Medicines for the Brain
December 20th, 2023
Corporate Overview
cerveau (sair-voh), noun, in French for brain or mind
NASDAQ: CRVO
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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 the intentions, plans, beliefs, expectations or forecasts for the future of CervoMed Inc. (the "Company"), including, but not limited to: the therapeutic potential of neflamapimod; anticipated milestones related to the Company's clinical development programs, including timelines for trial enrollment and reporting of data; the potential therapeutic value of neflamapimod; the Company's anticipated cash runway; and the potential commercial opportunity of neflamapimod, if approved. Terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately," "potential" or other words that convey uncertainty of future events or outcomes may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company's control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company's available cash resources and the availability of additional funds on acceptable terms; the Company's ability to design, initiate, enroll, execute, and complete its planned studies evaluating neflamapimod; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the U.S. Food and Drug Administration; the Company's ability to maintain its listing on the Nasdaq Capital Market, as well as comply with applicable Nasdaq rules and regulations; the market price of the Company's securities, which may be volatile due to a variety of factors, including changes in the competitive and highly regulated industry in which the Company operates; variations in operating performance across competitors; changes in laws and regulations affecting the Company's business; the Company's ability to remediate its previously disclosed material weaknesses in its internal controls over financial reporting in a timely manner; the Company's ability to successfully integrate the historical businesses of EIP and Diffusion and realize the anticipated benefits of the recent merger; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts, including the continued availability of funding for the U.S. federal government to support disbursements under the Company's grant from the National Institute on Aging; and the other factors discussed under the heading "Risk Factors" in the Company's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission ("SEC") on November 13, 2023, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this presentation speak as of November 13, 2023 (or such earlier date as may be identified) and the Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after this date, except to the extent required by law.
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CervoMed at a Glance
Late Clinical Stage
CNS Company
Attractive Commercial Opportunity in Dementia with Lewy bodies (DLB)
First-to-market Potential in DLB
Phase 2b Clinical Study Optimally Designed and Fully Funded
Multiple Value-Driving
Milestones Through 2024
Targeting synaptic dysfunction to treat age-related neurologic disorders; modulating drivers of the neurodegenerative
process including neuronal stress and inflammatory pathways
Major neurologic indication with 1.4M patients in the US and EU; >$3B US peak sales opportunity
Neflamapimod granted Fast Track designation by FDA and is poised to be the first to market treatment for DLB; positive
phase 2a data published in Nature Communications and in Neurology
Well-powered trial, stratified to identify patients mostly likely to benefit from neflamapimod further supports development success, optimizes path to market and reduces overall cost; awarded $21M grant from the NIH's National Institute on Aging (NIA) which will fully fund ongoing Phase 2b study1
First patient dosed in 160-patient Phase 2b DLB clinical study August'23; plans to complete enrollment in 1H24
and report primary efficacy results2 in 2H24
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1. The NIA grant funds will be disbursed over the course of study as costs are incurred. 2. Evaluated at the End of 16-weekplacebo-controlled portion of the study
Experienced Leadership Team
John Alam, MD
President, CEO & Co-Founder, Director
Former Chief Medical Officer and EVP Medicines Development, Vertex
Former Global Head Alzheimer's R&D at Sanofi
Led clinical development of Avonex for multiple sclerosis at Biogen
William Tanner, PhD Chief Financial Officer
20 years+ prior experience as a biotech and biopharma research analyst for leading healthcare investment banks including Vector Securities, SG Cowen, Leerink Swann, Lazard Capital Markets, Guggenheim Securities and Cantor Fitzgerald
DIRECTORS
Sylvie Gregoire, PharmD (Chair)
Co-Founder; Board member, Novo Nordisk, Revity (f/k/a Perkin Elmer), F2G, Former Executive VP, Biogen; Former President, HGT Division, Shire Pharmaceuticals
Jeff Poulton (Chair of Audit Committee)
CFO, Alnylam Pharmaceuticals (Nasdaq:ALNY) Former CFO, Shire Pharmaceuticals; CFO, Indigo Agr.
Jane H. Hollingsworth, JD
Managing Partner, Militia Hill Ventures
Former Chairman of the Board, Diffusion Pharmaceuticals
SCIENTIFIC ADVISORS
Marwan Sabbagh, MD
Prof. of Neurology at the Alzheimer's and Memory Disorders division of the Barrow Neurological Institute at Dignity Health/St Joseph's Hospital in Phoenix, Arizona
Camille and Larry Ruvo Endowed Chair for Brain Health and Director of Translational Research at Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas
Frank Zavrl
Former Board Member, Puma Biotechnology Retired Partner, Adage Capital
Robert J. Cobuzzi Jr., PhD
Chief Operating Officer, Director
President, Chief Executive Officer and Director of Diffusion since 2020
More than 25 years of cross-functional leadership and operational experience in pharmaceutical and biotechnology industries, including Endo, Adolor, Centocor and AstraMerck
Ole Isacson, MD (Chair)
Prof of Neurology (Neuroscience) Harvard Medical School
Lewis Cantley, PhD
Professor of Cell Biology, Harvard Medical School, Dana-Farber Cancer Inst.
