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United States securities and exchange commission logo
October 9, 2020
Jason Ma
President
Chelsea Worldwide Inc.
11 Marshall Road, Suite 1L
Wappingers Falls, New York 12590
Re: Chelsea Worldwide
Inc.
Registration
Statement on Form S-4
Filed September 10,
2020
File No. 333-248703
Dear Mr. Ma:
We have reviewed your registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe our comments apply to your
facts and
circumstances or do not believe an amendment is appropriate, please tell
us why in your
response.
After reviewing any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-4, filed September 10, 2020
Cover Page
1. Please amend to
register the PubCo Common Stock subject to the earn-out arrangements,
or advise.
2. Please revise the
disclosure in the final Q&A on page vii to identify, and if applicable,
quantify all incentives
and compensation to the Sponsor for consummating the merger.
Summary of the Proxy Statement/Consent Solicitation
Statement/Prospectus, page 1
3. Please revise the
disclosure to describe the voting power of Clene s common stock and
preferred stock.
4. Please provide
additional quantitative detail on page 3 concerning the breakdown of the
Jason Ma
FirstName LastNameJason
Chelsea Worldwide Inc. Ma
Comapany
October NameChelsea Worldwide Inc.
9, 2020
October
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amounts of TOTA Ordinary Shares, TOTA Warrants and TOTA Rights
outstanding and
that will exist in the form of PubCo Common Stock and PubCo Warrants
upon
consummation of the Business Combination, and the amount of Clene
common and
preferred stock outstanding. Include a description of the Clene common
and preferred
stock exchange mechanics, which first appear in the notes to the pro
forma financials on
page 175. Ensure that the revised disclosure allows an investor to
understand the
underlying share amounts for the percentages shown in the graphic on
page 5.
5. We note your references to Clene s product candidates as
first-in-class on page 2 and
throughout the registration statement. This term suggests that Clene's
product candidates
are effective and likely to be approved. Accordingly, please revise to
balance these
statements and provide context concerning the development and
regulatory status of
your product candidates and uncertainties concerning approval and
whether it will be first
in class in the future. Alternatively, please revise to delete these
references throughout
your registration statement.
6. Please reconcile the statement on page 7 that requests for redemption
may be withdrawn
at any time up to two business days immediately preceding the
Extraordinary General
Meeting with the statement on page 58 that requests for redemption
may be withdrawn
at any time up to the business day immediately preceding the
consummation of the
proposed Business Combination.
7. Please disclose on page 7 and elsewhere that the Business Combination
requires 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, which is currently only
mentioned in the
"Questions and Answers about the Business Combination, the
Extraordinary General
Meeting and the Consent Solicitation" section. Also, revise to
identify the Lead Investor.
8. You state that Tottenham s initial shareholders have agreed to vote
in favor of the
Reincorporation Merger Proposal and the Acquisition Merger Proposal,
and intend to vote
for the other Proposals but there is no agreement in place with
respect to voting on the
other Proposals. Please state the type of agreement entered into with
the initial
shareholders and file such exhibit pursuant to Item 601 of Regulation
S-K.
Comparative Per Share Information, page 13
9. Please remove the dollar sign in note 6 to improve clarity of the
nature of the exchange
ratio.
Risk Factors
Risks Relating to PubCo, page 52
10. Please include risk factor disclosure detailing the risks involved
with the provisions of
your proposed charter noted on pages 61-62, including, for instance,
having a classified
board, prohibiting shareholders from calling special meetings and
requiring more than a
majority vote for certain actions.
Jason Ma
FirstName LastNameJason
Chelsea Worldwide Inc. Ma
Comapany
October NameChelsea Worldwide Inc.
9, 2020
October
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Proposal No. 1 The Reincorporation Merger Proposal, page 60
11. Please revise your disclosure on page 62 to reflect the provisions in
the proposed
charter included as Annex B. In this regard, the disclosure on page 62
implies that the
requirements of the Securities Act and Exchange Act apply to claims
arising under the
Securities Act and the Exchange Act. However, in Annex B it appears
that claims arising
under the Securities Act and the Exchange Act must be brought in a US
federal court,
even though Section 22 of the Securities Act creates concurrent
jurisdiction for federal
and state courts over all claims arising under the Securities Act.
