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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): October 7, 2021

 

Clene Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-39834   85-2828339
(State or other jurisdiction   (Commission File Number)   (IRS Employer
of incorporation)       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

 

N/A

(Former name or former address, if changed since last report.)

 

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 7.01 Regulation FD Disclosure.

 

On October 7, 2021, Clene Inc. (the “Company”) released an updated corporate presentation (the “Corporate Presentation”) on its website, www.clene.com. A copy of the Corporate Presentation is furnished as Exhibit 99.1 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 or 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 99.1, 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, 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 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
Number
  Exhibit Description
     
99.1   Corporate Presentation dated October 7, 2021
104   Cover Page Interactive Date File (formatted as Inline XBRL)

 

1

 

 

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: October 7, 2021 By: /s/ Robert Etherington
    Robert Etherington
    President and Chief Executive Officer

 

 

2

 

Exhibit 99.1

 

CLNN (NASDAQ) October 6, 2021

 

 

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 - 1 (filed July 22 , 2021 ), 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

 

 

Lanxide Corporation Dupont Lanxide Composites Lanxide Armor Company Lanxide Performance Materials Lanxide Electronic Components CDO CLENE | Management Team 3

 

 

4 Clene Nanomedicine As of June 30, 2021 Cash on hand (unaudited): $63M Topline data from ALS Registration Trial 1 by mid - 2022 and 3 Phase 2 Trials 2 by end of 2021 >200 patient years of CNM - Au8 clinical exposure CNM - Au8® a gold nanocrystal suspension, in development as the first energetic catalyst to repair & improve neurological function Manufacturing expansion in progress, preparing for possible co mm e r ci a li z a ti o n in 2023 Strong IP: 130+ patents on C l ea n - S u r f ac e - Nanocrystal technology (CSN®) platform 1. HEALEY - ALS: https:// www.clinicaltrials.gov/ct2/show/NCT04297683 2. RESCUE - ALS: https: //w ww .clinicaltrials.gov/ct2/show/NCT04098406 ; REPAIR - PD: https: //w ww .clinicaltrials.gov/ct2/show/NCT03815916 ; REPAIR - MS:https:// www.clinicaltrials.gov/ct2/show/NCT03993171

 

 

5 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 1 CLENE | Platform & Pipeline (Anticipated Launch in 2021) Brain Imaging Biomarker Study Brain Imaging Biomarker Study Phase 2 2 H 2 0 2 2 2 H 2 0 2 1 O n g o i n g 1 H 2 0 2 3 * Cohort 1 co m p l e t e d C o m p l e t e d 1 H 2 0 2 4 1 H 2 0 2 2 *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 1 . A s o f 3 0 - J u n e - 2 0 21

 

 

CNM - Au8® | Catalytically - Active Nanotherapeutic Improved Cellular Energy Production & Utilization 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 6

 

 

CNM - Au8 | Integrating Physics With Biology Electron transfer (to - and - from) CNM - Au8 nanocrystals drives catalytic activity and cellular 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 N o v o e t a l . N atu r e N an o t e c h 3 , 59 8 – 6 0 2 ( 2 00 8 ) . C l e a n - Sur f a c ed Nanocrystals Up to 4,600 e - per second per nanocrystal 1 7

 

 

Treating Energetic 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 8

 

 

9 CNM - Au8 | MOA Therapeutic Effects a Nicotinamide Adenine Dinucleotide a Robinson et al. Sci Rep. 2020 Feb 11;10(1):1936. doi: 10.1038/s41598 - 020 - 58709 - w.

 

 

10 CNM - Au8 | Significant Global Opportunity 707,158 103,903 828,703 596,407 256,455 1,407,701 0 4 0 0 , 0 0 0 8 0 0 , 00 0 1,200,000 1,600,000 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; ~6.1M patients globally, data as of 2016.. PARKINSON’S DISEASE ~6.1M pts globally; $6B projected by 2026 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 4 0 , 0 0 0 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 u r 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) 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 Source: Lancet Neurol. 2019 Mar;18(3):269 - 285; ~2.2.M patients globally, data as of 2016 511,855 79,419 543,862 204,591 46,249 103,194 0 1 5 0 , 0 0 0 30 0 , 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 u r o p e J a p a n C h i n a Est. Diagnosed MS Patients by Region MULTIPLE SCLEROSIS ~ 2.2M pts gl o ba ll y ; $ 2 3 B m a rk e t 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, April 2021.

 

 

11 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 | Preclinical Evidence for Energetic Improvement Therapeutic Activity Across Remyelination + Neuroprotection Models

 

 

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 CNM - Au8 | MOA & Remyelination Data Published 12

 

 

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 13

 

 

Standard ICH M3(R2) Toxicology Program Genotoxicity I n V itro & I n V ivo (Rodent) Safety Pharmacology CNS, CV, Renal Dose Range Finding Rodent, Minipig Single Dose To x i c o ki ne t i c s Canine Multi - Dose To x i c o ki ne t i c s Canine (7 - Day) MTD Toxicokinetics Canine (4 - Wk) Max Feasible To x i c o ki ne t i c s Ro d e n t ( 1 - W k , S Q ) Max Feasible To x i c o ki ne t i c s Canine (3 - Wk) Chronic Toxicity Rodent Rodent (6 - Month) Chronic Toxicity Canine Canine (9 - Month) High Dose Toxicokinetics Rodent (3 - Wk) Carcinogenicity Dose Range Finding rasH2 (1 - Month) CNM - Au8 | Clean Toxicology Findings No Adverse Effect Level (NOAEL) Findings In All Studies 14

 

 

