UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 11, 2021
Clene Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39834 | 85-2828339 | ||
| (State or other jurisdiction | (Commission | (IRS Employer | ||
| of incorporation) | File Number) | Identification No.) |
|
6550 South Millrock Drive, Suite G50 Salt Lake City, Utah |
84121 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (801) 676 9695
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common Stock, par value US$0.0001 per share | CLNN | The Nasdaq Stock Market LLC | ||
| Warrants, to acquire one-half of one share of Common Stock for $11.50 per share | CLNNW | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 11, 2021, Clene Inc. (the “Company”) issued a press release announcing its operating and financial results for its first quarter ended March 31, 2021. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished in this Item 2.02, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing made by the Company under the Exchange Act or the Securities Act of 1933 (the “Securities Act”), as amended, regardless of any general incorporation language in any such filings, except as shall be expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
In connection with a presentation by the Company at the 2021 meeting of the European Network to Cure ALS (“ENCALS 2021”) on May 12, 2021, the Company released an updated corporate presentation (the “Corporate Presentation”) on its website, www.clene.com. A copy of the Corporate Presentation is filed as exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Company plans to use its website to disseminate future updates to the Corporate Presentation and may not file or furnish a Current Report on Form 8-K alerting investors if the Corporate Presentation is updated.
The information furnished in this Item 7.01, including Exhibit 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act, regardless of any general incorporation language in any such filings, except as shall be expressly set forth by specific reference in such a filing.
Forward-Looking Statements
This report, the press release and the presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. The forward-looking statements include, but are not limited to, our expectations, hopes, beliefs, intentions, strategies, estimates and assumptions concerning events and financial trends that may affect our future results of operations or financial condition. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements are based on information available as of the date of this report and our management’s current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. As a result of a number of known and unknown risks and uncertainties, our actual results and the timing of events may differ materially from those expressed or implied by these forward-looking statements due to a number of factors. Applicable risks and uncertainties include those related to the possibility that any results of operations and financial condition or the Company are preliminary and subject to final audit, and the risks listed under the heading “Risk Factors” and elsewhere in our Annual Report on Form 10-K filed on March 29, 2021, and our subsequent filings with the U.S. Securities and Exchange Commission. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. We disclaim any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as specifically required under applicable securities laws.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number |
Exhibit Description | |
| 99.1 | Press Release dated May 11, 2021 announcing the Company’s operating and financial results for its first quarter ended March 31, 2021 | |
| 99.2 | Corporate Presentation dated May 12, 2021 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Clene Inc. | ||
| Date: May 12, 2021 | By: | /s/ Robert Etherington |
| Robert Etherington | ||
| President, Chief Executive Officer and Director | ||
Exhibit 99.1
Clene Reports First Quarter 2021 Operating and Financial Highlights
Interim Phase 2 data indicate that CNM-Au8 has a homeostatic effect on brain bioenergetics and support its potential to drive meaningful neurological functional improvements in MS patients
Awarded Michael J. Fox Foundation (MJFF) grant to accelerate development of CNM-Au8 as a treatment for Parkinson’s disease
Phase 2 RESCUE-ALS trial and Phase 2 target engagement trials in MS and PD remain on track for topline data in 2H 2021
Cash of $48.0 million as of March 31, 2021
SALT LAKE CITY, May 11, 2021 -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative disease using bioenergetic nanocatalysis, today reported its first quarter 2021 operating and financial results.
“Clene is off to a strong start in 2021, having made great progress across its programs,” said Rob Etherington, president and chief executive officer of Clene. “During the first quarter, we announced compelling interim data in MS patients indicating that CNM-Au8 has a homeostatic effect on brain bioenergetics, which may allow it to ultimately slow or halt disease progression. We also received important external validation for our Parkinson’s Disease program in the form of a grant from the Michael J. Fox Foundation that will enable us to accelerate CNM-Au8’s development in this high unmet need indication. Looking ahead, we are on track to achieve multiple key inflection points across our pipeline over the remainder of the year, the most notable being the announcement of topline data from our placebo-controlled, Phase 2 RESCUE-ALS study in the second half of 2021. With our strong cash position, we will continue to work expeditiously on our mission to change the treatment paradigm for patients with neurodegenerative diseases.”
First Quarter 2021 and Recent Highlights
CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS):
Phase 3 registrational trial in ALS on track for full enrollment in second half of 2021
In the first quarter of 2021, the HEALEY ALS Platform trial, a multi-center, multi-regimen, placebo-controlled, Phase 3 / registrational clinical program evaluating the safety and efficacy of multiple investigational products for the treatment of ALS, reached 50% of its target enrollment for the first three of the ongoing studies, including CNM-Au8. This first-ever ALS platform trial is designed to reduce trial time, reduce costs, and increase patient participation in developing novel therapies for ALS. It includes substantial financial support from philanthropic donors and foundations and provides access to more than 50 expert ALS clinical trial sites across the U.S. Full enrollment of 160 patients into the CNM-Au8 portion of the trial is anticipated before the end of 2021, with topline data expected in the first half of 2022.
CNM-Au8 for the treatment of multiple sclerosis (MS)
Presented blinded interim data from the Phase 2 VISIONARY-MS
trial at ACTRIMS Forum 2021
Updated blinded interim data from VISIONARY-MS continue to support the potential of CNM-Au8 to drive meaningful neurological improvements
in people with MS. Interim blinded data from all enrolled participants (randomized 2:1, active CNM-Au8 to placebo) showed clinically relevant
mean improvements in key MSFC sub-scales, as well as a composite score including all of the MSFC sub-scales. The overall study population's
progress on study was compared to the mildest sub-population (EDSS ≤1.5) scores at Baseline (mixed-effects model; p<0.0001 vs. baseline).
These findings support CNM-Au8’s potential to drive meaningful neurological improvements in MS patients. Subject to ongoing pandemic-related
research restrictions at MS clinical trial sites, enrollment will advance through 2021.
