposal. Tottenham’s directors have interests that may be different from, or in addition to your interests as a shareholder. See “Proposal No. 2 The Acquisition Merger Proposal — Interests of Certain Persons in the Acquisition” in this proxy statement/consent solicitation statement/prospectus for further information.

PROPOSAL No. 3
THE INCENTIVE PLAN PROPOSAL

Summary of the Proposal

Purpose of the Incentive Plan Proposal

The following is a summary description of the Incentive Plan as proposed to be adopted by Tottenham in connection with the Business Combination. This summary is qualified in its entirety by reference to the complete text of the Incentive Plan, a copy of which is attached hereto as Annex C. Tottenham shareholders should refer to the Incentive Plan for more complete and detailed information about the terms and conditions of the Incentive Plan.

The purpose of the Incentive Plan is to attract and retain the services of (i) selected employees, officers, and directors of the combined company or any parent or subsidiary of PubCo, and (ii) selected nonemployee agents, consultants, advisers, and independent contractors of PubCo or any parent or subsidiary of PubCo. The intention is to provide a means whereby the combined company can align the long-term financial interests of its employees, consultants, and directors with the financial interests of its stockholders. The combined company’s employee equity compensation program, as implemented under the Incentive Plan, will allow the combined company to remain competitive with comparable companies in its industry by giving it the resources to attract and retain talented individuals to achieve its business objectives and build stockholder value. The ability to grant options and other equity-based awards will help the combined company to motivate employees, consultants, and directors and encourage them to devote their best efforts to the combined company’s business and financial success.

Approval of the Incentive Plan by the Tottenham shareholders is required, among other things, in order to: (i) comply with Nasdaq rules requiring stockholder approval of equity compensation plans; and (ii) allow the grant of incentive stock options to participants in the Incentive Plan.

In the event that Tottenham shareholders do not approve this Proposal, the Incentive Plan will not become effective. Approval of the Incentive Plan by Tottenham shareholders will allow the combined company to grant stock options, restricted stock unit awards and other awards at levels determined appropriate by its board of directors or compensation committee following the closing of the Business Combination. The Incentive Plan will also allow the combined company to utilize a broad array of equity incentives and performance cash incentives in order to secure and retain the services of its employees, directors and consultants, and to provide long-term incentives that align the interests of its employees, directors and consultants with the interests of its stockholders following the closing of the Business Combination.

Information Regarding Equity Incentive Program

It is critical to the combined company’s long-term success that the interests of its employees, directors and consultants are tied to its success as “owners” of the business. Approval of the Incentive Plan will allow the combined company to grant stock options and other equity awards to attract new employees and directors, retain existing employees and directors and provide incentives for such persons to exert maximum efforts for the combined company’s success and increase in stockholder value. The Incentive Plan allows the combined company flexibility in designing equity incentives, including traditional stock option grants, stock appreciation rights, restricted stock awards, restricted stock unit awards, other stock awards and performance stock awards to offer competitive equity compensation packages in order to retain and motivate the talent necessary for the Combined Company. The combined company anticipates registering shares issuable under the Incentive Plan with the SEC on a registration statement on Form S-8 when available following the completion of the Business Combination.

Description of the Incentive Plan

Subject to adjustment for various corporate actions such as stock splits or mergers described in more detail below, the shares to be offered under the Incentive Plan will consist of PubCo’s Common Stock, and the total number of shares of Common Stock that may be issued under the Incentive Plan shall be 12,000,000, all of which may be issued pursuant to Incentive Stock Options or any other type of award under the Incentive Plan. If an option or other award granted under the Incentive Plan expires, terminates or is cancelled, the unissued shares subject to that option or award shall again be available under the Incentive Plan. If shares awarded pursuant to the Incentive Plan are forfeited to or repurchased at original cost by the post-combined company, the number of shares forfeited or repurchased at original cost shall again be available under the Incentive Plan.

The Incentive Plan has been adopted and approved by the board and will become effective as of the closing of the Business Combination (the “Effective Date”). Options and stock awards may be granted at any time after the Effective Date and before termination of the Incentive Plan. The Incentive Plan will continue in effect until the earlier of (i) the date that is ten (10) years after the Effective Date or (ii) such time as all shares available for issuance under the Incentive Plan have been issued and all restrictions on the shares have lapsed. PubCo’s board may suspend or terminate the Incentive Plan at any time except with respect to options and stock awards then outstanding under the Incentive Plan. No options or stock awards may be granted under the Incentive Plan after its termination. Termination does not affect any outstanding options or stock awards, any right of PubCo to repurchase shares or the forfeitability of shares issued under the Incentive Plan.

The Incentive Plan will be administered by PubCo’s board of directors or compensation committee to which the Board may delegate any or all authority for administration of the Incentive Plan. If authority is delegated to the compensation committee, all references to the board in the Incentive Plan and in this description shall mean and relate to the committee, except (i) as otherwise provided by the board and (ii) that only the board may amend or terminate the Incentive Plan. The board or the compensation committee shall determine and designate the individuals to whom options or other awards shall be made (“Recipients”), the amount of such options or awards, and the other terms and conditions of such options or awards. Subject to the provisions of the Incentive Plan and applicable law, the board may adopt and amend rules and regulations relating to administration of the Incentive Plan, advance the lapse of any waiting period, accelerate any exercise date, waive or modify any restriction applicable to shares, and make all other determinations in the judgment of the board necessary or desirable for the administration of the Incentive Plan. The interpretation and construction of the provisions of the Incentive Plan and related agreements by the board shall be final and conclusive. The board may correct any defect or supply any omission or reconcile any inconsistency in the Incentive Plan or in any related agreement in the manner and to the extent it deems expedient to carry the Incentive Plan into effect, and the board shall be the sole and final judge of such expediency.

The board may, from time to time, take the following actions, separately or in combination, under the Incentive Plan: (i) grant incentive stock options as defined in Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”), (ii) grant options other than incentive stock options; and (iii) grant stock awards as defined in the Incentive Plan. Awards may be made to employees, including employees who are officers or directors, and to other individuals selected by the board; provided, however, that only employees of PubCo or any parent or subsidiary of PubCo are eligible to receive incentive stock options. The board will select the individuals to whom awards shall be made and shall specify the action taken with respect to each individual to whom an award is made.

With respect to each option grant, the board will determine the number of shares subject to the option, the exercise price, the duration of the option, the times at which the option may be exercised and whether the option is an incentive stock option or a non-statutory stock option. The exercise price per share will be determined by the board at the time of grant. The exercise price will not be less than 100% of the fair market value of the Common Stock covered by the option at the date the option is granted (110% for holders of 10% or more of PubCo’s voting power). The fair market value will be the closing price of the Common Stock on the last trading day before the date the option is granted, if the stock is publicly traded, or another value of the Common Stock as specified by the board in good faith. No Recipient of any option or other award under the Incentive Plan will have any rights as a stockholder with respect to any shares of Common Stock subject to such option or award until the date the Recipient becomes the holder of record of such shares.

The board may issue shares under the Incentive Plan as stock awards for any form of consideration determined by the board, including promissory notes and services and including no consideration or such minimum consideration as may be required by law. Stock awards shall be subject to the terms, conditions, and restrictions determined by the Board. The restrictions may include restrictions concerning transferability, repurchase by the post-combined company, and forfeiture of the shares issued, together with any other restrictions determined by the board. Stock awards subject to restrictions may be either restricted stock awards under which shares are issued immediately upon grant subject to forfeiture if vesting conditions are not satisfied or restricted stock unit awards under which shares are not issued until after vesting conditions are satisfied. The related stock award agreement may contain any terms, conditions, restrictions, representations, and warranties required by the board. No shares shall be issuable under a restricted stock unit award or similar stock award after the expiration of ten (10) years from the date such award is granted.

PubCo may require any Recipient of a stock award to pay to it in cash or by check amounts necessary to satisfy any applicable federal, state or local tax withholding requirements. If the Recipient fails to pay the amount demanded, PubCo may withhold that amount from other amounts payable to the Recipient, including salary, subject to applicable law. With the board’s consent, a Recipient may satisfy this obligation, in whole or in part, by instructing PubCo to withhold from any shares to be issued or by delivering to PubCo other shares of Common Stock; provided, however, that the number of shares so withheld or delivered shall not exceed the amount necessary to pay tax withholding to each jurisdiction calculated at the maximum tax rate applicable to income earned in that jurisdiction.

If PubCo’s outstanding Common Stock is increased or decreased or changed into or exchanged for a different number or kind of shares or other securities by reason of any stock split, reverse stock split, combination of shares, dividend payable in shares, recapitalization, reclassification or other distribution of Common Stock to stockholders generally without the receipt of consideration by PubCo, appropriate adjustment will be made by the board in the number and kind of shares available for grants under the Incentive Plan and in all other share amounts set forth in the Incentive Plan. In addition, the board will make appropriate adjustment in (i) the number and kind of shares subject to outstanding awards, and (ii) the exercise price per share of outstanding options, so that the Recipient’s proportionate interest before and after the occurrence of the event is maintained. Unless otherwise determined by the board, in the event of a merger, consolidation, plan of exchange, acquisition of property or stock, split-up, split-off, spin-off, reorganization or liquidation to which PubCo is a party or any sale, lease, exchange or other transfer (in one transaction or a series of related transactions) of all, or substantially all, of the assets of PubCo, the board shall, in its sole discretion and to the extent possible under the structure of the transaction and the Incentive Plan, with respect to each outstanding option and stock award under the Incentive Plan, choose how options and awards shall be handled.

The board may at any time modify or amend the Incentive Plan in any respect; provided, however, that any modification or amendment of the Incentive Plan shall be subject to stockholder approval to the extent required under applicable law or the rules of NASDAQ. No change in an option or other award already granted shall be made without the written consent of the Recipient if the change would adversely affect such Recipient.

Required Vote

Approval of the Incentive Plan Proposal requires the affirmative vote of the holders of a majority of the TOTA Ordinary Shares as of the record date represented in person or by proxy at the Extraordinary General Meeting and entitled to vote thereon. Adoption of the Incentive Plan is not conditioned upon the adoption of any of the other Proposals.

Recommendation of Tottenham’s Board of Directors

The Tottenham board of directors recommends a vote “FOR” adoption of the Incentive Plan Proposal.

PROPOSAL NO. 4
THE ESPP PLAN PROPOSAL

Summary of the Proposal

Purpose of the ESPP Plan Proposal

The following is a summary description of the ESPP Plan as proposed to be adopted by Tottenham in connection with the Business Combination. This summary is qualified in its entirety by reference to the complete text of the ESPP Plan, a copy of which is attached hereto as Annex D. Tottenham shareholders should refer to the ESPP Plan for more complete and detailed information about the terms and conditions of the ESPP Plan.

The purpose of the ESPP Plan is to attract and retain the services of employees and officers of the combined company or any parent or subsidiary of PubCo. The intention is to provide a means whereby the combined company can align the long-term financial interests of its employees and officers with the financial interests of its stockholders and to encourage employees to buy and hold shares of PubCo. The combined company’s employee equity compensation program, as implemented under the ESPP Plan, will allow the combined company to remain competitive with comparable companies in its industry by giving it the resources to attract and retain talented individuals to achieve its business objectives and build stockholder value. The ability to grant tax-advantaged opportunities to buy and hold the combined company’s stock at a discount is designed to motivate employees and encourage them to devote their best efforts to the combined company’s business and financial success.

Approval of the ESPP Plan by the Tottenham shareholders is required in order to comply with Nasdaq rules requiring stockholder approval of equity compensation plans. In the event that Tottenham shareholders do not approve this Proposal, the ESPP Plan will not become effective. Approval of the ESPP Plan by Tottenham shareholders will allow the combined company to offer employees the chance to purchase, on a tax-advantaged basis, PubCo stock at a discount to market following the closing of the Business Combination.

Information Regarding ESPP

It is critical to the combined company’s long-term success that the interests of its employees and officers are tied to its success as “owners” of the business. The company believes that this ESPP Plan will help attract new employees, retain existing employees and provide incentives for these employees to exert maximum efforts for the combined company’s success and increase in stockholder value.

Description of the ESPP Plan

Subject to adjustment for various corporate actions such as stock splits or mergers described in more detail below, the shares to be offered under the ESPP Plan will consist of PubCo’s Common Stock, and the total number of shares of Common Stock that may be issued under the ESPP Plan shall be 1,000,000.

The ESPP Plan has been adopted and approved by the board and will become effective on a date following the Merger to be determined by the Board. Offering Periods may run concurrently and will generally be of six months in duration, beginning on February 1st and August 1st each year; provided, however, that pursuant to Section 5 of the ESPP, the Committee may change the duration of future Offering Periods (subject to a maximum Offering Period of twenty-seven (27) months) or the start and end dates of future Offering Periods. The ESPP Plan will continue in effect until the earlier of (i) the date that is ten years after the date it is adopted or (ii) the ESPP Plan is terminated earlier pursuant to its terms. PubCo’s board may suspend or terminate the ESPP Plan at any time.

The ESPP Plan will be administered by PubCo’s board of directors or a committee of the board to which the board may delegate any or all authority for administration of the ESPP Plan. If authority is delegated to a committee, all references to the board or committee in the ESPP Plan and in this description shall mean and relate to the board or its committee, as then administering the ESPP Plan.

Eligible full-time employees as defined in the ESPP and determined with reference to Section 423 of the Code may participate if they have been employed by PubCo or a parent or subsidiary, such as Clene, for at least one month on the date the Offering Period begins. Such employees may elect to have up to ten percent of their regular pay withheld and accumulated for purchase of PubCo common stock during the Offering Period. Employees may not accumulate funds for the purchase of stock under the ESPP Plan in an amount greater than $25,000 worth of such stock

as determined based on the closing sale price of the stock at the beginning of the relevant Offering Period. In addition, no employee may purchase more than 3,000 shares of Purchaser common stock in any single Offering Period. At the end of the Offering Period, all amounts sufficient to purchase a full share of PubCo common stock are used to purchase such shares at a price equal to 85% of the closing sale price of PubCo common stock as of the first or last or last day of the Offering Period, whichever is lower. The difference between the value of the shares purchased and the aggregate purchase price (gain) is not recognized as income for tax purposes by the employee until the date the employee sells the shares. This tax deferral creates an additional incentive for employees to buy and hold the common stock of PubCo, thus creating an additional financial incentive for employees to desire the success of the company.

A participant in the ESPP Plan may change the amount of their pay being withheld during the Offering Period in accordance with the policies of the board, including a complete withdrawal from the ESPP Plan and a refund of accumulated amounts (without interest). The participant’s rate of deduction will remain unchanged from one Offering Period to the next unless the participant requests a change. No employee is required to participate in the ESPP Plan.

At the conclusion of an Offering Period, the purchased shares are transferred as soon as is practicable into the name of the purchasing employee. The combined company anticipates registering shares issuable under the Incentive Plan with the SEC on a registration statement on Form S-8 when such Form is available following the completion of the Business Combination.

