Clene Inc. · NASDAQ:CLNN
Clene — Investor Presentation (November 2024)
30 slides from Clene's investor presentation, Nov 13, 2024
Slide 1: Clene
> cLene NASDAQ: CLNN clene.com a |
Slide 2: Forward Looking Statements
Forward Looking Statements “hs preseraion cota “orerd long sateen win the mening Seton 23 othe Saute Echang At 1934 a amended nd Seton 27A the Secure Ac of 232, amended whch ate tended ob covered bythe “sal harbor prvstons tated by those a, Clr’ rar olig statement nclae, but re at iret slaterets eri
Slide 3: The Problem / A New Approach
THE PROBLEM + inneurodegeneratve deste, impated mitochondrial sine —7 A NEW APPROACH + Clene's pioneering catalytic nanotherapetiso teat pctene
Slide 4: Building the Clinical Case for Neuroprotection & Remyelination
Building the Clinical Case for Neuroprotection & Remyelination | assess (Q)) | Gree \ J \ Growing Body of Clinical Evidence Across ALS and MS Support Au8 Therapeutic Potential to Treat ative Disea: y Nanotherapeutic Manufacturing nted patents PLUS Trade Secrets Strong IP: 150+ gr ‘ wares pcvene
Slide 5: CNM-Au8 | Surface Catalysis Improves Mitochondrial Function
CNM-Au8?® | Surface Catalysis Improves Mitochondrial Function MITOCHONDRIAL NEURONAL SURVIVAL FUNCTION “AND FUNCTION NAD+ > > ; = “ (CNM-Au8 Nanocrystal Catalysis mctene
Slide 6: Over 700 Years of Subject Exposure Without Identified Safety Signals
Over 700 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 ance Over 700 Years of Subject as Predominantly Mild-to: Exposure Without Moderate Severity Eee Findin
Slide 7: Promising Evidence from Two Phase 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 IEALEY ALS saetorm Trl ts RESCUE ALS Patient Earlyto-Mid-Stage — csiveo.nigstage Mid-to-tate-Stage are Demographics (4s) Een e MESO | ist negmenc)) || Meini
Slide 8: CNM-Au8 | Clinical Worsening Concordant in Two Phase Trials
CNM-Au8 | Clinical Worsening Concordant in Two Phase 2 Trials Evidence for Decreased Clinical Worsening Events Across Two Phase 2 Studies ‘Time to Clinical Worsening | CNM-Au8 30mg Fst Occurence of Death, PAY, THacheostomy or Feeling Tube HEALEY ALS Pato Til | Kapaneor Esra Regier ¢Popton acy Regen
Slide 9: CNM-Au8 | ALS Survival at 30mg Concordant in Two Phase Trials
CNM-Au8 | ALS Survival at 30mg Concordant in Two Phase 2 Trials Ak RESCUE Bistiorm tral Unadjusted Survival seta omeee vo dant en ie Suri During Binds Period soci SEES venga ieee a paca mctene
Slide 10: CNM-Au8 30mg Treatment Improved Long-Term Survival vs. PRO-ACT/MINDAUS
CNM-Au8 30mg Treatment Improved Long-Term Survival vs. Propedpitypcut Matched PRO-ACT & MiNDAUS (Australian) Controls PRO-ACT Controls MINDAUS Controls ‘CNM. Au 30m Long Term Survival] RESCUE-ALS Tal ‘ia is a ain CNM Aus Randoszedfe23an ex Pac to CNM AS (6) ‘ain GN Aus endorsed rea aoe Pacebo CNM Aa
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-Aus in Participants with Amyotrophic Lateral Sclerosis 24-Week Treatment Period (3:1 randomization, 120 act
Slide 12: Survival Signal | >90% Reduced Risk of Death HEALEY ALS
Survival Signal | >90% Reduced Risk of Death HEALEY ALS with CNM-Au8 30mg Shared Placebo Across Regimens CNM-Au8 Regimen Only (Regimen C) ‘CNM. Aut 90mg Survival] Adjusted Cox Proportional Hazard ui valyss Sut(A Shred Paco, Ropers. 8,©. 0). ‘Stitzar Rectan at Wook 20 (1- Haead Ratio, 98% Condence Ia
Slide 13: Delayed Time to ALS Clinical Worsening
Delayed Time to ALS Clinical Worsening Leonia CNM-Au8 30mg | Within Regimen Analysis (Primary Model) ‘Time to Clinical Worsening | CNM-Au8 30mg First Occurence of Death, PAV, Tracheostomy or Feeding Tube HEALEY ALS Platform Tral | Kaplan-Meier Estimate Regimen C Population, Efficacy Regimen Only ‘CN
Slide 14: Origination of NfL in Bloodstream
Origination of NfL in Bloodstream t t Neurofilament Proteins + Cytoskeletal proteins highly S = specific for neurons. Pak 2 SOS Ve + Comprising 85% of neuronal pane) \ structural proteins. te a — * Determine axon diameter. on < t= = INN Sy p * Any disorder/disease shows NfL C ( damage. Neurofilament
Slide 15: Continued Long Term Plasma NfL Decline in the OLE
Continued Long Term Plasma NfL Decline in the OLE 76-Weeks post baseline MMRM (CNM-Au8 30mg) LS Geometric Mean Ratio “charge tom Bessie (CNM-Aus 30mg Plasma N/L Geometric Mean Change [RGC Within Regimen Analys | Long Term Extension | Quanterix 4NPA ‘Al Evauable wih Basoino,n=90, LS Goomete Mean Dife
Slide 16: Validation of NfL Association with Clinical Outcomes
Validation of NfL Association with Clinical Outcomes Post Hoc | Clinical Worsening Event (Average Events per Patient per Group) Clinical Worsening Events Frequency is Associated with Higher Baseline [NFL Responder Analyses in Participants with a NFL Decline of 25% (Post- ‘Nfl. Levels (by Quartile) B
Slide 17: CNM-Au8 NfL Responders Demonstrated Robust NfL Declines
CNM-Au8 NfL Responders Demonstrated Robust NfL Declines Beton Sn NFL Decline by Participant NIL Decline Across Responders (cnet Buin #900," “PON. Responder Inde at CANA mg and mg cia rndomized patpans wh content and uted NA doles mctene
Slide 18: CNM-Au8 NfL Responders Showed Slowed ALSFRS-R Decline
CNM-Au8 NfL Responders Showed Slowed ALSFRS-R Decline Siettorm tat NFL Responders vs. NfL Non-Responders ALSFRS-R Decline ALSERS-R Respiratory Subdomain ‘Long-Tem ALSERS-A Respiratory Subscore Change by NL Responder Stats THEATEY ALS Pato al ACh wate Coven ft 6 12) ‘ha. Para i feeporauhon Fg iat lor
Slide 19: CNM-Au8 30mg Treatment Improved Long-Term Survival vs. PRO-ACT/NHC
CNM-Au8 30mg Treatment Improved Long-Term Survival vs. Pro| ween Matched PRO-ACT & NHC Controls PRO-ACT Controls Natural History Consortium Controls ‘CRIA 20 mg Lang Term Sura HEALEY ALS Pato a ‘rail NALS = an ex Placebo to CNMALS fo) (A sg (= 70 ws PRO-ACT Property Matched Carl 322) ‘oN Au dog vs.