Jeff Cummings, MD, PhD
Director, Chambers-Grundy Center for Transformative Neuroscience at UNLV
Heidi McBride, PhD
Professor, Dept. of Neurology & Neurosurgery, McGill University
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Company Overview
Targeting Synaptic Dysfunction to Treat Neurodegenerative Disease
CervoMed began trading on NASDAQ (CRVO) in August 2023 following a completed merger between EIP Pharma, Inc. and Diffusion Pharmaceuticals Inc.
Headquartered: Boston, MA
Lead program: Neflamapimod | Neflamapimod licensed from Vertex in 2014 |
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Neflamapimod IP covered by multiple issued patents around method of use for specific disease indications and formulations, expiring at various dates through to 2039
Neflamapimod Background
Oral small molecule highly selective inhibitor of the protein kinase p38a, a major activator of the cellular stress pathways in response to neuroinflammation
Supported by growing positive data:
Neflamapimod offers first to market treatment option for dementia with Lewy bodies (DLB) with
the potential to reverse neurodegenerative
process in basal forebrain and address cognitive, functional and motor aspects of the disease
- In preclinical and clinical studies, neflamapimod reversed neurodegenerative process in basal forebrain
- In phase 2a trial in patients with DLB, neflamapimod versus placebo improved cognitive, functional and motor aspects of the disease. Effects most prominent in patients with pure DLB
- Safety profile well defined, with clinical safety data in greater than 300 study participants
Prior phase 2 studies in Alzheimer's disease (AD) demonstrated target engagement:
• Reduction vs. placebo of CSF levels of p-tau and total tau; increased volume and functional connectivity of basal forebrain by MRI
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Neflamapimod Mechanism of Action
Neuro-inflammation | APP | α-synuclein |
p38α | ↑ Rab5 | ||
(-) | |||
Neflamapimod
Synaptic Dysfunction, Tau Pathology, NGF Signaling Defect
Cholinergic Degeneration
Basal Forebrain
APP - Amyloid Precursor Protein; NGF Nerve Growth Factor
Medial
Temporal | Memory & Attentional |
Lobe/ | Deficits, Gait Dysfunction |
Hippocampus |
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Alam & Nixon, Molecular Neurodegeneration, 2023
Medicines for the Brain
Opportunity in
Dementia with
Lewy Bodies (DLB)
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Dementia with Lewy Bodies (DLB)
What is DLB?
Disease associated with abnormal deposits of a protein called alpha- synuclein in the brain. These deposits, called Lewy bodies, affect chemicals in the brain whose changes, in turn, can lead to problems with thinking, movement, behavior, and mood1
Patients incur greater rate of cognitive decline, higher healthcare costs, report lower quality of life, and have caregivers with higher levels of distress compared to patients with Alzheimer's disease (AD)
Treatment Landscape and Unmet Need
No approved therapies; limited drugs in development
Current standard of care is cholinesterase inhibitor therapy that only transiently improves cognition and does not impact motor component
Market Opportunity
3rd most common neurodegenerative disease (after AD and PD)
~700,000 individuals in each of US and EU
Neflamapimod has the potential to be the first disease- modifying approach because it treats the primary pathology: cholinergic degeneration in the basal forebrain
DLB affects ~1.4 million
individuals in the US and EU
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1. https://www.nia.nih.gov/health/what-lewy-body-dementia-causes-symptoms-and-treatments
Neflamapimod for DLB: Well-Positioned Commercially
Potential to reverse the neurodegenerative process, address cognitive, functional and motor aspects of DLB
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>$3B Peak US | 03 |
Sales for First to Market
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Significant Patient Numbers:
Approximately 700,000 in each of US & EU
Growth in Diagnosis Rates:
Increasing awareness of disease
Opportunity to Improve Existing Treatment Paradigm:
High unmet treatment needs remain with currently utilized cholinesterase inhibitors
Diagnosed and managed by neurologists
Specialist Disease
High Medical Need / Pricing Leverage: Relative to AD
Greater rate of cognition decline, lower quality of life, higher hospitalization costs, higher caregiver burden
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Disclaimer
Cervomed Inc. published this content on 21 December 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 December 2023 09:10:33 UTC.