CervoMed Inc. · NASDAQ:CRVO
CervoMed — EIP Pharma — Merger or Acquisition (March 2023)
25 slides from CervoMed's merger presentation, Mar 30, 2023
Slide 1: Corporate Presentation
Corporate Presentation March 30th 2023 0
Slide 2: No Offer or Solicitation
No Offer or Solicitation This communication does not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful pr
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, but not
Slide 4: EIP Pharma at a Glance
EIP Pharma at a Glance Late Clinical Stage Differentiated approach to age-related neurologic disorders with a late-stage CNS Company lead clinical asset; pipeline of additional indications and second asset Phase 2b Ready Neflamapimod has the potential to be the first disease-modifying treatment for
Slide 5: Opportunity for Therapeutics Targeting Basal Forebrain Cholinergic Degeneration
Opportunity for Therapeutics Targeting Basal Forebrain Cholinergic Degeneration • Age-related degeneration of the basal Basal Forebrain forebrain cholinergic system plays major role in many neurologic disorders: – Dementia with Lewy bodies (DLB), where it is the primary pathology – Early stages of A
Slide 6: EIP Pharma Pipeline
EIP Pharma Pipeline EIP Comm. PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Rights NEFLAMAPIMOD Dementia with Lewy WW ENTERING PHASE 2B bodies* Recovery after Anterior PHASE 2 READY WW Circulation Ischemic Stroke Early-onset Alzheimer’s PHASE 2 READY WW Disease (EOAD) EIP200 (novel co-crystal) Multiple CNS WW
Slide 7: Dementia with Lewy Bodies (DLB)
Dementia with Lewy Bodies (DLB) What is DLB? Affects ~1.4 million individuals in • Disease associated with abnormal deposits of a protein called alpha-synuclein in the brain. These deposits, called Lewy bodies, affect chemicals in the brain the US and EU whose changes, in turn, can lead to problems
Slide 8: Neflamapimod for DLB: Well-Positioned Commercially
Neflamapimod for DLB: Well-Positioned Commercially Approximately Significant Patient 700,000 in each of Numbers US & EU Diagnosed and managed Growth in Increasing awareness by neurologists Specialist Disease >$5B US Peak Diagnosis Rates of disease Sales for the First to Market Relative to AD: • Grea
Slide 9: Neflamapimod: Background
Neflamapimod: Background • Potent, highly selective, blood-brain-barrier penetrant oral small molecule inhibitor of p38α • Licensed in 2014 from Vertex Pharmaceuticals, which had: – Discovered the compound utilizing their proprietary structure-based drug discovery platform – Completed chronic repeat
Slide 10: Robust Preclinical Pharmacology Package
Robust Preclinical Pharmacology Package In Ts2 mice 4 weeks neflamapimod In Vitro treatment reverses neurodegenerative process in the basal forebrain and Demonstrated potent effects, with IC50 restores functional deficits (Nat. between 20nM and 30nM Communications, 2022) In Vivo • Reverses Rab5+ end
Slide 11: Neflamapimod Reverses Cholinergic Dysfunction and Degeneration
Neflamapimod Reverses Cholinergic Dysfunction and Degeneration Cholinergic neurons in basal forebrain Ts2 mice Down Syndrome transgenic mouse model Develop adult-onset basal forebrain cholinergic degeneration Treated with vehicle or 3 mg/kg NFMD BID x 28 days Reversed basal forebrain cholinerg
Slide 12: Neflamapimod Appears to Reverse Basal Forebrain Atrophy, assessed by MRI
Neflamapimod Appears to Reverse Basal Forebrain Atrophy, assessed by MRI Neflamapimod treatment is associated with increased basal forebrain volume and functional connectivity 15 Early AD patients treated with neflamapimod NbM – Nucleus basalis of Meynert, largest cluster of cholinergic neurons in t
Slide 13: Neflamapimod: Development Status
Neflamapimod: Development Status • Completed long-term toxicology studies in two species Toxicology • At 40 mg thrice daily in humans greater than 10-fold safety margin to no-adverse- event level in long-term animal toxicity studies • Simple 3-step drug synthesis process CMC • Phase 3 ready drug sub
