Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (September 2023)
31 slides from Clene's investor presentation, Sep 25, 2023
Slide 1: Clene Corporate Presentation
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Slide 2: Forward Looking Statements
Forward Looking Statements “Ths presentation contin “forward-looking statements” within the soning of Seton 216 fhe Secure Eachange Act of 1934, x waned, an Section 7A of he Sci Ac of 1993, 8 ended, whic ar tended abe covered by the “cafe harbor provisions cebed by thos ns lene’ frwariockng taterert
Slide 3: Growing Body of Clinical Evidence for CNM-Au8
CNM-Au8 treatment resulted CNM-Au8 demonstrated global in statistically significant neurological improvement in urvival benefit of 75% stable relapsing MS as an de d risk of death adjunct to immunomodulatory through 3.5 year DMTs Growing Body of Clinic
Slide 4: Neurodegenerative Diseases Share A Common Mechanism: Decline In Brain Energy
Neurodegenerative Diseases Share A Common Mechanism: A Decline In The Brain’s Ability To Produce Energy Brain Energy Potential ‘Specific Neuronal Populations Are Vulnerable to Energetic Failure Declines With Normal Aging PARKINSON'S DISEASE Depaminerie Neurons muenue SCLEROSIS FRONTOTEMPORAL ‘Axonal
Slide 5: CNM-Au8 | Pioneering A New Drug Class To Improve Cellular Energy
CNM-Au8® | Pioneering A New Drug Class To Improve Cellular Energy Production And Utilization CNM-Aus athianiicetiacds Improved Energy Production and Nanocrystals Utilization lan urtaced, Iv Faceted Increased NAD i Increased ATP Decreased reactive = | oxygen species Pile Increased proteostasis Suspen
Slide 6: Significant Global Opportunity for Treatment in Combination with Standard of Care
Significant Global Opportunity for Treatment in Combination with Standard of Care Motor Neuron Multiple Parkinson’s Disease #2: Sclerosis (MS) Disease (PD) IOUS NOS... NE © Slee Go oo @ LAWS RS coed pciene
Slide 7: Two REPAIR Trials Demonstrated Target Brain Engagement and Improved Energy Metabolism
Two REPAIR Trials Demonstrated Target Brain Engagement and Improved Energy Metabolism in Early Parkinson’s and Stable Relapsing MS tentially meaningful 10% improvement in intial molecule for energy pr Study Objective: to demonstrate target engagement for CNM-AuB Acer emmemamniS imicg as Peering inte
Slide 8: RESCUE-ALS Encouraging Efficacy Signals in Phase 2 Trial
& RESCUES Encouraging Efficacy Signals in Phase 2 Trial 1° & 2° Endpoints Study Objecti esc ALs Primary & Sacondy 3 “insti Cnage a2 ch ect preservation of motor neuron function ir Townes a © maoccun cm) people with early ALS a aaa measured by MUNIX ee “ agement nt om Study D tudy D voy © recom ek bl
Slide 9: RESCUE-ALS CNM-Au8 Improved Patient Function, QOL, and Slowed Clinical Worsening
a RESCUE CNM-Au8 Improved Patient Function, QOL, and Slowed Time to ALS Clinical Worsening Phase 2 Study: 36-Week Placebo-Control Treatment Period 1:1 Randomization (Active 30 mg: Placebo); N=4S enrolled with early Als Proportion with <6 [ALS Specific QOL ALS Clinical Worsening point decline > cLene
Slide 10: RESCUE OLE | Preserved ALSFRS-R Functional Decline
A RESCUE OLE | Preserved ALSFRS-R Functional Decline Early CNM-Au8 Treatment Impacts Long-Term Function Compared to Original Placebo ALSFRS-R Slope ALSFRS-R Slope ALSFRS-R Slope Baseline to Week 48 Week 60 [OLE Week 24] to Week 120 ‘Summary sre eo gn 2st es mr Ae ca, sepa attain er tay ars sparc ant