If PubCo’s outstanding Common Stock is increased or decreased or changed into or exchanged for a different number or kind of shares or other securities by reason of any stock split, reverse stock split, combination of shares, dividend payable in shares, recapitalization, reclassification or other distribution of Common Stock to stockholders generally without the receipt of consideration by PubCo, appropriate adjustment will be made by the board in the number and kind of shares available for grants under the ESPP Plan and in all other share amounts set forth in the ESPP Plan. In addition, the board will make appropriate adjustment in the number and kind of shares for the current Offering Period so that the employee’s proportionate interest before and after the occurrence of the event is maintained. Unless otherwise determined by the board, in the event of a merger, consolidation, plan of exchange, acquisition of property or stock, split-up, split-off, spin-off, reorganization or liquidation to which PubCo is a party or any sale, lease, exchange or other transfer (in one transaction or a series of related transactions) of all, or substantially all, of the assets of PubCo, the board shall, in its sole discretion and to the extent possible under the structure of the transaction and the ESPP Plan, arrange for the assumption of the ESPP Plan or shorten the then-current Offering Period so that it ends on or before the completion of such event.

The board may at any time modify or amend the ESPP Plan in any respect; provided, however, that any modification or amendment of the ESPP Plan shall be subject to stockholder approval to the extent required under applicable law or the rules of Nasdaq.

Required Vote

Approval of the ESPP Plan Proposal requires the affirmative vote of the holders of a majority of the TOTA Ordinary Shares as of the record date represented in person or by proxy at the Extraordinary General Meeting and entitled to vote thereon. Adoption of the ESPP Plan is not conditioned upon the adoption of any of the other Proposals.

Recommendation of Tottenham’s Board of Directors

The Tottenham board of directors recommends a vote “FOR” adoption of the ESPP Plan Proposal.

PROPOSAL No. 5
THE ADJOURNMENT PROPOSAL

Purpose of the Adjournment Proposal

In the event there are not sufficient votes for, or otherwise in connection with, the adoption of the Reincorporation Merger, the Acquisition Merger Agreement, and the Incentive Plan Proposal, the Tottenham board of directors may adjourn the Extraordinary General Meeting to a later date, or dates, if necessary, to permit further solicitation of proxies. In no event will Tottenham seek adjournment which would result in soliciting of proxies, having a shareholder vote, or otherwise consummating a business combination after November 6, 2020.

Required Vote

Approval of the Adjournment Proposal requires the affirmative vote of the holders of a majority of the TOTA Ordinary Shares as of the record date represented in person or by proxy at the Extraordinary General Meeting and entitled to thereon. Adoption of the Adjournment Proposal is not conditioned upon the adoption of any of the other Proposals.

Recommendation of Tottenham’s Board of Directors

The Tottenham board of directors recommends a vote “FOR” adoption of the Adjournment Proposal.

CLENE’S SOLICITATION OF WRITTEN CONSENT

Purpose of the Consent Solicitation

You are being asked to consent to adopt and approve in all respects the merger agreement and the transactions contemplated thereby (the “Clene Merger Proposal”). For details as to the Clene Merger Proposal, see “Proposal No. 2 The Acquisition Merger Proposal.”

Recommendation of the Clene Board of Directors

After consideration, the Clene board of directors determined that the Merger Agreement, the Acquisition Merger contemplated by the Merger Agreement and the other transactions contemplated by the Merger Agreement were advisable and in the best interests of Clene and its stockholders. Clene’s board of directors adopted and approved the Merger Agreement and the transactions contemplated thereby and to be undertaken in connection therewith, including, without limitation, the Acquisition Merger, and directed that the Merger Agreement be submitted to the holders of Clene common stock and preferred stock for adoption. The Clene board of directors recommends that the stockholders of Clene adopt the Merger Agreement and approve the transactions contemplated thereby by submitting a written consent in accordance with the certificate of incorporation and bylaws of Clene.

Clene’s Board of Director’s Reasons for Approving the Merger

In reaching its decision to adopt and approve, and declare advisable, the Merger Agreement and the transactions contemplated thereby and resolving to recommend that Clene stockholders adopt and approve the Merger Agreement and approve the merger and the other transactions contemplated by the Merger Agreement, the Clene board of directors consulted with Clene’s management, as well as its advisors, and considered a number of factors, including its knowledge of Clene’s business, operations, financial condition, earnings and prospects, and its knowledge of the financial and capital markets and the risks associated with pursuing a merger with a special acquisition company. Among the various factors that the Clene board of directors considered in favor of its decision are:

•        Other Alternatives.    It is the belief of the Clene board of directors that the proposed merger represents the best potential transaction for Clene to create greater value for Clene’s stockholders, while also providing greater liquidity by owning stock in a public company.

•        Advantages Over a Traditional IPO.    The Clene board of directors considered that the merger provided certain advantages over a traditional IPO. In particular, the Clene board of directors considered that, based on available information at the time, including with respect to the conditions of the IPO market for, and valuations of, companies of a similar size and industry as Clene, the merger with Tottenham was likely to provide for a more time- and cost-effective means to capital with a higher likelihood of completion in light of the committed equity investments, greater valuation certainty and less dilution to Clene’s existing stockholders.

•        Terms of the Merger Agreement.    The Clene board of directors considered the terms and conditions of the Merger Agreement, including but not limited to the nature and scope of the closing conditions and the likelihood of obtaining any necessary regulatory approvals, in addition to the transactions contemplated thereby, including the Acquisition Merger.

•        Valuation.    The Clene board of directors considered the implied equity value of approximately $542.5 million for Clene in light of valuations received by Clene in previous rounds of capital raise.

•        Access to Capital.    The Clene board of directors expects that the merger would be a more time- and cost-effective means to access capital, repay a portion of its existing indebtedness and reduce leverage than other options considered, including an IPO.

•        Benefit from Being a Public Company.    The Clene board of directors believes that as a public company, Clene will have the flexibility and financial resources to pursue and execute a growth strategy to increase stockholder value and will benefit from being publicly traded, and can effectively utilize the broader access to capital and public profile that are associated with being a publicly traded company.

The Clene board of directors also considered the following negative factors:

•        Risk that merger may not be completed.    The Clene board of directors considered the risk that the merger might not be consummated in a timely manner or at all, due to a lack of stockholder approval or failure to satisfy various conditions to closing.

•        Expenses and challenges.    The Clene board of directors considered the expenses to be incurred in connection with the merger and related administrative challenges associated with combining the companies.

•        Restrictions on operation of Clene’s business.    The Clene board of directors considered the fact that, although Clene will continue to exercise, consistent with the terms and conditions of the Merger Agreement, control and supervision over its operations prior to the completion of the merger, the Merger Agreement generally obligates Clene, subject to Tottenham’s prior consent (which consent may not be unreasonably withheld, delayed or conditioned), to conduct its business in the ordinary course of business consistent with past practice and in accordance with specified restrictions, which might delay or prevent Clene from undertaking certain business opportunities that might arise pending completion of the merger.

•        Other risks.    The Clene board of directors considered various other risks associated with the combined organization and the merger, including the risks described in “Risk Factors.”

The foregoing discussion of the factors considered by the Clene board of directors is not intended to be exhaustive, but, rather, includes the material factors considered by the Clene board of directors. In reaching its decision to adopt and approve, and declare advisable, the Merger Agreement, the merger and the other transactions contemplated by the Merger Agreement, the Clene board of directors did not quantify or assign any relative weights to the factors considered, and individual directors may have given different weights to different factors. The Clene board of directors considered all these factors as a whole, including discussions with, and questioning of, Clene’s management and financial and legal advisors, and, overall, considered these factors to be favorable to, and to support, its determination.

The Clene board of directors concluded that the potentially negative factors associated with the merger were outweighed by the potential benefits that it expected Clene stockholders would receive as a result of the merger, including the belief of the Clene board of directors that the merger would increase the immediate value of shares of Clene common stock and preferred stock. Accordingly, the Clene board of directors determined that the merger and the other transactions contemplated by the Merger Agreement are advisable and in the best interests of, Clene and its stockholders, and adopted and approved, and declared advisable, the Merger Agreement, the merger and the other transactions contemplated by the Merger Agreement. The Clene board of directors recommends that Clene stockholders adopt the Merger Agreement and approve the transactions contemplated thereby.

Record Date

The Clene board of directors has set [•], 2020 (the “Clene record date”) as the record date for determining the Clene stockholders entitled to sign and deliver written consents with respect to the Clene Merger Proposal.

Clene Stockholders Entitled to Consent

Only Clene stockholders of record holding shares of common stock or preferred stock as of the close of business on the Clene record date are entitled to sign and deliver a written stockholder consent with respect to the Clene Merger Proposal. As of the close of business on the Clene record date, there were 124,961,500 shares of Clene common stock, 115,649,483 shares of Series A preferred stock, 30,007,852 shares of Series B preferred stock, 52,291,267 shares of Series C preferred stock, and 67,620,060 shares of Series D preferred stock outstanding and entitled to sign and deliver written consents with respect to the Clene Merger Proposal. You are urged to return a completed, dated and signed written consent by [•], New York City time, on [•], 2020.

Consents; Required Consents

In accordance with the certificate of incorporation and by-laws of Clene, approval of the Clene Merger Proposal by the Clene stockholders will require the affirmative vote or consent of (a) Clene common stock and Clene preferred stock voting as a single class, (b) All classes of Clene preferred stock voting together as a separate class, (c) Clene Series B preferred stock voting as a separate class, (d) Clene Series C preferred stock voting as a separate class, (e) Clene Series D preferred stock voting as a separate class, and (f) the “Lead Investor” as defined in the Company’s Series D Preferred Stock Purchase Agreement, which is Symbiosis II, LLC.

At the time of entry into the Merger Agreement, United Technologies and General Resonance entered into shareholder support agreements with Tottenham agreeing to vote approximately 34.2% of the issued and outstanding capital stock for the transaction after the registration statement of which this joint proxy statement/consent solicitation statement/prospectus forms a part is declared effective by the SEC.

Submission of Consents

You may consent to the Clene Merger Proposal with respect to your shares of Clene common stock and preferred stock by completing, dating and signing the written consent enclosed with this proxy statement/consent solicitation statement/prospectus and returning it to Clene.

If you hold shares of Clene common stock or preferred stock as of the close of business on the Clene record date then you will receive an email from one of Clene’s attorneys, Meg Krivanec, requesting that you sign and submit the written stockholder consent via DocuSign. If you wish to submit your consent, you must promptly complete the DocuSign request. If you have any questions regarding the DocuSign processes or experience any difficulties, you should reach out to Meg Krivanec via email at meg.krivanec@stoel.com. Clene does not intend to hold a stockholders’ meeting to consider the Clene Merger Proposal, and, unless Clene decides to hold a stockholders’ meeting for such purposes, you will be unable to vote in person by attending a stockholders’ meeting.

The Clene board of directors has set [•], New York City time, on [•], 2020 as the target date for the receipt of written consents, which is the date on which Clene expects to receive the written consents of [•] and [•] under the Clene support agreement. Clene reserves the right to extend the final date for the receipt of written consents beyond [•], 2020. Any such extension may be made without notice to Clene stockholders. Once a sufficient number of consents to adopt the Clene Merger Proposal has been received, the consent solicitation will conclude.

Executing Consents; Revocation of Consents

You may execute a written consent to approve of the Clene Merger Proposal. A written consent to approve the Clene Merger Proposal is equivalent to a vote for such proposal. If you fail to execute and return your written consent, or otherwise withhold your written consent, it has the same effect as voting against the Clene Merger Proposal and the Clene Charter Amendment Proposals.

If you are a record holder of shares of Clene common stock or preferred stock as of the close of business on the Clene record date, you may change or revoke your written consent (subject any contractual obligations you may otherwise have) at any time prior to [•] local time, on [•], 2020 (or, if earlier, before the consents of a sufficient number of shares to approve the Clene Merger Proposal have been delivered to Clene). If you wish to change or revoke your consent before that time, you may do so by sending a notice of revocation by emailing a .pdf copy to Meg Krivanec via email at meg.krivanec@stoel.com. However, pursuant to the Clene support agreement, the written consent to be received by Clene from United Technologies and General Resonance will be irrevocable.

Solicitation of Consents; Expenses

The expense of preparing, printing and mailing these consent solicitation materials is being borne by Clene. Officers and employees of Clene may solicit consents by telephone and personally, in addition to solicitation by mail. These persons will receive their regular salaries but no special compensation for soliciting consents.

Appraisal Rights

Under the DGCL, if a Clene stockholder does not wish to accept the merger consideration provided for in the merger agreement, does not consent to the adoption of the merger agreement and the merger is consummated, such stockholder has the right to seek appraisal of his, her or its shares of Clene common stock and to receive payment in cash for the fair value of his, her or its shares of Clene common stock exclusive of any element of value arising from the accomplishment or expectation of the merger, as determined by the Delaware Court of Chancery, together with interest, if any, to be paid upon the amount determined to be the fair value of such shares of Clene common stock. These rights are known as appraisal rights. The “fair value” of such shares of Clene common stock as determined by the Delaware Court of Chancery may be more or less than, or the same as, the merger consideration that a stockholder of record is otherwise entitled to receive for the same number of shares of Clene common stock under the terms of the

merger agreement. Stockholders of Clene who elect to exercise appraisal rights must comply with the provisions of Section 262 of the DGCL to perfect their rights. Strict compliance with the statutory procedures in Section 262 of the DGCL is required. Stockholders of Clene who wish to exercise appraisal rights, or preserve the ability to do so, must not deliver a signed written consent adopting the merger agreement.

This section is intended only as a brief summary of the material provisions of the statutory procedures under the DGCL that a Clene stockholder must follow in order to seek and perfect appraisal rights. This summary, however, is not a complete statement of all applicable requirements and the law pertaining to appraisal rights under the DGCL, and is qualified in its entirety by reference to Section 262 of the DGCL, the full text of which is attached as Annex E to this proxy statement/consent solicitation statement/prospectus. The following summary does not constitute any legal or other advice, nor does it constitute a recommendation that stockholders exercise their appraisal rights under Section 262 of the DGCL. Unless otherwise noted, all references in this summary to “stockholders” or “you” are to the record holders of shares of Clene common stock immediately prior to the effective time of the merger as to which appraisal rights are asserted. A person having a beneficial interest in shares of Clene common stock held of record in the name of another person must act promptly to cause the record holder to follow the steps summarized below properly and in a timely manner to perfect appraisal rights.

Section 262 of the DGCL requires that where a merger agreement is adopted by a written consent of stockholders in lieu of a meeting of stockholders, stockholders entitled to appraisal rights must be given notice that appraisal rights are available. A copy of Section 262 of the DGCL must be included with such notice. The notice must be provided after the merger is approved and no later than 10 days after the effective date of the merger. Only those Clene stockholders who did not submit a written consent adopting the merger agreement and who have otherwise complied with Section 262 of the DGCL are entitled to receive such notice. The notice may be given by Clene. If given at or after the effective date of the merger, the notice must also specify the effective date of the merger; otherwise, a supplementary notice will provide this information. This proxy statement/consent solicitation statement/prospectus is not intended to constitute such a notice. Do not send in your demand before the date of such notice because any demand for appraisal made prior to your receipt of such notice may not be effective to perfect your rights.

