Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (February 2023)
27 slides from Clene's investor presentation, Feb 27, 2023
Slide 1: Clene
> cLene NASDAQ: CLNN clene.com £4
Slide 2: Forward Looking Statements
Forward Looking Statements ‘Ths presematoncortans “ornardeoig statements within the meni of Section 21C ofthe Sects Exchange Ac 138,08 ened, and Section 27 the Secues e of 193338 amended, whchte intended tobe ovred by the “ae harbor” provers rated bytes an. Clee’ frward ong terns inde but fe a std s
Slide 3: Building the Clinical Case for Neuroprotection
Building the Clinical Case for Neuroprotection & NM-Au8 demonstrated sblished brain ; statistically significant val benefit of 60: sed risk of death through 120 wk: Growing Body of Clinic etary Nanotherapeutic Man Strong IP: 150+ granted pat yor ts PLUS Remyelination @VISIONARY-MS CNM-Au8 demonstrat
Slide 4: Neurodegenerative Diseases Share A Common Mechanism: Decline In Brain Energy Production
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 opominerpc Neurons utr SCLEROSIS oot 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 IMechianlantc ettects Improved Energy Production and Nanocrystals Utilization ten Sra, High Feed shapes Increased NAD 4 ~ Increased ATP \ => = | Decreased reactive EI oxygen species \ y ome Increased
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 Parkinsons Disease ss2... Sclerosis (MS) Disease (PD) IOUS = MOSM... MES SBsse Co. pair, ( P seme us 28 mctene
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 nstrated a potentially meaningfi NAD+/NADH ratio, an essential molecule for ens Study Objective: to demonstrate target engagement for CNM-Au on CNS biomarkers related to
Slide 8: RESCUE | Encouraging Efficacy Signals in Phase 2 Trial
6 RESCUE » Encouraging Efficacy Signals in Phase 2 Trial 1° & 2° Endpoints Study Objective: Detect cast ry eed Ee preservation of motor oon : ‘cro neuron function in people | ca with early ALS as measured by MUNIX Studi 1 ne dy Design: ee paver er 36-week blinded treatment | with ongoing long-term a
Slide 9: RESCUE CNM-Au8 Improved Patient Function, QOL, and Slowed ALS Disease Progression
& RESCUE CNM-Au8 Improved Patient Function, QOL, and Slowed ALS Disease Progression Phase 2 Study: 36-Week Placebo-Control Treatment Period 1:1 Randomization (Active 30 mg: Placebo); N=45 enrolled with early Als Proportion with <5 ALS Specie QOL AS Disease Progression point dectine 215 ana ration ne
Slide 10: RESCUE Demonstrated Significant Impact on Long-Term Survival
ts rescue Demonstrated Significant Impact on Long-Term Survival 60% Decreased Risk of Death through 120 weeks a oer nstrated a : : af 1 : vaca rate: o4oe |. E me peo eeepc fl. mteeeeeoeeremet 22 =e eeeiene tpi Pe EEE EE EE Eokn —————— — pega mctene
Slide 11: 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 12: Survival Signal | Reduced Risk of Death with 30mg
Survival Signal | >90% Reduced Risk of Death with 30mg Shared Placebo Across Regimens ‘CNM-Au8 30mg Survival | Adjusted Cox Proportional Hazard Ful Anaiyss Sel (Al Shred Placebo Regimens A,B,C, D) Sy Hazard Reduction at Wook 26 (1 -Hazard Rat, 85% Contnce ioral) est oe nat» cepa (PA So & ov wo HEALE
Slide 13: 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 60% decreased risk of HEALEY ALS isk reduction of AM RESCUE death through 120 MRAM cath at 30mg at 24 weeks ei afl poveah TO etponsecinaney anc emt), Ramen ~ me 7 onome a a pcvene
