CervoMed (NasdaqCM:CRVO) FY Conference March 23, 2026 03:00 PM ET Company ParticipantsMatt Winton - CCO and CBOModeratorGood afternoon, everyone. I am Boobalan Pachaiyappan, Managing Director and Senior Biotech Analyst at Roth Capital Partners. With me today is Matt Winton, who is the Chief Commercial Officer and Chief Business Officer of CervoMed. For those who are new to the story, CervoMed is developing oral drugs for neurodegenerative diseases, including dementia with Lewy bodies, ALS, and FTD, and so o ...

Core Insights - New analyses from the Phase 2b RewinD-LB clinical trial indicate that DLB patients with lower plasma pTau181 levels experienced greater clinical benefits from neflamapimod, suggesting its potential to target the underlying causes of dementia with Lewy bodies (DLB) [1][2][12] - The findings support the company's patient enrichment strategy and dosing regimen for the upcoming Phase 3 trial [1][2] Clinical Trial Details - The RewinD-LB trial included an initial randomized phase comparing neflamapimod to placebo, followed by a neflamapimod-only extension phase [3][8] - In the initial phase, participants did not achieve expected plasma drug concentration levels, resulting in no statistically significant improvement on the primary endpoint [3][4] - The extension phase with a new batch of capsules (DP Batch B) showed statistically significant and clinically meaningful slowing of disease progression [4] Treatment Response and Biomarkers - Treatment response increased across DLB patient subgroups with lower pTau181 levels, indicating a higher likelihood of patients without Alzheimer's disease (AD) co-pathology benefiting from neflamapimod [2][5] - The analyses revealed a consistent improvement in clinical endpoints at progressively lower plasma pTau181 levels, with a significant difference in CDR-SB scores between treatment groups [5][6] Future Directions - The company plans to initiate a global Phase 3 trial in the second half of 2026, focusing on patients with DLB and low pTau181 levels [14] - The planned trial will utilize a pTau181 cut-off of <21 pg/mL, estimated to include 80-90% of patients without AD co-pathology, who are believed to be most likely to respond to treatment [6][12] Drug Mechanism and Efficacy - Neflamapimod is an investigational drug that inhibits p38 MAP kinase, targeting neuroinflammation and synaptic dysfunction [12][13] - Previous studies have shown that neflamapimod can restore synaptic function and improve cognitive and functional outcomes in DLB patients [13]

Core Insights - New analyses indicate that dementia with Lewy bodies (DLB) patients with lower plasma pTau181 levels experienced greater clinical benefits from neflamapimod in a Phase 2b clinical trial, suggesting a potential to target the underlying disease biology [1][2][5] - The findings support the company's patient enrichment strategy and dosing regimen for the upcoming Phase 3 trial [1][2] Clinical Trial Details - The RewinD-LB Phase 2b trial included an initial randomized phase comparing neflamapimod to placebo, followed by a neflamapimod-only extension phase [3][10] - In the initial phase, participants did not achieve expected plasma drug concentration levels, resulting in no statistically significant improvement on the primary endpoint [3][4] - The extension phase with a new batch of capsules (DP Batch B) showed statistically significant and clinically meaningful slowing of clinical progression compared to the initial batch [4] Treatment Response and Biomarkers - Treatment response increased progressively across DLB patient subgroups with lower plasma pTau181 levels, indicating a higher likelihood of patients without Alzheimer's disease (AD) co-pathology [2][5] - The analyses revealed a strong association between neflamapimod response and the absence of AD co-pathology, reinforcing confidence in the drug's potential to slow disease progression [2][5] Statistical Findings - Within-participant comparisons showed that at the lowest plasma pTau181 levels (<21 pg/mL), the average change in Clinical Dementia Rating Sum of Boxes (CDR-SB) was -1.11, indicating significant clinical improvement [6][7] - The mean change in the Alzheimer's Disease Cooperative Study — Clinical Global Impression of Change (ADCS-CGIC) score also demonstrated a greater effect at lower pTau181 levels [7][8] Future Plans - The company plans to initiate a global Phase 3 trial in the second half of 2026, focusing on patients with DLB enriched for those without AD co-pathology [16] - The planned trial will utilize a pTau181 cut-off level of <21 pg/mL, estimated to include 80% to 90% of patients without AD co-pathology [8][16]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 March 17, 2026 Date of Report (Date of earliest event reported) CervoMed Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) (Commission File Number) Delaware 001-37942 30-0645032 (I.R.S. Employer Identification No.) 20 Park Plaza, Suite 424 Boston, Massachusetts 02116 (Address of principa ...