Following Clene’s receipt of sufficient written consents to adopt the merger agreement, Clene will send all non-consenting Clene stockholders who satisfy the other statutory conditions the notice regarding the receipt of such written consents and the availability of appraisal rights. A Clene stockholder electing to exercise his, her or its appraisal rights will need to take action at that time, in response to such notice, but this description is being provided to all Clene stockholders now so you can determine whether you wish to preserve your ability to demand appraisal rights in the future in response to such notice.

In order to preserve your right to receive notice and to demand appraisal rights, you must not deliver a written consent adopting the merger agreement. As described below, you must also continue to hold your shares through the effective date of the merger.

If you elect to demand appraisal of your shares of Clene common stock, you must, within 20 days after the date of mailing of the notice, make a written demand for the appraisal of your shares of Clene common stock to Clene, at the specific address which will be included in the notice of appraisal rights. Do not submit a demand before the date of the notice of appraisal rights because a demand that is made before the date of such notice may not be effective to perfect your appraisal rights.

A Clene stockholder wishing to exercise appraisal rights must hold of record the shares of Clene common stock on the date the written demand for appraisal is made. In addition, a holder must continue to hold of record the shares of Clene common stock through the effective date of the merger. Appraisal rights will be lost if your shares of Clene common stock are transferred prior to the effective time. If you are not the stockholder of record, you will need to follow special procedures as discussed further below.

If you and/or the record holder of your shares of Clene common stock fail to comply with all of the conditions required by Section 262 of the DGCL to perfect your appraisal rights, and the merger is completed, your shares of Clene common stock (assuming that you hold them through the effective time of the merger) will be converted into the right to receive the merger consideration in respect thereof, as provided for in the merger agreement, but without interest, and you will have no appraisal rights with respect to such shares.

As noted above, a holder of shares of Clene common stock wishing to exercise his, her or its appraisal rights must, within 20 days after the date of mailing of the notice of appraisal rights, make a written demand for the appraisal of his, her or its shares of Clene common stock. The demand must reasonably inform Clene of the identity of the stockholder of record and his, her or its intent to demand appraisal of the fair value of the shares held by such holder. Only a holder of record of shares of Clene common stock issued and outstanding immediately prior to the effective date will be entitled to assert appraisal rights for the shares of Clene common stock registered in that holder’s name. The demand for appraisal should be executed by or on behalf of the holder of record of the shares of Clene common stock, fully and correctly, as the stockholder’s name appears on the Clene stock certificate(s), as applicable, should specify the stockholder’s name and mailing address and the number of shares registered in the stockholder’s name, and must state that the person intends thereby to demand appraisal of the stockholder’s shares of Clene common stock in connection with the merger. The demand cannot be made by the beneficial owner of shares of Clene common stock if such beneficial owner does not also hold of record such shares. A beneficial owner of shares of Clene common stock held in “street name” who desires appraisal should take such actions as may be necessary to ensure that a timely and proper demand for appraisal is made by the record holder of such shares. Shares held through brokerage firms, banks and other financial institutions are frequently deposited with and held of record in the name of a nominee of a central security depository, such as Cede & Co. Any beneficial holder desiring appraisal who holds shares through a brokerage firm, bank or other financial institution is responsible for ensuring that the demand for appraisal is made by the record holder. The beneficial holder of such shares should instruct such firm, bank or institution that the demand for appraisal be made by the record holder of the shares, which may be the nominee of a central security depository if the shares have been so deposited. As required by Section 262, a demand for appraisal must reasonably inform Clene of the identity of the holder(s) of record (which may be a nominee as described above) and of such holder’s intention to seek appraisal of such shares. If shares of Clene common stock are owned of record in a fiduciary capacity (such as by a trustee, guardian or custodian) execution of the demand for appraisal should be made in that capacity. If the shares of Clene common stock are held of record by more than one person, as in a joint tenancy or tenancy in common, the demand should be executed by or for all joint owners. An authorized agent, including an authorized agent for two or more joint owners, may execute the demand for appraisal on behalf of a holder of record; however, the agent must identify the record holder or holders and expressly disclose the fact that, in executing the demand, he, she or it is acting as agent for the record holder or holders. A record holder who holds shares of Clene common stock as a nominee for others, may exercise appraisal rights with respect to such shares held for one or more beneficial owners, while not exercising such rights with respect to shares held for other beneficial owners. In that case, the written demand should state the number of shares of Clene common stock as to which appraisal is sought. Where no number of shares of Clene common stock is expressly mentioned, the demand for appraisal will be presumed to cover all shares of Clene common stock held in the name of the record holder. Stockholders who hold their shares of Clene common stock in brokerage accounts or other nominee forms and who wish to exercise appraisal rights are urged to consult with their brokers to determine the appropriate procedures for the making of a demand for appraisal by such a nominee.

At any time within 60 days after the effective date of the merger, but not thereafter, any stockholder who has not commenced an appraisal proceeding or joined a proceeding as a named party may withdraw the demand for appraisal and accept the merger consideration for his, her or its shares of Clene common stock by delivering to Clene a written withdrawal of the demand for appraisal. However, any such attempt to withdraw the demand made more than 60 days after the effective date of the merger will require written approval of Clene. Unless the demand for appraisal is properly withdrawn by the stockholder who has not commenced an appraisal proceeding or joined that proceeding as a named party within 60 days after the effective date of the merger, no appraisal proceeding in the Delaware Court of Chancery will be dismissed as to any Clene stockholder without the approval of the Delaware Court of Chancery, and such approval may be conditioned upon such terms as the court deems just. If Clene does not approve a request to withdraw a demand for appraisal when that approval is required, or if the Delaware Court of Chancery does not approve the dismissal of an appraisal proceeding, the stockholder will be entitled to receive only the appraised value determined in any such appraisal proceeding, which value could be less than, equal to or more than the merger consideration for his, her or its shares of Clene common stock.

Within 120 days after the effective date of the merger, either Clene (as the surviving corporation of the merger) or any stockholder who has complied with the requirements of Section 262 of the DGCL and is entitled to appraisal rights under Section 262 of the DGCL may commence an appraisal proceeding by filing a petition in the Delaware Court of Chancery demanding a determination of the fair value of the shares of Clene common stock held by all stockholders entitled to appraisal. Upon the filing of such a petition by a stockholder, service of a copy of such petition

shall be made upon Clene. Mosaic has no present intent to cause Clene to file such a petition and has no obligation to cause such a petition to be filed, and stockholders should not assume that Clene will file a petition. Accordingly, it is the obligation of the holders of Clene common stock to initiate all necessary action to perfect their appraisal rights in respect of such shares of Clene common stock within the time prescribed in Section 262 of the DGCL, as the failure of a stockholder to file such a petition within the period specified could nullify his, her or its previous written demand for appraisal. In addition, within 120 days after the effective date of the merger, any stockholder who has properly complied with the requirements for the exercise of appraisal rights, upon written request, will be entitled to receive from Clene a statement setting forth the aggregate number of shares of Clene common stock for which a written consent adopting the merger agreement was not submitted and with respect to which demands for appraisal have been received, and the aggregate number of holders of such shares. The statement must be mailed within 10 days after such written request has been received by Clene or within 10 days after the expiration of the period for delivery of demands for appraisal, whichever is later. A person who is the beneficial owner of shares of Clene common stock may, in such person’s own name, file a petition for appraisal or request from Clene such statement.

If a petition for appraisal is duly filed by a stockholder and a copy of the petition is served upon Clene, then Clene will be obligated, within 20 days after receiving service of a copy of the petition, to file with the Delaware Register in Chancery a duly verified list containing the names and addresses of all stockholders who have demanded an appraisal of their shares of Clene common stock and with whom agreements as to the value of their shares of Clene common stock have not been reached. After notice to stockholders who have demanded appraisal, if such notice is ordered by the Delaware Court of Chancery, the Delaware Court of Chancery is empowered to conduct a hearing upon the petition and to determine those stockholders who have complied with Section 262 of the DGCL and who have become entitled to appraisal rights provided thereunder. The Delaware Court of Chancery may require stockholders who have demanded payment for their shares of Clene common stock to submit their stock certificates to the Delaware Register in Chancery for notation of the pendency of the appraisal proceedings, and if any stockholder fails to comply with that direction, the Delaware Court of Chancery may dismiss the proceedings as to that stockholder.

After determination of the stockholders entitled to appraisal of their shares of Clene common stock, the Delaware Court of Chancery will appraise such shares of Clene common stock, determining their fair value as of the effective date of the merger after taking into account all relevant factors exclusive of any element of value arising from the accomplishment or expectation of the merger, together with interest, if any, to be paid upon the amount determined to be the fair value. When the fair value has been determined, the Delaware Court of Chancery will direct the payment of such value upon surrender by those stockholders of the Clene stock certificates, representing their shares of Clene common stock. Holders of Clene common stock considering seeking appraisal should be aware that the fair value of their shares of Clene common stock as determined under Section 262 could be more or less than or the same as the consideration they would receive pursuant to the merger if they did not seek appraisal of their shares of Clene common stock and that investment banking opinions as to fairness from a financial point of view are not necessarily opinions as to fair value under Section 262. The Delaware Supreme Court has stated that “proof of value by any techniques or methods which are generally considered acceptable in the financial community and otherwise admissible in court” should be considered in the appraisal proceedings. In addition, Delaware courts have decided that the statutory appraisal remedy, depending on factual circumstances, may or may not be a dissenter’s exclusive remedy Unless the court in its discretion determines otherwise for good cause shown, interest from the effective date of the merger of the merger through the date of payment of the judgment will be compounded quarterly and will accrue at 5% over the Federal Reserve discount rate (including any surcharge) as established from time to time during the period between the effective date of the merger and the date of payment of the judgment. At any time before the entry of judgment in the proceedings, Clene may pay to each stockholder entitled to appraisal an amount in cash, in which case interest shall accrue thereafter as provided above only upon the sum of (1) the difference, if any, between the amount so paid and the fair value of the shares as determined by the Court of Chancery and (2) interest theretofore accrued, unless paid at that time. The costs of the appraisal action (which do not include attorneys’ fees or the fees and expenses of experts) may be determined by the Delaware Court of Chancery and taxed upon the parties as the Delaware Court of Chancery deems equitable under the circumstances. The Delaware Court of Chancery may also order that all or a portion of the expenses incurred by a stockholder in connection with an appraisal, including, without limitation, reasonable attorneys’ fees and the fees and expenses of experts utilized in the appraisal proceeding, be charged pro rata against the value of all the shares entitled to be appraised.

No representation is made as to the outcome of the appraisal of fair value as determined by the court and stockholders should recognize that such an appraisal could result in a determination of a value lower than, or the same as, the merger consideration. Moreover, none of Mosaic or Clene anticipates offering more than the merger consideration to any stockholder exercising appraisal rights and Mosaic and Clene reserve the right to assert, in any appraisal proceeding, that, for purposes of Section 262 of the DGCL, the “fair value” of a share of Clene common stock is less than the per share merger consideration.

Under the merger agreement, holders of Clene preferred stock will have their shares converted into shares of Clene common stock immediately prior to the effective time. Accordingly, the foregoing discussion is applicable to holders of Clene preferred stock in their capacity as holders of Clene common stock immediately prior to the merger.

FAILING TO FOLLOW PROPER STATUTORY PROCEDURES MAY RESULT IN LOSS OF YOUR APPRAISAL RIGHTS. In view of the complexity of Section 262 of the DGCL, holders of shares of Clene common stock who may wish to pursue appraisal rights should consult their legal and financial advisors.

Holders of TOTA common stock are not entitled to appraisal rights in connection with the merger under Delaware law.

MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES OF THE BUSINESS COMBINATION

In the opinion of Loeb & Loeb LLP, the following is a general discussion of the material U.S. federal income tax consequences (i) of the Reincorporation Merger to U.S. Holders (defined below) of TOTA Ordinary Shares, TOTA Rights, and TOTA Warrants (collectively, the “Tottenham securities”), (ii) of the Acquisition Merger to U.S. Holders of Clene common stock and Clean warrants (collectively, the “Clene securities”), (iii) of the ownership and disposition of PubCo Common Stock and PubCo Warrants (collectively, the “PubCo securities”) received in the Business Combination to U.S. Holders and Non-U.S. Holders and (iv) exercise of redemption rights by holders of Tottenham securities that are U.S. Holders.

This discussion is based on provisions of the Code, the Treasury Regulations promulgated thereunder (whether final, temporary, or proposed), administrative rulings of the IRS, and judicial decisions, all as in effect on the date hereof, and all of which are subject to differing interpretations or change, possibly with retroactive effect. This discussion does not purport to be a complete analysis or listing of all potential U.S. federal income tax considerations that may apply to a holder as a result of the Business Combination or as a result of the ownership and disposition of PubCo securities. In addition, this discussion does not address all aspects of U.S. federal income taxation that may be relevant to particular holders nor does it take into account the individual facts and circumstances of any particular holder that may affect the U.S. federal income tax consequences to such holder, and accordingly, is not intended to be, and should not be construed as, tax advice. This discussion does not address the U.S. federal 3.8% Medicare tax imposed on certain net investment income or any aspects of U.S. federal taxation other than those pertaining to the income tax, nor does it address any tax consequences arising under any tax laws other than the U.S. federal income tax law, such as gift or estate tax laws, U.S. state and local, or non-U.S. tax laws or, except as discussed herein, any tax reporting obligations of a holder of Tottenham securities, Clene securities or PubCo securities. Holders should consult their own tax advisors regarding such tax consequences in light of their particular circumstances.

No ruling has been requested or will be obtained from the IRS regarding the U.S. federal income tax consequences of the Business Combination or any other related matter; thus, there can be no assurance that the IRS will not challenge the U.S. federal income tax treatment described below or that, if challenged, such treatment will be sustained by a court.

This summary is limited to considerations relevant to holders that hold Tottenham securities or Clene securities and, after the completion of the Business Combination, PubCo securities, as “capital assets” within the meaning of section 1221 of the Code (generally, property held for investment). This discussion does not address all aspects of U.S. federal income taxation that may be important to holders in light of their individual circumstances, including holders subject to special treatment under the U.S. tax laws, such as, for example:

•        banks or other financial institutions, underwriters, or insurance companies;

•        traders in securities who elect to apply a mark-to-market method of accounting;

•        real estate investment trusts and regulated investment companies;

•        tax-exempt organizations, qualified retirement plans, individual retirement accounts, or other tax-deferred accounts;

•        expatriates or former long-term residents of the United States;

•        subchapter S corporations, partnerships or other pass-through entities or investors in such entities;

•        dealers or traders in securities, commodities or currencies;

•        grantor trusts;

•        persons subject to the alternative minimum tax;

•        U.S. persons whose “functional currency” is not the U.S. dollar;

•        persons who received TOTA Ordinary Shares or Clene common stock through the issuance of restricted stock under an incentive plan or through a tax-qualified retirement plan or otherwise as compensation;

U.S. Holders

U.S. Federal Income Tax Consequences of the Reincorporation Merger to U.S. Holders of Tottenham Securities

If the Reincorporation Merger Qualifies as a Reorganization

General U.S. Federal Income Tax Consequences

The U.S. federal income tax consequences of the Reincorporation Merger to U.S. Holders will depend primarily on whether the Reincorporation Merger qualifies as a reorganization within the meaning of Section 368(a)(1)(F) of the Code. Under Section 368(a)(1)(F) of the Code, a reorganization is a “mere change in identity, form, or place of organization of one corporation, however effected” (an “F Reorganization”). The Reincorporation Merger should qualify as an F Reorganization. However, the provisions of the Code that govern reorganizations are complex, and due to the absence of direct guidance on the application of Section 368(a)(1)(F) to a merger of a corporation holding only investment-type assets such as Tottenham, the qualification of the Reincorporation Merger as an F Reorganization is not entirely clear. U.S. Holders should be aware that PubCo has not requested and does not intend to request a ruling from the IRS with respect to the U.S. federal income tax treatment of the Reincorporation Merger. There can be no assurance that the IRS will not take a contrary position to views expressed herein or that a court will not agree with a contrary position of the IRS.