Slide 14: 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 Treatment Emer Adverse Event Participants with Any TEAE CNM-Au8 30 me, CNM-Au8 60 mg [ | Participants with Related TEAEs | 39% 34% 29% 43% Partic : ae amy
Slide 15: VISIONARY-MS Core Design Elements
VISIONARY-MS Core Design Elements Phase 2 Study: 48-Week Placebo-Contro!Treatment Period. Randomization (Active [15mg, 30 mg]: Placebo) Serenng DO "EER GEE 0-+/+-0-O—_@—_o—__@—_0—_@—_0—_@ 2 = * Enrolled stable relapsing remitting MS participants with chronic optic neuropathy on background DMT 1=73 o
Slide 16: Baseline Demographics and Study Analysis
Baseline Demographics 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) M od ITT (mITT) Analysis Population @VISIONARY-| | CNM-Au8 15 mg (n=24) | CNM-Au8 30 mg,
Slide 17: CNM-Au8 Demonstrated Vision and Global Neurological Improvement in Stable MS
CNM-Au8 Demonstrated Vision and Global QVISIONARY Neurological Improvement in Stable MS patients on DMTs 4) Significantly improved Vision ina | Improvement o, ry = ah 4. ‘change in modified Ms Functional Composite (mMSFC) {Change in Low Contrast Letter Acuity (LCLA) LCLA Change inthe Aocted Eye {CLA
Slide 18: VISIONARY-MS Measures of Axonal Integrity
@VISIONARY-MS VISIONARY-MS Measures of Axonal Integrity 1. Visual Evoked Potentials (VEP) 2. Advanced MRI Techniques Multi-focal Amplitude and Latency Changes Diffusion Tensor Imaging (OT!) changes Fractional Angotropy Brain Ditfsivity ‘What Happens in the Visual System Happens Throughout the MS Bra
Slide 19: CNM-Au8 Improved Signal in the Visual Pathway
CNM-Au8 Improved Signal in the Visual Pathway QUISIONARY NS ‘mf-VEP Mean Amplitude Percent (%) Change ITT Population, LS Mean = SEM, Segments Nesod by Partpant VER Atctd Eye VEP Fetow Eye Increased Amplitude (Signal Strength) From the Eye to the Brain's Ht = Visual Cortex oy . © Pesto os] © CMAs ate
Slide 20: 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 PEEEEEEES mctene
Slide 21: Summary | Consistent Paraclinical Evidence of Neuroprotective Effect
Summary | Consistent Paraclinical Evidence of Neuroprotective Effect Favoring CNM-Au8 Treatment Metti — A nthin total Corebral White Matter Diffusion Tensor Imaging (DTI) ra within the whole brain Cavebru measure of Fractional "*wthn tte whol brain (cerebrum) ‘Anisotropy (FA) FA win total Cerebral N
Slide 22: VISIONARY-MS Safety Summary
VISIONARY-MS Safety Summary @VISIONARY-| 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 Adverse Events CNM-Aug CNM-AuB
Slide 23: CNM-Au8 Consistently Favors Treatment of MS Progression
ISIONARY-MS CNM-Au8 Consistently Favors Treatment of MS Progression Independent of an Immunomodulatory Effect ‘+ MS patients continue to progress with increasing cognitive and functional Garonne deficits accumulating even while receiving disease-modifying therapies—a significant unmet medical need *
Slide 24: Years of Subject Exposure Without Identified Safety Signals Across ALS, MS, and PD
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 Animal To: BY eS 2 ed 400 Years of S Resulted in as Predominantly Mild-to A rave Effect Level (NOAEL) M
Slide 25: Growing Body of Evidence for CNM-Au8
Growing Body of Evidence for CNM-Au8° Key Findings Amyotrophic ‘ona is (ALS) PEASY ALS Yar Somat “ity ‘snes Parkinsons Disease (PD) mctene
Slide 26: Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases
Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases [evisionary-s yl « D | strong i: pctene
Slide 27: Clene Nanomedicine
> cLene J=— NANOMEDICINE