Slide 20: EAP Participant Enrollment
EAP Participant Enrollment * AILEAP participants (CNM-Au8 30mg) enrolled through 15-December-2023 with EDC data entry + Survival updated through the 14-January-2024 data cut £8901 in eolaboration wih the: EAPOL Healey Center (GH) The Healey center covered I “est | alls costs and eC Dhlamthropie dona
Slide 21: EAP Survival vs. ALS Natural History and PRO-ACT
EAP Survival vs. ALS Natural History and PRO-ACT Abs. Matched Controls | Control-Matched EAP and All EAP ALS Natural History Study | EAP Matched (n=220) PRO-ACT | EAP Matched (n=220) EAP Long-Term Sri PRO-ACT Propet Maced Cros ‘EAP Parca wh Basins Covert 22 to “Tato arCae ray . [" sn] |cnomwag monn
Slide 22: VISIONARY-MS Core Design Elements
VISIONARY-MS Core Design Elements Phase 2 Study: 48-Week Placebo-Control Treatment Period. Randomization (Active [15mg, 30 mal: Placebo) Serenng DO "EE GEE 0-+/-0-0—_@—_0—_@ 0 —_@ 0 4 = * Enrolled stable relapsing remitting MS participants with chronic optic neuropathy on background OMTS + 92% treat
Slide 23: CNM-Au8 Demonstrated Vision and Global Neurological Improvement
CNM-Au8 Demonstrated Vision and Global @VISIONARY-MS Neurological Improvement in Stable MS patients on DMTs Significantly Improved Vision (aioe Global Neurological amare ‘change in ow Contrast Letter Acuity (UCLA) change in madifid MS Functional Composite (mMSFC) LOLAChange nthe Aoi LOLA sect eo, HE
Slide 24: Long-Term LCLA Improvement in LTE Participants
Long-Term LCLA Improvement in LTE Participants QUISIONARY TS Low Contrast Letter Acuity Original Active (CNM-AU8) Original Placebo Leni LCUA| Change rom Basen tl Creel oth Eye) /AActve Longin LcLA| Change rom Baseine (Tota Corel, Both yes) LTE Pacers OnpatyRncorze eM m5 mT Papen InLTE Portspons Orge
Slide 25: CNM-Au8 Improved Information Signal Strength & Speed
CNM-Au8 Improved Information Signal Strength & Speed in the Visual Pathway @VISIONARY-MS Improved Amplitude Improved Latency Longa wee ge nb ange ate Longa Pec Change m oenaignSiage Seaman cena enn — mureninne ett ae Serta Seams To, eee Serbo me a ‘Reser on rn So SO remo i = i ‘Amplitude = Signal St
Slide 26: Long-Term SDMT Improvement in LTE Participants
Long-Term SDMT Improvement in LTE Participants @VISIONARY-MS Symbol Digit Modality Test | Working Memory & Cognition Original Active (CNM-Au8) Longitudinal SOMT | Change rom Baseline (Total Score) | AN Active ‘nLTE ParicpontsOrgeay Rarcoized io CNMEAGS (05) ITT Popltion {US Mean = SEM, Change rom Ba
Slide 27: CNM-Au8 Treatment Demonstrated MS Lesion Repair
CNM-Au8 Treatment Demonstrated MS Lesion Repair @VISIONARY-MS and Promoted Remyelination 2 Lesion Myelin Water Fraction 2 Lesion Axial Diffusivity (Remyelination) (Axonal integrity) ‘Cuno 2 Laan yan Wate Faction nn Cartan suger ee Per . >" tlene
Slide 28: Clene | CNM-Au8 Path to Regulatory Approval
Clene | CNM-Au8 Path to Regulatory Approval (2024 ID 4088 fete mctene
Slide 29: Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases
Evidence Supports CNM-Au8 Therapeutic Potential to Treat Neurodegenerative Diseases CNM-Au8” Fevisionaerusy x fist pctene
Slide 30: Clene Nanomedicine
> cLene p= NANOMEDICINE