Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (August 2021)
33 slides from Clene's investor presentation, Aug 5, 2021
Slide 1: CLNN (NASDAQ)
CLNN (NASDAQ)
Slide 2: Forward Looking Statements
Forward Looking Statements 2 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, yo
Slide 3: Management Team
Lanxide Corporation Dupont Lanxide Composites Lanxide Armor Company Lanxide Performance Materials Lanxide Electronic Components CDO CLENE | Management Team Ted Jeong , DM 3
Slide 4: Clene Nanomedicine
4 Clene Nanomedicine Cash on hand: 48M End of Q1 + PIPE & Venture debt of $24M Topline data from One Registrational Trial 1 by 1H 2022 and 4 Phase 2 Trials 2 by end of 2021 >180 patient years of CNM - Au8 clinical exposure CNM - Au8® in clinical development as the first energetic catalyst to repair
Slide 5: Platform & Pipeline
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 1H 2022
Slide 6: Evolution of Gold as a Therapeutic Modality
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 Surfa
Slide 7: Energy Enhancing Nanotherapeutic
CNM - Au8® | Energy Enhancing Nanotherapeutic Improved Cellular Energy Production & Utilization E nergy > 100 Trillion Nanocrystals per 60 mL Dose (At 30mg) Oral Suspension; Once Daily 13 nm Median Diameter (Ribosome = 20 - 30 nm) Clean Surfaced Faceted Nanocrystal Novel mechanism of action to addre
Slide 8: Integrating Physics With Biology
CNM - Au8 | Integrating Physics With Biology Electron Transfer Is Fundamental to Energy Production 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 scatt
Slide 9: Treating Energetic Failure
Treating Energetic 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
Slide 10: Mechanism of Action
CNM - Au8 | MOA Therapeutic Effects a Nicotinamide Adenine Dinucleotide a 10
Slide 11: Significant Global Opportunity
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
Slide 12: Evidence for Energetic Improvement
12 CNM - Au8 | Evidence for Energetic 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.
Slide 13: MOA & Remyelination Data Published
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
Slide 14: Clinical Program Overview
Successful Phase 1 First - In Humans Safety Trial + Chronic Animal Toxicity Studies Phase 2 Brain Target 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
Slide 15: Clean Toxicology Findings
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
Slide 16: Phase 1 First In Human Study Completed
• 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 •
Slide 17: Phase 2 REPAIR Brain Energetic Metabolites Study
17 • 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
Slide 18: NAD+/NADH Age Related Decline By P-MRS Imaging
18 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. 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 + /NADH unit decline per decade (~
Slide 19: Improved Brain Energy Ratio
CNM - Au8 Improved Brain Energy Ratio Elevated NAD+/NADH Ratio 19 Data on File, Clene Nanomedicine, Inc. Phase 2
Slide 20: Phase 2 RESCUE-ALS Study
(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 + AL
Slide 21: Predictive Endpoints of Disease Progression
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: Predictive Biomarker of Clinical Progression MUNIX Longitudinal Progressi
Slide 22: Primary Endpoint: Emerging Evidence of MUNIX Benefit
Primary Endpoint: Emerging Evidence of MUNIX Benefit Phase 2 Improvement 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” Pr
Slide 23: Secondary Endpoint: Forced Vital Capacity
SVC Avg. Slope Decline (% points/month) Slope Est. (9 - mo n t h s) Empower ( − 2.73%) - 24.6% Benefit ( − 2.74%) - 24.7% PRO - ACT ( - 2.90%) - 26.1% − 10. 5 − 19. 6 − 6. 7 Andrews et al. JAMA Neurol. 2018;75(1):58 - 64. Phase 2 Robert Glanzman MD FAAN, et al. “A Blinded Interim Update on RESCUE -
Slide 24: Phase 3 ALS Registration Study
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
Slide 25: Phase 2 Chronic Optic Neuropathy in MS
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, Placeb
Slide 26: Measuring MS Functional Improvement
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
Slide 27: Emerging Evidence of Clinical 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
Slide 28: Strong Intellectual Property
C S N 28 ® Clean surface nanocrystal (CSN) therapeutics Trade Secrets Patent Status Issued & Allowed Patents 130+ Pending Applications >30 Total Patents/ Applications >160 Patent Description Process And Me thod/ D e vic e (Clean Surface; Gold CSN) State of Matter (CNM - Au8) Method of Use (Prevent D
Slide 29: Proprietary Nanocrystal Manufacturing
Clene | Proprietary Nanocrystal Manufacturing In - House ISO8 Clean Room Clinical Production in North East, MD Validated CMC Processes 29 Designed to be Scalable to Commercialization Patented H ydro - electr o - Crystallization Proprietary Trade Secrets
Slide 30: Anticipated Timeline & Investor Catalysts 2020-2023
Anticipated Timeline & Investor Catalysts 2020 - 2023 30
Slide 31: Investment Highlights
31 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 • Energy enhancing nanotherapeutic • Robust Preclinical Remyelination & Neuroprotection Data
Slide 32: Investment Highlights
CLENE | Investment Highlights CG ‘CNM-ZnAg for COVID-19 G Unmet Medical Need & Market Opportunity G Lead Asset: CNM-Aus for Neuro Repair + Energy enhancing _—*_No Effective Diseasé nanotherapeutic Modifying Drugs for + Robust Preclinical ALS or PO Remyelination & + NoMS Therapies Neuroprotection Dat
Slide 33: & Clinical Development 6550 South Millrock Drive, Suite G50 Salt Lake City, UT 84121
& 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: 4 - August - 2021