Slide 1: Clene Inc. (NASDAQ: CLNN)
Exhibit 99.2 ®cLene NASDAQ: CLNN clene.com
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: Commitment and Experienced Leadership
| Commitment and Experienced Leadership COMMITTED TO REVOLUTIONIZING TREATMENT FOR PEOPLE WITH NEURODEGENERATIVE DISEASES TO RESTORE AND PROTECT NEURONAL HEALTH
Slide 4: Clene is Focused on Core Brain Energy Deficits in Neurodegenerative Diseases
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. Clene is Focused on Core Brain Energy Deficits in Neurodegenerative Diseases ~0.5% NAD+/NADH unit decline per decade (~0.13 mV un
Slide 5: Significant Global Opportunity
Significant Global Opportunity 1 Clarivate, DRG, ALS 2020. 2 Westad et al. 2017, doi:10.1038/nrd.2017.107;. 3 Parkinson’s Market Data Forecast, April 2021.. 4. Cheng HC, Ulane CM, Burke RE. Clinical progression in Parkinson disease and the neurobiology of axons. Ann Neurol 2010;67:715-725.. EMERGING
Slide 6: CNM-Au8: Catalytically-Active Nanocrystals Improve Energy Production
CNM-Au8® | Catalytically-Active Nanocrystals Improves Energy Production to Promote Neuroprotection and Remyelination CNM-Au8 Nanocrystal Suspension Mechanistic Effects Improved Energy Production and Utilization Promotes Neuroprotection and Remyelination CNM-Au8 Nanocrystals Clean Surfaced, Highly Fa
Slide 7: CNM-Au8 Improves ALS Motor Neuron Survival & Neuron Connections
CNM-Au8 Improves ALS Motor Neuron Survival & Neuron Connections Induced Pluripotent Stem Cell In Vitro Results – Motor Neuron Markers CNM-Au8® | Preclinical Evidence for Energetic Improvement Karen S. Ho et al. “Redox-enhancing nanocatalysis improves motor neuron survival in vitro and SOD1 mouse mot
Slide 8: CNM-Au8: Neuroprotection & Remyelination
CNM-Au8® | Neuroprotection & Remyelination Growing Evidence Supports CNM-Au8 Clinical Potential CNM-Au8 treatment effect on ALS disease progression and potential impact on survival Established brain target engagement in early Parkinson’s Disease (PD) and stable relapsing Multiple Sclerosis (MS) Phas
Slide 9: CNM-Au8: Safety Summary
CNM-Au8® | Safety Summary Over 350 Years of Subject Exposure Without Identified Safety Signals Patient Exposure Across PD, MS, & ALS Long-term dosing experience up to 125 weeks All Animal Toxicology Studies Resulted in No-Adverse Effect Level (NOAEL) Findings Clean Toxicology Findings Multiple speci
Slide 10: REPAIR Program Demonstrated Target Engagement and Improved Brain 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 CNM-Au8® | REPAIR Program Demonstrated Target Engagem
Slide 11: Evidence for Motor Neuron Protection
Vucic et al. BMJ Open. 2021 Jan 11;11(1):e041479. Data on File, Clene Nanomedicine, Inc. Study obj CNM-Au8® | Evidence for Motor Neuron Protection Results in favor of CNM-Au8 treatment but study underpowered 1° & 2° Endpoints Study Objective: Detect preservation of motor neuron function in people wi
Slide 12: Significant Impact on Key Functional ALS Measures
Proportion with <6 point decline CNM-Au8® | Significant Impact on Key Functional ALS Measures (Exploratory Endpoint Pre-specified) 1ALS Disease Progression defined as: Death, or Tracheostomy, or Non-invasive ventilation, or Gastrostomy tube RESCUE-ALS: A Phase 2, randomized, double-blind, placebo-co
Slide 13: CNM-Au8: CAFS: Survival & ALSFRS-R
CNM-Au8® | CAFS: Survival & ALSFRS-R Berry et al. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Apr;14(3):162-8. 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: Impact on Long-Term Survival
CNM-Au8® | Impact on Long-Term Survival 70% Improvement vs. ENCALS Predicted Survival (Interim Analysis) RESCUE-ALS Long-Term Observed Survival (OLE Participants) vs. ENCALS Predicted Median Survival; All Open Label Participants, Interim Analysis All OLE participants. Data censored as of 10-March-20
Slide 15: Phase 2/3 HEALEY ALS Platform Trial 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 Anticipated topline data: 3Q 2022 (Stopped for futility) Paganoni et al. Ann Neur
Slide 16: Phase 2/3 Integrated Function & Survival Endpoints
Paganoni et al. Ann Neurol. 2022 Feb;91(2):165-175. Berry et al. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Apr;14(3):162-8. Individual Scoring ALSFRS-R Decline Survival CAFS Rank participants based on time to death or ALSFRS-R change Phase 2/3 Integrated Function & Survival 1° and Key 2°
Slide 17: VISIONARY-MS Phase 2 Trial Design
Exploratory Endpoints 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) At Week 24 Up to 48-Week Placebo-Control 2:1 Randomization (Active: Placebo) 15mg, 30mg, Placebo (n=73 of 150)
Slide 18: 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 19: COVID-19 Trial Endpoints
1. Substantial alleviation is a patient global impression of severity scored as mild or normal. 2. Complete alleviation is a patient global impression of severity scored as normal Time to complete alleviation2 of COVID-19 symptoms through Day 28 Proportion hospitalized for COVID-19 related medical s
Slide 20: Strong IP & Manufacturing Capability
Trade Secrets 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; Antimic
Slide 21: Anticipated Timeline & Upcoming Milestones
Anticipated Timeline & Upcoming Milestones VISIONARY-MS Move data bubble to match VISIONARY March 31, 2022 Cash and investments on hand (unaudited): $36.6M
Slide 22: Growing Phase Evidence Supports CNM-Au8 Commercial Potential
CNM-Au8® | Growing Phase 2 Evidence Supports CNM-Au8 Commercial Potential
Slide 23: Clene Inc. HQ & Clinical Development
©2022 Clene Inc. Version: 9-May-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