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): February 26, 2021

 

Clene Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		01-39834		85-2828339
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

6550 South Millrock Drive, Suite G50 Salt Lake City, Utah		84121
(Address of principal executive offices)		(Zip Code)

 

Tel: 801-676-9695

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐	Written communication 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-commencements 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.

 

In connection with presentations to certain of its existing and potential shareholders (the “Shareholder Presentations”), Clene Inc. (the “Company”), will provide preliminary cash on hand information as of December 31, 2020. Cash on hand is the main component of cash and cash equivalents on the Company’s consolidated balance sheets, and there is no material difference between the two numbers. Based on unaudited, preliminary financial information, the Company has found cash on hand as of December 31, 2020 to have been approximately $59 million.

 

This preliminary information is based on management's initial analysis of the Company’s financial condition as of December 31, 2020. The company will issue its audited financial statements as part of its annual report on Form 10-K, which it expects to file in March 2021.

 

Forward Looking Statements: The financial information set forth in this Form 8-K reflects the company’s current preliminary revenue estimates, is subject to the completion of its audit process, and is subject to change. The company’s full fourth quarter and year 2020 results could differ materially from the preliminary estimates provided in this Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this Form 8-K. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.

 

Item 7.01 Regulation FD Disclosure

 

In connection with presentations by Clene Nanomedicine, Inc. (“Clene”), a wholly owned subsidiary of the Company, at the Americas Committee for Treatment and Research in Multiple Sclerosis (“ACTRIMS”) Forum 2021 given on February 26, 2021, Clene presented blinded interim data from its VISIONARY-MS study and updated interim data from its REPAIR-MS study. A copy of the slide presentations that accompanied Clene’s presentations at the ACTRIMS Forum 2021 are attached as Exhibits 99.1 and 99.2 to this Form 8-K and are incorporated by reference herein.

 

In addition, attached as Exhibit 99.3 to this Form 8-K and incorporated into this Item 7.01 by reference is the slide presentation that the accompanied the Shareholder Presentations.

 

The information being furnished under this Item 7.01, including Exhibit 99.1, of this Current Report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other document filed by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number		Exhibit Description
99.1		Slide Presentation concerning VISIONARY-MS study
99.2		Slide Presentation concerning REPAIR-MS study
99.3		Slide Presentation provided to shareholders

 

  

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	Clene Inc.
Date: February 26, 2021	By:	/s/ Robert Etherington
		Robert Etherington
		President, Chief Executive Officer and Director

 

  

2

Exhibit 99.1

 

Robert Glanzman, MD FAAN For the VISIONARY - MS Investigators R . G l a n z m a n , M D F AA N 1 , H . Bea d n a l l MBBS F R A C P 2 , A . Klistorner , M. Barnett, MBBS FRACP 2 , R. Sergott MD 3 , A. Rynders 1 , K. Ho, PhD 1 , M. Mortenson MS 1, M. Hotchkin 1 1 Holladay, UT/United States, 2 Camperdown, NSW/Australia, 3 Philadelphia, PA/United States of America P05 0 Update to a Phase 2 clinical trial of catalytic gold nanocrystals, CNM - Au8, for the treatment of chronic optic neuropathy 1

Disclosures I a m a n e m p l o y e e o f C l en e N a n o m e d i c i n e , I n c . and receive salary and stock options Acknowledgements Dr. Heidi Beadnall MBBS, FRACP Dr. Steve Vucic MBBS FRACP, PhD Prof Neurology Dr. Jeanette Lerchner - Scott MD, PhD, FRACP Dr. Stefan Blum MD, FRACP, PhD Dr. Bruce Taylor B m e d sc i , M B B S , MD , F R A CP Dr. Deborah Field MBBS, FRACP Dr. Richard Macdonell MD , F R A CP , F A F RM 2 Dr. Anneke Van der Walt MBChB, PhD, FRACP A/Prof Neurology

C N M - Au8 | M o A : N a n o c a t a l y t i c E l e c t r o n T r a n s f e r 3

