Medicines for the Brain

April 2024

Corporate Overview

cerveau (sair-voh), noun, in French for brain or mind

NASDAQ: CRVO

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 and the completion and achievement of primary endpoints in the Company's ongoing Phase 2b clinical Trial; the potential therapeutic value of neflamapimod; the Company's anticipated cash runway and use of proceeds from its recent private placement; 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 or the issuance of additional shares of the Company's common stock, including upon the issuance of outstanding warrants or otherwise; variations in operating performance across competitors; changes in laws and regulations affecting the Company's business; 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 Annual Report on Form 10-K for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission ("SEC") on March 29, 2024, 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 April 22nd, 2024 (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.

1

Company Overview

Targeting Synaptic Dysfunction to Treat Age-Related Neurologic Disorders

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: Oral neflamapimod for the treatment of

Licensed from Vertex Pharmaceuticals; developed for

Dementia with Lewy bodies

CNS indications by EIP Pharma/CervoMed

2

Neflamapimod IP covered by multiple issued patents around method of use for specific disease indications and formulations, expiring at various dates through to 2039

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

Robert J. Cobuzzi Jr., PhD

DIRECTORS

Joshua Boger, PhD (Chair)

Executive Chair, Alkeus Therapeutics. Founder, former CEO, Vertex Pharmaceuticals

Sylvie Gregoire, PharmD

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

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

Frank Zavrl

Former Board Member, Puma Biotechnology Retired Partner, Adage Capital

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 companies, including Endo, Adolor, Centocor and AstraMerck

Kelly Blackburn, MHA

SVP, Clinical Development

Former VP, Clinical Affairs at aTyr Pharma; VP, Clinical Development Operations at Vertex. Led global clinical operations for Kalydeco® for the treatment of cystic fibrosis, Incivek® for hepatitis C, and Velcade® for multiple myeloma

SCIENTIFIC ADVISORS

Ole Isacson, MD (Chair)

Prof of Neurology (Neuroscience) Harvard Medical School

Lewis Cantley, PhD

Professor of Cell Biology, Harvard Medical School, Dana-Farber Cancer Institute; Laureate, Breakthrough Prize in Life Sciences

Jeff Cummings, MD, PhD

Director, Chambers-Grundy Center for Transformative Neuroscience at UNLV

Heidi McBride, PhD

Professor, Dept. of Neurology & Neurosurgery, McGill University

3

Financial Overview1

Post-offering,

8,253,741 shares

outstanding, all

common stock

Completed private placement with leading healthcare investors on April 1, 2024

Upfront gross proceeds of $50.0 million

Up to an additional $99.4 million of gross proceeds tied to exercise of Series A warrants; with positive top-line data from ongoing Phase 2b trial, exercise permitted no later than 180 days after data announcement

CervoMed has cash runway through the end of 2025,

not including any additional proceeds that may be received upon the exercise of Series A warrants

4

1. As of April 2, 2024, and inclusive of the upfront proceeds and issuance of shares of common stock in connection with the Company's private placement completed April 1, 2024. For additional financial and other information, refer to (i) the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, and (ii) the Company's Current Report on Form 8-K filed with the SEC on March 28, 2024.

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 early phase of the degenerative process in the brain, including neuronal stress and inflammatory pathways

Major neurologic indication with 700,000 patients in the US; >$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, Neurology, and JPAD

Well-powered trial, stratified to identify patients most likely to benefit from neflamapimod supports development success and path to market, while reducing 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; plan to complete enrollment in 2Q24 and report primary efficacy results and other top-linedata2 in 4Q24

5

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

Neflamapimod Background

Oral brain penetrant small molecule highly selective inhibitor of the protein kinase p38α, a major activator of the cellular stress pathways in response to neuroinflammation

Licensed from Vertex Pharmaceuticals in 2014

Supported by robust dataset:

Neflamapimod offers first to market treatment option for dementia with Lewy bodies (DLB) with the potential to reverse the underlying disease process in the basal forebrain and address cognitive, functional and motor aspects of the disease

  • In preclinical and clinical studies, neflamapimod reverses the underlying disease process in the basal forebrain
  • Chronic, repeat dose toxicology studies completed, with 10-fold safety margin at 40mg TID in humans to NOAEL in those studies
  • 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 ptau and total tau; increased volume and functional connectivity of basal forebrain by MRI

6

Neflamapimod Mechanism of Action

Basal Forebrain Cholinergic Complex

Primary site of pathology in DLB

Dementia

Short

Term

Memory

Hippocampus

Basal Forebrain

Release of acetylcholine through cortical connections modulate cognitive and motor tasks

7 Adapted from Alam & Nixon, Molecular Neurodegeneration, 2023

Neuroinflammation,

Aggregated Proteins (e.g., α-synuclein)

(-)

p38α

Neflamapimod

  • Rab5

Tau Pathology, Defects in Axonal Transport and NGF Signaling

Cholinergic Dysfunction & Degeneration

Basal Forebrain

NGF: Nerve Growth Factor

Neflamapimod Reverses Cholinergic Dysfunction and Degeneration in Preclinical Study

TS2 mouse model of Down Syndrome (DS)

  • Ts2 mice have both DS-like defects during early development and adult-onset of basal forebrain cholinergic neuron degeneration
  • Treated with vehicle or 3 mg/kg neflamapimod twice daily x 28 days, starting at month 6

Reversed basal forebrain cholinergic neuron loss and restored cholinergic function

  • Significantly increased (+30% vs. controls, p<0.001) and normalized the number of cholinergic neurons in basal forebrain
  • Normalized performance in both open field and novel object recognition behavioral tests of cholinergic function

Mechanistic effects of neflamapimod

  • Decreased Rab5 activation and reversed Rab5+ endosomal pathology
  • Normalized levels of activated (phosphorylated) p38 and its downstream

targets MK2 and MNK1

Cholinergic neurons in basal forebrain

Healthy Mice Treated

DS Mice Treated

DS Mice Treated

with Vehicle

with Vehicle

with Neflamapimod

Cholinergic neurons identified by staining for choline acetyl transferase expression

8

Nature Communications, 13, Article number: 5308 (2022). https://www.nature.com/articles/s41467-022-32944-3

Neflamapimod Appears to Reverse Basal Forebrain Atrophy, Assessed by MRI

Neflamapimod treatment is associated with a significant increase of basal forebrain volume and functional connectivity in patients with Early (Amyloid PET+) AD

MRI scans obtained before and after 12-weeks neflamapimod treatment in 15 Early AD Patients

Prins et al, JPAD, 2024

Donepezil (cholinesterase inhibitor) treatment only slows decline in basal forebrain volume in a similar patient population (prodromal AD)

MRI scans before and after donepezil 10mg/day (N=75) or Placebo (N=88) for 12 months

% Change

0.74%

Annualized

0.30%

Mean

NbM Volume

Cavedo et al, Scientific Reports, 2017

9

NbM - Nucleus basalis of Meynert, the largest cluster of cholinergic neurons in the basal forebrain; DGM - Deep Grey Matter

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

Cervomed Inc. published this content on 22 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 May 2024 15:50:04 UTC.