Presented interim data from the Phase 2 REPAIR-MS trial at ACTRIMS
Forum 2021:
REPAIR-MS utilizes high-field strength magnetic resonance spectroscopy (31P-MRS) to evaluate the effects of orally administered
CNM-Au8 on the brain metabolic profile in people with MS. Updated interim data from the trial show significant CNS target engagement
of CNM-Au8 with catalytic bioenergetic improvements in NAD+/NADH ratio and normalization of adenosine triphosphate (ATP) levels, two
key CNS metabolic markers. Together, these data indicate that orally administered CNM-Au8 has positive effects on brain bioenergetics
in MS patients. Clene expects to complete REPAIR-MS and report topline data in the second half of 2021.
CNM-Au8 for the treatment of Parkinson’s disease (PD):
Awarded Michael J. Fox Foundation (MJFF) grant to accelerate
the development of CNM-Au8 in PD
The MJFF funding will support preclinical studies in two complementary models of PD that will be led by Dr. Karen Ho, head of translational
medicine at Clene in partnership with academic and CRO collaborators. The project will further evaluate the effects of CNM-Au8 on the
survival and bioenergetic profiles of human PD patient dopaminergic neurons in the presence of PD-related neurotoxins and characterize
the effects of CNM-Au8 on motor behaviors and neuronal survival in an animal model of PD, both of which will facilitate the advancement
of CNM-Au8 into Phase 2 efficacy trials in PD patients.
CNM-ZnAg for the treatment of infectious diseases, including COVID-19:
Initiated a Phase 2 study of CNM-ZnAg for patients with COVID-19
in Brazil:
CNM-ZnAg is Clene’s second key asset intended for broad anti-viral and anti-microbial use. Clene has received official ANVISA approval
in Brazil to commence its multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of CNM-ZnAg
liquid solution in acutely symptomatic, non-hospitalized COVID-19 patients. The primary endpoint will evaluate the incidence of hospitalization
at day 28, with secondary endpoints assessing time to symptom resolution. The trial is expected to enroll approximately 276 patients
randomized 1:1:2 to receive either a low or high dose of CNM-ZnAg or placebo in a double-blind fashion, in addition to standard supportive
care. Clene expects to report topline results from the trial in the second half of 2021.
Corporate Highlights:
Intellectual Property:
Clene recently received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for methods of using CNM-Au8 for the treatment
of patients with MS, as well as two additional Notice of Allowances from the USPTO for patent applications covering device and process
claims for its platform technology and advanced stage clean-surfaced nanocrystal therapeutic candidates. The resulting patents will add
to Clene’s robust intellectual property portfolio in the field of clean-surfaced nanocrystal therapeutics, which includes over 130
issued and allowed patents and approximately 30 additional applications pending.
Anticipated 2021 Milestones:
| ● | HEALEY ALS Platform Trial full enrollment: 2H 2021 |
| ● | Phase 2 RESCUE-ALS topline data: 2H 2021 |
| ● | Phase 2 REPAIR-MS topline data: 2H 2021 |
| ● | Phase 2 REPAIR-PD topline data: 3Q 2021 |
| ● | Phase 2 CNM-ZnAg COVID-19 topline data: 2H 2021 |
| ● | Initiation of Phase 2 RESCUE-PD efficacy trial: 2H 2021 |
First Quarter 2021 Financial Results
Cash Position:
Clene’s cash totaled approximately $48.0 million as of March 31, 2021, compared to approximately $59.3 million as of December 31, 2020. The decrease in cash during the first quarter ended March 31, 2021 was primarily due to approximately $9.2 million of net cash used in operating activities, $0.2 million of net cash used in investing activities, and $1.9 million of net cash used in financing activities. We expect that our cash as of March 31, 2021 will be sufficient to fund our operating expenses into mid-2022.
R&D Expenses:
Research and development (“R&D”) expenses were approximately $6.3 million for the first quarter ended March 31, 2021, compared to $3.2 million for the same period in 2020. The year over year increase is primarily attributable to (i) the progression of our drug candidates through the clinical development process, including increased enrollment into the REPAIR-PD and the REPAIR-MS studies, and calendar payments due for our participation in the HEALEY-ALS Platform Trial; and (ii) $1.3 million of share-based expense related to restricted stock unit (“RSU”) awards included in R&D expenses.
G&A Expenses:
General and administrative (“G&A”) expenses were $5.4 million for the first quarter ended March 31, 2021, compared to $0.8 million for the same period in 2020. The year over year increase is primarily attributable to (i) increased professional expenses, legal fees, accounting fees, tax fees, and insurance expenses as a result of becoming a public company on December 30, 2020; and (ii) $1.9 million of share-based expense related to RSU awards included in G&A expenses.
Net Loss:
Clene’s loss from operations was $11.7 million and $4.0 million for the quarters ended March 31, 2021 and 2020, respectively. Clene’s net loss was $39.8 million, or $0.66 per share, for the first quarter ended March 31, 2021, compared to a net loss of $3.9 million, or $0.23 per share, for the first quarter ended March 31, 2020. Included in the net loss for the first quarter ended March 31, 2021 is an unrealized loss from the change in fair value of contingent earn-out liabilities of $28.6 million.
About RESCUE-ALS
RESCUE-ALS is a Phase 2 multi-center, randomized, double-blind, parallel-group, placebo-controlled study examining the efficacy, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in patients with early amyotrophic lateral sclerosis (ALS). The trial completed enrollment in 2H 2020. 45 subjects were randomized 1:1 to receive either active treatment with CNM-Au8 (30 mg) or placebo in addition to their current standard of care over a 36-week treatment period. The objective of the study is to assess the impact of improving neuronal bioenergetics, reducing reactive oxygen species, and promoting protein homeostasis with CNM-Au8 on disease progression in patients with early ALS. CNM-Au8 was selected by FightMND of Australia and Clene was provided a substantial grant to investigate efficacy in ALS utilizing novel electromyography endpoints at two expert sites in Australia. Topline data are expected in 2H 2021. For more information, please see ClinicalTrials.gov Identifier: NCT04098406.