Background DMT Treatment & Demographics 1 3 - J a nu a r y - 2021 B li n d e d D a ta U pd a te 4 B as e li ne Values Sub j e ct s n (%) Age [ y r s . ] mean (SD) EDSS m ea n (SD) Time from MS Onset [yrs.] m ea n ( SD ) ON History [%] All 52 38.0 1.8 6.0 76% (100%) (8.9) (1.5) (3.8) Female 37 37.7 1.7 6.4 73% (71%) (8.3) (1.6) (3.8) Male 15 40.1 2.0 5.1 80% (29%) (9.7) (1.4) (3.8) Mo n oclo n al Antibody 1 n (%) Oral Ther a py 2 n (%) Injectable ( Gla t iram er acetate) n (%) No DMT n (%) 27 (52%) 19 (36.5%) 2 (4%) 4 (8%) 19 (51%) 14 (38%) 2 (5%) 2 (5%) 8 (53%) 5 (33%) 0 (0%) 2 (13%) 1 Monoclonal antibody includes alemtuzumab, natalizumab, rituximab, ocrelizumab. 2 Oral includes fingolimod, dimethyl fumarate, teriflunomide, thyroxine, and oral combinations. DMT Background Treatment Baseline Demographics

5 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 ) 1 5 m g , 3 0 m g , P l a c e b o (n = 1 5 0) Exploratory Endpoints • Optical Coherence Tomography (OCT) • Multi - focal VEP Amplitude & Latency • Full field - VEP Amplitude & Latency • MRI Endpoints • Visual Function (High Contrast) • PRO / QOL / EDSS 1 ι 2 ι Ch a ng e Co mp o s i t e Clinical Response 9HPT / SDMT / T25FW / LCLA / EDSS - 42 to - 1 24 - Week Blinded Fixed Treatment Period Up to 24 - Week Blinded Extension Period (Until LPLV 24Wk Visit) LPLV *Subject to ongoing COVID - 19 related site research restrictions generally implemented to protect MS patients taking standard - of - care immunosuppressive therapies

( T L T V + E = 1 2 3 4 5 6 7 8 9 KEY SDMT Z - Score Change Change in Enrolled Study Population Compared to Baseline (BL) ‘Mild’ EDSS (<=1.5) 6

9HPT (Non - Dominant) Z - Score Change Change in Enrolled Study Population Compared to Baseline (BL) ‘Mild’ EDSS (<=1.5) 7

T25FW Z - Score Change Change in Enrolled Study Population Compared to Baseline (BL) ‘Mild’ EDSS (<=1.5) 8

LCLA (Best - Corrected) Z - Score Change Change in Enrolled Study Population Compared to Baseline (BL) ‘Mild’ EDSS (<=1.5) 9

(m)MSFC Mean Z - Score Change 6 - component (SDMT, LCLA [L/R], 9HPT [D/ND], T25FW) ( T L T V + E = 1 2 3 4 5 6 7 8 9 KEY 10

Conclusions • These interim, blinded data support the potential for CNM - Au8 therapy to demonstrate meaningful neurological improvement in patients with MS • VISIONARY - MS is an innovative Phase 2 study examining the potential for CNM - Au8 to promote neurological improvement in a stable RMS population with chronic visual impairment, as an adjunct to approved DMTs • CNM - Au8 is a novel, nanocatalytic therapy shown to promote remyelination and neuroprotection via increasing bioenergetic capacity, enhancing protein homeostasis, and reducing harmful ROS 11

Exhibit 99.2

 

Robert Glanzman, MD FAAN On behalf of REPAIR - MS Investigators Jimin Ren 1 , Austin Rynders 2 , Benjamin Greenberg 1 , Karen S. Ho 2 , Robert Glanzman 2 , Michael T. Hotchkin 2 1 University of Texas Southwestern Medical Center 2 Clene Nanomedicine, Inc. P 0 4 3 Effects of Nanocatalysis on CNS Bioenergetic Markers in Patients Treated with CNM - Au8: Interim Results from a Phase 2 31 Phosphorous Magnetic Resonance Imaging Study in Relapsing MS 1

Disclosures I am an employee of Clene Nanomedicine, Inc. and receive salary and stock options 2

C N M - Au8 | M o A : N a n o c a t a l y t i c E l e c t r o n T r a n s f e r 3

• Difference in average metabolites (e.g., NAD+, NADH) concentration at Week 12 - 16 • Difference in average brain membrane markers (PCr, PME, PE, etc.) at Week 12 - 16 • Pharmacodynamic biomarkers at Week 12 - 16 Change in Brain Bioenergetic Potential (NAD+/NADH) vs. Baseline Visit safety assessment dispense drug Visit safety assessment dispense drug Visit Pr i m a r y E n dp o i n t Visit Fo ll o w - up Visit ba s e li n e assessments dispense drug 1 ι 2 ι R E P A I R : P ha s e 2 3 1 P - M R S I m a g i n g 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 in Relapsing MS + 4

