Corporate Presentation October 2022 Exhibit 99.3
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 by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this presentation and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our substantial dependence on the successful commercialization of our drug candidates, if approved, in the future; our inability to maintain the listing of our common stock on Nasdaq; our significant net losses and net operating cash outflows; our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our ability to obtain and maintain protection of intellectual property for our technology and drugs; our reliance on third parties to conduct drug development, manufacturing and other services; our limited operating history and our ability to obtain additional funding for operations and to complete the licensing or development and commercialization of our drug candidates; the impact of the COVID-19 pandemic on our clinical development, commercial and other operations; changes in applicable laws or regulations; the effects of inflation; the effects of staffing and materials shortages; the possibility that we may be adversely affected by other economic, business, and/or competitive factors; and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this presentation, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this presentation is as of the date of this presentation. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this presentation.
CLENE | Building Clinical Neuroprotective Evidence Significant Opportunity Targeting neurodegenerative diseases such as ALS and Multiple Sclerosis >$1B commercial opportunity in each indication CNM-Au8® Clinical Results Long-term follow-up of RESCUE-ALS Phase 2 participants demonstrated statistically significant survival benefit; 70% decreased risk of death Positive Topline Results from the Phase 2 VISIONARY-MS Trial; CNM-Au8 demonstrated global neurological improvements in stable relapsing MS as adjunctive therapy to immunomodulatory DMTs CNM-Au8 demonstrated a >90% reduction in risk of death or permanently assisted ventilation for the 30 mg dose at 24 weeks in pre-specified exploratory results in the HEALEY ALS Platform Trial Proprietary Platform Strong IP Proprietary nanotherapeutic manufacturing Strong IP, including 150+ granted patents and manufacturing trade secrets
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 decline per decade (~0.13 mV units per year by 31P-MRS Imaging) Brain Energy Potential Declines With Normal Aging Closed squares = averaged data by age group: 21–26 yrs, 33–36 yrs, and 59–68 yrs old; Open squares = individual subject values PARKINSON’S DISEASE Dopaminergic Neurons AMYOTROPHIC LATERAL SCLEROSIS Motor Neurons HUNTINGTON’S DISEASE Medium Spiny Neurons FRONTOTEMPORAL DEMENTIA Spindle Neurons Specific Neuronal Populations Are Vulnerable to Energetic Failure MULTIPLE SCLEROSIS Axonal Degeneration Energetic impairments in the CNS both pre-dispose and drive progression in neurodegenerative diseases
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 Effects CNM-Au8 Nanocrystal Suspension = By targeting energy metabolism, CNM-Au8 may protect neuronal health
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 progression in Parkinson disease and the neurobiology of axons. Ann Neurol 2010;67:715-725.. Urgent unmet need to develop neuroprotective treatment to support cells’ energetic efficiency and resilience (MS) (PD)
Building the Clinical Case for Neuroprotection & Remyelination CNM-Au8 demonstrated statistically significant survival benefit 70% decreased risk of death Established brain target engagement in early PD and stable relapsing MS patients CNM-Au8 demonstrated neurological improvements in people with stable relapsing MS as adjunctive therapy to immunomodulatory DMTs Growing Body of Clinical Evidence Across ALS and MS Supports CNM-Au8 Therapeutic Potential
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, 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 ALS Specific QOL ALS Disease Progression Phase 2 Study: 36-Week Placebo-Control Treatment Period 1:1 Randomization (Active 30 mg: Placebo); 45 enrolled with early ALS
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. Time to all-cause mortality amongst participants originally randomized to CNM-Au8 compared to participants originally randomized to placebo through 31-Aug-2022. Vital status and date of death (as applicable) were captured for all subjects withdrawn from the study. Lost-to-follow-up (active, n=1; placebo, n=1) censored as of the date of last study contact (Active: Feb-2021; Placebo: Feb-2022). All OLE ex-placebo CNM-Au8 transitioned participants within the placebo group. All alive subjects are right censored as of 31-Aug-2022. Early CNM-Au8 treatment demonstrated a significant survival benefit: Follow-up of active compared to initial placebo randomization* 70% decreased risk of death *9-month delayed treatment start (ex-placebo) or no treatment
CNM-Au8 Demonstrated Global Neurological Improvement in Stable MS patients on DMTs Change in Low Contrast Letter Acuity (LCLA) 1 2 Change in modified MS Functional Composite (mMSFC) Phase 2 Study: 48-Week Placebo-Control Treatment Period 2:1 Randomization (Active [15mg, 30 mg]: Placebo) Enrolled stable relapsing remitting MS participants with chronic optic neuropathy on background DMTs n=73 of 150 planned – study ended prematurely due to COVID-19 pandemic-related enrollment challenges Data on File, Clene Nanomedicine, Inc.
CNM-Au8 Improved Axonal Integrity and Retinal Structure Data on File, Clene Nanomedicine, Inc. Increased Amplitude (Signal Strength) Exploratory Endpoint Improved Temporal Segment GCL & RNFL Exploratory Endpoint mf-VEP amplitude OCT retinal nerve fiber & ganglion cell layers
CAFS (Joint-Rank) Slow Vital Capacity 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 Sclerosis Therapy Development. Ann Neurol. 2022; 91:165-175. . Weighted Average of Slope Change & Hazard Ratio Weighting based on # of Mortality Events
Healey ALS Platform Trial CNM-Au8 Results No evidence for treatment effect at 24 weeks for either adjusted ALSFRS-R, CAFS, or SVC (combined 30 & 60 mg doses) Potential survival signal: >90% decreased risk of death at 30mg Mortality/PAV, p=0.028; Mortality = 0.057 (Regimen only) Mortality/PAV, p=0.042; Mortality = 0.075 (Shared placebo) Well tolerated with no definitive safety signals Data on File, Clene Nanomedicine, Inc.
24-Week Survival Signal | >90% Reduced Risk of Death at 30 mg *Shared Placebo Across Regimens * p-values are not adjusted for multiple comparisons; exploratory analyses by dose *CNM-Au8 Regimen Only Data on File, Clene Nanomedicine, Inc.
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 Effect Level (NOAEL) Findings Clean Toxicology Findings Multiple species up to 9-months treatment Up to maximum feasible dosing without any toxicology findings related to CNM-Au8 Assessed as Predominantly Mild-to-Moderate Severity and Transient Well Tolerated Adverse Event (AE) Profile No SAEs related to CNM-Au8 considered severe, life-threatening, or resulting in death AEs predominantly mild-to-moderate Data on File, Clene Nanomedicine, Inc. MS: Multiple Sclerosis, ALS: Amyotrophic lateral sclerosis, and PD: Parkinson's Disease.
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 weeks in Regimen-Only and in Full Analysis (Shared Placebo) (P=0.028 to 0.075) CNM-Au8 demonstrated a >90% risk reduction of death at 30 mg CNM-Au8 demonstrated 70% decreased risk of death Data on File, Clene Nanomedicine, Inc.
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 adjunctive DMT standard of care Established brain target engagement & safety Key Findings Ongoing to establish target engagement & safety in non-active, progressive MS Ongoing
Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases 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 suspension, in development as the first cellular energetic catalyst to remyelinate1 & protect neurological function Strong IP: 150+ patents on nanotherapeutic platform >90% decreased risk of death with 30 mg in ALS >400 patient years of CNM-Au8 clinical exposure Demonstrated global neurological improvement in MS patients on adjunctive DMT standard of care As of June 30, 2022, cash and investments on hand (unaudited): $26.3M
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