Slide 11: RESCUE OLE | Reduced Risk of ALS Clinical Worsening
Bt RESCUE OLE | Reduced Risk of ALS Clinical Worsening The risk of ALS clinical worsening was decreased 52% for CNM-Au8 Hara rao® 0478 osm wader 0225101015 Legeark, p= 0454 compared to placebo in OLE up to 168 weeks Clinical worsening events included: + Death, + Tracheostomy, + Need for non-invasive
Slide 12: RESCUE-ALS Survival Benefit vs. Original Placebo up to 3.5 years
a RESCUE Unadjusted Survival Difference: 10.1 Month Survival Benefit vs. Original Placebo up to 3.5 years ‘overall Survival (Cause Mot) RESCUE.ALS Biron LPL at IT Poel 6) Proparien Et Fe apa ier Aros loserk p= 00m Cross-Over Adjusted Survival Difference: 19.3 Month {rose-OverAajusted Analysis of Sur
Slide 13: RESCUE Consistent Long-Term Survival Benefit Compared to Historical Matched PRO-ACT Placebo Controls
& RESCUE. Consistent Long-Term Survival Benefit Compared to Historical Matched PRO-ACT Placebo Controls CNM-Au8 treatment demonstrated a significant pared to matched CT Roc cntn apron 12.00 patertrecars om mute completed nal wl. ‘metoal auza marae amore parol domed Ct A cond to propane onal dene rom
Slide 14: HEALEY ALS Platform Trial Design
‘A Multi-center, Randomized Double-Blind, Placebo-Controlled HEALEY ALS Clinical Trial Assessing the Efficacy, Safety, Tolerability, Platform Trial Pharmacokinetics, and Pharmacodynamics of CNM-Au8 in Participants with Amyotrophic Lateral Sclerosis 24-Week Treatment Period (3:1 randomization, 120 ac
Slide 15: Survival Signal | >90% Reduced Risk of Death with CNM-Au8 30mg
Survival Signal | >90% Reduced Risk of Death with CNM-Au8 30mg Shared Placebo Across Regimens ‘Cut. Au 30mg Survival | Adjusted Cox Proportional Hazard Ful Anais Set (Al Shared Pacabo, Rogers AB, C,0). Se Hazard Reduction a Wook 22 (1 Hava ato 05% Contdence ara) ese ten corm tire HEALEY ALS Platform
Slide 16: Delayed Time to Clinical Event Summary
Delayed Time to Clinical Event Summary CNM-Au8 30mg | Within Regimen Analysis (Primary Model) Tracheostomy Permanent Assisted Ventilation (uw 22 hours pee day) Feeding Tube Placement CNM-Au8 30mg delayed time to clinical worsening at 6 months eommoodpe ‘CNM-Au8 30mg | Clinical Event Risk Reduction ‘
Slide 17: Plasma NfL Difference | CNM-Au8 vs. Placebo
Plasma NfL Difference | CNM-Au8 vs. Placebo All RGC Participants Plasma NEL RGC Within Regimen Analyis | Quanterix 4NPA [AIIRCG (n=161); Difference of LS Means on Ln Scale (SE) Difference of LS Means on Ln Scale (SE) = -0.010 (0.048); p= 0.040, 448 - 47.9% 2 § j 1.05: i 2 $3 1.00. i 2 I 23% goss Y O
Slide 18: Long-Term Survival | Propensity Matched Placebo
Long-Term Survival | Propensity Matched Placebo PRO-ACT Placebo Matching vs. Regimen C CNM-Au8 30mg HEALEY ALS Blattorm Tal von (0) or Pret) 0c Pct acs (n=322) Onset Age “| 55.410.) 55.4 (21.1) s50(114) Seren ma a) a BMI (kg/m?) | 27.4 (5.3) 26.5 (4.9) 27.2(5.2) 26.6 (5.0) painters arr) zoe) B70 ayo
Slide 19: Long-Term Survival | Propensity Matched Placebo
Long-Term Survival | Propensity Matched Placebo PRO-ACT Placebo vs. CNM-Au8 30mg CNM-Au8 30mg HEALEY CNM-Au8 30mg Integrated Meta-Analysis HEALEY-ALS Platform Long-Term Survival Integrated Meta-Analysis of CNM-Au8 30mg Long-Term Survival CCR Aus domg Observed Survival vs, PRO-ACT Nath Placabo Contro
Slide 20: CNM-Au8 | ALS Clinical Worsening Summary
