Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (October 2022)
19 slides from Clene's investor presentation, Oct 3, 2022
Slide 1: Corporate Presentation October 2022
Corporate Presentation October 2022 Exhibit 99.3
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created
Slide 3: CLENE | Building Clinical Neuroprotective Evidence
CLENE | Building Clinical Neuroprotective Evidence Significant Opportunity Targeting neurodegenerative diseases such as ALS and Multiple Sclerosis >$1B commercial opportunity in each indication CNM-Au8® Clinical Results Long-term follow-up of RESCUE-ALS Phase 2 participants demonstrated statisticall
Slide 4: Neurodegenerative Diseases Share A Common Mechanism: Decline In Brain Energy Production
Fu, H., et al; Nature Neuroscience (2018) 21: 1350-1358. Zhu et al. Proc Natl Acad Sci USA 2015 Mar 3;112(9):2876-81. Rone et al. J Neurosci. 2016 Apr 27;36(17):4698-707. Neurodegenerative Diseases Share A Common Mechanism: A Decline In The Brain’s Ability To Produce Energy ~0.5% NAD+/NADH unit decl
Slide 5: CNM-Au8: Pioneering A New Drug Class To Improve Cellular Energy Production
CNM-Au8® | Pioneering A New Drug Class To Improve Cellular Energy Production And Utilization Improved Energy Production and Utilization CNM-Au8 Nanocrystals Clean Surfaced, Highly Faceted Shapes Robinson et al. Sci Rep. 2020 Feb 11;10(1):1936. Data on File, Clene Nanomedicine, Inc. Mechanistic Effec
Slide 6: Significant Global Opportunity for Treatment in Combination with Standard of Care
Significant Global Opportunity for Treatment in Combination with Standard of Care 1 Clarivate, DRG, ALS 2020. 2. https://pubmed.ncbi.nlm.nih.gov/17974351/ 3. Westad et al. 2017, doi:10.1038/nrd.2017.107;. 4. Parkinson’s Market Data Forecast, April 2021.. 5. Cheng HC, Ulane CM, Burke RE. Clinical pro
Slide 7: Building the Clinical Case for Neuroprotection & Remyelination
Building the Clinical Case for Neuroprotection & Remyelination CNM-Au8 demonstrated statistically significant survival benefit 70% decreased risk of death Established brain target engagement in early PD and stable relapsing MS patients CNM-Au8 demonstrated neurological improvements in people with st
Slide 8: CNM-Au8 Improved Patient Function and QOL, and Slowed ALS Disease Progression
Proportion with <6 point decline CNM-Au8 Improved Patient Function and QOL, and Slowed ALS Disease Progression 1ALS Disease Progression defined as: Death, or Tracheostomy, or Non-invasive ventilation, or Gastrostomy tube Vucic et al. RESCUE-ALS Trial Results: A Phase 2, Randomized, Double-Blind, Pla
Slide 9: Significant Impact on Long-Term Survival with 70% Decreased Risk of Death
Demonstrated Significant Impact on Long-Term Survival with 70% Decreased Risk of Death RESCUE-ALS Active vs. Placebo Randomization Long-Term Observed Survival (Interim Analysis) Data on File, Clene Nanomedicine, Inc. Time to all-cause mortality amongst participants originally randomized to CNM-Au8 c
Slide 10: CNM-Au8 Demonstrated Global Neurological Improvement in Stable MS patients on DMTs
CNM-Au8 Demonstrated Global Neurological Improvement in Stable MS patients on DMTs Change in Low Contrast Letter Acuity (LCLA) 1 2 Change in modified MS Functional Composite (mMSFC) Phase 2 Study: 48-Week Placebo-Control Treatment Period 2:1 Randomization (Active [15mg, 30 mg]: Placebo) Enrolled sta
Slide 11: CNM-Au8 Improved Axonal Integrity and Retinal Structure
CNM-Au8 Improved Axonal Integrity and Retinal Structure Data on File, Clene Nanomedicine, Inc. Increased Amplitude (Signal Strength) Exploratory Endpoint Improved Temporal Segment GCL & RNFL Exploratory Endpoint mf-VEP amplitude OCT retinal nerve fiber & ganglion cell layers
Slide 12: HEALEY ALS Platform Trial Design and Endpoints
CAFS (Joint-Rank) Slow Vital Capacity Survival (Death + PAV) Change in ALSFRS-R slope adjusted by mortality Registration Study: 24-Week Treatment Period (3:1 randomization, 120 active [30mg, 60mg]: 40 placebo) 1 2 Paganoni et al. Adaptive Platform Trials to Transform Amyotrophic Lateral Sclerosis Th
Slide 13: Healey ALS Platform Trial CNM-Au8 Results
Healey ALS Platform Trial CNM-Au8 Results No evidence for treatment effect at 24 weeks for either adjusted ALSFRS-R, CAFS, or SVC (combined 30 & 60 mg doses) Potential survival signal: >90% decreased risk of death at 30mg Mortality/PAV, p=0.028; Mortality = 0.057 (Regimen only) Mortality/PAV, p=0.04
Slide 14: 24-Week Survival Signal | >90% Reduced Risk of Death at 30 mg
24-Week Survival Signal | >90% Reduced Risk of Death at 30 mg *Shared Placebo Across Regimens * p-values are not adjusted for multiple comparisons; exploratory analyses by dose *CNM-Au8 Regimen Only Data on File, Clene Nanomedicine, Inc.
Slide 15: Over 400 Years of Subject Exposure Without Identified Safety Signals
Over 400 Years of Subject Exposure Without Identified Safety Signals Across ALS, MS, and PD Over 400 Years of Subject Exposure Without Identified Safety Signals Patient Exposure Across ALS, MS & PD Long-term dosing experience up to 150 weeks All Animal Toxicology Studies Resulted in No-Adverse Effec
Slide 16: CNM-Au8 Has Demonstrated ALS Survival Benefit at 30 mg Dose in Two Phase 2 Studies
CNM-Au8 Has Demonstrated ALS Survival Benefit at 30 mg Dose in Two Phase 2 Studies Long-term follow-up up to 2.5 years show 70% decreased risk of death (original active vs original placebo randomization), P=0.0115 (i) Risk of Death or (ii) Risk of Death or Permanently Assisted Ventilation at 24 week
Slide 17: Growing Body of Evidence for Clene Nanotherapeutics
Growing Body of Evidence for Clene Nanotherapeutics Data on File, Clene Nanomedicine, Inc. Disease 2022 2021 2023 Demonstrated survival benefit Demonstrated survival signal at 6 months Established brain target engagement & safety Demonstrated global neurological improvement in MS patients on adjunct
Slide 18: Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases
Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases Data on File, Clene Nanomedicine, Inc. 1Robinson et al. Sci Rep. 2020 Feb 11;10(1):1936.2https://clinicaltrials.gov/ct2/show/NCT04414345. 70% decreased risk of death in ALS CNM-Au8® a gold nanocrystal suspension, in
Slide 19: Clene Inc. Addresses
©2022 Clene Inc. Version: 3-Oct-2022 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