Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (March 2023)
29 slides from Clene's investor presentation, Mar 6, 2023
Slide 1: Clene
> cLene NASDAQ: CLNN clene.com
Slide 2: Forward Looking Statements
Forward Looking Statements ‘Tis presentation cota fernadocirg statements win the meaning of Sein 21 the Sete xchange et of 93,05 amend, and Secon 27a the Sets Ae of 293, 98 nde whch re tended tobe coed by he “ae htko prone ested by thor ns Ces ears statements nce, bt ate at ies, tere regal te “rourm
Slide 3: Building the Clinical Case for Neuroprotection & Remyelination
Building the Clinical Case for Neuroprotection & Remyelination VISIONARY-MS. in Jeath of relapsing adjunct to immunomodulatory DMTs nefit of 60% of death
Slide 4: Neurodegenerative Diseases Share A Common Mechanism
Neurodegenerative iseases Share A Common Mechanism: A Decline In The Brain’s Ability To Produce Energy Brain Energy Potential Declines With Normal Aging. ‘Specific Neuronal Populations Are Vulnerable to Energetic Failure Dopomineri Neurons SCLEROSIS FRONTOTENPORAL ‘onal Degeneration ping teurons HUN
Slide 5: CNM-Au8 | Pioneering A New Drug Class To Improve Cellular Energy Production And Utilization
CNM-Au8® | Pioneering A New Drug Class To Improve Cellular Energy Production And Utilization cNM-Aus Frarcec or oeem Improved Energy Production and Nanocrystals Utilization Clan site, ested - £ Increased NAD Increased ATP / Decreased reactive ‘oxygen species fl Increased proteostasis Soenson pctene
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 Sclerosis (MS) Disease (PD) Fee || eo NO GOB... = NDE $B” (f) cunt drs ae tase Gp \ exsing treatments ony CE Inetective, monty gente [0 ‘sroctmmanomadsiaton LiWMS,.2S pctene
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 jemonstrated a po! |ADH ratio, an al moleci Study Objective: to demonstrate target engagement for CNM-AuB on CNS blomatkers related to energetic effects in 1° Endpoint e
Slide 8: RESCUE-ALS
it RESCUE Study Objective: Detect J tte preservation of motor neuron function in people eam with early ALS as measured [Aula by MUNIX ‘i 36-week blinded treatment with ongoing long-term open-label follow-up Encouraging Efficacy Signals in Phase 2 Trial 1° & 2° Endpoints eseve AL Primary & Secondary
Slide 9: RESCUE-ALS: CNM-Au8 Improved Patient Function, QOL, and Slowed Time to ALS Clinical Worsening
& 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=45 enrolled with eatly Als Proportion with <6 ALS Specific QOL, ALS Clinical Worsening point decline AS0ieu
Slide 10: RESCUE-ALS OLE | Preserved ALSFRS-R Functional Decline
ft RESCUE! OLE | Preserved ALSFRS-R Functional Decline Early CNM-Au8 Treatment Impacts Long-Term Function Compared to Original Placebo ALSFRS- Slope ALSFRS-R Slope ALSERS-R Slope Baseline to Week 48, Week 60 [OLE Week 24] to Week 120 ‘Summary. re A SRNR u [mcs | i reno + CNM-Au8 preserved functional
Slide 11: RESCUE-ALS OLE | Decreased ALS Time to Clinical Worsening
8% RESCUE\\S OLE | Decreased ALS Time to Cl ical Worsening Rescue-ALS OLE Disease Progression Events Proportion Event Free by Study Visit (14-July-2022 Data Cut) Kaplan-Meier Analyses Hazard ratio= 0478 95% Wald Cl= 0.22510 1.015 Loprank, p= 0.0498 The risk of ALS clinical wor: decreased ~50% for CN
Slide 12: RESCUE-ALS Demonstrated Significant Impact on Long-Term Survival
Ab RESCUE « Demonstrated Significant Impact on Long-Term Sui Decreased Risk of Death through 120 weeks Long-Term Survival (Al-Cause Morality Originally Randomized Active vs Placebo Intrim Aras (14-Jul-2022, Population, Al Subjects rom Randomization "Lengtom via Sus sug a sy wincaa). Early CNM-Au8 tr
Slide 13: 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 Registration Study: 24-Week Treatment Period (3:1 ra
Slide 14: Survival Signal | >90% Reduced Risk of Death with 30mg
Survival Signal | >90% Reduced Risk of Death with 30mg Shared Placebo Across Regimens ‘Cn. Somg Survival | Adjusted Cox Proportional Hazard uit Sel (A Stare Paco, Regent A, 8, C, 0). Sila Reduson nook 26 (1- Maer Rate, 0 Cotes herve Pann) +| Pre a2] ora, HEALEY ALS Platform Trial (CNIM-Au8 Regimen O
Slide 15: CNM-Au8 Has Demonstrated ALS Survival Benefit in Two Phase 2 Studies