About the HEALEY ALS Platform Trial
The HEALEY ALS Platform trial is a perpetual multi-center, randomized, double-blind, placebo-controlled Phase 3 registration program designed to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple investigational products in early symptomatic amyotrophic lateral sclerosis (ALS) patients. Funded by philanthropic donors and led by Harvard’s Massachusetts General Hospital, HEALEY is the first-ever ALS platform trial designed to reduce trial time, costs, and increase patient participation in developing novel therapies. This landmark platform trial tests multiple treatments utilizing a combined placebo group. CNM-Au8 was selected as one of the first drugs to be evaluated. Full enrollment of 160 patients into the CNM-Au8 study through 54 expert ALS U.S. clinical trial sites is expected by end of 2021. Subjects are randomized 3:1 to receive either active treatment or placebo daily for a 24-week treatment period. The primary endpoint is rate of change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Secondary endpoints include change in respiratory function over time as measured by slow vital capacity and change in muscle strength over time as measured isometrically using hand-held dynamometry. Topline data are expected 1H 2022. For more information, please see ClinicalTrials.gov Identifier: NCT04297683.
About VISIONARY-MS
VISIONARY-MS is a Phase 2, multi-center, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of CNM-Au8 as a remyelinating and neuro-reparative treatment in stable relapsing multiple sclerosis (MS) patients with chronic visual impairment. 150 participants are being enrolled through 10 expert MS clinical trial sites in Australia. Subjects are randomized 1:1:1 (high-dose:low-dose:placebo). The primary endpoint is improvement in Low Contrast Letter Acuity (LCLA) from baseline to week-24. Key secondary endpoints include improvements from baseline to week-24 in the remaining modified-Multiple Sclerosis Functional Composite (MSFC) subscales (Symbol Digit Modalities Test, 9-Hole Peg Test, and Timed 25-Foot Walk). Interim blinded data from the Phase 2 VISIONARY-MS trial presented at ACTRIMS Forum 2021 Meeting demonstrated exposure-dependent, statistically significant improvements in both LCLA scores and across the averaged components of the modified MSFC scale for the study population in comparison to baseline values from the mildest sub-population (p<0.001). Subject to ongoing pandemic-related research restrictions at MS clinical trial sites, enrollment will advance through 2021. For more information see ClinicalTrials.gov Identifier: NCT03536559.
About REPAIR-MS and REPAIR-PD
REPAIR-MS and REPAIR-PD are Phase 2, single-center, active-only, sequential group studies examining the brain metabolic effects, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in patients who have been diagnosed with MS within 15 years of screening or in patients with PD who have been diagnosed within three years of screening. Investigators and participants are blinded to dose. Participants received orally delivered CNM-Au8, the concentrated nanocrystalline gold (Au) suspension, daily each morning for 12 weeks. Participants undergo 31P-MRS brain imaging scans to semi-quantitatively measure CNS bioenergetic metabolites at baseline, prior to administration of drug, and at the end-of-study following at least 12 weeks of exposure to CNM-Au8. The objective of these studies is to demonstrate target engagement for CNM-Au8 on CNS biomarkers related to bioenergetics and neuronal membrane stability in patients with MS and PD. The studies are taking place at the University of Texas Southwestern Medical Center with a team of internationally recognized experts in brain imaging and treatment of disorders of the CNS. For more information see ClinicalTrials.gov Identifiers: NCT03993171 and NCT03815916.
About CNM-Au8
Clene’s lead drug candidate, CNM-Au8, a bioenergetic nanocatalyst, is a stable, aqueous suspension of catalytically active gold (Au) nanocrystals. Resulting from a patented manufacturing breakthrough, the self-organized, clean surfaced nanocrystals of CNM-Au8 drive critical cellular bioenergetic reactions in the brain that increase cellular energy, enhance neurorepair, and improve neuroprotection. CNM-Au8 crosses the blood-brain barrier and is not associated with the toxicities related to synthetic gold compounds or nanoparticles manufactured via alternative methods. CNM-Au8 is currently being evaluated in a Phase 3 registration trial in amyotrophic lateral sclerosis (ALS), a Phase 2 trial examining disease progression via a novel electromyography technique in patients with early ALS, a Phase 2 trial for the treatment of chronic optic neuropathy in patients with stable relapsing multiple sclerosis (MS), and Phase 2 brain target engagement studies in patients with Parkinson’s disease (PD) and MS. CNM-Au8 has demonstrated safety in Phase 1 studies in healthy volunteers and has shown both remyelination and neuroprotective effects in multiple preclinical (animal) models. Preclinical data, both published in peer-reviewed journals and presented at scientific congresses, demonstrate that treatment of neuronal cultures with CNM-Au8 improves survival of neurons, protects neurite networks, decreases intracellular levels of reactive oxygen species and improves mitochondrial capacity in response to cellular stresses induced by numerous disease-relevant neurotoxins. Oral treatment with CNM-Au8 improved functional behaviors in rodent models of ALS, MS, and PD versus vehicle (placebo).