REPAIR - MS | 3 1 P M R S Ima g i n g Mo d a l i t y A T P  -  - P C r G P E G P C PC PE Pi in Pi ex  - NAD UD PG Full Volume Coil Partial Volume Coil Pi in - intracellular inorganic phosphate Pi ex - extracellular inorganic phosphate PC - phosphocholine PE - phosphoethanolamine GPE - glycerophosphoethanolamine GPC - glycerophosphocholine ATP - ࢻ , ATP - ࢼ , ATP - ࢽ NAD+/NADH (partial coil only) NAD Pool (Full coil) UDPG – uridine diphosphate glucose P C r – p h o s p h o c r e a t in e (normalization factor) Average change in Area Under Curve by 31P peak (per 2 cm 3 voxel, ~600 voxels per subject); normalized by PCr 5

REPAIR - MS Baseline Demographics 2 7 − J a nu a r y − 2 0 2 1 D a t a U p d a t e Ba s e li ne Values S u bje c ts n (%) Age [ y rs . ] mean (SD) EDSS m e an (SD) Time from MS Onset [yrs.] mean (SD) N ataliz um a b Treatment (%) All 9 (100%) 46.5 (10.8) 3.6 (2.3) 7.2 (5.0) 100% Female 7 39.7 3.0 6.5 100% (78%) (11.6) (2.2) (3.7) Male 2 48.5 3.8 11.3 100% (22%) (10.6) (3.9) (2.9) 6

REPAIR − MS | Percent Change in NAD + /NADH [Partial Volume Coil] CNM - Au8 Increases Brain NAD + /NADH Ratio 7

CNM - Au8 Normalizes Brain ATP Levels Correlation of % Change versus BL value by Subject for Ƒ − ATP &  − ATP [Full Volume Coil] 8

CNM - Au8 Open Label (m)MSFC Clinical Data SDMT & 9HPT 9

Con cl u s io n s • Data demonstrate CNM - Au8 target engagement in brains of MS patients • Catalytic bioenergetic improvements demonstrated across key CNS metabolic markers - NAD+/NADH ratio - ATP ( ߙ , ߛ ) 10

Exhibit 99.3

 

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 en t 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 48 - weeks Exposure in Clinical Trials • 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 • Cash on Hand at end of 2020 of $ 59 . 3 M USD (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 patients planned for 1H 2021 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) • 100+ 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 100+ Gr a n t ed Patents CLENE | Platform & Pipeline (Anticipated Launch in 2021) Brain Imaging Biomarker Study Brain Imaging Biomarker Study 1H 2022 2H 2021 O ngo i n g 5 1H 2022* 2H 2021* 2H 2021* 1H 2024 2H 2021 *Subject to ongoing COVID - 19 related site research restrictions generally implemented to protect MS patients taking standard - of - care immunosuppressive therapies Bioenergetic Na noc a t a lyst

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 noc a t a l y s i s Clene’s Patented Breakthrough

CNM - Au8 | Bioenergetic Nanocatalyst 7 Me t a bo li c Eff i c i ency

CNM - Au8 | Integrating Physics With Biology Nanocatalytic Electron Transfer Surface Based Catalytic Activity Electrons (e - ) Move Freely Across Nanocrystal Surface Vertices, Edges, & 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). Clean - Surfaced 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 ff icie ncy D y sp h agia/ Dysarthria Cognitive Im p a i rm ent 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 rm ent Spinal Cord (Move m ent) Dexterity & Coo r di n atio n Visual Im p a i rm ent Neu r o n Ac ti v at e d A str ocy te Demyelination Oligodendrocyte Myelin She ath Com pr om is e d Axon Dendritic R e tra c ti o n Neuromuscular Junction Impairment A c tivat e d Astrocyte 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 Source: Lancet Neurol. 2018 Nov;17(11):939 - 953. 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 MOTOR NEURON DISEASE (ALS, Other Orphan Disorders) ALS sales >$1B globally by 2029 1 . Current drugs are largely ineffective, mostly generic. Source: Lancet Neurol. 2019 Mar;18(3):269 - 285 511,855 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 emye li n ati on Data 13