12. Please revise the disclosure to provide an explanation of any material
differences between
the rights of Tottenham s shareholders and the rights of PubCo s
shareholders. Also refer
to Rule 14a-4(a)(3) and identify clearly and impartially each separate
matter intended to
be acted upon. For instance, and without limitation, we note that the
reincorporated
PubCo entity has a classified board of directors which is not the case
for Tottenham. For
additional guidance, please refer to the interpretations
available at:
https://www.sec.gov/divisions/corpfin/guidance/exchange-act-rule-14a-
4a3.htm.
Proposal No. 2 The Acquisition Merger Proposal, page 63
13. Please revise the disclosure to briefly describe the non-solicitation
requirements of Section
7.3 of the Merger Agreement.
14. In your discussions of the Tottenham earn-out shares, please reconcile
the reference to the
Sponsor receiving earn-out shares and the initial shareholders
receiving earn-out shares.
See for example pages 63 (which references Milestone 1 Sponsor
Earn-out Shares) and
176, referencing the Sponsor, and pages 4 and Annex A-15, referencing
the initial
shareholders. In general, please be sure to distinguish between the
initial shareholders and
the Sponsor where appropriate.
15. Please revise the disclosure on page 65 and elsewhere as appropriate
to briefly describe
the COVID-19 implications reflected in the Merger Agreement. Please
also disclose that
the closing conditions under the Merger Agreement include requirements
that (i)
Tottenham remain listed on Nasdaq and 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 and (ii) the additional listing application for the
closing payment shares
issued to Clene s stockholders is approved by Nasdaq.
16. Please revise the disclosure to provide more detail about the lock-up
agreements and
registration rights agreements. For instance, with respect to the
lock-up agreements, please
include the time limit from page 206, state the number of shares the
lockup agreements
are expected to cover and provide a brief overview of the exceptions.
With respect to the
registration rights agreements, include the number of shares covered
by the registration
rights.
Jason Ma
FirstName LastNameJason
Chelsea Worldwide Inc. Ma
Comapany
October NameChelsea Worldwide Inc.
9, 2020
October
Page 4 9, 2020 Page 4
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17. Please revise the disclosure to explain whether Clene s collective
fair market value
satisfies the 80% test.
Material U.S. Federal Income Tax Consequences of the Business Combination, page
87
18. Please file a tax opinion as an exhibit to the filing or provide us
your analysis why the tax
consequences are not material to an investor and therefore no tax
opinion is required to be
filed. Refer to Item 601(b)(8) of Regulation S-K and Section III.A.2
of Staff Legal
Bulletin 19. Also revise, as applicable, to discuss whether there is
uncertainty
concerning U.S. federal income tax consequences stemming from
uncertainty regarding
whether the Reincorporation Merger will qualify as a reorganization.
Business of Clene, page 100
19. On page 102 you state A Phase 1 First-In-Human study demonstrated
the safety and
tolerability of CNM-Au8 in healthy human volunteers. You also state
on page 11, with
respect to your Phase 1 trial of CNM-Au8, All doses used in this
study were determined
to be safe and well-tolerated and on page 121: Administration of
the dietary supplement
was therefore found to be safe and well-tolerated over the 7-day
dosing period. Please
revise these and all similar statements throughout your prospectus
that state or imply that
your product candidates are safe or effective as these determinations
are solely within the
authority of the FDA and comparable regulatory bodies.
20. Please shorten the length of the arrows for the clinical studies that
are not yet completed in
the pipeline table on page 103. For instance, each of the Phase 2
arrows for CNM-AU8
needs to be shortened, as well as the arrow for CNM-PtAu7 given
disclosure on page 123
indicates this is in the research stage, and the arrow for CNM-AgZn17
given the
disclosure on page 123 indicates this is still ongoing preclinical
trials. Please tell us why
you feel it is appropriate to include the Expanded Access Program in
the table, and how
you determined the arrow should show the Expanded Access Program as a
Phase 2 study.
Please also clarify the disclosure regarding whether the COVID-19
clinical studies have
begun, and if they have not begun please clarify this in the pipeline
table.