About Clene
Clene, a clinical-stage biopharmaceutical company focused on neurodegenerative disease, is leading the way by using nanotechnology to treat bioenergetic failure, which underlies many neurological diseases. Clene has innovated a novel nanotherapeutic platform to create a new class of drugs—bioenergetic nanocatalysts. Clene’s lead drug candidate, CNM-Au8, is a concentrated nanocrystalline gold (Au) suspension that drives critical cellular bioenergetic reactions in the CNS. CNM-Au8 increases cellular energy to accelerate neurorepair and improve neuroprotection. Currently, CNM-Au8 is being investigated for efficacy and safety in a Phase 3 registration trial for ALS and in Phase 2 trials for multiple sclerosis and Parkinson’s disease. Clene has also advanced into the clinic an aqueous solution of ionic zinc and silver for anti-viral and anti-microbial uses. The company is based in Salt Lake City, Utah with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Clene's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene’s control and could cause actual results to differ materially and adversely from expected results. Factors that may cause such differences include Clene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Clene’s ability to achieve commercial success for its marketed products and drug candidates, if approved; Clene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Clene’s reliance on third parties to conduct drug development, manufacturing and other services; Clene’s limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on Clene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in Clene’s Annual Report filed on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Clene’s subsequent filings with the U.S. Securities and Exchange Commission. Clene undertakes no obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Revenue: | ||||||||
| Product revenue | $ | 199 | $ | 70 | ||||
| Royalty revenue | 14 | - | ||||||
| Total revenue | 213 | 70 | ||||||
| Operating expenses: | ||||||||
| Cost of revenue | 243 | 58 | ||||||
| Research and development | 6,275 | 3,202 | ||||||
| General and administrative | 5,390 | 812 | ||||||
| Total operating expenses | 11,908 | 4,072 | ||||||
| Loss from operations | (11,695 | ) | (4,002 | ) | ||||
| Other income (expense), net: | ||||||||
| Interest expense | (551 | ) | (51 | ) | ||||
| Gain on extinguishment of notes payable | 647 | - | ||||||
| Change in fair value of preferred stock warrant liability | - | 112 | ||||||
| Change in fair value of derivative liability | - | 4 | ||||||
| Change in fair value of Clene Nanomedicine contingent earn-out | (25,610 | ) | - | |||||
| Change in fair value of Initial Shareholders contingent earn-out | (2,961 | ) | - | |||||
| Australia research and development credit | 339 | - | ||||||
| Other income (expense), net | 3 | (4 | ) | |||||
| Total other income (expense), net | (28,133 | ) | 61 | |||||
| Net loss before income taxes | (39,828 | ) | (3,941 | ) | ||||
| Income tax benefit | 72 | - | ||||||
| Net loss | (39,756 | ) | (3,941 | ) | ||||
| Other comprehensive income: | ||||||||
| Foreign currency translation adjustments | 24 | 6 | ||||||
| Total other comprehensive income | 24 | 6 | ||||||
| Comprehensive loss | $ | (39,732 | ) | $ | (3,935 | ) | ||
| Net loss per share-- basic and diluted | (0.66 | ) | (0.23 | ) | ||||
| Weighted average common shares used to compute basic and diluted net loss per share | 60,670,932 | 17,357,505 | ||||||
CLENE INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 48,041 | $ | 59,275 | ||||
| Accounts receivable | 123 | 21 | ||||||
| Inventory | 355 | 191 | ||||||
| Prepaid expenses and other current assets | 4,824 | 3,502 | ||||||
| Total current assets | 53,343 | 62,989 | ||||||
| Right-of-use assets | 1,006 | 1,029 | ||||||
| Property and equipment, net | 4,182 | 4,225 | ||||||
| TOTAL ASSETS | $ | 58,531 | $ | 68,243 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 739 | $ | 1,124 | ||||
| Accrued liabilities | 2,730 | 3,960 | ||||||
| Income tax payable | 164 | 164 | ||||||
| Deferred revenue from related parties | 112 | 112 | ||||||
| Operating lease obligations, current portion | 202 | 194 | ||||||
| Finance lease obligations, current portion | 139 | 190 | ||||||
| Clene Nanomedicine contingent earn-out, current portion | - | 5,924 | ||||||
| Total current liabilities | 4,086 | 11,668 | ||||||
| Operating lease obligations, net of current portion | 1,723 | 1,785 | ||||||
| Finance lease obligations, net of current portion | 210 | 205 | ||||||
| Notes payable | 1,844 | 1,949 | ||||||
| Deferred income tax | 214 | 260 | ||||||
| Clene Nanomedicine contingent earn-out, net of current portion | 77,663 | 46,129 | ||||||
| Initial Shareholders contingent earn-out | 8,867 | 5,906 | ||||||
| TOTAL LIABILITIES | 94,607 | 67,902 | ||||||
| Stockholders’ equity (deficit): | ||||||||
| Common stock, $0.0001 par value: 100,000,000 shares authorized; 59,574,382 and 59,526,171 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 6 | 6 | ||||||
| Additional paid-in capital | 156,886 | 153,571 | ||||||
| Accumulated deficit | (193,317 | ) | (153,561 | ) | ||||
| Accumulated other comprehensive income | 349 | 325 | ||||||
| TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) | (36,076 | ) | 341 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ | 58,531 | $ | 68,243 | ||||
Media Contact
Andrew Mielach
LifeSci Communications
(646) 876-5868
amielach@lifescicomms.com
Investor Contact
Bruce Mackle
LifeSci Advisors, LLC
(929) 469-3859
bmackle@lifesciadvisors.com
Source: Clene Inc.