Reported positive Phase 2b RewinD-LB clinical data at CTAD 2025; additional analyses to be presented at AD/PD 2026 Obtained alignment with FDA and global regulators for planned Phase 3 trial design in patients with DLB and selected Phase 3 formulation, dose and dosing regimen Multiple potential catalysts anticipated in the second half of 2026, including initiation of the planned Phase 3 trial, topline data from Phase 2a ischemic stroke recovery trial, initial topline data from Phase 2a primary progressive a ...

分组1 - CervoMed Inc. reported a quarterly loss of $0.88 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.79, and compared to a loss of $0.80 per share a year ago, indicating an earnings surprise of -10.93% [1] - The company posted revenues of $0.01 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 98.06%, and down from $2.16 million in the same quarter last year [2] - CervoMed Inc. shares have declined approximately 45.2% since the beginning of the year, contrasting with the S&P 500's decline of 2.5% [3] 分组2 - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The estimate revisions trend for CervoMed Inc. was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), suggesting the shares are expected to perform in line with the market in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.88 on revenues of $0.55 million, and for the current fiscal year, it is -$2.33 on revenues of $2.7 million [7] 分组3 - The Medical - Biomedical and Genetics industry, to which CervoMed Inc. belongs, is currently ranked in the bottom 43% of over 250 Zacks industries, indicating that the industry's outlook can significantly impact stock performance [8]

Corporate Developments - CervoMed completed a merger with EIP Pharma on August 16, 2023, with EIP becoming a wholly-owned subsidiary[16]. - The company completed a merger on August 16, 2023, which was treated as a "reverse recapitalization" under US GAAP, resulting in the name change from "Diffusion Pharmaceuticals Inc." to "CervoMed Inc."[210]. - The principal corporate office is located at 20 Park Plaza, Suite 424, Boston, Massachusetts 02116, with a contact number of (617) 744-4400[211]. - The company was originally incorporated in Nevada in 1995 and reincorporated in Delaware in 2015, indicating a history of strategic corporate structuring[210]. Financial Activities - The company raised approximately $149.4 million through a private placement of 2,532,285 units on April 1, 2024[17]. - CervoMed's financial outlook includes estimates regarding expenses, future revenues, and capital requirements[22]. - The Vertex Agreement includes potential milestone payment obligations of up to $117.0 million, with $100,000 already paid to Vertex[97]. - The royalty payments to Vertex will be on a sliding scale in the low- to mid-teens percentage of net sales, depending on sales thresholds[96]. Clinical Trials and Research - CervoMed received a $21.3 million grant from the National Institute on Aging to support the RewinD-LB Trial, with $21.0 million awarded in January 2023[19]. - The RewinD-LB Trial is a Phase 2b clinical trial evaluating neflamapimod for treating dementia with Lewy bodies, with final results announced in October 2025[19]. - The company is initiating the RESTORE Trial, a Phase 2a clinical trial for neflamapimod in patients recovering from ischemic stroke, in Q2 2025[19]. - Neflamapimod is the only clinical drug candidate that has shown statistically significant improvements on clinical endpoints and a biomarker of neurodegeneration in both Phase 2a and Phase 2b clinical trials[31]. - The planned Phase 3 trial will enroll approximately 300 patients with DLB without AD co-pathology and will utilize a primary endpoint of mean change in CDR-SB over 32 weeks[46]. - The ongoing RESTORE Trial is evaluating neflamapimod in up to 90 participants recovering from ischemic stroke, with primary outcomes including change in Fugl-Meyer Assessment of Motor Recovery after Stroke[74]. - Neflamapimod has been selected for the EXPERTS-ALS platform to evaluate its impact on NfL levels in approximately 35 ALS participants over 18-24 weeks[77]. Drug Development and Mechanism - Neflamapimod's mechanism of action targets neuroinflammation, which is believed to impair synaptic communication and lead to cognitive and motor dysfunction[30]. - Neflamapimod is positioned as a potential first-in-class treatment for DLB without AD co-pathology, which comprises approximately 50% of all DLB patients[45]. - The AscenD-LB Trial enrolled 91 participants and demonstrated significant improvement in dementia severity (CDR-SB, p=0.023) and functional mobility (TUG test, p=0.044) with neflamapimod compared to placebo[48]. - In the RewinD-LB Trial, treatment improved change in CDR-SB by 1.12 points (p=0.004 vs. placebo) and ADCS-CGIC score by 0.82 points (p=0.004 vs. placebo) in patients without AD co-pathology[69]. Regulatory and Compliance - The FDA granted neflamapimod Fast Track Designation for DLB in October 2019 and Orphan Drug Designation for frontotemporal dementia in November 2024[79]. - Regulatory compliance is crucial, as failure to meet FDA requirements could lead to sanctions that adversely affect the company's operations[123]. - The FDA approval process involves multiple stages, including nonclinical studies, IND submission, and clinical trials, which require substantial time and financial resources[124][126]. - The FDA aims to review NDAs within 10 months after acceptance for filing, or within 6 months for priority review applications[136]. Intellectual Property - The company emphasizes the importance of intellectual property protection for its current and future product candidates[22]. - The company holds a patent for novel co-crystals of neflamapimod, expiring in 2038, which may enhance the drug's solubility and physical properties[101]. - The company holds ten main patent families related to neflamapimod, with expiration dates ranging from 2032 to 2044, ensuring a strong intellectual property position[114][120]. - The company is actively pursuing patent protection in various jurisdictions, including the US, Europe, and Japan, to safeguard its proprietary technologies[113]. Market and Competition - There is increasing competition in the market for treatments of DLB and other neurodegenerative diseases, with established pharmaceutical firms and smaller biotech companies pursuing various therapies[108]. - The company identifies limited competition in later-stage development for DLB, with Cognition Therapeutics, Inc. being a notable competitor focusing on symptomatic treatment rather than the underlying disease[109]. - The company faces potential challenges from competitors with greater financial resources and established market presence, impacting recruitment and clinical trial execution[111]. Employee and Governance - The company has 15 full-time employees as of December 31, 2025, maintaining the same number as the previous year[194]. - The company offers a competitive total rewards package, including a 90% employer contribution to family medical coverage and stock option grants to promote retention[198]. - The company has a highly qualified Scientific Advisory Board comprised of leaders in cell biology, intracellular signal transduction, neurotherapeutics, and translational neuroscience[209]. - The executive team includes John Alam as President and CEO, William Elder as CFO, and other key positions held by experienced professionals in their respective fields[207]. Risks and Challenges - The company emphasizes the importance of considering risk factors that could adversely affect its business and financial condition, which may lead to a decline in the market price of its securities[213]. - The company acknowledges that additional risks not currently known or believed to be immaterial could adversely affect its operations and financial condition[214]. - Significant uncertainty exists regarding the coverage and reimbursement status of FDA-approved products, which can affect sales and financial performance[177]. - Compliance with various healthcare laws and regulations is costly and time-consuming, with potential penalties for violations that could adversely affect operations[176].