If the Reincorporation Merger qualifies as an F Reorganization and subject to the PFIC rules discussed below under the heading “— Passive Foreign Investment Company Status,” and the discussion below regarding the effect of Section 367 of the Code, a U.S. Holder that exchanges its Tottenham securities pursuant to the Reincorporation Merger should not recognize gain or loss on the exchange of Tottenham securities for PubCo securities. The aggregate adjusted tax basis of a U.S. Holder in the PubCo Common Stock received as a result of the Reincorporation Merger should equal the aggregate adjusted tax basis of the TOTA Ordinary Shares and the TOTA Rights surrendered in the exchange, and the aggregate adjusted tax basis in the PubCo Warrants received as a result of such exchange should equal the aggregate adjusted tax basis of the TOTA Warrants surrendered in the exchange, in each case increased by any amount included in income of such U.S. Holder under Section 367(b) of the Code (as discussed below). A U.S. Holder’s holding period for the PubCo securities received in the exchange should include the holding period for the Tottenham securities surrendered in the exchange.

Effect of Section 367 of the Code to U.S. Holders of TOTA Ordinary Shares

Section 367 of the Code applies to certain non-recognition transactions involving foreign corporations, including a domestication of a foreign corporation in a transaction that qualifies as an F Reorganization. When it applies, Section 367 imposes U.S. federal income tax on certain United States persons in connection with transactions that would otherwise be tax-free. Section 367(b) generally will apply to U.S. Holders that exchange TOTA Ordinary Shares (but not rights) for PubCo Common Stock as part of the Reincorporation Merger.

A. U.S. Holders Who Own 10 Percent or More of the Voting Power or Value of Tottenham

A U.S. Holder that on the day of the Reincorporation Merger beneficially owns (directly, indirectly or constructively) (i) ten percent (10%) or more of the total combined voting power of all classes of Tottenham stock entitled to vote or (ii) ten percent (10%) or more of the total value of shares of all classes of Tottenham stock (a “U.S. Shareholder”) must include in income as a dividend the “all earnings and profits amount” attributable to the TOTA Ordinary Shares it directly owns, within the meaning of Treasury Regulation Section 1.367(b)-2(d). Complex attribution rules apply in determining whether a U.S. Holder owns 10% or more of the total combined voting power of all classes of Tottenham securities entitled to vote or 10% or more of the total value of shares of all classes of Tottenham securities for U.S. federal income tax purposes, and all U.S. Holders are urged to consult their tax advisors with respect to these attribution rules.

A U.S. Shareholder’s all earnings and profits amount with respect to its TOTA Ordinary Shares is the net positive earnings and profits of the corporation (as determined under Treasury Regulation Section 1.367(b)-2(d)(2)) attributable to the TOTA Ordinary Shares (as determined under Treasury Regulation Section 1.367(b)-2(d)(3)) but without regard to any gain that would be realized on a sale or exchange of such TOTA Ordinary Shares.

Accordingly, under Treasury Regulation Section 1.367(b)-3(b)(3), a U.S. Shareholder will be required to include in income as a deemed dividend the all earnings and profits amount (as defined in Treasury Regulation Section 1.367(b)-2(d)) with respect to its TOTA Ordinary Shares as a result of the Reincorporation Merger. Any such U.S. Shareholder that is a corporation may, under certain circumstances, effectively be exempt from taxation on a portion or all of the deemed dividend pursuant to Section 245A of the Code. See “— Passive Foreign Investment Company Status” for a discussion of whether the amount of inclusion under Section 367(b) of the Code should be reduced by amounts required to be taken into account by a Non-Electing Shareholder under the proposed Treasury regulations under Section 1291(f) of the Code.

B. U.S. Holders Who Own Less Than 10 Percent of the Voting Power and Value of Tottenham

A U.S. Holder that on the day of the Reincorporation Merger beneficially owns (directly, indirectly or constructively) TOTA Ordinary Shares with a fair market value of $50,000 or more but less than (i) ten percent (10%) of the total combined voting power of all classes of Tottenham stock entitled to vote and (ii) ten percent (10%) of the total value of shares of all classes of Tottenham stock must either recognize gain with respect to the Reincorporation Merger or, in the alternative, elect to recognize the “all earnings and profits” amount, in each case as described below.

Unless a U.S. Holder makes the “all earnings and profits election” as described below, such holder generally must recognize gain (but not loss) with respect to PubCo securities received in exchange for its TOTA Ordinary Shares pursuant to the Reincorporation Merger. Any such gain would be equal to the excess of the fair market value of such PubCo securities received over the U.S. Holder’s adjusted tax basis in the TOTA Ordinary Shares surrendered in exchange therefor. Subject to the PFIC rules discussed below, such gain would be capital gain, and should be long-term capital gain if the U.S. Holder held the TOTA Ordinary Shares for longer than one year.

In lieu of recognizing any gain as described in the preceding paragraph, a U.S. Holder may elect to include in income the all earnings and profits amount attributable to its TOTA Ordinary Shares under Section 367(b). There are, however, strict conditions for making this election, as enumerated in the Treasury regulations.

U.S. Holders are strongly urged to consult with their own tax advisors regarding whether to make this election and if the election is determined to be advisable, the appropriate filing requirements with respect to this election. See “— Passive Foreign Investment Company Status” for a discussion of whether the amount of inclusion under Section 367(b) of the Code should be reduced by amounts required to be taken into account by a Non-Electing Shareholder under the proposed Treasury regulations under Section 1291(f) of the Code.

A U.S. Holder (who is not a U.S. Shareholder) that beneficially owns (directly, indirectly or constructively) TOTA Ordinary Shares with a fair market value of less than $50,000 would not be required to recognize any gain or loss or include any part of the all earnings and profits amount in income under Section 367(b) of the Code in connection with the Reincorporation Merger.

If the Reincorporation Merger Does Not Qualify as a Reorganization

If the Reincorporation Merger fails to qualify as an F Reorganization, and subject to the PFIC rules discussed below under the heading “— Passive Foreign Investment Company Status,” a U.S. Holder that exchanges its Tottenham securities for PubCo securities in the Reincorporation Merger will recognize gain or loss equal to the difference between (i) fair market value of the PubCo securities received and (ii) the U.S. Holder’s adjusted tax basis in the Tottenham securities exchanged therefor. A U.S. Holder’s aggregate tax basis in the PubCo securities received will be the fair market value of the PubCo securities on the date of the Reincorporation Merger. The U.S. Holder’s holding period for the PubCo securities received pursuant to the Reincorporation Merger will begin on the day after the date of the Reincorporation Merger.

Such gain or loss will be a capital gain or loss and will be a long-term capital gain or loss if the U.S. Holder’s holding period for the Tottenham securities exceeds one year at the time of the Reincorporation Merger. Long-term capital gains recognized by non-corporate U.S. Holders, including individuals, currently are subject to reduced rates of U.S. federal income taxation. The deductibility of capital losses is subject to limitations under the Code. Any such gain or loss recognized by a U.S. Holder will generally be treated as U.S. source gain or loss.

U.S. Holders should consult their own tax advisors as to the particular consequences to them of the exchange of Tottenham securities for PubCo securities pursuant to the Reincorporation Merger, the qualification of the Reincorporation Merger as an F Reorganization, and the application of Section 367(b) to the Reincorporation Merger.

Passive Foreign Investment Company Status

Even if the Reincorporation Merger qualifies as an F Reorganization, the Reincorporation Merger may be a taxable event to U.S. Holders of Tottenham securities under the passive foreign investment company, or “PFIC,” provisions of the Code, to the extent that Section 1291(f) of the Code applies. Because Tottenham is a blank check company with no current active operating business, based upon the composition of its income and assets, and upon a review of its financial statements, Tottenham believes that it likely was a PFIC for its most recent taxable year ended on December 31, 2019, and will likely be considered a PFIC for its current taxable year which ends as a result of the Reincorporation Merger.

A. Definition and General Taxation of a PFIC

A non-U.S. corporation will be classified as a PFIC for any taxable year (a) if at least 75% of its gross income consists of passive income, such as dividends, interest, rents and royalties (except for rents and royalties earned in the active conduct of a trade or business), and gains on the disposition of property that produces such income, or (b) if at least 50% of the fair market value of its assets (determined on the basis of a quarterly average) is attributable to assets that produce, or are held for the production of, passive income (including for these purposes its pro rata share of the gross income and assets of any corporation (and, if certain proposed Treasury regulations are applied, partnerships) in which it is considered to own at least 25% of the interest, by value). The determination of whether a foreign corporation is a PFIC is made annually.

If Tottenham is determined to be a PFIC for any taxable year (or portion thereof) that is included in the holding period of a U.S. Holder of Tottenham securities and, in the case of TOTA Ordinary Shares, the U.S. Holder did not make either (a) a timely qualified election fund, or “QEF,” election under Section 1295 of the Code for Tottenham’s first taxable year as a PFIC in which the U.S. Holder held (or was deemed to hold) TOTA Ordinary Shares or (b) a QEF election along with a “purging election,” both of which are discussed further below, such holder generally will be subject to special rules with respect to:

•        any gain recognized by the U.S. Holder on the sale or other disposition of its Tottenham ordinary shares or Tottenham rights; and

•        any “excess distribution” made to the U.S. Holder (generally, any distributions to such U.S. Holder during a taxable year of the U.S. Holder that are greater than 125% of the average annual distributions received by such U.S. Holder in respect of the TOTA Ordinary Shares during the three preceding taxable years of such U.S. Holder or, if shorter, such U.S. Holder’s holding period for the Tottenham ordinary shares).

Under these rules,

•        the U.S. Holder’s gain or excess distribution will be allocated ratably over the U.S. Holder’s holding period for the Tottenham securities;

•        the amount allocated to the U.S. Holder’s taxable year in which the U.S. Holder recognized the gain or received the excess distribution, or to the period in the U.S. Holder’s holding period before the first day of Tottenham’s first taxable year in which it qualified as a PFIC, will be taxed as ordinary income;

•        the amount allocated to other taxable years (or portions thereof) of the U.S. Holder and included in its holding period will be taxed at the highest tax rate in effect for that year and applicable to the U.S. Holder; and

•        the interest charge generally applicable to underpayments of tax will be imposed in respect of the tax attributable to each such other taxable year of the U.S. Holder.

In general, if Tottenham is determined to be a PFIC, a U.S. Holder may avoid the PFIC tax consequences described above with respect to its TOTA Ordinary Shares by making a timely QEF election (or a QEF election along with a purging election), as described below. Pursuant to the QEF election, a U.S. Holder will be required to include in income its pro rata share of Tottenham’s net capital gain (as long-term capital gain) and other earnings and profits (as ordinary income), on a current basis, whether or not distributed, in the taxable year of the U.S. Holder in which or with which Tottenham’s taxable year ends.

B. Impact of PFIC Rules on Certain U.S. Holders

The impact of the PFIC rules on a U.S. Holder of Tottenham securities will depend on whether the U.S. Holder has made a timely and effective election to treat Tottenham as a QEF, for Tottenham’s first taxable year as a PFIC in which the U.S. Holder held (or was deemed to hold) TOTA Ordinary Shares, or if the U.S. Holder made an effective QEF election along with a “purging election,” as discussed below. A U.S. Holder’s ability to make an effective QEF election with respect to Tottenham is contingent upon, among other things, the provision by Tottenham of certain information that would enable the U.S. Holder to make and maintain a QEF election. If Tottenham determines it is a PFIC for any taxable year, it will endeavor to provide to a U.S. Holder upon request such information as the IRS may require, including a PFIC annual information statement, in order to enable the U.S. Holder to make and maintain a QEF election. However, there is no assurance that Tottenham will have timely knowledge of its status as a PFIC in the future or of the required information to be provided. A U.S. Holder of a PFIC that made a timely and effective QEF election for Tottenham’s first taxable year as a PFIC in which the U.S. Holder held (or was deemed to hold) TOTA Ordinary Shares, or that made a QEF election along with a purging election, as discussed below, is hereinafter referred to as an “Electing Shareholder.” A U.S. Holder of a PFIC that did not make a timely and effective QEF election for Tottenham’s first taxable year as a PFIC in which the U.S. Holder held (or was deemed to hold) TOTA Ordinary Shares, or that did not make a QEF election along with a purging election, is hereinafter referred to as a “Non-Electing Shareholder.”

As indicated above, if a U.S. Holder of TOTA Ordinary Shares has not made a timely and effective QEF election with respect to Tottenham’s first taxable year as a PFIC in which the U.S. Holder held (or was deemed to hold) Tottenham ordinary shares, such U.S. Holder generally may nonetheless qualify as an Electing Shareholder by filing on a timely filed U.S. income tax return (including extensions) a QEF election and a purging election to recognize under the rules of Section 1291 of the Code any gain that it would otherwise recognize if the U.S. Holder sold its TOTA Ordinary Shares for their fair market value on the “qualification date.” The qualification date is the first day of Tottenham’s tax year in which Tottenham qualifies as a QEF with respect to such U.S. Holder. The purging election can only be made if such U.S. Holder held TOTA Shares on the qualification date. The gain recognized by the purging election will be subject to the special tax and interest charge rules treating the gain as an excess distribution, as described above. As a result of the purging election, the U.S. Holder will increase the adjusted tax basis in its TOTA Ordinary Shares by the amount of the gain recognized and will also have a new holding period in the TOTA Ordinary Shares for purposes of the PFIC rules.

A U.S. Holder may not make a QEF election with respect to its TOTA Rights or TOTA Warrants. As a result, if a U.S. Holder of TOTA Rights or TOTA Warrants sells or otherwise disposes of such rights (including for this purpose exchanging the TOTA Rights for PubCo Common Stock in the Reincorporation Merger), any gain recognized will be subject to the special tax and interest charge rules treating the gain as an excess distribution, as described above, if Tottenham were a PFIC at any time during the period the U.S. Holder held the TOTA Rights or TOTA Warrants.