Exhibit 99.2
CLNN (NASDAQ)
Forward Looking Statements This presentation contains "forward - looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 . Clene's actual results may differ from its expectations, estimates, and projections and consequently, you should not rely on these forward - looking statements as predictions of future events . Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward - looking statements . These forward - looking statements involve significant known and unknown risks and uncertainties, many of which are beyond Clene’s control and could cause actual results to differ materially and adversely from expected results . Factors that may cause such differences include Clene’s ability to demonstrate the efficacy and safety of its drug candidates ; the clinical results for its drug candidates, which may not support further development or marketing approval ; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval ; Clene’s ability to achieve commercial success for its marketed products and drug candidates, if approved ; Clene’s ability to obtain and maintain protection of intellectual property for its technology and drugs ; Clene’s reliance on third parties to conduct drug development, manufacturing and other services ; Clene’s limited operating history and its ability to obtain additional funding for operations and to complete the licensing or development and commercialization of its drug candidates ; the impact of the COVID - 19 pandemic on Clene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in Clene’s recently filed registration statement on Form S - 4 /A as well as discussions of potential risks, uncertainties, and other important factors in Clene’s subsequent filings with the U . S . Securities and Exchange Commission . Clene undertakes no obligation to release publicly any updates or revisions to any forward - looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law . All information in this presentation is as of the date of presented or the date made publicly available . The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this presentation . 2
3 Unmet Medical Need & Market Opportunity Lead Asset: CNM - Au8 for Neuro Repair Clinical D e v e lo p m e nt Pipeline Strong IP Portfolio Financials CNM - ZnAg for COVID - 19 CLENE | Investment Highlights • Nanocatalyst of Intracellular Biological Reactions • Robust Preclinical Remyelination & Neuroprotection Data Across Multiple Animal Models in: MS, ALS, and Parkinson’s Disease • NOAEL Findings From All Toxicity Studies • Acceptable Phase 1 Safety Profile • Up to 76 Weeks Exposure in Clinical Trials; Up to 85 Weeks in ALS Expanded Access • Two Phase 2 Brain Target Engagement Studies in PD and MS with Top Line Results anticipated in 2021 • Three Phase 2 POC Studies in ALS, MS, and COVID with Results Anticipated in the next 12 - 18 Months • Phase 3 ALS Registrational Trial in with Full Results Anticipated in 1H 2022 • Ongoing ALS Early Access Program • USA FDA Granted ALS Orphan Drug Designation • CLNN (NASDAQ) • $31.9M USD (Gross) Raised via SPAC merger + PIPE ( 2020 ) • Cash on Hand at end of Q 1 2021 of $ 48 . 0 M (Unaudited) • Anticipated Cash Runway into mid - 2022 • $114M USD Raised Privately (Series A - D) • +$18M in Additional Grant and Indirect Financial Support for ALS and MS Phase 2 & 3 Clinical Programs • Zinc - Silver Antiviral + Immune Support • Phase 2 Trial in Brazil To Treat Acutely Symptomatic Non - Hospitalized COVID - 19 Patients Underway 1st Endpoint: Prevention of Hospitalization 2nd Endpoint: Time to S y m p t o m at i c Imp r o vemen t (Up to 28 Days) • Results Anticipated 2H 2021 • 130+ Issued Patents Worldwide; 30+ Pending Patent Applications • State of Matter Claims Cover Myelin Protection M ech a nisms , Remyelination, and Neuroprotection to 2035 (with Patent Restoration Term) • Manufacturing Device and Process Patents to 2030 and Beyond • No Effective Disease - Modifying Drugs for ALS or PD • No MS Therapies Clinically Impact Remyelination & Neurorepair • Remyelination and Neurorepair Sales Could Exceed $10B per annum 1 ALS is a Lethal Motor Neuron Disease With Suboptimal Therapies PD is Highly Prevalent With No Disease Modifying Treatments 1 Data on file, Clene Nanomedicine, Inc.
Lanxide Corporation Dupont Lanxide Composites Lanxide Armor Company Lanxide Performance Materials Lanxide Electronic Components CDO CLENE | Management Team Ted Jeong , DM 4
Novel electro - chemistry platform produces catalytic Clean Surface Nanocrystal drugs designed to avoid toxicities associated with synthetic chemistry 130+ Gr a n t ed Patents CLENE | Platform & Pipeline (Anticipated Launch in 2021) Brain Imaging Biomarker Study Brain Imaging Biomarker Study 1 H 2 0 2 2 2 H 2 0 2 1 O n g o i n g 5 2 H 2 0 22 * 2 H 2 0 2 1 * 2 H 2 0 2 1 * 1 H 2 0 2 4 2 H 2 0 2 1 *Subject to ongoing COVID - 19 related site research restrictions generally implemented to protect MS patients taking standard - of - care immunosuppressive therapies Bioenergetic Na n o c a t a l y s t
Chinese & Ayurvedic Gold Preparations (China, Arabia, India) Monoatomic Gold Salts for Rheumatoid Arthritis (IM Sodium Aurothiomalate; IM Aurothioglucose; Oral Auranofin) gold 3,4,5 - triacetyloxy - 6 - (acetyloxymethyl oxane - 2 - thiolate; triethylphosphanium Au ( Gold) 2020+ Catalytic Clean Surfaced Faceted Gold Nanocrystals 1950s – 2000s 2500 – 1000 BC 1 9 30 – 1980s Surface Modified and Functionalized Colloidal Gold Particles Drug Carriers; Photothermal Therapy 6 Evolution of Gold as a Therapeutic Modality Pioneering Bioenergetic Na n o c a t a l y s i s Clene’s Patented Breakthrough