21. In the discussion of market potential on page 106, please revise to
provide support for the
statement that receipt of regulatory approval would result in
significant commercial sales
potentially exceeding billions of dollars annually. Include, as
applicable, a discussion of
the number of people affected by the diseases targeted by Clene s
product candidates that
are in clinical trials and the importance of any limiting factors,
such as adequate coverage
and reimbursement rates from governmental healthcare programs and
commercial payors.
22. Please provide p-values for the graphics in Figure 4 on page 108 and
Figure 5 on page
109. We note that Figures 4E and 4F and Figures 5C and 5D have
asterisks that, based on
the asterisk in Figure 6, indicate p-values were meant to be included.
Please provide a
brief explanation of the disclosed p-values and how p-values are used
to measure
statistical significance. Please also increase the size of the
graphics in Figure 5 on page
109 so they are legible.
Jason Ma
FirstName LastNameJason
Chelsea Worldwide Inc. Ma
Comapany
October NameChelsea Worldwide Inc.
9, 2020
October
Page 5 9, 2020 Page 5
FirstName LastName
23. Please further describe the in vivo studies for MS mentioned at the
top of page 113.
24. On page 114 you state Once again, these data demonstrated
consistent, clinically relevant
improvements in LCLA, SDMT, 9HPT, and T25FW in the population as a
whole. Please
revise the disclosure to explain why you believe this data is
significant given it includes
participants taking the placebo and such participants are improving
without taking the
medication. Please also explain the meaning of low contrast letter
acuity ( LCLA ).
25. Please revise the disclosure to state the amount of the fee Clene will
pay in connection
with the Healey-ALS Platform Trial, mentioned on page 120, to the
extent material, and
file the agreement with the Sean M. Healey & AMG Center for ALS at
Massachusetts
General Hospital pursuant to Item 601(b)(10) of Regulation S-K or tell
us why you
believe it is not required to be filed.
26. Please revise page 120 to briefly explain what an Expanded Access
Program is and why it
is significant, including the requirements for achieving this
designation and its impact on
Clene s clinical development.
27. Please provide additional detail in support of the statement on page
121 that [i]n
nonclinical studies, CNM-ZnAg demonstrated significant anti-viral
activity against three
different viral pathogens and numerous bacterial, fungal and
parasitic pathogens.
Please also provide the number of participants in the seven-day human
tolerability study
for CNM-ZnAg mentioned on page 121.
28. In the description of the industrial food processing facility study,
please revise to clarify
whether any of the employees continued to work after treatment
initiation. Please also
explain why you believe symptoms decreased rapidly and showed a marked
improvement
in global impression of change for those that reported symptoms, given
it appears that less
than 50% ever reported feeling any better. Given this is an
uncontrolled study, please
discuss, if known, how long it takes for symptoms to resolve or for a
person infected with
COVID-19 to test negative.
29. On page 124 you mention certain collaborations with Johns Hopkins
University,
Cambridge University, Northwestern University, the George Washington
University and
the University of Edinburgh. Please revise to describe these
arrangements and tell us why
you did not file any agreements concerning these arrangements as
exhibits pursuant to
Item 601(b)(10) of Regulation S-K.
30. Please file the license and exclusive supply agreement with 4Life
Research LLC as an
exhibit pursuant to Item 601(b)(10) of Regulation S-K. We note, in
that respect, that you
state you have not licensed your technology or CSN therapeutics to any
other parties other
than 4Life, and that 4Life is a related party. Please revise the
disclosure on page 126 to
describe the term of the agreement, the number of years from the first
commercial sale
that royalties are payable and the termination grounds.
31. Please specify the product candidates or technologies to which your
patents relate and the
expiration dates on page 127.
Jason Ma
FirstName LastNameJason
Chelsea Worldwide Inc. Ma
Comapany
October NameChelsea Worldwide Inc.
9, 2020
October
Page 6 9, 2020 Page 6
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32. Please tell us why you believe that the lease for your Maryland
facility is not required to
be filed as an exhibit pursuant to Item 601(b)(10)(ii)(D) of
Regulation S-K.