U.S. Holders that hold (or are deemed to hold) stock of a foreign corporation that qualifies as a PFIC may elect to annually mark such stock to its market value if such stock is regularly traded on a national securities exchange that is registered with the Securities and Exchange Commission or certain foreign exchanges or markets of which the IRS has approved (a “mark-to-market election”). The Nasdaq Stock Market currently is considered to be an exchange that would allow a U.S. Holder to make a mark-to-market election. U.S. Holders are urged to consult their own tax advisors regarding the availability and tax consequences of a mark-to-market election with respect to their TOTA Ordinary Shares under their particular circumstances.

C. Effect of PFIC Rules on the Reincorporation Merger

Even if the Reincorporation Merger qualifies as an F Reorganization, Section 1291(f) of the Code requires that, to the extent provided in regulations, a U.S. person that disposes of stock of a PFIC (including rights to acquire stock of a PFIC) must recognize gain notwithstanding any other provision of the Code. No final Treasury regulations are in effect under Section 1291(f). Proposed Treasury regulations under Section 1291(f), or the “Proposed Regulations,” were promulgated in 1992, with a retroactive effective date once they become finalized. If finalized in their present form, the Proposed Regulations would require taxable gain recognition by a Non-Electing Shareholder with respect to its exchange of Tottenham securities for PubCo securities in the Reincorporation Merger if Tottenham were classified as a PFIC at any time during such U.S. Holder’s holding period in Tottenham securities. Any such gain would be treated as an “excess distribution” made in the year of the Reincorporation Merger and subject to the special tax and interest charge rules discussed above under “— Definition and General

Taxation of a PFIC.” In addition, the Proposed Regulations would provide coordinating rules with Section 367(b) of the Code, whereby, if the gain recognition rule of the Proposed Regulations applied to a disposition of PFIC stock that results from a transfer with respect to which Section 367(b) requires the shareholder to recognize gain or include an amount in income as a distribution under Section 301 of the Code, the gain realized on the transfer is taxable as an excess distribution under Section 1291 of the Code, and the excess, if any, of the amount to be included in income under Section 367(b) over the gain realized under Section 1291 is taxable as provided under Section 367(b). See “— U.S. Federal Income Tax Consequences — Effect of Section 367 of the Code.” The Proposed Regulations should not apply to an Electing Shareholder with respect to its TOTA Ordinary Shares for which a timely QEF election, a QEF election along with a purging election, or mark-to-market election is made. An Electing Shareholder may, however, be subject to the rules discussed below under the section entitled “— U.S. Federal Income Tax Consequences — Effect of Section 367 of the Code.” In addition, as discussed above, since a QEF election cannot be made with respect to TOTA Rights and TOTA Warrants, the Proposed Regulations should apply to cause gain recognition under the PFIC rules on the exchange of TOTA Rights for PubCo Common Stock and TOTA Warrants for PubCo Warrants pursuant to the Reincorporation Merger. It is not possible to determine at this time whether, in what form, and with what effective date, final Treasury Regulations under Section 1291(f) of the Code will be adopted.

The rules dealing with PFICs and with the QEF election and purging election (or a mark-to-market election) are very complex and are affected by various factors in addition to those described above. Accordingly, a U.S. Holder of Tottenham securities should consult its own tax advisor concerning the application of the PFIC rules to such securities under such holder’s particular circumstances.

U.S. Federal Income Tax Consequences of the Acquisition Merger to U.S. Holders of Clene Securities

Clene and Tottenham intend that, for U.S. federal income tax purposes, the Acquisition Merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. The obligation of Clene to effect the Acquisition Merger is conditioned on Clene’s receipt of an opinion from Kirkland & Ellis LLP, to the effect that, for U.S. federal income tax purposes, the Acquisition Merger will constitute a “reorganization” within the meaning of Section 368(a) of the Code.

Clene does not currently intend to waive this opinion condition to its obligation to complete the Acquisition Merger. If Clene waives this opinion condition after the registration statement of which this joint proxy statement/consent solicitation statement/prospectus forms a part is declared effective by the SEC, and if the U.S. federal income tax consequences of the Acquisition Merger have materially changed, Clene will recirculate this proxy statement/consent solicitation/prospectus and resolicit the votes of Clene stockholders.

This opinion of counsel does not address any state, local or foreign tax consequences of the Acquisition Merger. It is based on certain assumptions and representations as to factual matters from Clene, Tottenham, PubCo and Merger Sub, as well as certain covenants by those parties. In addition, the opinion is based on current law and cannot be relied upon if current law changes with retroactive effect. The opinion of counsel is not binding upon the IRS or the courts, and there is no assurance that the IRS or a court will not take a contrary position. Clene and Tottenham do not intend to request a ruling from the IRS about any aspects of the U.S. federal income tax consequences of the Acquisition Merger. If any of the assumptions, representations, covenants or undertakings is incorrect, incomplete, inaccurate or is violated, the opinion cannot be relied upon and the U.S. federal income tax consequences of the merger could differ from those described below.

Subject to the qualifications and limitations set forth herein, U.S. Holders of Clene common securities will generally not recognize any gain or loss as a result of the Acquisition Merger. Pursuant to the Acquisition Merger, U.S. Holders of Clene common stock will receive shares of PubCo Common Stock in exchange for their shares of Clene common stock, and U.S. holders of Clene warrants will receive shares of PubCo Warrants in exchange for their Clene warrants. Each U.S. Holder’s tax basis in the shares of PubCo Common Stock received in the Acquisition Merger will be the same as his, her or its tax basis in the shares of Clene common stock surrendered in the Acquisition Merger in exchange therefor, and each U.S. Holder’s tax basis in the PubCo Warrants received in the Acquisition Merger will be the same as his, her or its tax basis in the Clene warrants surrendered in the Acquisition Merger in exchange therefor. The holding period of the shares of PubCo Common Stock received in the Acquisition Merger by the U.S. Holder will include the holding period of the shares of Clene common stock surrendered in the Acquisition Merger in exchange therefor, and the holding period of the PubCo Warrants received in the Acquisition Merger by the U.S. Holder will include the holding period of the Clene warrants surrendered in the Acquisition Merger in exchange therefor.

In addition, pursuant to the Merger Agreement, U.S. Holders of Clene common stock may receive contingent consideration in the form of additional shares of PubCo Common Stock under certain circumstances. Any additional shares of PubCo Common Stock received by U.S. Holders pursuant to the Merger Agreement are expected to be viewed as contingent consideration in the Acquisition Merger and should generally be received on a tax-free basis in the manner described above. However, the treatment of contingent consideration received in a “reorganization” within the meaning of Section 368(a) of the Code, including a U.S. Holder’s tax basis in any shares of PubCo Common Stock received as contingent consideration, is unclear under current law, and there can be no assurance that the IRS will not take a contrary position to that described herein or that a court will not agree with a contrary position of the IRS in the event of litigation. Additionally, under Code Section 483, a portion of the value of any shares of PubCo Common Stock received by a U.S. Holder as contingent consideration will be treated as interest for U.S. federal income tax purposes that must be accounted for in accordance with the holder’s regular method of accounting. The amount of imputed interest is equal to the excess of (1) the fair market value of the shares of PubCo Common Stock, if any, received as contingent consideration over (2) the present value of such amount as of the effective time, discounted at the applicable federal rate in effect at the effective time. A U.S. Holder’s tax basis in any shares of PubCo Common Stock received as contingent consideration will be increased by the amount treated as imputed interest.

All U.S. Holders are urged to consult their tax advisors as to the tax consequences to them of the Acquisition Merger, including the potential receipt of contingent consideration, under such holder’s particular circumstances.

U.S. Federal Income Tax Consequences of Ownership and Disposition of PubCo Securities

The following discussion is a summary of certain material U.S. federal income tax consequences of the ownership and disposition of PubCo securities to U.S. Holders who receive such PubCo securities pursuant to the Business Combination.

Distributions on PubCo Common Stock

The gross amount of any distribution on PubCo Common Stock that is made out of PubCo’s current and accumulated profits (as determined for U.S. federal income tax purposes) will generally be taxable to a U.S. Holder as ordinary dividend income on the date such distribution is actually or constructively received by such U.S. Holder. Any such dividends paid to corporate U.S. Holders generally will qualify for the dividends received deduction if the requisite holding period is satisfied. Dividends paid to a non-corporate U.S. Holder generally will constitute “qualified dividends” that will be subject to tax at the maximum tax rate accorded to long-term capital gains.

Non-corporate U.S. Holders that do not meet a minimum holding period requirement or that elect to treat the dividend income as “investment income” pursuant to Section 163(d)(4) of the Code (dealing with the deduction for investment interest expense) will not be eligible for the reduced rates of taxation applicable to qualified dividends. In addition, the rate reduction will not apply to dividends if the recipient of a dividend is obligated to make related payments with respect to positions in substantially similar or related property. This disallowance applies even if the minimum holding period has been met.

To the extent that the amount of any distribution made by PubCo on the PubCo Common Stock exceeds PubCo’s current and accumulated earnings and profits for a taxable year (as determined under U.S. federal income tax principles), the distribution will first be treated as a tax-free return of capital, causing a reduction (but not below zero) in the adjusted basis of the U.S. Holder’s PubCo Common Stock, and to the extent the amount of the distribution exceeds the U.S. Holder’s tax basis, the excess will be taxed as capital gain recognized on a sale or exchange as described below under “— Sale, Exchange, Redemption or Other Taxable Disposition of PubCo Securities.”

Sale, Exchange, Redemption or Other Taxable Disposition of PubCo Securities

A U.S. Holder will generally recognize gain or loss on any sale, exchange, redemption, or other taxable disposition of PubCo Common Stock and PubCo Warrants in an amount equal to the difference between the amount realized on the disposition and such U.S. Holder’s adjusted tax basis in such PubCo Common Stock or PubCo Warrants. Any gain or loss recognized by a U.S. Holder on a taxable disposition of PubCo Common Stock or PubCo Warrants will generally be capital gain or loss and will be long-term capital gain or loss if the holder’s holding period in the PubCo Common Stock or PubCo Warrants exceeds one year at the time of the disposition. Preferential tax rates may apply

to long-term capital gains recognized by non-corporate U.S. Holders (including individuals). The deductibility of capital losses is subject to limitations. Any gain or loss recognized by a U.S. Holder on the sale or exchange of PubCo Common Stock or PubCo Warrants will generally be treated as U.S. source gain or loss.

Exercise or Lapse of a PubCo Warrant

Except as discussed below with respect to the cashless exercise of a PubCo Warrant, a U.S. Holder generally will not recognize gain or loss upon the acquisition of a share of PubCo Common Stock on the exercise of a PubCo Warrant for cash. A U.S. Holder’s tax basis in a share of PubCo Common Stock received upon exercise of the PubCo Warrant generally will be an amount equal to the sum of the U.S. Holder’s tax basis in the PubCo Warrant exchanged therefor and the exercise price. The U.S. Holder’s holding period for a share of PubCo Common Stock received upon exercise of the PubCo Warrant will begin on the date following the date of exercise (or possibly the date of exercise) of the PubCo Warrants and will not include the period during which the U.S. Holder held the PubCo Warrants. If a PubCo Warrant is allowed to lapse unexercised, a U.S. Holder generally will recognize a capital loss equal to such holder’s tax basis in the PubCo Warrant.

The tax consequences of a cashless exercise of a warrant are not clear under current tax law. A cashless exercise may be tax-free, either because the exercise is not a gain realization event or because the exercise is treated as a recapitalization for U.S. federal income tax purposes. In either tax-free situation, a U.S. Holder’s basis in the PubCo Common Stock received would equal the holder’s basis in the PubCo Warrant exercised therefor. If the cashless exercise were treated as not being a gain realization event, a U.S. Holder’s holding period in the PubCo Common Stock would be treated as commencing on the date following the date of exercise (or possibly the date of exercise) of the PubCo Warrant. If the cashless exercise were treated as a recapitalization, the holding period of the PubCo Common Stock would include the holding period of the PubCo Warrant exercised therefor.

It is also possible that a cashless exercise could be treated in part as a taxable exchange in which gain or loss would be recognized. In such event, a U.S. Holder would recognize gain or loss with respect to the portion of the exercised PubCo Warrants treated as surrendered to pay the exercise price of the PubCo Warrants (the “surrendered warrants”). The U.S. Holder would recognize capital gain or loss with respect to the surrendered warrants in an amount generally equal to the difference between (i) the fair market value of the PubCo Common Stock that would have been received with respect to the surrendered warrants in a regular exercise of the PubCo Warrants and (ii) the sum of the U.S. Holder’s tax basis in the surrendered warrants and the aggregate cash exercise price of such warrants (if they had been exercised in a regular exercise). In this case, a U.S. Holder’s tax basis in the PubCo Common Stock received would equal the U.S. Holder’s tax basis in the PubCo Warrants exercised plus (or minus) the gain (or loss) recognized with respect to the surrendered warrants. A U.S. Holder’s holding period for the PubCo Common Stock would commence on the date following the date of exercise (or possibly the date of exercise) of the PubCo Warrant.

Due to the absence of authority on the U.S. federal income tax treatment of a cashless exercise, there can be no assurance which, if any, of the alternative tax consequences and holding periods described above would be adopted by the IRS or a court of law. Accordingly, U.S. Holders should consult their tax advisors regarding the tax consequences of a cashless exercise of PubCo Warrants.

Certain U.S. Federal Income Tax Consequences to U.S. Holders of Tottenham Securities of Exercising Redemption Rights

In the event that a U.S. Holder elects to redeem its TOTA Ordinary Shares for cash, the treatment of the transaction for U.S. federal income tax purposes will depend on whether the redemption qualifies as sale or exchange of the TOTA Ordinary Shares under Section 302 of the Code or is treated as a distribution under Section 301 of the Code with respect to the U.S. Holder. Subject to the PFIC rules discussed above under the heading “— Passive Foreign Investment Company Status,” if the redemption qualifies as a sale or exchange of the TOTA Ordinary Shares, the U.S. Holder will be treated as recognizing capital gain or loss equal to the difference between the amount realized on the redemption and such U.S. Holder’s adjusted tax basis in the TOTA Ordinary Shares surrendered in such redemption transaction. Any such capital gain or loss generally will be long-term capital gain or loss if the U.S. Holder’s holding period for the TOTA Ordinary Shares redeemed exceeds one year. Long-term capital gains recognized by non-corporate U.S. Holders will be eligible to be taxed at reduced rates. The deductibility of capital losses is subject to limitations.

Subject to the PFIC rules discussed above under the heading “— Passive Foreign Investment Company Status,” if the redemption does not qualify as a sale or exchange of TOTA Ordinary Shares, the U.S. Holder will be treated as receiving a corporate distribution. Such distributions generally will constitute dividends for U.S. federal income tax purposes to the extent paid from Tottenham’s current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Distributions in excess of current and accumulated earnings and profits will constitute a return of capital that will be applied against and reduce (but not below zero) the U.S. Holder’s adjusted tax basis in the TOTA Ordinary Shares. Any remaining excess will be treated as gain realized on the sale or other disposition of the TOTA Ordinary Shares. Dividends paid to a U.S. Holder that is a taxable corporation generally will qualify for the dividends received deduction if the requisite holding period is satisfied. With certain exceptions (including, but not limited to, dividends treated as investment income for purposes of investment interest deduction limitations) and provided certain holding period requirements are met, dividends paid to a non-corporate U.S. Holder generally will constitute “qualified dividends” that will be subject to tax at the maximum tax rate accorded to long-term capital gains. However, it is unclear whether the redemption rights with respect to the TOTA Ordinary Shares may prevent a U.S. Holder from satisfying the applicable holding period requirements with respect to the dividends received deduction or the preferential tax rate on qualified dividend income, as the case may be.