CNM - Au8 | Bioenergetic Nanocatalyst Improved Cellular Energetic Support E n e r g y > 100 Trillion Nanocrystals per 60 mL Dose (At 30mg) Oral Suspension; Once Daily 13 nm Median Diameter (R i b o s o me = 2 0 - 30 n m ) Clean Surfaced Faceted Nanocrystal Novel mechanism of action to address a range of CNS diseases CNM - Au8 Nanocrystal Cellular 7
CNM - Au8 | Integrating Physics With Biology Electron Transfer Is Fundamental to Energy Production Surface Based C a t a l y t i c A c t i v i t y Electrons (e - ) Move Freely Across Na n o c r y s t a l S u r f ace V e r t i c e s , E d g e s , & Faces Key to Catalytic Activity AuNP Catalyzed Oxidation of Ascorbic Acid 1 a. Rayleigh scattering measured by dark field microscopy of surface plasmon resonance of scattering spectra of the AuNP decahedron before and at 1 , 2 , 3 and 60 min after electron injection by ascorbate ions . b. Spectral shift as a function of time for the catalysis reaction and for the control experiment .. 1 Novo et al. Nature Nanotech 3, 598 – 602 (2008). C l e a n - Sur f a c ed Nanocrystals Up to 4,600 e - per second per nanocrystal 1 8
Treating Bioenergetic Failure | Common Pathological Mechanism In Neurodegenerative Disorders (MS, ALS, PD) Respiratory In s u f f ici e ncy D y sp h a g i a / Dysarthria Cognitive Im p a i r m e nt Muscle Weakness/Atrophy ALS Neuronal Metabolic Failure MS Oligodendrocyte Remyelination Failure and Neuronal Die - Off Vandoorne et al. Acta Neuropathologica (2018) 135:489 – 509. Rone et al. J Neurosci. 2016 Apr 27;36(17):4698 - 707. Cognitive Im p a i r m e nt Spinal Cord ( M o v e m e n t ) Dexterity & Co o r di n a t i o n Visual Im p a i r m e nt N eur o n A c ti v a t e d A s tr o c y te Demyelination Oligodendrocyte Myelin S he a th C o mp r o m i s e d Axon Dendritic R e tra c ti o n Neuromuscular Junction Impairment A c t i va t e d As t r o c y t e 9
CNM - Au8 | MOA Therapeutic Effects a Nicotinamide Adenine Dinucleotide a 10
11 CNM - Au8 | Significant Global Opportunity 707,158 103,903 828,703 596,407 256,455 1,407,701 0 4 00 , 0 0 0 800,000 1 , 2 00 , 00 0 1 , 6 00 , 0 0 0 U . S . C a n a d a W. Europe Central/E. Europe J a p a n C h i n a Est. Diagnosed PD Patients by Region So u r c e : La n c e t N eurol . 2 0 1 8 N o v ; 1 7 ( 11 ) : 93 9 - 9 5 3 . PARKINSON’S DISEASE ~7M pts globally; $6B projected by 2025 3 2 ND most common neurodegenerative disorder; only symptomatic treatments 62,531 10,013 71,288 10,946 13,893 54,405 0 2 0 , 00 0 40,000 6 0 , 00 0 8 0 , 00 0 U . S . C a n a d a W. Europe C e n t r a l / E . E ur o p e J a p a n C h i n a Est. Diagnosed MND Patients by Region Source: Lancet Neurol. 2018 Dec;17(12):1083 - 1097. MND includes amyotrophic lateral sclerosis, spinal muscular atrophy, hereditary spastic paraplegia, primary lateral sclerosis, progressive muscular atrophy, and pseudobulbar palsy M O T O R N EU R O N D I S E A S E (ALS, Other Orphan Disorders) AL S sa l e s > $ 1 B gl o b a ll y by 2 0 2 9 1 . Cur r e nt drugs are largely ineffective, mostly generic. So u r c e : La n c e t N eurol . 2 0 1 9 M a r ; 1 8 ( 3 ) : 269 - 2 8 5 511,855 79,419 543,862 204,591 46,249 103,194 0 1 5 0 , 0 0 0 300 , 00 0 4 5 0 , 0 0 0 600,000 U . S . C a n a d a W. Europe C e n t r a l / E . E ur o p e J a p a n C h i n a Est. Diagnosed MS Patients by Region MULTIPLE SCLEROSIS ~2.5M pts globally; $23B market 2 Only approved treatments are immunomodulators. 1 Clarivate, DRG, ALS 2020 . 2 Westad et al. 2017, doi:10.1038/nrd.2017.107. 3 Parkinson’s Market Data Forecast, February 2020.
12 CNM - Au8 | Evidence for Bioenergetic Improvement Therapeutic Activity Across Remyelination + Neuroprotection Models 1 Robinson et al. Sci Rep. 2020, DOI: 10.1038/s41598 - 020 - 58709 - w. . 2 Ho et al. Society for Neuroscience Meeting, 2019. Ho et al. Motor Neuron Disease Associating Meeting, 2019. Data on File, Clene Nanomedicine, Inc. 1 2
CNM - Au8 | MOA & Remyelination Data Published Robinson et al. Sci Rep. 2020 Feb 11;10(1):1936. doi: 10.1038/s41598 - 020 - 58709 - w Lysolecithin R e m y e li n a ti o n Data 13
Successful Phase 1 First - In Humans Safety Tr i al + C h r o n ic Animal Toxicity Studies P h a s e 2 B r a i n T a r g e t Engagement 31 P - Magnetic Resonance Phase 2 MS Clinical Remyelination & Neurorepair CNM - Au8 | Clinical Program Overview Phase 3 Phase 2 & 3 ALS Clinical Neurorepair Phase 2 14
CNM - Au8 | Clean Toxicology Findings All Studies Resulted in No Adverse Effect Level (NOAEL) a Standard ICH M3(R2) Toxicology Program Genotoxicity I n V itro & I n V ivo (Rodent) Safety Pharmacology CNS, CV, Renal Dos e R a n ge Finding Rodent, Minipig Single Dose To x i c o ki n e t i c s Canine Multi - Dose To x i c o ki n e t i c s Canine (7 - Day) MTD Toxicokinetics Canine (4 - Wk) Max Feasible To x i c o ki n e t i c s Ro d e n t ( 1 - W k , S Q ) Max Feasible To x i c o ki n e t i c s Canine (3 - Wk) Ch r o ni c To x i ci ty Rodent Rodent (6 - Month) Ch r o ni c To x i ci ty Canine Canine (9 - Month) High Dose Toxicokinetics Rodent (3 - Wk) a N O AEL = No D o s e L i mi t i ng T o x i cit i e s O b s e r ve d Carcinogenicity Dose Range Finding rasH2 (1 - Month) 15