Slide 14: Target Engagement: Neflamapimod Reduces CSF tau levels in Early AD
Target Engagement: Neflamapimod Reduces Cerebrospinal fluid (CSF) tau levels in patients with Early AD In preclinical studies, inhibition of p38α reduces Clinical Trial Results with Neflamapimod tau phosphorylation and aggregation 161 Randomized 83 Placebo 78 Neflamapimod Change from baseline (pg/mL
Slide 15: Phase 2a Exploratory Clinical Study in Dementia with Lewy Bodies
Phase 2a Exploratory Clinical Study in Dementia with Lewy Bodies (DLB) Outcome Measures Patients • DLB-specific • Mild-to-Moderate DLB by Neuropsychological Test consensus criteria Battery (NTB, a cognitive test (McKeith, Neurology, 2017) battery) • Abnormal dopamine uptake 16-WEEK TREATMENT, DOUBLE
Slide 16: AscenD-LB Outcome Measures
AscenD-LB Outcome Measures *DLB-specific cognitive test battery designed to assess attention, executive function and visual learning NTB composite: results of all six tests combined into single z-score Attention composite: Detection and Identification tests combined into single z-score Nature Commun
Slide 17: AscenD-LB Efficacy Results
AscenD-LB Efficacy Results • Clinically relevant positive Comparison of all neflamapimod effects of 40 mg TID (40mg BID and 40mg TID) with neflamapimod on multiple Comparison of neflamapimod 40mg TID placebo aspects of mild-to-moderate with placebo DLB: Drug-Placebo Drug-Placebo Difference On- Diffe
Slide 18: Biomarker Results Support Enrichment Strategy for Future Trials
Biomarker Results Support Enrichment Strategy for Future Trials • 35-50% of patients with DLB have biomarker evidence of Alzheimer’s Effect Size at 40mg TID in patients disease (AD) with plasma ptau181 below cut-off – Represent patients with extensive neurodegeneration (neuronal loss) in the NTB 0.5
Slide 19: Learnings from Phase 2a Study That Enhance Probability of Success in Phase 2b
Learnings from Phase 2a Study That Enhance Probability of Success in Phase 2b • Optimal dose is 40mg TID • Clinical endpoints that can detect effects on both cognitive and motor function (specifically, CDR-SB and TUG) perform better than endpoints that are purely focused on evaluating cognition – In
Slide 20: Phase 2b Confirmatory Study in DLB Protocol EIP21-NFD-504
Phase 2b Confirmatory Study in DLB Protocol EIP21-NFD-504 Outcome Measures Patients • 1º: CDR-Sum of Boxes • DLB by consensus criteria • 2º: Cognition assessed by (McKeith, Neurology, 16-WEEK TREATMENT, DOUBLE-BLIND DLB-specific 2017) NFMD 40 mg TID or placebo, daily Neuropsychological Test Battery
Slide 21: Potential to Broaden Opportunity
Potential to Broaden Opportunity • Additional indications in which dysfunction or degeneration of basal forebrain cholinergic system plays major pathogenic role: – Functional recovery after anterior circulation ischemic stroke – Alzheimer’s disease (AD): Early-onset AD (EOAD) or Late Onset AD (in co
Slide 22: Leadership Team
Leadership Team John Alam, MD Kelly Blackburn President, CEO & Co-Founder VP, Clinical Development Sylvie Gregoire, PharmD Darryl Patrick, DVM, PhD Executive Chair & Co-Founder VP, Non-Clinical Development William Tanner, PhD Chief Financial Officer Board of • • Sylvie Grégoire, PharmD: Executive Ch
Slide 23: Key Upcoming Anticipated Milestones/Catalysts
Key Upcoming Anticipated Milestones/Catalysts 1H 2023 2H 2023 2024 NIA approves $21M grant for Close merger transaction; Complete enrollment in Phase Phase 2b begin trading as a public 2b DLB study (1H) company (mid-year) Signed merger agreement Report data from placebo- with Diffusion Pha
Slide 24: Summary
Summary Differentiated Approach to Age-related Neurologic Disorders with a Late-Stage Asset Major value creation potential in phase 2b read-out in dementia with Lewy bodies EIP Experienced Management Team and Board of Directors Pharma Potential to broaden opportunity through additional indications a
Slide 25: Thank you
Thank you 24