Whether a redemption qualifies for sale or exchange treatment will depend largely on the total number of TOTA Ordinary Shares treated as held by the U.S. Holder (including any TOTA Ordinary Shares constructively owned by the U.S. Holder as a result of owning TOTA Warrants or TOTA Rights) relative to all of the TOTA Ordinary Shares outstanding both before and after the redemption. The redemption of TOTA Ordinary Shares generally will be treated as a sale or exchange of the TOTA Ordinary Shares (rather than as a corporate distribution) if the redemption (i) is “substantially disproportionate” with respect to the U.S. Holder, (ii) results in a “complete termination” of the U.S. Holder’s interest in Tottenham or (iii) is “not essentially equivalent to a dividend” with respect to the U.S. Holder. These tests are explained more fully below.

In determining whether any of the foregoing tests are satisfied, a U.S. Holder takes into account not only TOTA Ordinary Shares actually owned by the U.S. Holder, but also TOTA Ordinary Shares that are constructively owned by it. A U.S. Holder may constructively own, in addition to stock owned directly, stock owned by certain related individuals and entities, including those in which the U.S. Holder has an interest or that have an interest in such U.S. Holder, as well as any stock the U.S. Holder has a right to acquire by exercise of an option, which would generally include TOTA Ordinary Shares which could be acquired pursuant to the exercise of the TOTA Warrants or TOTA Rights. In order to meet the substantially disproportionate test, (i) the percentage of Tottenham’s outstanding voting stock actually and constructively owned by the U.S. Holder immediately following the redemption of the TOTA Ordinary Shares must be less than 80% of the percentage of Tottenham’s outstanding voting stock actually and constructively owned by the U.S. Holder immediately before the redemption, (ii) the U.S. Holder’s percentage ownership (including constructive ownership) of the outstanding Tottenham common stock (both voting and nonvoting) immediately after the redemption must be less than 80% of such percentage ownership (including constructive ownership) immediately before the redemption; and (iii) the U.S. Holder must own (including constructive ownership), immediately after the redemption, less than 50% of the total combined voting power of all classes of stock of Tottenham entitled to vote. There will be a complete termination of a U.S. Holder’s interest if either (i) all of the shares of the TOTA Ordinary Shares actually and constructively owned by the U.S. Holder are redeemed or (ii) all of the shares of the TOTA Ordinary Shares actually owned by the U.S. Holder are redeemed and the U.S. Holder is eligible to waive, and effectively waives in accordance with specific rules, the attribution of stock owned by certain family members and the U.S. Holder does not constructively own any other TOTA Ordinary Shares. The redemption of the TOTA Ordinary Shares will not be essentially equivalent to a dividend if a U.S. Holder’s conversion results in a “meaningful reduction” of the U.S. Holder’s proportionate interest in Tottenham. Whether the redemption will result in a meaningful reduction in a U.S. Holder’s proportionate interest in Tottenham will depend on the particular facts and circumstances. However, the IRS has indicated in a published ruling that even a small reduction in the proportionate interest of a small minority shareholder in a publicly held corporation who exercises no control over corporate affairs may constitute such a “meaningful reduction.” A U.S. Holder should consult with its own tax advisors as to the tax consequences of a redemption.

If none of the foregoing tests is satisfied, then the redemption will be treated as a corporate distribution. After the application of those rules regarding corporate distributions, any remaining tax basis of the U.S. Holder in the redeemed ordinary shares will be added to the U.S. Holder’s adjusted tax basis in its remaining TOTA Ordinary Shares, or, if it has none, to the U.S. Holder’s adjusted tax basis in its TOTA Warrants or possibly in other TOTA Ordinary

•        PubCo is or has been a “United States real property holding corporation” for U.S. federal income tax purposes at any time during the shorter of the five-year period ending on the date of disposition or the Non-U.S. Holder’s holding period for such securities disposed of, and either (A) shares of PubCo Common Stock are not considered to be regularly traded on an established securities market or (B) such Non-U.S. Holder has owned or is deemed to have owned, at any time during the shorter of the five-year period preceding such disposition and such Non-U.S. Holder’s holding period more than 5% of the outstanding shares of PubCo Common Stock. There can be no assurance that shares of PubCo Common Stock will be treated as regularly traded on an established securities market for this purpose.

A non-corporate Non-U.S. Holder described in the first bullet point immediately above will be subject to tax on the net gain derived from the sale under regular graduated U.S. federal income tax rates. An individual Non-U.S. Holder described in the second bullet point immediately above will be subject to a flat 30% tax on the gain derived from the sale, which may be offset by certain United States source capital losses, even though the individual is not considered a resident of the United States, provided that the individual has timely filed U.S. federal income tax returns with respect to such losses. If a Non-U.S. Holder that is a foreign corporation falls under the first bullet point immediately above, it will be subject to tax on its net gain in the same manner as if it were a United States person as defined under the Code and, in addition, may be subject to the branch profits tax equal to 30% (or such lower rate as may be specified by an applicable income tax treaty) of its effectively connected earnings and profits, subject to adjustments.

If the last bullet point immediately above applies to a Non-U.S. Holder, gain recognized by such Non-U.S. Holder on the sale, exchange or other disposition of PubCo securities generally will be subject to tax at generally applicable U.S. federal income tax rates. In addition, a buyer of such PubCo securities from a Non-U.S. Holder may be required to withhold U.S. income tax at a rate of 15% of the amount realized upon such disposition. PubCo will generally be classified as a “U.S. real property holding corporation” if the fair market value of its “United States real property interests” equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests and its other assets used or held for use in a trade or business, as determined for U.S. federal income tax purposes. PubCo does not expect to be classified as a “U.S. real property holding corporation” following the Business Combination. However, such determination is factual in nature and subject to change, and no assurance can be provided as to whether PubCo is or will be a U.S. real property holding corporation with respect to a Non-U.S. Holder following the Business Combination or at any future time.

Exercise or Lapse of a PubCo Warrant

The U.S. federal income tax treatment of a Non-U.S. Holder’s exercise of a PubCo Warrant, or the lapse of a PubCo Warrant held by a Non-U.S. Holder, generally will correspond to the U.S. federal income tax treatment of the exercise or lapse of a warrant by a U.S. holder, as described under “— U.S. Holders — Exercise or Lapse of a PubCo Warrant,” above, although to the extent a cashless exercise results in a taxable exchange, the consequences would be similar to those described under “— Sale, Exchange, Redemption or Other Taxable Disposition of PubCo Securities,” above for a Non-U.S. Holder’s gain on the sale or other disposition of PubCo securities.

Information Reporting and Backup Withholding

PubCo generally must report annually to the IRS and to each holder the amount of cash dividends and certain other distributions it pays to such holder on such holder’s PubCo securities and the amount of tax, if any, withheld with respect to those distributions. In the case of a Non-U.S. Holder, copies of the information returns reporting those distributions and withholding also may be made available to the tax authorities in the country in which the Non-U.S. Holder is a resident under the provisions of an applicable income tax treaty or agreement. Information reporting is also generally required with respect to proceeds from the sales and other dispositions of PubCo securities to or through the U.S. office (and in certain cases, the foreign office) of a broker. In addition, certain information concerning a U.S. Holder’s adjusted tax basis in its PubCo securities and adjustments to that tax basis and whether any gain or loss with respect to such securities is long-term or short-term also may be required to be reported to the IRS.

Products

Our CSN therapeutic candidates aim to address high unmet medical needs in several disease areas including:

(1)    disease modification of central nervous system disorders, including MS, PD and ALS;

(2)    the treatment of infectious diseases, including COVID-19;

(3)    accelerated wound healing and scar formation; and,

(4)    the treatment of several cancer types.

In addition to the development of faceted, clean-surfaced nanocrystals, our electro-crystal-chemistry platform can produce ionic solutions of various transition elements including silver, zinc, and others — elements which have proven historical utility in the treatment of disease.

•        CNM-Au8, our lead asset, is a highly concentrated aqueous suspension of clean-surfaced, faceted nanocrystalline gold (“Au”). CNM-Au8’s nanocatalytic mechanisms target the bioenergetic deficits, oxidative stress, and accumulation of misfolded proteins that are common to many neurodegenerative diseases. CNM-Au8 is hypothesized to act as a neuroprotective and remyelinating therapy in neurodegenerative disease states in order to: 1) drive, support, and maintain beneficial metabolic and energetic intracellular reactions within diseased, stressed, and/or damaged cells, 2) directly catalyze the reduction of harmful, reactive oxygen species, and 3) promote protein homeostasis via activation of the heat shock factor-1 pathway, recognized to dampen the cytotoxicity caused by misfolded and denatured proteins, which are known to occur ubiquitously in neurodegenerative diseases. We believe that CNM-Au8 is the only drug candidate in development with these unique nanocatalytic mechanisms of action. Nonclinical toxicology studies have demonstrated no adverse effect levels (“NOAELs”) even up to maximum feasible dosing levels for oral administration. In vitro and in vivo pharmacology studies have demonstrated that CNM-Au8 treatment enhances remyelination and neuroprotection in numerous models of MS, PD, and ALS. A Phase 1 First-In-Human study did not reveal safety or tolerability concerns for CNM-Au8 in healthy human volunteers dosed in accordance with the study protocol. There are five Phase 2 clinical studies presently underway evaluating the efficacy and safety of CNM-Au8 for the treatment of MS, PD, and ALS and one Phase 3 clinical trial underway that has the potential to fully support a New Drug Application (NDA) for the treatment of ALS, each of which is discussed in detail below.

•        CNM-ZnAg is a broad-spectrum antiviral, antibacterial agent comprised of zinc (Zn2+) and silver (Ag+) ions under development to treat disease-causing infections, such as COVID-19, and to provide immune support for symptom resolution. Zn2+ and Ag+ ions are produced in aqueous solutions using our electrochemistry platform; combining Zn2+ and Ag+ ions made in this manner leads to enhanced bioavailability of Zn2+ and potentially, synergistic immune effects. One clinical study is planned to begin in the fourth quarter of 2020, in Brazil, to determine ZnAg efficacy for the symptomatic treatment in subjects with COVID-19.

•        CNM-AgZn-17 is a gel polymer suspension of Ag+ and Zn2+ under development for treatment of infectious diseases and to support wound healing. We have demonstrated in in vitro assays that CNM-AgZn17 has broad-based anti-viral and anti-bacterial activity against common and antibiotic resistant pathogens such as Methicillin-resistant Staphylococcus aureus. We have also shown enhanced wound healing benefits in animal models of diabetic wound healing and decreased scar formation following burns. We anticipate filing an Investigational New Drug (IND) application with the FDA and subsequently plan to initiate a Phase 1 dermal First-In-Human safety study with CNM-AgZn17 in 2021.

•        CNM-AuPt7 is a gold-platinum combination nanocrystal with the potential to be an effective treatment for oncology indications. We have demonstrated in vitro up-regulation of pro-apoptotic and down-regulation of anti-apoptotic genes in the human breast cancer cell lines EFM-19 and MT-3 using CNM-PtAu7. We have further demonstrated down-regulation of genes associated with the electron transport chain activity which may relate to changes in tumorigenesis activity. We anticipate initiating standard animal toxicology programs in late 2021 with an IND filing planned between 2022 – 2023, subject to evaluation of the safety and efficacy learnings from the preclinical oncology assays and toxicology findings.

Dietary Supplements

Dietary supplements are marketed and distributed through our wholly owned subsidiary, dOrbital, Inc. (“dOrbital”). These include:

•        rMetxTM (ZnAg Immune Boost) is an aqueous zinc-silver ion dietary (mineral) supplement made using our electrochemistry platform with bioactive immune-supporting properties. rMetxTM is sold through dOrbital, and, a substantially similar product under the tradename, Zinc FactorTM, is sold by 4Life Research LLC (“4Life”), an international supplier of health supplements and a related party, under a supply agreement.

•        KHC46 is an aqueous gold dietary (mineral) supplement of very low-concentration Au nanoparticles produced using our electrochemistry platform. KHC46 has different production methods and physiochemical properties than our lead drug candidate, CNM-Au8. KHC46 is licensed exclusively to 4Life for worldwide marketing and distribution.

Clinical Development Pipeline

We have four Phase 2 clinical studies presently underway for the treatment of neurodegenerative disorders including MS, ALS, and PD, one Expanded Access Program for ALS patients, one Phase 3 study presently underway for disease-modification in ALS, and one Phase 2 clinical study commencing shortly in COVID-19 patients. The chart below reflects the respective stages of our main product candidates.

Our CSN Therapeutics Platform

We have developed a new pharmaceutical technology, CSN therapeutics. By uniting concepts from nanotechnology, plasma physics, material science, and biochemistry, we have created and refined a proprietary electrocrystallization method that results in pure or combination nanocrystals of the transition elements that are clean-surfaced, highly faceted, and biologically catalytically active. These nanocrystals can be concentrated in aqueous suspensions and orally administered. We are further able to produce ionic solutions of various transitions elements utilizing the same technology platform. Once in the gastrointestinal system, nanocrystals pass into the blood stream, and accumulate in organs such as the liver, kidneys, and spleen, with lower amounts crossing the blood brain barrier and reaching the brain, spinal cord, and cerebrospinal fluid. Nanocrystals can remain active within the body for at least several days before they are eliminated via the hepatobiliary-fecal system as well as via the urinary system.

Once inside the body, CSN therapeutics cross cellular membranes and enter cells where they directly donate and receive electrons within biological systems. In this way, each nanocrystal acts as a potent nanocatalyst, that can drive, support, and maintain beneficial metabolic and energetic intercellular reactions within diseased, stressed, and damaged cells. These catalytic, nanocrystal-based therapeutic drugs represent an entirely new approach to drug development, substantially differing from the standard paradigm of small-molecule drugs and large-molecule biologics. Unlike traditional pharmacological approaches, which are limited to single targets or specific signaling pathways, our technology platform has produced metallic nanocrystals that are beneficial through multi-modal activities in multiple cell types across multiple diseases. By utilizing intracellular medicinal catalysts to support bioenergetic reactions within cells, we believe this technology represents a revolutionary advance in the treatment of the underlying pathophysiology of neurodegeneration and related diseases associated with bioenergetic failure.

Figure 1 below shows examples of the kinds of nanocrystals that can be produced using our CSN therapeutic platform.

Figure 1. Representative CSN Therapeutic Nanocrystals

Figure 1. Representative transmission electron micrographs of the commonly observed crystalline shapes of gold nanocrystals (CNM-Au8) resulting from our CSN therapeutic platform. Insets are wireframes illustrating each classic shape: A, pentagonal bipyramid; B, tetrahedron; and C, hexagonal bipyramid. These nanocrystals are 10-13 nm in diameter.

