Slide 1: Corporate Presentation August 2022
Corporate Presentation August 2022 Exhibit 99.2
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: 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: 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 CNM-Au8 demo
Slide 9: Over 350 Years of Subject Exposure Without Identified Safety Signals
Over 350 Years of Subject Exposure Without Identified Safety Signals Across ALS, MS & PD Over 350 Years of Subject Exposure Without Identified Safety Signals Patient Exposure Across ALS, MS & 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: Encouraging Efficacy Signals in RESCUE-ALS Phase 2 Trial
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
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 Core Design Elements
Core Design Elements Change in Low Contrast Letter Acuity (LCLA) 1 2 https://clinicaltrials.gov/ct2/show/NCT03536559, Data on File, Clene Nanomedicne, Inc. Change in modified MS Functional Composite (mMSFC) Enrolled stable relapsing remitting MS participants with chronic optic neuropathy on backgrou
Slide 17: Baseline Demographics Showed Balanced Randomization and Clinical Profile
Baseline Demographics Showed Balanced Randomization and Clinical Profile Baseline Value mean (sd) Age (yrs) Sex n, (%) Female Race n, (%) White Weight (kg) EDSS Score Years from Dx Months Since Relapse CNM-Au8 15 mg (n=24) 38.4 (10.2) 15 (63%) 23 (96%) 78.0 (17.1) 1.83 (1.3) 6.5 (5.0) 53 (57) CNM-Au
Slide 18: Pandemic Significantly Impacted Study Conduct
Pandemic Significantly Impacted Study Conduct Study was ended prematurely due to COVID enrollment challenges (as announced February 2022) Enrolled 73 of 150 planned Underpowered due to limited enrollment Pre-specified statistical threshold set at p=0.10 COVID restrictions precluded direct Sponsor mo
Slide 19: Modified ITT (mITT) Analysis Population
modified ITT (mITT) Analysis Population Censored observations included Change in mobility assist device (cane to walker) for T25FW (n=1) Invalid data from 1 of 11 sites (n=9) with LCLA testing execution errors Multiple testing locations with different light boxes and varying ambient lighting conditi
Slide 20: CNM-Au8 Treatment Significantly Improved Vision
CNM-Au8 treatment significantly improved vision Primary outcome - low contrast letter acuity (LCLA) LCLA in the Affected Eye Data on File, Clene Nanomedicine, Inc. mITT excludes one site where data inconsistencies were observed in both active and placebo participants LCLA 2.5% Contrast
Slide 21: mMSFC Composite Mean Standardized Change
Lead 2nd EP | (m)MFSC Composite Mean Standardized Change (6-domain) CNM-Au8 demonstrated global neurological improvement by the modified MS functional composite LCLA SDMT 9HPT T25FWT Data on File, Clene Nanomedicine, Inc. mITT excludes one site where data inconsistencies were observed in both active
Slide 22: Neurological Improvement Driven by Cognition, Manual Dexterity, and Low Contrast Vision
CNM-Au8 neurological improvement was driven by cognition, manual dexterity, and low contrast vision LCLA SDMT 9HPT T25FWT Data on File, Clene Nanomedicine, Inc. mITT excludes one site where data inconsistencies were observed in both active and placebo participants
Slide 23: mMFSC Averaged Rank Sum Score
2nd EP | mMFSC Averaged Rank Sum Score CNM-Au8 treatment improved functional outcomes Improvement relative to placebo decline Score all subjects versus all other subjects by each mMSFC domain Better function than comparison Same function as comparison Worse function than comparison Data on File, Cle
Slide 24: Safety Summary
Safety Summary Treatment Emergent Adverse Events (TEAEs) CNM-Au8 15 mg number (%) CNM-Au8 30 mg number (%) Placebo number (%) Subjects with any TEAE 21 (88%) 25 (100%) 22 (92%) Subjects with SAE 1 (4%) 2 (8%) 2 (8%) Subjects with Related TEAEs 2 (8%) 5 (20%) 2 (8%) Subjects Discontinued due to TEAE
Slide 25: CNM-Au8 Efficacy Summary
CNM-Au8 Efficacy Summary First therapy to demonstrate global neurological improvement in MS patients on top of background DMT standard of care Independent quantitative biomarkers of myelin and axonal integrity Clinical and functional improvements LCLA vision improvement mMFSC global neurological imp
Slide 26: 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 27: Anticipated Timeline & Upcoming Milestones
Anticipated Timeline & Upcoming Milestones Sufficient Cash to Hit Key Milestones in 2022 June 30, 2022 Cash and investments on hand (unaudited): $26.3M
Slide 28: Growing Evidence Supports CNM-Au8 Commercial Potential
CLENE | Growing Phase 2 Evidence Supports CNM-Au8 Commercial Potential June 30, 2022 Cash and investments on hand (unaudited): $26.3M 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 first ce
Slide 29: Clene Inc. Locations
©2022 Clene Inc. Version: 15-Aug-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