Management s Discussion and Analysis of Financial Condition and Results of
Operations of
Clene, page 142
33. Please expand your disclosure in the Business of Clene section to
disclose more
information regarding the material terms of the grants mentioned on
page 143, such as any
conditions on funding, obligations under the grants, and the
intellectual property rights of
each party. Please file as exhibits any material written agreements
with the entity that
awarded grants pursuant to Item 601(b)(10) of Regulation S-K or tell
us why such
agreements are not required to be filed.
34. Please revise your COVID-19 disclosure to specifically state any
material impacts
COVID-19 has had on your business. You state there have not been any
material impacts
but on page 116 imply you were forced to pause you REPAIR-PD trial,
and on page 151
you disclose that you took out a PPP loan under the CARES Act.
Tottenham s Business, page 158
35. We note your disclosure on page 139 concerning the lack of litigation
involving Clene.
Please revise to also include compliance and legal proceedings
disclosure concerning
Tottenham.
Notes to Unaudited Pro Forma Condensed Combined Financial Information, page 175
36. Please revise the two instances of $0.1320 on page 175 to remove
the dollar signs to
improve clarity.
37. Please provide a calculation of the estimated Exchange Ratio of
0.1320, including the
calculation of Closing Payment Shares. Also clarify why you expect the
Closing Price per
Share in the calculation to be $10.
Directors, Executive Officers, Executive Compensation and Corporate Governance
of Clene,
page 183
38. For each director, please revise the disclosure to briefly discuss the
specific experience,
qualifications, attributes or skills that led to the conclusion that
the person should serve as
a director for the registrant. See Item 401(e)(1) of Regulation S-K.
39. With respect to the Summary Compensation table on page 187, please add
the footnotes
required by Instruction 1 to Item 402(n)(2)(v) and (n)(2)(vi) of
Regulation S-K, or advise.
Additionally, with respect to the Outstanding Equity Awards table on
page 187, please
add the footnotes required by Instruction 2 to Item 402(p)(2) of
Regulation S-K. With
respect to the Director Compensation table, for each director, please
disclose by footnote
the information required by the Instruction to Item 402(r)(2)(iii) and
(iv) and Instruction 1
to Item 402(n)(2)(v) and (n)(2)(vi) of Regulation S-K (as the latter
is required by the
Jason Ma
FirstName LastNameJason
Chelsea Worldwide Inc. Ma
Comapany
October NameChelsea Worldwide Inc.
9, 2020
October
Page 7 9, 2020 Page 7
FirstName LastName
Instruction to Item 402(r) of Regulation S-K).
PubCo s Directors and Executive Officers after the Business Combination, page
194
40. Please state which of PubCo s directors will be considered
independent and which
members of the compensation committee and nominating and corporate
governance
committee will be considered independent.
Security Ownership of Certain Beneficial Owners and Management Prior to the
Business
Combination, page 199
41. Please clarify the header on page 199 to state, if true, that the
table and accompanying
description represents ownership of Tottenham.
42. Please provide the beneficial ownership disclosure of Clene. Refer to
Item 6(d)
of Schedule 14A and Item 403 of Regulation S-K.
Security Ownership of the Combined Company after the Business Combination, page
201
43. Please revise your disclosure to identify the natural person or
persons who have voting
and/or investment control of the shares held by AK Holdings Company,
LC on page 203.
Refer to Item 403 of Regulation S-K required by Item 6 of Schedule
14A.
Exhibit Index, page II-4
44. Please revise Annex A or the exhibit index to include a list briefly
identifying the contents
of all omitted schedules for your Merger Agreement. Refer to Item
601(b)(2) of
Regulation S-K.
General
45. Please include a form of proxy card marked as preliminary in
your next amendment.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
Jason Ma
Chelsea Worldwide Inc.
October 9, 2020
Page 8
You may contact Tracey McCoy at (202) 551-3772 or Terence O'Brien at
(202) 551-
3355 if you have questions regarding comments on the financial statements and
related
matters. Please contact Margaret Schwartz at (202) 551-7153 or Joe McCann at
(202) 551-
6262 with any other questions.
FirstName LastNameJason Ma Sincerely,
Comapany NameChelsea Worldwide Inc.
Division of Corporation
Finance
October 9, 2020 Page 8 Office of Life Sciences
FirstName LastName