Nanocatalysis

A catalyst lowers the activation energy of a chemical reaction in such a way as to accelerate the rate of the reaction, without being consumed in the reaction. In doing so, it does not change the equilibrium of the substrates and products, and it can catalyze both forward and reverse reactions until homeostasis, or a balance of substrates and products, has been achieved.

Several industrial uses of metal nanocatalysts have been discovered, but to our knowledge, we are the only company currently developing nanocatalysts to directly modulate biological systems as therapeutic drug candidates. Prior to our invention of the CSN therapeutic platform, the methods employed to make stable nanoparticles required the use of organic solvents or capping agents, which would contaminate the surfaces of the nanoparticles and be substantially difficult to remove. There are multiple conflicting reports in the literature regarding the toxicity of these nanoparticles, ranging from reportedly non-toxic to highly toxic to living organisms. We believe this lack of consistency may have been due to the varying degrees to which different nanoparticle preparations were contaminated with organic reagents, leading to observed toxic effects. Because our electrocrystal chemistry method does not involve the use of any organic solvents or reduction chemicals, we have observed that our nanocrystals possess substantially higher catalytic activity in living organisms than those reported for nanoparticles made using other methods. All of the toxicology studies completed with our lead asset, CNM-Au8, have resulted in NOAEL findings.

Transition metal nanocatalysts are surface catalysts. Unlike enzymes, which are protein catalysts that lower activation energies using active site binding pockets, metal nanocatalysts carry out their catalytic activities on their surfaces, where they act as exceptionally efficient electron donors and receivers. For this reason, unmodified, clean surfaces that are free of contaminating chemicals are extremely important for catalytic activity. The facets and vertices of the nanocrystals serve as the surface areas where electron exchange can take place. Metal nanocatalysts have been shown to have a variety of different catalytic activities, including superoxide dismutase, peroxidase, and catalase-like activities

for reducing reactive oxygen species, to reactions involving the oxidation of glucose, ascorbic acid, or the energetic metabolite, nicotinamide adenine dinucleotide (“NAD”). Figure 2 is an illustration of nanocatalysis, showing a single gold nanocrystal converting molecules of nicotinamide adenine dinucleotide hydride (“NADH”) in the background into NAD in the foreground. Gold nanocrystals have been described as electron reservoirs because their surfaces can readily accept as well as donate thousands of electrons per second in order to catalyze biochemical reactions, allowing them to accelerate reaction rates to extraordinarily high levels. For example, the conversion of NADH to NAD is usually very slow at room temperature. Upon addition of our gold nanocrystal suspension CNM-Au8, we have observed the very rapid conversion of NADH into NAD. Importantly, the NAD reaction drives adenosine triphosphate (ATP) production in both the mitochondrion as well as in the cytoplasm, via a reaction called glycolysis. ATP is the universal currency of energy in all living things; without the ability to convert NADH to NAD and vice versa, cells would be quickly depleted of ATP energy stores and die. CSN therapeutics capture the natural, extraordinary nanocatalytic activities of clean-surfaced, faceted nanocrystals to produce metabolites of high energetic or protective value to the cell.

Figure 2. Nanocatalysis Mechanism Representation

Figure 2. Illustration of nanocatalytic activity (Not to scale). A pentagonal bipyramidal gold nanocrystal is shown with its electron cloud to represent the ability of the nanocrystal to rapidly exchange electrons with substrates interacting with its surface. In the background, NADH molecules drawn as dark chemical ball-and-stick figures are catalytically converted into NAD in the foreground as bright pink ball-and-stick figures. A pink and blue mitochondrion on the left can use available NAD for the generation of ATP (Illustrated by Ella Maru).

Our Focus on Central Nervous System Disorders

Over the past several decades, traditional small molecule and biologic drug development approaches have suffered serious setbacks in the attempts to address nervous system disorders. A likely contributor to these setbacks is the multifactorial mechanisms underlying these diseases themselves, which are sufficiently complex they may not be amenable to “one drug-one target” disease modification. In the face of these failures, we believe our new paradigm of nanocrystal drug development, producing novel drugs with unique nanocatalytic, multi-modal mechanisms of action, is advantageous.

Multiple lines of evidence now point to bioenergetic failure as a key contributor to neurodegenerative disease. Neurons, and their associated support cells, in particular oligodendrocytes, are amongst the highest energy-consuming cells in the body: the brain represents only two percent of human body weight, yet it consumes over twenty-percent of the body’s metabolic energy. As humans age, our cell’s ability to convert food into energy in the form of ATP becomes less efficient. Eventually, the nervous system’s demand for ATP surpasses the cells’ ability to supply it, and as a consequence, neurons begin to fail and subsequently die. Genetic and environmental factors determine which neuronal types are most susceptible to bioenergetic failure in any individual. In PD, dopaminergic and other neuronal cell types manifest mitochondrial failure, leading to impaired energy production. In ALS, mitochondrial dysfunction is considered a hallmark of both sporadic and familial ALS, and several genetic causal variants of ALS have been linked to dysregulated neuronal energy metabolism. In MS, the cells capable of remyelinating damaged axons have been shown to be under metabolic stress, rendering them incapable of undergoing the energetically demanding process of repairing damaged myelin.

Preclinical work has shown that CNM-Au8 nanocrystals cross the blood brain barrier to potentially protect multiple central nervous system cell types. In multiple preclinical studies, we have demonstrated these central nervous system cells may benefit from nanocatalysis in several ways: oligodendrocytes receive an energetic boost sufficient to drive myelin production; dopaminergic, hippocampal and cortical neurons improve energy metabolism sufficient to enhance survival and maintain function in response to multiple disease-relevant stressors. Human astrocytes derived from patients with ALS have the capacity to kill motor neurons when grown in a co-culture, and these motor neurons exhibit markedly reduced toxicity when co-cultures are treated with CNM-Au8. By their very nature, faceted clean-surfaced nanocrystals with nanocatalytic capabilities circumvent many of the challenges that have plagued the central nervous system pharmaceutical drug development field in the past. Importantly, the mechanism by which they act through nanocatalysis produces several useful energetic metabolites while reducing the presence of harmful ones. These mechanisms are well suited to address the complex failures that occur in neurodegenerative diseases on multiple levels and within multiple central nervous system cell types.

The innovation of CSN therapeutics is that we are positioned to address the most significant challenge posed by numerous central nervous system diseases. Unlike the “one drug-one target” model, faceted clean surfaced nanocrystals act by multiple mechanisms to enhance the cellular bioenergetic state, while simultaneously and independently reducing oxidative stress and stimulating protein homeostasis inside central nervous system cells. Each nanocrystal is capable of exchanging thousands of electrons per second, potentially addressing deficits in diseased central nervous system cells in a manner that does not further deplete the cells of their internal energy stores. Our data demonstrate CSN therapeutics thereby support cells and replenish cellular bioenergetic deficiencies. In other words, CSN therapeutics support the cells of the central nervous system with the basic building blocks of energy they require to function normally.

Market Potential of CSN Therapeutics for Neurodegenerative Diseases

Despite the urgent demand for treatments and the tremendous market opportunities for neurodegenerative disease therapeutics, effective treatments are limited. Currently, there are no existing therapies that either promote remyelination or have been demonstrated to improve function in people with non-active, progressive MS. People with non-active, progressive MS account for approximately one-third of all MS cases and they suffer progressive loss of function, severely reduced quality of life and shortened life spans. Further, the current FDA-approved therapeutic agents for ALS have very limited disease-modifying effects. And, there are no currently available disease-modifying therapies for PD. All of the existing PD therapies are limited to symptomatic improvement and none have been shown to prevent or slow the loss of dopaminergic neurons. If the clinical studies presently underway provide evidence of remyelination or demonstrate improved neurological function, CSN therapeutics will have significant commercial sales potential in treating MS, PD, or ALS.

Not a single approved MS drug worldwide has been approved to show an effect on remyelination and neuroprotection. CNM-Au8’s effects on remyelination and neuroprotection for central nervous system disorders, together with the urgent market demand for safe and effective treatments, provides us with a global unique first-mover-advantage with significant market potential for the treatment of central nervous system diseases. Our most advanced CSN therapeutic candidate, CNM-Au8, has been developed to address the significant unmet medical needs in the treatment of the central nervous system disorders, MS, PD, and ALS. MS, PD, and ALS each severely impact healthspan and lifespan of those who suffer from these disorders, resulting in significant demand for disease-modifying treatments.

CNM-Au8 and Restoration of Bioenergetic Metabolism in MS, ALS, and PD

Overview

CNM-Au8 is a concentrated, orally-delivered suspension of pure gold nanocrystals in pharmaceutical grade water buffered with sodium bicarbonate. A single 60 milliliter, 30 milligram dose contains over one quadrillion nanocrystals. The median ferret diameter of CNM-Au8 nanocrystals is approximately 13 nanometers with each nanocrystal consisting of an estimated 30,000 to 70,000 gold atoms. CNM-Au8’s nanocatalytic mechanism, directly donating and/or receiving electrons, enhances intracellular bioenergetic reaction rates without requiring associated energetic investment from cells, thus increasing cells’ net energetic capacity. CNM-Au8 treatment results in improved bioenergetic metabolism within cells of the central nervous system. Through this mechanism, CNM-Au8 may protect multiple neuronal and glial populations including oligodendrocytes and/or neurons from oxidative, inflammatory, hypoxic, and excitotoxic insults, potentially resulting in enhanced myelination and improved neuronal survival while preserving neurite processes and synapse integrity.

Standard ICH M3(R2) toxicology studies were conducted on CNM-Au8 in three animal species, which yielded no toxicity findings resulting in a NOAEL finding up to maximum feasible dosing. A First-in-Humans Phase 1 Clinical Trial of orally administered single and multiple ascending doses of CNM-Au8 was then carried out in 86 healthy human volunteers. All doses (up to 90 mg/day) of CNM-Au8 were well-tolerated.

CNM-Au8 has received regulatory approval to proceed to Phase 2 clinical studies designed to assess the safety and efficacy of CNM-Au8 for brain metabolite target engagement and functional and physiologic improvements indicative of remyelination, and neuroprotection. Details for each clinical trial of CNM-Au8 are given below in the Clinical Development Plan section for each indication.

Mechanism of Action

CNM-Au8 acts through nanocatalysis to improve the bioenergetics, reduce harmful reactive oxygen species, and induce protein homeostatsis, via the heat shock protein-1 pathway in nervous system cells. These unique mechanism of actions lead to a cascade of beneficial effects as summarized in Figure 3.

Figure 3. Nanocatalytic Biological Mechanism of Action

Figure 3. CNM-Au8 mediated nanocatalysis enhances cellular energetic capacity and decreases oxidative stress, resulting in increased NAD and ATP production as well as increased proteostatic activity via the heat shock factor 1 pathway. Together, these activities lead to a cascade of enhanced disease responses in neurons, oligodendrocytes, and astrocytes, cell types that are most vulnerable to energetic deficiencies. CNM-Au8 thereby mediates remyelination and neuroprotective effects in neurodegenerative diseases such as MS, ALS, and PD.

One of the key metabolites catalyzed by CNM-Au8 is nicotinamide adenine dinucleotide (“NAD+”) (Fig. 4). NAD+ and its reduced partner NADH are vital for driving cellular energy ATP-generating reactions in living cells (Fig. 4A). Brain imaging studies have shown the ratio of NAD+ to NADH typically decreases with aging. Lowered NAD+ levels in both the blood and brain have been associated with neurological diseases such as schizophrenia, multiple sclerosis, Parkinson’s Disease, and Huntington’s Disease. Boosting NAD+ activity in neurodegenerative disease preclinical models has consistently demonstrated beneficial anti-aging and neuroprotective effects. CNM-Au8 exhibits higher catalytic activity for directly oxidizing NADH into NAD than any other commercially available gold nanoparticle we have tested (Fig. 4C, D). We have shown that treating cultured nervous system cells with CNM-Au8 increases their intracellular pools of NAD+ and ATP, demonstrating that CNM-Au8 increases the energetic capacity of central nervous system cells (Fig. 4E, F). This optimization of ATP allows oligodendrocytes to increase myelin production, as well as help numerous other types of central nervous system cells resist environmental and disease-related stressors that would otherwise cause them to die.

One significant stressor shared by many neurodegenerative diseases is the accumulation of harmful reactive oxygen species (“ROS”) within neurons as their energetic demands begin to exceed their ability to produce enough ATP to carry out normal functions. Chronic oxidative stress, caused by accumulation of ROS, can overwhelm the mitochondrial systems that normally tightly regulate ROS levels. Accumulation of excess ROS damages cell membranes, allows calcium ion imbalances, and eventually leads to cell death.

Figure 4. NAD Oxidation and Biological Effects on ATP and NAD+

Figure 4. Bioenergetic nanocatalysis by CNM-Au8. A, The NAD-NADH reduction-oxidation couple plays a key role in both ATP-generating reactions, glycolysis and mitochondrial electron transport chain (“ETC”) oxidative phosphorylation. B, Ultraviolet-visible light spectroscopy was used to show the catalytic activity of CNM-Au8 with time. As the reaction progresses, NADH is consumed, as demonstrated by the decrease in the NADH absorbance peak at 340 nm, while NAD+ is generated, as shown by the corresponding increase in the NAD+ absorbance peak at 260 nm. C, the rate of decay of the NADH absorbance peak is greater for CNM-Au8 than it is for citrate-reduced gold, nanoparticles of 10 nm (orange) and 30 nm (red) diameters (purchased from the National Institute of Standards and Technology), indicating that CNM-Au8 has a catalytic rate at least three-fold higher than NIST comparators under the

same reaction conditions. D, Catalytic rate of CNM-Au8 is demonstrably superior to several commercially available gold nanoparticles. Sigma Aldrich provides reactant-free, “citrate reduced” gold nanoparticles, in which extra procedures are used to clean the surfaces of reactants. “Citrate” gold nanoparticles may still have residual reactants present in the suspensions. E, Intracellular NAD+ levels increase in response to CNM-Au8 treatment in primary rodent neuron-glial co-cultures. F, Intracellular ATP levels increase in primary rodent oligodendrocyte cultures in response to CNM-Au8 treatment. E-F, one-way ANOVA, corrected for multiple comparisons, quantities shown are group means +/− SEM. *p < 0.05; **p < 0.01

In addition to boosting NAD+ levels inside nervous system cells, CNM-Au8 directly acts to reduce ROS by directly catalyzing their reduction (Fig. 5). CNM-Au8 possesses anti-oxidative catalytic activity and has been demonstrated to directly reduce oxygen radicals in a superoxide dismutase-like manner, as well as convert hydrogen peroxide into water and oxygen in a catalase-like manner (Fig. 5A, B). Anti-oxidative activity for CNM-Au8 has been demonstrated in primary mouse oligodendrocyte cultures, in which basal levels of ROS were reduced with treatment (Fig. 5C). In a Parkinson’s Disease in vitro model, ROS generated by treating primary rodent dopaminergic cells with the neurotoxin 1-methyl-4-phenylpyridinium (“MPP”) was lowered in response to CNM-Au8 treatment in the presence of MPP (Fig. 5D). Previous drug development efforts for neurodegenerative diseases have included numerous antioxidants, all of which failed to show disease-modifying effects. We believe CNM-Au8 remains in a different class from standard antioxidants because, to our knowledge, no other antioxidant demonstrates catalytic ability to increase bioenergetic metabolites NAD+ and ATP, while independently catalytically decreasing reactive oxygen species.

