Slide 1: Healey ALS Platform Trial CNM-Au8 Results Webcast
Healey ALS Platform Trial CNM-Au8 Results Webcast October 2022 Exhibit 99.2
Slide 2: Introduction & CLNN Program Update
Introduction & CLNN Program Update Rob Etherington, President and Chief Executive Officer I Clene Inc. HEALEY ALS Platform Trial Results for CNM-Au8 Merit Cudkowicz, M.D., MSc I Chief of Neurology at Massachusetts General Hospital Director of the Sean M. Healey & AMG Center for ALS Clene Milestones
Slide 3: 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 4: Growing Clinical Evidence Across ALS and MS Supports CNM-Au8 Therapeutic Potential
CLENE | Growing Clinical Evidence Across ALS and MS Supports CNM-Au8 Therapeutic Potential 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 suspensi
Slide 5: Building the Clinical Case for Neuroprotection & Remyelination
Building the Clinical Case for Neuroprotection & Remyelination Demonstrated statistically significant survival; 70% decreased risk of death Established brain target engagement in early PD and stable relapsing MS patients First therapy to demonstrate global neurological improvement in MS patients on
Slide 6: CNM-Au8: Pioneering A New Drug Class To Improve Cellular Energy Production And Utilization
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 7: 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 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 8: Merit Cudkowicz, M.D., MSc
Merit Cudkowicz, M.D., MSc Director of the Sean M. Healey & AMG Center for ALS Chief of the Department of Neurology at MGH, and the Julieanne Dorn Professor of Neurology at Harvard Medical School Principal Investigator and Sponsor of the Healey ALS Platform Trial Results for CNM-Au8 Regimen
Slide 9: Registration Study: 24-Week Treatment Period Design and Endpoints
CAFS (Joint-Rank) Slow Vital Capacity (SVC) 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 Sclero
Slide 10: Participant Disposition
Participant Disposition | With Shared Placebo 523 assessed for eligibility for Regimens A, B, or D 163 assessed for eligibility for Regimen C (CNM-Au8) 400 were excluded from Shared Placebo 369 randomized to active (Regimen A, B, or D) 31 excluded due to: screen failures (14), timed out of screening
Slide 11: Primary: No Effect on Mortality Adjusted ALSFRS-R Change at 24 Weeks
Primary | No Effect on Mortality Adjusted ALSFRS-R Change at 24 Weeks (30mg & 60mg combined) All shared controls ALSFRS-R component includes only survivors Mortality is accounted for using common treatment effect Model adjusts for covariates: Time since symptom onset Pre-baseline ALSFRS-R slope Edar
Slide 12: No Effect on Key Secondary Endpoints
No Effect on Key Secondary Endpoints at 24 Weeks (30mg & 60mg combined) Combined Assessment of Function and Survival (CAFS) change at 24 weeks was not significant No effect on Slow Vital Capacity (SVC) at 24 weeks
Slide 13: 24-Week Survival Signal: >90% Risk Reduction at 30mg
24-Week Survival Signal | >90% Risk Reduction at 30mg *Shared Placebo Across Regimens * p-values are not adjusted for multiple comparisons; exploratory analyses by dose *CNM-Au8 Regimen Only
Slide 14: Safety
Safety Occurrence of TEAEs were balanced between CNM-Au8 and placebo No SAEs were assessed as related to CNM-Au8 Higher incidence of SAEs at 60mg dose Treatment Emergent Adverse Events (TEAEs) Placebo (%) CNM-Au8 30 mg (%) CNM-Au8 60 mg(%) Subjects with Any TEAE 90% 92% 93% Subjects with Related TEA
Slide 15: Healey ALS Platform Trial CNM-Au8 Summary
Healey ALS Platform Trial CNM-Au8 Summary No evidence for treatment effect at 24 weeks for either adjusted ALSFRS-R, CAFS, or SVC (combined doses) Potential survival signal: >90% decreased risk at 30mg Mortality/PAV, p=0.028; Mortality = 0.057 (Regimen only) Mortality/PAV, p=0.042; Mortality = 0.075
Slide 16: Robert Glanzman, M.D., FAAN, Clene Chief Medical Officer
Robert Glanzman, M.D., FAAN Clene Chief Medical Officer
Slide 17: CNM-Au8 Has Demonstrated ALS Survival Benefit 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 18: 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 19: CNM-Au8 Question and Answers
CNM-Au8 Question and Answers Merit Cudkowicz, M.D., MSc Chief, Department of Neurology at MGH Director of the Sean M. Healey & AMG Center for ALS Robert Glanzman, M.D., FAAN Chief Medical Officer Clene Nanomedicine, Inc. Rob Etherington Chief Executive Officer Clene Nanomedicine, Inc. Michael Hotchk