Slide 1: Physiologic and Anatomical Evidence of Neuronal Repair and Remyelination from the Long-Term OLE
Phase 2 Physiologic and Anatomical Evidence of Neuronal Repair and Remyelination from the Long-Term Open- Label Extension of the Phase 2 VISIONARY-MS Trial Benjamin Greenberg, MD On behalf of the VISIONARY-MS Investigators
Slide 2: Disclosures
Disclosures Long-Term Open-Label Extension • Dr. Greenberg has received consulting fees from Alexion, Novartis, EMD Serono, Horizon Therapeutics/Amgen, Genentech/Roche, Signant, IQVIA, Sandoz, Sanofi/Genzyme, TG Therapeutics, Cycle Pharma, Arialys, Clene Nanomedicine, Syneos, and PRIME Education • H
Slide 3: Treatment and Participant Disposition in the Long-Term OLE
Treatment and Participant Disposition in the Long-Term OLE Long-Term Open Label Extension Disposition CNM-Au8 30 mg Oral Suspension Randomized in Double-Blind (n=73) Eligible for LTE n=69 (95%) Clean Surfaced, Enrolled in LTE Highly Faceted Nanocrystals n=55 (80%) Cellular Energetic Original CNM-Au8
Slide 4: Objective: Demonstrate Physiologic and Anatomical Evidence Supporting Clinical Effects for LCLA and SDMT Improvement
Objective: Demonstrate Physiologic and Anatomical Evidence Long-Term Supporting Clinical Effects for LCLA and SDMT Improvement Open Label Extension LCLA LTE Change (CNM-Au8) SDMT LTE Change (CNM-Au8) Low Contrast Letter Acuity Symbol Digit Modalities Test 4 Data on File, LTE: LS mean difference vs.
Slide 5: 96% of LCLA Responders Were Associated with MRI DTI Improvements in Axial Diffusivity
96% of LCLA Responders Were Associated with MRI DTI Improvements Long-Term in Axial Diffusivity (AD) and/or Magnetization Transfer Ratio (MTR) Open Label Extension LCLA Responders with AD and/or MTR Improvement In the Cerebrum or Optic Radiation MTR Responders (Green) 100% (all shaded regions; n = 4
Slide 6: 91% of LCLA Responders Were Associated with multi-focal VEP Improvements
91% of LCLA Responders Were Associated with multi-focal VEP Long-Term Improvements in Latency (Conduction Velocity) and Amplitude (Signal Strength) Open Label Extension LCLA Responders with mf-VEP Latency and/or Amplitude Improvement VEP Amplitude VEP Latency Responders 100% (all shaded regions; n =
Slide 7: 98% of SDMT Responders Were Associated with MRI DTI Improvements in Axial Diffusivity
98% of SDMT Responders Were Associated with MRI DTI Improvements in Long-Term Axial Diffusivity (AD) and/or Magnetization Transfer Ratio (MTR) Open Label Extension SDMT Responders with AD and/or MTR Improvement In the Cerebrum or Optic Radiation MTR Responders AD 5% (Green) 100% (all shaded regions;
Slide 8: 91% of SDMT Responders Were Associated with multi-focal VEP Improvements
91% of SDMT Responders Were Associated with multi-focal VEP Long-Term Improvements in Latency (Conduction Velocity) and/or Amplitude (Signal) Open Label Extension SDMT Responders Were Associated with mf-VEP Latency and/or Amplitude Improvement SDMT VEP Amplitude Responder 100% (all shaded regions; n
Slide 9: SDMT LTE Change Correlated with MRI DTI and mf-VEP Metrics
SDMT LTE Change Correlated with MRI DTI and mf-VEP Metrics Long-Term Open Label Extension 9 Clene Nanomedicine, Inc. Data on File
Slide 10: Conclusions
Conclusions Long-Term Open Label Extension • Nearly all participants with SDMT and LCLA improvement had concordant improvements on MRI DTI (AD and MTR) and VEP improvement • These analyses confirm the improvement of structure and function in the brains of MS patients treated with CNM-Au8 during the
Slide 11: Physiologic and Anatomical Evidence of Neuronal Repair and Remyelination from the Long-Term OLE
Phase 2 Physiologic and Anatomical Evidence of Neuronal Repair and Remyelination from the Long-Term Open- Label Extension of the Phase 2 VISIONARY-MS Trial Benjamin Greenberg, MD On behalf of the VISIONARY-MS Investigators