CNM-Au8 | ALS Clinical Worsening Summary Evidence for Decreased Clinical Worsening Events Across Two Phase 2 Studies ‘Time to ALS Clinical Worsening Frat Ocorenoe of Deh, Tracheostomy, Assisi Veriton, o Feeding Tube TTT Population (Ar Randemiod, Kaplan Esra AQpresoue Ghia tng Pato mas) wea ‘ernie 68
Slide 21: CNM-Au8 Has Demonstrated ALS Survival Benefit at 30mg Dose in Two Phase 2 Studies
CNM-Au8 Has Demonstrated ALS Survival Benefit at 30mg Dose in Two Phase 2 Studies HEALEY ALS Platform Trial Cross-Over Adjusted Survival - ers 8 ne -— eines oa |} ______4. ter pciene
Slide 22: Promising Evidence from Two Phase 2 Trials and Long-Term Data
Promising Evidence from Two Phase 2 Trials and Long-Term Data CNM-Au8 Demonstrated Survival, Delayed Clinical Worsening, and Preserved Function Be rescuess eu & ‘AS Patient ‘ Real World pliant EarlytoMid Stage Early-toMidStage — MidtoLotestage —Midtoatestage ‘eat World Duration ab-weeks Upto 173 wee
Slide 23: HEALEY ALS Platform Safety Summary
HEALEY ALS Platform Safety Summary * Occurrence of TEAEs were balanced between CNM-Au8 and placebo * No SAEs were assessed as related to CNM-Au8 CNM-At 60n Participants with Any TEAE | Participants with Related TEAEs 39% 34% 29% 43% “Participants with SAE 9% 17% 10% 16% | Participants with Related S
Slide 24: VISIONARY-MS Core Design Elements
VISIONARY-MS Core Design Elements STUDY Phase 2 Study: 48-Week Placebo-Control Treatment Period 2:1 Randomization (Active [15mg, 30 mg]: Placebo) Screening DOGO O-++-0-0-——® eo @ oe <4 = * Enrolled stable relapsing remitting MS participants with chronic optic neuropathy on background OMTs * 9296 tre
Slide 25: CNM-Au8 Demonstrated Vision and Global Neurological Improvement in Stable MS
CNM-Au8 Demonstrated Vision and Global @VISIONARY-MS Neurological Improvement in Stable MS patients on DMTs Global Neurological impr nt Change in Low Contrast Letter Acuity (LCLA) Change in modified MS Functional Composite (mMSFC} inacegetanenasigs LOLA atte, ST eran dominat SOME, T2SPW Init Poputon
Slide 26: CNM-Au8 Improved Information Transfer from Eye to Brain
CNM-Au8 Improved Informa Increased Amplitude From the Eye to the Brain’s . = = = . (Signal Strength) Visual Cortex in Signal in the Visual Pathway ‘mf-VEP Mean Amplitude Percent (%) Change ITT Population, LS Mean = SEM, Segments Nested by Participant toy VEPAMected Eye VEP Fallow Eye |W 48 LS-Mean D
Slide 27: CNM-Au8 Preserved White Matter Integrity Throughout the Brain
CNM-Au8 Preserved White Matter Integrity Throughout the —@visionary-ms Brain Preserved Whole Brain White Matter Integrity Consistent Effect Across All Brain Regions Don Tersorimaaing| rector Aniscvopy (A) Change Brain (Cerebrum). iri Popdaton Ss Se Change om Basing ‘an Sgr and fur pcvene
Slide 28: Over Years of Subject Exposure Without Identified Safety Signals
Over 500 Years of Subject Exposure Without Identified Safety Signals Across ALS, MS, and PD Clean Toxicology Well Tolerated Patient Exposure Across Findings ‘Adverse Event (AE) Profile ALS, MS & PD All Animal Toxicology sulted in as Predominantly Mild-to Effect Level (NOAEL) of SU Expo: thou Identif
Slide 29: Clene | CNM-Au8 Path to Regulatory Approval
Clene | CNM-Au8 Path to Regulatory Approval MID-2023 2024 MID-2024 i L 1 La rr) > cLene
Slide 30: Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases
Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases Strong IP: 150+ HEALEY ALS — x» . pctene
Slide 31: Clene Nanomedicine
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