CNM-Au8 Has Demonstrated ALS Survival Benefit at 30 mg Dose in Two Phase 2 Studies fe LSC RGLE SEE Gi) ENRAMARE >90% risk reduction of (6 RESCUEA| death through 120 BERCTUMUEI death at 24 weeks Longs su cam oa cm. 2g utd Cox Propet arte Cen "inst nestor ‘tere (tt aa ae 8 St * 2 ag i we eal PAN as +
Slide 16: 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 Participants with Any TEAE 92% 93% Participants with Related TEAEs 29% 43% Participants with SAE 10% 16% Participants with Related SAEs 0% 0% | Participants Wi
Slide 17: VISIONARY-MS Core Design Elements
—_ VISION. IARY-MS Core Design Elements sTuoy Phase 2 Study: 48-Week Placebo-Control Treatment Period 2:1 Randomization (Active [15mg, 30 mg]: Placebo) secon) DO: "a: a2 e ‘oa 30 36 “42 9-+1-0-0——_@—_0—_@ 0 0. * Enrolled stable relapsing remitting MS participants with chronic optic neuropathy on bac
Slide 18: Baseline Demographics and Study Analysis
Baseline Demograp! s and Study Analysis * All participants diagnosed with stable relapsing remitting MS with chronic optic neuropathy * 92% treated with background DMTs (inc 53% monoclonal antibodies, 32% oral) + Modified ITT (mITT) Analysis Population )VISIONARY- “CNM-AuB 25 mg 384 3) 780 1.83 65 5
Slide 19: 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 Significantly Improved Vision {change in tow Contrast Letter Acuity (LCLA) LOLA changain the Acts Eve ‘mit tS ean = Se Wesk4aLeaMean tron = 218 96% Ci 00810833 = 0086 salen change rom Barlne G
Slide 20: VISIONARY-MS Advanced MRI Techniques
@VISIONARY-MS Advanced MRI Techniques Diffusion Tensor Imaging (DTI) changes VISIONARY-MS Measures of Axonal Integrity tind }| j ie | hoy Vey! q ve a ‘What Happens in the Visual System Happens ‘Throughout the MS Brain 2» ame pctene
Slide 21: CNM-Au8 Improved Information Signal in the Visual Pathway
@VISIONARY-MS CNM-Au8 Improved Information Signal in the Visual Pathway Increased Amplitude (Signal Strength) From the Eye tothe Brain's gy Visual Cortex i é > Paco aed Ee oo CNM ALA alow Be “Paco Fetow Ee Woots (Post Rando) YEP Aoctd y0Oned at Longe any at Gatlne mctene
Slide 22: CNM-Au8 Preserved White Matter Integrity Throughout the Brain
IONARY-MS CNM-Au8 Preserved White Matter Integrity Throughout the @v! Brain Preserved Whole Brain White Matter Integrity Consistent Effect Across All Brain Regions ition Tensor imaging | Fractional Anisotropy (FA) Change on eas aig Fractal nctony FA) "nol Grain (Cereb) ITT Population, LS Mean » SEM
Slide 23: Summary | Consistent Paraclinical Evidence of Neuroprotective Effects
Summary | Consistent Paraclinical Evidence of Neuroprotective Effects Favoring CNM-Au8 Treatment Paraclinical Paraclinical Measure ae <a a Endpoint Ls Mean Change — Week 48 sale at can wine wb rain (aera ps 00309 Dison Tensor Improvementsof _Newopretectionand presenation Imaging (OT) ane cooug — otl
Slide 24: VISIONARY-MS Safety Summary
VISIONARY-MS Safety Summary @VISIONARY-MS: CNM-Au8 treatment was safe and well-tolerated - Treatment emergent adverse events (TEAEs) were transient and predominantly mild-to-moderate - No dose limiting adverse events; no related serious adverse events Treatment Emergent Adver: (TEAEs) Subjects with
Slide 25: CNM-Au8 is Consistently Favored for Treatment of MS
CNM-Au8 is Consistently Favored for Treatment of MS Progression Independent of an Immunomodulatory Effect JONARY-MS ‘* MS patients continue to progress with increasing cognitive and functional Significant Opportunity deficits accumulating even while receiving disease-modifying therapies—a significan
Slide 26: Over Years of Subject Exposure Without Identified Safety Signals
Over 400 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 Studies Assessed Resulted in as Predominantly Mild-to- ee Findings and Tran: sah
Slide 27: Growing Body of Evidence for CNM-Au8
Growing Body of Evidence for CNM-Au8° Amyotrophic fer ALS) Parkinsons Disease (PD) 7} aon ama ao lestones cayeuaeal cists “ites pe ase Sere ‘commenter bctene
Slide 28: Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases
Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases [avisionary-Ms } « “4 Strong I 150+ ranothera is RESCUE Pattoren Tra pctene
Slide 29: Clene
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