• 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 (a c ti v e : c o n t ro l ) – 1 d o s i n g d a y; 17 - day follow - up • Multi - ascending dose – 4 c o h o r t s o f ~ 1 2 s u b j e c t s (n=46) – 15, 30, 60, 90 mg – 3:1 randomized ( a c ti v e : c o n t r o l ) – 21 days daily dosing + follow - up (Up to 50 days) Phase 1 First In Human Study Completed (n=86) >200 Years of Human Exposure CNM - Au8 | Well Tolerated; No Dose - Limiting Safety I ssu es To D ate + L o n g - T e r m E x t e n s i o n + L o n g - T e r m E x t e n s i o n + L o n g - T e r m E x t e n s i o n >90 Weeks Exposure in Clinical Trials; >100 Weeks in ALS Expanded Access 15

 

 

• Difference in brain NAD+ and NADH fraction at Week 12 - 16 • 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 Energetic Metabolites 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 N = Up to 15 per dosing cohort (7.5, 15, 30, or 60 mg) Phase 2 Exploratory Stable R e l a p s i ng MS 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 (REPAIR) + Early Pa r k in s on ’ s Disease 16

 

 

17 NAD + /NADH | Age Related Decline of Brain Energy Metabolism (By 31 P - MRS Imaging) Zhu et al. Proc Natl Acad Sci USA . 2015 Mar 3;112(9):2876 - 81. Closed squares = averaged data by age group: 21 – 26 yrs, 33 – 36 yrs, and 59 – 68 yrs old; Open squares= individual subject values ~0 . 5 % NAD + / N A D H un i t d ec li n e p e r d ec ad e (~0.13 mV units per year) NAD + Declines / NADH Increases (Aging Change by Decade)

 

 

CNM - Au8 | Improved Brain Energy Metabolism Increased NAD+/NADH Ratio in MS & PD Patients Phase 2 Results 1 ƒ E n dpo i n t 2 ƒ Endpoints NAD is an essential molecule responsible for cellular energy production 18

 

 

β - ATP is used by the cell to maintain cellular metabolism and normal function Phosphorylation potential is the amount of available phosphorous that can be used to make ATP in times of stress or high metabolic activity CNM - Au8 | Treatment Normalized Key Markers of Brain Metabolism in PD Patients Phase 2 Results Exploratory Endpoint Post Hoc Endpoint 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) % Cha ng e i n Su m o f M o t o r Unit Index (MUNIX) For the Abductor Digiti Minimi (ADM), Abductor Pollicis Brevis (APB), Biceps Brachii (BB), Tibialis Anterior (TA) 1 ι Key Secondary Absolute MUNIX change Forced Vital Capacity (FVC) 2 ι M U NIX 20

 

 

MUNIX Decline Precedes ALSFRS - R Decline MUNIX | Sensitive Biomarker of ALS Disease Progression M o t o r U n i t Index ( M U NIX) Sensitive method of detecting motor neuron loss What is MUNIX? Why MUNIX? Early Indicator o f AL S d is e ase progression MUNIX is a method of estimating the number of functioning lower motor neurons that can direct muscle fibers More sensitive decline in ALS compared to ALSFRS - R Muscle Fibers Spinal Cord Motor N e u r o n 21

 

 

Phase 2 Improvement Emerging Blinded Evidence Predictive of Clinical Efficacy | MUNIX(4) Sum Change 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. 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 Bli n d ed Rate of Vital C a p a c ity Los s I s Les s Than Comparable Clinical Trial Datasets 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. 23

 

 

Exploratory Endpoints • Combined Joint Rank (S u r v i v al + AL S F R S - R) • Voice pathology • PRO (ALSAQ) • Pharmacodynamic markers Slow Vital Capacity 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 : 2 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 ) 15 m g , 3 0 m g , P l a c e b o ( n= 15 0) • 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 2023* *Subject to ongoing COVID - 19 related site research restrictions generally implemented to protect MS patients taking standard - of - care immunosuppressive therapies

 

 

26 LCLA Phase 2 Primary: Functional Visual Improvement LCLA Correlates with clinically meaningful deficits in QOL, EDSS and MSFC, MRI, and OCT 1 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 Symbol Digit Modalities Timed 25 - Ft Walk Measuring MS Functional Improvement 1 Balcer et la. Mult Scler. 2017 Apr;23(5):734 - 747. doi: 10.1177/1352458517690822.

 

 

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. 27 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) 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 ® Clean surface nanocrystal (CSN) therapeutics Trade Secrets Patent Status b Issued & Allowed Patents 130+ Pending Applications >30 Total Patents/ 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 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 28 a With Patent Restoration Term (assuming 5 - year extension). b As of 30 - June - 2021.

 

 

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 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 29

 

 

Anticipated Timeline & Investor Catalysts 2 0 2 0 - 2 0 23 Facility Venture Debt $20M 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 • Energy enhancing nanotherapeutic • 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 • >90 Weeks Exposure in Clinical Trials; >100 Weeks in ALS Expanded Access (EAP) • Two Phase 2 Brain Target Engagement Studies in PD and MS with Top Line Results Reported Aug 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 mid - 2022 • Ongoing ALS Early Access Program • USA FDA Granted ALS Orphan Drug Designation • CLNN (NASDAQ) • Cash on Hand at end of Q2 2021 of $63.0M (Unaudited) • Anticipated Cash Runway to EOY 2022 • 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 Symptomatic Im p r o v em en t (Up to 28 Days) • Results Anticipated 1H 2022 • 130+ Issued Patents Worldwide, as of June 2021; 30+ Pending Patent Applications • State of Matter Claims Cover Myelin Protection M e c h a n i s m s , 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 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: 6 - October - 2021