• Most frequent TEAEs by System Organ Class: Nervous/GI - Nearly all of the TEAEs were Grade 1 s e v e r i t y (m i l d ) • No serious TEAEs, TEAEs leading to discontinuation of treatment, or TEAEs considered severe, life - threatening, or resulting in death • No dose responsive TEAEs observed in SAD or MAD • Single - ascending dose – 4 cohorts of 8 subjects plus one repeat (n=40) – 15, 30, 60, 90 mg – 3:1 randomized ( ac t ive:con t rol) – 1 dose; 17 - day follow - up • Multi - ascending dose – 4 cohorts of ~12 subjects (n=46) – 15, 30, 60, 90 mg – 3:1 randomized ( ac t ive:con t rol) – 21 days daily dosing + follow - up (Up to 50 days) Phase 1 First In Human Study Completed (n=86) CNM - Au8 | Well Tolerated; No Dose - Limiting Safety Issues + L o n g - T e r m E x t e n s i o n 16 + L o n g - T e r m E x t e n s i o n Ph a s e 2 & 3 C l i n i c a l ( > 1 4 0 Y e ar s E x po s u r e ) Up to 76 Weeks Exposure in Clinical Trials; Up to 85 Weeks in ALS Expanded Access + L o n g - T e r m E x t e n s i o n
17 • Difference in NAD+ and NADH fraction at Week 12 - 16 • Difference in other bioenergetic metabolites (e.g., ATP, PCr, NAD) concentration at Week 12 – 16 • Difference in brain membrane markers (PE, PC, etc.) at Week 12 – 16 Change in Brain Bioenergetic Potential (NAD+/NADH) vs. Baseline 1 ι 2 ι CNM - Au8 Effects on Brain Bioenergetic Metabolites A Phase 2 , Open Label, Sequential Group, Investigator Blinded Study of Magnetic Re sonance Sp e c t r o s c o p y ( 3 1 P - M R S ) t o A sse s s t h e E ff e c t s o f C N M - A u 8 f o r t h e B i o e n e r g e ti c I m p r o v e me n t of Impaired Neuronal R edox State Visit S a f e ty Assessment Dispense Drug Visit S a f e ty Assessment Dispense Drug Visit Primary Endpoint Visit F o ll o w - up Visit Ba s e line Assessments Dispense Drug - 16 N = Up to 15 per dosing cohort (7.5, 15, 30, or 60 mg) Phase 2 Anticipated Top - Line Results (Cohort 1): Repair - PD: 2H 2021 Repair - MS: 2H 2021* *Subject to ongoing COVID - 19 related site research restrictions generally implemented to protect MS patients taking standard - of - care immunosuppressive therapies
NAD + /NADH | Age Related Decline By 31 P - MRS Imaging Zhu et al. Proc Natl Acad Sci USA . 2015 Mar 3;112(9):2876 - 81. 18 Closed squares = averaged data by age group: 21 – 26 yrs, 33 – 36 yrs, and 59 – 68 yrs old; Open squares= individual subject values ~0.05% NAD + /NADH unit decline per year (~0.13 mV units per year) NAD + Decline &. NADH Increase (Aging Change by Decade)
CNM - Au8 Improved Brain Metabolic Markers Elevated NAD+/NADH & Normalized ATP Levels in MS Glanzman, R., J. Ren, A. Rynders, B. Greenberg, R.B. Dewey, K. S. Ho, and M. T. Hotchkin. “Effects of Nanocatalysis on CNS Bioenergetic Markers in Patients Treated with CNM - Au8: Interim Results from a Phase 2 31Phosphorous Magnetic Resonance Imaging Study in Relapsing MS.” Presented at the ACTRIMS Forum 2021, February 26th, 2021. Phase 2 Interim Data 19
(January 2020); FPFV 16 - Jan - 2020; 45 of 42 enrolled (Nov - 2020) Phase 2 Anticipated full unblinded data readout: 2H 2021 Exploratory Endpoints • Other Electromyography (SH i, NP i, MUSIX, MScan) • ALSFRS - R • Change in Rate of ALSFRS - R progression • QOL • Combined Joint - Rank (Survival + ALSFRS - R) Ch a ng e i n Su m of Motor Unit Index For the Abductor Digiti Minimi (ADM), Abductor Pollicis Brevis (APB), Biceps Brachii (BB), Tibialis Anterior (TA) 1 ι Key Secondary: Forced Vital Capacity 2 ι 20
Predictive E n dp o i n t s of Disease Progression Clinical E n dp o i n t s • ALSFRS - R • Pulmonary Function (Vital Capacity) • Mortality • Loss of Motor Units M o t o r Un i t I n d e x ( MU N IX) Measuring ALS Disease Progression Electromyography Predicts Clinical Progression Historical Longitudinal Controls 21
Robert Glanzman MD FAAN, et al. “A Blinded Interim Update on RESCUE - ALS: A Randomized, Placebo - Controlled, Phase 2 Study to Determine the Effects of CNM - Au8 to Slow Disease Progression in Amyotrophic Lateral Sclerosis” Presented at ENCALS 2021 Virtual Meeting, 12 - May - 2021. Emerging Evidence of Primary Endpoint MUNIX(4) Improvement Phase 2 Improvement 22
SVC Avg. Slope Decline (% p oi n ts/mo n t h) Slope Est. (9 - mo n t h s) Empower ( − 2.73%) - 24.6% Benefit ( − 2.74%) - 24.7% PRO - ACT ( - 2.90%) - 26.1% − 1 0 . 5 − 1 9 . 6 − 6 . 7 Andrews et al. JAMA Neurol. 2018;75(1):58 - 64. Phase 2 23 Emerging Evidence of Clinical I m p rovem e n t | F or c e d V i tal C a p a c i ty
Exploratory Endpoints • Combined Joint Rank (Survival + ALSFRS - R) • Voice pathology • PRO (ALSAQ) • Pharmacodynamic markers Slo w V it a l C a p a city Hand Held Dynamometry Change in AL S F R S - R Registration Study: 24 - Week Treatment Period (3:1 randomization, 120 active [30mg, 60mg]: 40 placebo) (July 2020) (n=160) (n=160) (n=160) 1 ι 2 ι Phase 3 Multiple Independent Regimens with Pooled Placebo Anticipated full unblinded data readout : 1 H 2022 24
