Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (February 2021)
31 slides from Clene's investor presentation, Feb 26, 2021
Slide 1: CLNN (NASDAQ)
CLNN (NASDAQ)
Slide 2: Forward Looking Statements
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
Slide 3: Clene Investment Highlights
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 & Neur
Slide 4: Clene Management Team
Lanxide Corporation Dupont Lanxide Composites Lanxide Armor Company Lanxide Performance Materials Lanxide Electronic Components CDO CLENE | Management Team Ted Jeong , DM 4
Slide 5: Platform & Pipeline
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
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: Bioenergetic Nanocatalyst Metabolic Efficiency
CNM - Au8 | Bioenergetic Nanocatalyst 7 Me t a bo li c Eff i c i ency
Slide 8: Integrating Physics With Biology
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
Slide 9: Treating Bioenergetic Failure
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 D
Slide 10: MOA Therapeutic Effects
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 Bioenergetic Improvement
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, 20
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 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
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: Effects on Brain Bioenergetic Metabolites
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 Ph
Slide 18: Improved Brain Metabolic Markers in MS & PD
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 Tw
Slide 19: Improved Brain Metabolic Markers in MS
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
Slide 20: Phase 2 ALS Study Design
(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 Pha
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 Predicts Clinical Progression 21
Slide 22: Emerging Evidence of Primary Endpoint MUNIX
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. Emerg
Slide 23: 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 24: Phase 2 Chronic Optic Neuropathy in MS
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, Pla
Slide 25: 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 26: 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 27: Strong Intellectual Property
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 D
Slide 28: Proprietary Nanocrystal Manufacturing
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
Slide 29: Anticipated Timeline & Investor Catalysts 2020-2023
Anticipated Timeline & Investor Catalysts 2020 - 2023 United T herapeutics 29
Slide 30: Clene Investment Highlights
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 & Neurop
Slide 31: Clene Inc. Addresses
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