Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (July 2022)
21 slides from Clene's investor presentation, Jul 21, 2022
Slide 1: Corporate Presentation July 2022
Corporate Presentation July 2022 Exhibit 99.1
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 | Entering a Transformative Period
CLENE | Entering a Transformative Period Significant Opportunity Targeting neurodegenerative diseases such as ALS and Multiple Sclerosis >$1B commercial opportunity in each indication CNM-Au8® Emerging Clinical Results Long-term follow-up of RESCUE-ALS Phase 2 participants demonstrated statistically
Slide 4: Neurodegenerative Diseases Share A Common Mechanism: A Decline In The Brain's Ability To Produce Energy
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: CNM-Au8 Improves ALS Motor Neuron Function & Survival
CNM-Au8 Improves ALS Motor Neuron Function & Survival Induced Pluripotent Stem Cell In Vitro Results – Motor Neuron Markers Preclinical Evidence of Remyelination and Neuroprotection Karen S. Ho et al. “Redox-enhancing nanocatalysis improves motor neuron survival in vitro and SOD1 mouse motor functio
Slide 7: 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 8: Building the Case for Neuroprotection & Remyelination
Building the Case for Neuroprotection & Remyelination RESCUE-ALS trial supports CNM-Au8 slowed disease progression in ALS Demonstrated statistically significant survival benefit; 70% decreased risk of death Established brain target engagement in early PD and stable relapsing MS patients Interim blin
Slide 9: Over 350 Years of Subject Exposure Without Identified Safety Signals Across MS, ALS & PD
Over 350 Years of Subject Exposure Without Identified Safety Signals Across MS, ALS & PD Over 350 Years of Subject Exposure Without Identified Safety Signals Patient Exposure Across MS, ALS & PD Long-term dosing experience up to 125 weeks All Animal Toxicology Studies Resulted in No-Adverse Effect L
Slide 10: Two REPAIR Trials Demonstrated Target Brain Engagement and Improved Energy Metabolism
1. Zhu et al. Proc Natl Acad Sci USA 2015 Mar 3;112(9):2876-81.. 2. Glanzman et al Improvement of Brain Energy Metabolism in Relapsing Multiple Sclerosis Patients - Results from Phase 2 REPAIR-MS Clinical Trial With CNM-Au8, ACTRIMS February 2022 Two REPAIR Trials Demonstrated Target Brain Engagemen
Slide 11: RESCUE-ALS Trial Results: Encouraging Efficacy Signals in Phase 2
Vucic et al. RESCUE-ALS Trial Results: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of CNM-Au8 to Slow Disease Progression in Amyotrophic Lateral Sclerosis; Presented at International Symposium on ALS/MND; 7-10 December 2021 \. Encouraging Efficacy Signals in Phase 2 Trial Results i
Slide 12: 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 13: CAFS Results: Slowed Disease Progression
CAFS Results: Slowed Disease Progression Data on File, Clene Nanomedicine, Inc. . Exploratory Endpoint Pre-specified ALSFRS-R Decline Survival CAFS King’s Clinical Stage 4 Modified CAFS Exploratory Endpoint Post Hoc
Slide 14: 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. Early CNM-Au8 treatment demonstrated a significant survival benefit: Long-term foll
Slide 15: HEALEY ALS Platform Trial Registration Study Design
CAFS (Joint-Rank) Survival & ALSFRS-R Slow Vital Capacity Survival Change in ALSFRS-R slope + survival Registration Study: 24-Week Treatment Period (3:1 randomization, 120 active [30mg, 60mg]: 40 placebo) 1 2 Phase 2/3 (Stopped for futility) Paganoni et al. Adaptive Platform Trials to Transform Amyo
Slide 16: VISIONARY-MS Phase 2 Study Design
Treatment of Visual Pathway Deficits In Chronic Optic Neuropathy for Assessment of Remyelination in Non-Active Relapsing MS Change in Low Contrast Letter Acuity (LCLA) 1 2 https://clinicaltrials.gov/ct2/show/NCT03536559, Data on File, Clene Nanomediicne, Inc. Change in modified MS Functional Composi
Slide 17: Significant Clinical Improvement Across Blinded Study Population
Significant Clinical Improvement Across Blinded Study Population Primary Endpoint: LCLA (Best-Corrected) & Secondary Endpoint: (m)MSFC Phase 2 2° | (m)MSFC 1° | LCLA Glanzman et al. VISIONARY-MS: Update to a Phase 2 Clinical Trial of CNM-Au8, Catalytically Active Gold Nanocrystals Suspension, for th
Slide 18: Strong IP & Manufacturing Capability
Trade Secrets Global Patent Status b Patent Description Issued & Allowed Patents 150+ Pending Applications ~20 Total Patents/ Applications >170 Process And Method/Device (Clean Surface; Gold CSN) State of Matter (CNM-Au8) Method of Use (Prevent Demyelination & MoA) Method of Use (Bi-Metallic Au/Pt;
Slide 19: Anticipated Timeline & Upcoming Milestones
Anticipated Timeline & Upcoming Milestones Sufficient Cash to Hit Key Milestones in 2022
Slide 20: CLENE | Growing Phase Evidence Supports CNM-Au8 Commercial Potential
CLENE | Growing Phase 2 Evidence Supports CNM-Au8 Commercial Potential March 31, 2022 Cash and restricted cash on hand (unaudited): $36.6M ALS Registration Trial Topline data in 3Q 20222 >350 patient years of CNM-Au8 clinical exposure CNM-Au8® a gold nanocrystal suspension, in development as the fir
Slide 21: Clene Inc. Locations
©2022 Clene Inc. Version: 21-July-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