25 Exploratory Endpoints Treatment of Vis ual Pathway Deficits I n Chronic O ptic N europathy for A ssessment of R em y elination in Non - Active Relapsing MS Change in Low Contrast Letter Acuity (LCLA) At Week 24 Up to 48 - Week Placebo - Control 2:1 Randomization (Active: Placebo ) 15mg, 30mg, Placebo (n=150) • Optical Coherence Tomography (OCT) • Multi - focal VEP Amplitude & Latency • Full field - VEP Amplitude & Latency • MRI Endpoints • Visual Function (High Contrast) • QOL / EDSS 1 ι 2 ι Ch a ng e Co mp o s i t e Clinical Response 9HPT / SDMT / T25FW / LCLA / EDSS Phase 2 - 42 to - 1 24 - Week Blinded Fixed Treatment Period Up to 24 - Week Blinded Extension Period (Until LPLV 24Wk Visit) LPLV Anticipated top - line unblinded data: 2H 2022* *Subject to ongoing COVID - 19 related site research restrictions generally implemented to protect MS patients taking standard - of - care immunosuppressive therapies
LCLA Phase 2 Primary: Functional Visual Improvement LCLA Correlates with clinically meaningful deficits in QOL, EDSS and MSFC, MRI, and OCT MS Functional Endpoints Phase 2 Exploratory: Neuroprotection/Remyelination Endpoints The Visual System is a Window into the Brain ( T L T V + E = 1 2 3 4 5 6 7 8 9 KEY 9 - Hole Peg Test 26 Symbol Digit Modalities Timed 25 - Ft Walk Measuring MS Functional Improvement
LCLA (Best - Corrected) Emerging Evidence of Clinical Improvement Glanzman, R., H. Beadnall, M. T. Hotchkin, A. Klistorner, M. Barnett, R. Sergott, A. Rynders, K. S. Ho, and Mark G. Mortenson. “Update to a Phase 2 clinical trial of catalytic gold nanocrystals, CNM - Au8, for the treatment of chronic optic neuropathy.” Presented at the ACTRIMS Forum 2021, February 26, 2021. SD M T 6 - Co mp o n e n t I nt e g r a t e d (m)MSFC Phase 2 Improvement Improvement Improvement ( T L T V + E = 1 2 3 4 5 6 7 8 9 KEY ( T L T V + E = 1 2 3 4 5 6 7 8 9 KEY Z - Score change compared to the least - affected patients at Baseline (with EDSS <= 1.5) 27 All Available Values (by Completed Subject Visit) Mixed Effects Model, Dunnett’s test for multiplicity; * p<0.05, ** p<0.01, *** p<0.001, **** p<0.0001
C S N 28 ® Clean surface nanocrystal (CSN) therapeutics Trade Secrets Patent Status Issu e d & All o w e d Patents 130+ Pending Applications >30 To t a l P a t e nt s / Applications >160 Patent Description Process And Me t h o d / D e v i c e (Clean Surface; Gold CSN) State of Matter (CNM - Au8) Method of Use (Prevent Demyelination & MoA) Method of Use (Bi - Metallic Au/Pt; Antimicrobial) Plasma Conditioning E l e c t r o d e D e s i g n & Cycling Trough Flow, T e mp , P r ess u r e Co nc e nt r a t i o n & Filtration Strong Intellectual Property Extensive Patent Portfolio With Protection Through 2035 a & Proprietary Trade Secrets; Plus 7 - year Orphan Drug Designation a With Patent Restoration Term (assuming 5 - year extension).
Cl e n e | P r op ri e t a r y N a n oc r y s t al Ma n u fac t u ri n g In - House ISO8 Clean Room Clinical Production in North East, MD Va l i d a t e d C M C Processes 29 Designed to be Scalable to Commercialization Patented H y d ro - el ec t r o - Crystallization P r o p r i e t a r y T r ade Secrets
Anticipated Timeline & Investor Catalysts 2 0 2 0 - 2 0 23 United T h e ra p e u ti c s 30
31 Unmet Medical Need & Market Opportunity Lead Asset: CNM - Au8 for Neuro Repair Clinical D e v e lo p m e nt Pipeline Strong IP Portfolio Financials CNM - ZnAg for COVID - 19 CLENE | Investment Highlights • Nanocatalyst of Intracellular Biological Reactions • Robust Preclinical Remyelination & Neuroprotection Data Across Multiple Animal Models in: MS, ALS, and Parkinson’s Disease • NOAEL Findings From All Toxicity Studies • Acceptable Phase 1 Safety Profile • Up to 76 Weeks Exposure in Clinical Trials; Up to 85 Weeks in ALS Expanded Access • Two Phase 2 Brain Target Engagement Studies in PD and MS with Top Line Results anticipated in 2021 • Three Phase 2 POC Studies in ALS, MS, and COVID with Results Anticipated in the next 12 - 18 Months • Phase 3 ALS Registrational Trial in with Full Results Anticipated in 1H 2022 • Ongoing ALS Early Access Program • USA FDA Granted ALS Orphan Drug Designation • CLNN (NASDAQ) • $31.9M USD (Gross) Raised via SPAC merger + PIPE ( 2020 ) • Cash on Hand at end of Q 1 2021 of $ 48 . 0 M (Unaudited) • Anticipated Cash Runway into mid - 2022 • $114M USD Raised Privately (Series A - D) • +$18M in Additional Grant and Indirect Financial Support for ALS and MS Phase 2 & 3 Clinical Programs • Zinc - Silver Antiviral + Immune Support • Phase 2 Trial in Brazil To Treat Acutely Symptomatic Non - Hospitalized COVID - 19 Patients Underway 1st Endpoint: Prevention of Hospitalization 2nd Endpoint: Time to S y m p t o m at i c Imp r o vemen t (Up to 28 Days) • Results Anticipated 2H 2021 • 130+ Issued Patents Worldwide; 30+ Pending Patent Applications • State of Matter Claims Cover Myelin Protection M ech a nisms , Remyelination, and Neuroprotection to 2035 (with Patent Restoration Term) • Manufacturing Device and Process Patents to 2030 and Beyond • No Effective Disease - Modifying Drugs for ALS or PD • No MS Therapies Clinically Impact Remyelination & Neurorepair • Remyelination and Neurorepair Sales Could Exceed $10B per annum 1 ALS is a Lethal Motor Neuron Disease With Suboptimal Therapies PD is Highly Prevalent With No Disease Modifying Treatments 1 Data on file, Clene Nanomedicine, Inc.
Clene Inc. HQ & Clinical Development 6550 South Millrock Drive, Suite G50 Salt Lake City, UT 84121 R&D and Manufacturing 500 Principio Parkway, Suite 400 North East, MD 21901 © 2021 Clene Inc. Version: 11 - May - 2021