Successful Phase 1 First - In Humans Safety Trial + Chronic Animal Toxicity Studies Phase 2 Brain Biomarker (Proof of Target Effect) 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 In Vitro & In Vivo (Rodent) Safety Pharmacology CNS, CV, Renal Dose Range Finding Rodent, Minipig Single Dose Tox icokin e tic s Canine Multi - Dose Tox icokin e tic s Canine (7 - Day) MTD Toxicokinetics Canine (4 - Wk) Max Feasible Tox icokin e tic s Rodent (1 - Wk, SQ) Max Feasible Tox icokin e tic s Canine (3 - Wk) Chronic Toxicity Rodent Rodent (6 - Month) Chronic Toxicity Canine Canine (9 - Month) High Dose Toxicokinetics Rodent (3 - Wk) 15 a NOAEL = No Dose Limiting Toxicities Observed

• Most frequent TEAEs by System Organ Class: Nervous/GI - Nearly all of the TEAEs were Grade 1 severity (mild) • 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 + No Related SAEs or Related Study Discontinuations In Any Study Phase 1 First In Human Study Completed (n=80) Phase 2 & 3 Clinical (>75 Years Exposure) CNM - Au8 | Well Tolerated With No Known Safety Issues + Long - Term Extension follow - up (Up to 50 days) 16 + Long - Term Extension

17 • Difference in 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 Spectro s co p y ( 31 P - M R S) to A sses s the Effects of C N M - A u 8 f or t h e Bioe n ergetic I m prove m ent of Impaired Neuronal R edox State Visit Safety Assessment Dispense Drug Visit Safety Assessment Dispense Drug Visit Primary Endpoint Visit F ollo w - up Visit Ba seline 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

CNM - Au8 Improved Brain Metabolic Markers Elevated NAD+/NADH & Normalized ATP Levels in MS & PD 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 Two Phase 2 31 - Phosphorous Magnetic Resonance Imaging Studies.” Presented at the MSVirtual 2020, September 11, 2020. Phase 2 Interim Data 18

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; 42 of 42 enrolled (7 - Sep - 2020) Change in Electromyography (Motor Unit Index) Abductor Digiti Minimi, Abductor Pollicis Brevis, Biceps Brachii, Tibialis Anterior 1 ι • MScanFit MUNE • Motor Unit Size Index • Neurophysiological Index • Split Hand Index 2 ι Phase 2 Exploratory Endpoints • ALSFRS - R • Combined Joint - Rank (Survival + ALSFRS - R) • FVC • Change in Rate of ALSFRS - R progression • QOL Anticipated full unblinded data readout: 2H 2021 20

Predictive Endpoints of Disease Progression Clinical E ndpoint s • ALSFRS - R • Pulmonary Function (Vital Capacity) • Mortality • Loss of Motor Units Motor Unit Index (MUNIX) Measuring ALS Disease Progression Electromyography Predicts Clinical Progression 21

Robert Glanzman MD FAAN, et al. “Design, Objectives, and Preliminary Blinded Data from the Ongoing RESCUE - ALS Trial of CNM - Au8 to Slow Disease Progression in Amyotrophic Lateral Sclerosis Patients” Presented at 31st International Symposium on ALS/MND (Virtual 2020),, December 10 th , 2020. Emerging Evidence of Primary Endpoint MUNIX(4) and Clinical Improvement Phase 2 22

Exploratory Endpoints • Combined Joint Rank (Survival + ALSFRS - R) • Voice pathology • PRO (ALSAQ) • Pharmacodynamic markers Slow Vital Capacity Hand Held Dynamometry Change in ALSF RS - 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 23

24 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 Change Composite 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: 1H 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 25 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 - Component Integrated (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) 26 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 27 ® Clean surface nanocrystal (CSN) therapeutics Trade Secrets Patent Status Issued & Allowed Patents 100+ Pending Applications >30 Total Patents/ Applications >130 Patent Description Process And Me thod/ D e vic 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 Electrode Design & Cycling Trough Flow, Temp, Pressure Concentration & 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).

Clene | Proprietary Nanocrystal Manufacturing In - House ISO8 Clean Room Clinical Production in North East, MD Validated CMC Processes 28 Designed to be Scalable to Commercialization Patented H ydro - electr o - Crystallization Proprietary Trade Secrets

Anticipated Timeline & Investor Catalysts 2020 - 2023 United T herapeutics 29

Unmet Medical Need & Market Opportunity Lead Asset: CNM - Au8 for Neuro Repair Clinical D e v e lo p m en t 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 Toxicity Studies, Including Chronic • Acceptable Phase 1 Safety Profile • Up to 48 - weeks Exposure in Clinical Trials • 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 • Cash on Hand at end of 2020 of $ 59 . 3 M USD (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 patients planned for 1H 2021 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) • 100+ 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 30 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: 26 - February - 2021