Figure 5. Reduction of Reactive Oxygen Species

Figure 5. CNM-Au8 is a catalytically active antioxidant. A, SOD-like activity of CNM-Au8 on superoxide radicals was measured using a colorimetric SOD assay kit (Cayman Chemical). B, Decay of the absorbance peak of hydrogen

peroxide (H2O2) as the dismutation of H2O2 takes place in the presence of CNM-Au8 (green) or comparator AuNPs of similar diameter (red) or no gold (black). C,D, Neurotoxin (MPP+) induced mitochondrial stress and death of dopaminergic neurons in primary E15 rat co-cultures is prevented by CNM-Au8 (green), as determined by TH+ cell number (not shown), reduction of ROS as measured as by the fraction of dopaminergic (“TH”) cells fluorescing with CELLROX Green signal, a marker of cytosolic oxidizing environment (C), and increased mitochondrial membrane potential (Mitotracker Red CMXRos) (D). C-D, one-way ANOVA, corrected for multiple comparisons, quantities shown are group means +/− SEM. *p < 0.05; **p < 0.01, ***p < 0.001; ****p < 0.0001.

Previous drug development efforts in the neurodegenerative disease space have targeted misfolded protein aggregates as toxic drivers of disease; for example, alpha-synuclein in PD, amyloid beta in Alzheimer’s Disease, and TAR DNA binding protein 43 (“TDP-43”) in ALS. An important component of the mechanism of action of CNM-Au8 is its ability to dose-dependently reduce aggregated alpha-synuclein and TDP-43 in cellular models of PD and ALS, respectively (Fig. 6). We believe this activity is, at least in part, attributable to the robust induction of twenty gene transcripts of the Heat Shock Factor 1 pathway, which we observed in oligodendrocytes in response to CNM-Au8 treatment (Robinson, et al. Nanocatalytic activity of clean-surfaced, faceted nanocrystalline gold enhances remyelination in animal models of multiple sclerosis. Sci Rep 10, 1936 (2020)) as well as due to an indirect cellular response to NAD upregulation, which has been shown to activate autophagic and proteostatic responses.

In summary, CNM-Au8 exhibits a novel mechanism of action via its nanocatalytic activities, involving:

(1)    Enhancement of bioenergetic metabolism via increased production of NAD+ and ATP

(2)    Reduction of oxidative stress, and

(3)    Enhancement of proteostatic, autophagic responses that reduce accumulation of toxic protein aggregates that are hallmarks of neurodegenerative diseases.

Figure 6. Reduction in Misfolded Protein Aggregates

Figure 6. CNM-Au8 reduces accumulation of protein aggregates in cellular models of PD and ALS. A) Primary culture of E15 rat mesencephalic neurons were pre-treated with vehicle, CNM-Au8, or positive control BDNF for 48h on day 4 of culture. 6-OHDA (20 uM) was added for 48 h then fixed and stained for anti-TH and anti- a-syn. B, Rat spinal motor neurons were cultured and treated with vehicle, glutamate (5 uM) or glutamate (5 uM) and CNM-Au8, then fixed and stained for anti-neurofilament, anti-TDP-43, and Hoechst. Group means plotted +/- SEM. * p <0.05; ** p < 0.01; *** p < 0.001; **** p< 0.0001; treatment vs. vehicle, one-way ANOVA corrected for multiple comparisons.

Safety and Tolerability of CNM-Au8

We completed a Phase 1 First-In-Human study of CNM-Au8 in 2016 to demonstrate it was safe for further clinical development, and to assess the pharmacokinetic profile at different dosing concentrations.

Trial design.    The Phase 1 First-In-Human study of CNM-Au8 was a randomized, placebo-controlled, double-blind, escalating single- and multiple-dose study to evaluate the safety, tolerability, and pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There were two phases to this study: a single-ascending dose (“SAD”) phase and a multiple-ascending dose (“MAD”) phase. The SAD Phase was conducted first followed by the MAD Phase of the study.

•        Single Ascending Dose: 40 subjects were randomized to CNM-Au8 (n=30) or placebo (n=10) at a 3:1 ratio in single dose escalating cohorts who received CNM-Au8 at 15 mg, 30 mg, 60 mg, or 90 mg with follow-up study duration for each subject of 18 days.

•        Multiple Ascending Dose: 46 subjects were randomized to CNM-Au8 (n=35) or placebo (n=11) in multiple dose cohorts who received CNM-Au8 at 15mg, 30 mg, 60 mg, and 90 mg with the duration of treatment at 21 days and follow-up of each subject was up to 50 days.

Safety.    Safety assessments revealed no significant findings. All doses used in this study were determined to be well-tolerated based on the frequency of reported treatment emergent adverse events (“TEAEs”). TEAEs occurred more frequently on placebo (86%) than in the CNM-Au8 dosing groups in both the SAD and MAD phases combined (75%). No subjects discontinued the study due to TEAEs and no serious adverse events (“SAEs”) were reported across any treatment group. The most frequently reported TEAEs were almost entirely of Grade 1 (mild) severity and transient. The most frequently reported TEAEs consisted of headaches, somnolence, fatigue, abdominal pain, diarrhea, nausea, and dizziness.

Pharmacokinetics.    PK analyses from the MAD Phase showed that at the end of 21 days, the maximum concentration of gold in blood was determined to be 1.53 ng/mL, 1.98 ng/mL, 2.35 ng/mL, and 3.33 ng/mL for each group dosed with 15, 30, 60, or 90 mg respectively. Pharmacokinetic (PK) analyses demonstrated that CNM-Au8 has a half-life of 14-21 days. The end-of-study drug exposure levels in humans either matched or exceeded the equivalent exposure that demonstrated neuroprotection and remyelination efficacy in animal models.

Conclusion.    The First-In-Human safety results demonstrated no safety signals following dosing with CNM-Au8 at or above clinically used doses and drug exposure levels in humans either matched or exceeded the equivalent exposure that demonstrated neuroprotection and remyelination efficacy in animal models.

After successful completion of Phase 1 studies of CNM-Au8, we progressed CNM-Au8 into Phase 2 studies designed to test the efficacy of CNM-Au8 in specific disease indications. Based on the safety findings and the strength of our preclinical remyelination and neuroprotection data, we have initiated five Phase 2 studies in central nervous system disorders including MS, PD, and ALS. We are partnering with a major academic institution in implementing a Phase 3 clinical program in ALS, which is already underway. We are accumulating increasing human safety exposure in our ongoing Phase 2 and Phase 3 clinical programs. To date, on a blinded basis we have seen no concerning or dose-limiting safety signals, and the independent data safety monitoring board overseeing our randomized double blind placebo controlled trials has recommended continuing the conduct of the trials following unblinded evaluation of the safety data.

Multiple Sclerosis

MS Market Opportunity

Multiple sclerosis is an inflammatory and degenerative disorder of the central nervous system involving immune-mediated destruction of the brain, optic nerves, and spinal cord. MS results from autoimmune attacks on the myelin sheath, the protective covering wrapping the axons of neurons. When myelin is destroyed by autoinflammatory immune attacks, neurons become damaged and can ultimately die, leading to motor symptoms, cognitive disability, visual impairment and other neurological impairments.

MS typically begins between the ages from 20 to 40, and it is the leading cause of non-traumatic disability in young adults. Women are affected approximately three-times as often as men, except in individuals with the less common, primary-progressive form of the disease, where there is no gender preponderance. MS is the most common inflammatory demyelinating disease, with a prevalence that varies considerably, from high levels in North America and Europe to low rates in Eastern Asia and sub-Saharan Africa.

The diagnosis of multiple sclerosis is predominantly a clinical one that is aided by radiological tests (e.g., magnetic resonance imaging). Other diagnostic methods include blood tests, evoked potential tests, lumbar puncture, and optical coherence tomography, which is a new technology for examining the effects of multiple sclerosis on the health of nerve cells and axons in the retina. Utilizing magnetic resonance imaging, a new diagnostic classification for multiple sclerosis—clinically isolated syndrome has been included in the updated 2017 International (McDonald) Criteria. Ongoing improvements in diagnostic technologies may increase the number of patients diagnosed with multiple sclerosis.

MS Current Therapies and Limitations

All of the currently available drugs for treating multiple sclerosis either treat the symptoms caused by MS or act to reduce the degree of autoimmune-mediated inflammation. These drugs are typically referred to as disease-modifying therapies (“DMTs”). Nearly all of the current approved DMTs are approved for the treatment of relapsing forms of MS (“RMS”). They commonly act via immunosuppression or via immunomodulation, and thereby act to minimize autoimmune-associated attacks on myelin. Immunomodulatory DMTs reduce the risk of having an inflammatory attack, referred to as a “relapse”, and can slow the development of disability in those patients having attacks (i.e., “active” patients). As a corollary, DMTs may possibly diminish the risk of conversion of relapsing MS to secondary progressive multiple sclerosis (“SPMS”). The newer DMTs have been shown to substantially reduce autoimmune-mediated attacks and to delay the progression of the disease in active patients. However, there are no drugs available which can reduce the ongoing loss of function (i.e., disease progression) in non-active (those no longer having attacks) MS patients. None of the approved DMTs have been shown to clinically improve remyelination of damaged and demyelinated axons in MS lesions. Currently available DMTs for the treatment of MS include: Injectable medications, Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Extavia (interferon beta-1b), Copaxone (glatiramer acetate), Plegridy (peginterferon beta-1a), Rebif (interferon beta-1a), Glatiramer acetate generic equivalent (Glatiramer Acetate Injection, Glatopa (glatiramer acetate); Oral medications, Aubagio (teriflunomide), Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Mavenclad (cladribine), Mayzent (siponimod); Infusion medications, Lemtrada (alemtuzumab), Novantrone (mitoxantrone), Ocrevus (ocrelizumab), and Tysabri (natalizumab). Advances in MS treatment with new B-cell depleting therapies, including ocrelizumab, have largely ameliorated inflammatory disease activity as measured by the reduction in risk of having relapses and the lack of occurrence of new gadolinium enhancing (inflammatory) lesions, as detected by MRI. However, despite the stabilization of MS disease activity in active MS patients by these agents for these MS patients, significant improvements in overall function has not been shown. Importantly, for the DMTs that have been approved to date, efficacy and safety are generally inversely correlated.

There is an increasing demand for better treatment strategies. Although current drugs for multiple sclerosis can reduce the risk of an inflammatory attack and slow down the progression of the disease in some MS patients, patients’ responses to drugs can be variable and suboptimal. For non-active MS patients, there is no available DMT that can substantially alter their progressive worsening. Also, the side effects of current MS drugs range from mild to serious, which may lead to reduced patient adherence.

Potential Advantages of CNM-Au8 for MS

We believe that CNM-Au8 has the potential to be a global first-in-class remyelinating and neuroprotective disease-modifying nanotherapeutic drug for MS. CNM-Au8 supports neurologic functions by enhancing bioenergetic activities in neurons and oligodendrocytes that have been attacked by the disease. Unlike the current immunomodulating MS DMTs, CNM-Au8 is thought to act to directly support neuroprotection and remyelination by improving bioenergetics, reducing harmful reactive oxygen species and inducing protective heat shock protein mechanisms. CNM-Au8 is administered orally, penetrates the blood brain barrier, and to date has a favorable safety, tolerability, and toxicology profile. Used alternately or in conjunction with standard immunomodulatory DMTs, CNM-Au8 treatment may improve patients’ quality of life and potentially reverse disease progression because of its enhancing bioenergetic activities in neurons and oligodendrocytes that have been attacked by the disease, even in patients whose inflammatory attacks are well-controlled.

Summary of Nonclinical Pharmacology Myelination Studies for MS

Myelination is a complex process resulting in the wrapping of axons by oligodendrocyte (“OL”) membranes containing specialized proteins and lipids. The resulting myelin sheath provides metabolic support to the axon and facilitates axonal electrical conduction, which in turn allows for central nervous system processing of motor, sensory, and higher order cognitive functions. During active myelination, OLs synthesize on the order of 100,000 proteins per

detectable improvements in behaviors in both open field and fine motor kinetics assessments. Figure 7 shows examples of the observed induction of myelination by CNM-Au8 from selected in vitro and in vivo experiments reported in Robinson et al.

Figure 7. Remyelination Summary

Figure 7. A summary of myelinating activities of CNM-Au8. Top row, Left: illustration of the demyelination (red) of a neuron’s axon (yellow) that occurs in MS. Right: Illustration of restored myelination along the axon (blue) provided by the OL (blue cell). Middle row: isolated primary mouse OL precursors treated with vehicle control (left), 3 μg/mL CNM-Au8, or positive control and myelin-inducing agent tri-iodothyronine (“T3”). Cells are fixed and stained for Myelin Basic Protein (“MBP”), a marker of mature myelin in red, and the nuclear stain DAPI in blue, to reveal the presence of all OL precursor cells in the field of view. Many more cells expressing MBP are seen in the CNM-Au8 treated cells compared to vehicle-treated cells. Bottom row: transmission electron images of slices of corpus callosum of mice treated with, left to right: no cuprizone, cuprizone for five weeks, CNM-Au8 for five weeks, or cuprizone for five weeks and CNM-Au8 for the last three of the five weeks. Myelin can be seen as dark rings in each micrograph. Cuprizone treatment destroys myelin, while CNM-Au8 treatment alone does not change myelin. CNM-Au8 treatment of cuprizone-treated animals results in the recovery of myelin in the brains of these animals.

Clinical Development of CNM-Au8 as a Disease-Modifying Drug for MS

Based on safety findings in our Phase 1 clinical study of CNM-Au8 and our robust preclinical remyelination data, we have launched two Phase 2 clinical studies to investigate the effects of CNM-Au8 on MS patients.

Figure 8. VISIONARY-MS Blinded LCLA Data (All Eyes) Percent Change vs. Baseline

Glanzman, R., H. Beadnall, M. T. Hotchkin, A. Klistorner, M. Barnett, R. Sergott, A. Rynders, K. S. Ho, and Mark G. Mortenson. “A Phase 2 Clinical Trial of Catalytic Gold Nanocrystals, CNM-Au8, for the Treatment of Chronic Optic Neuropathy.” Presented at the MSVirtual 2020, September 11, 2020.

Available blinded safety data from VISIONAYRY-MS indicate that CNM-Au8 is well-tolerated with most adverse events characterized as mild in severity. No serious adverse events related to the investigational product (e.g., placebo, CNM-Au8) have been reported to date. The most frequently reported adverse events include headache, upper respiratory infection, and sore throat. The full unblinded results from the study are anticipated near the end of 2021, subject to ongoing COVID-19 related research restrictions.