1 Medicines for the Brain Corporate Presentation March 2026 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 the CervoMed Inc. (Company), including, but not limited to: the therapeutic potential of neflamapimod, including the degree of sustainability of any therapeutic eff ...

Core Insights - CervoMed is advancing its drug candidate neflamapimod for treating dementia with Lewy bodies (DLB), a condition with no approved treatments in the US or EU [1][6] - The company plans to initiate a Phase 3 trial in DLB patients, specifically targeting those without Alzheimer's disease co-pathology, in the second half of 2026 [6] Group 1: Clinical Trial Results - In the Phase 2b RewinD-LB trial, neflamapimod showed a statistically significant and clinically meaningful slowing of clinical progression in DLB patients without Alzheimer's disease co-pathology [2] - Secondary analyses will present new outcomes based on pre-specified plasma pTau181 levels, supporting the planned Phase 3 trial's patient selection criteria [2] Group 2: Upcoming Presentations - CervoMed will present findings at the AD/PD 2026 conference in Copenhagen, including an oral presentation on neflamapimod's treatment effects in DLB patients [5] - A scientific symposium sponsored by CervoMed will discuss advances in DLB research and new drug development strategies, featuring presentations from leading researchers [4] Group 3: Drug Development Strategy - Neflamapimod targets critical disease processes in neuroinflammation and neurodegeneration, aiming to inhibit a key enzyme involved in these processes [6] - The company is focusing on understanding the dose-response relationship of neflamapimod through new pharmacokinetic and pharmacodynamic analyses from the RewinD-LB trial [4]

Core Insights - CervoMed Inc. has completed a Phase 1 study of a new stable crystal form of neflamapimod, which shows a pharmacokinetic profile that overlaps with the active drug used in previous trials [1][2] - The company plans to initiate a Phase 3 trial for dementia with Lewy bodies (DLB) using a dosing regimen of 50mg three times daily (TID) to ensure therapeutic plasma drug concentrations are achieved [1][2][3] Group 1: Study Results and Dosing Regimen - The selected dose for the Phase 3 study is 50mg TID of the stable crystal form of neflamapimod, increased from 40mg to ensure adequate plasma concentrations [2][3] - The pharmacokinetic profiles of the new formulation and the previously used drug product batch (DP Batch B) are largely overlapping, indicating consistency in drug behavior [2][3] Group 2: Manufacturing and Formulation Improvements - CervoMed has developed a controlled manufacturing process that produces only the stable crystal form of neflamapimod, addressing previous issues with cross-batch variability and underperformance [3] - The new formulation aims to mitigate the challenges faced with earlier drug product batches that contained multiple solid-state forms, which affected bioavailability [3] Group 3: Clinical Development and Efficacy - Neflamapimod is an investigational drug targeting neuroinflammation and synaptic dysfunction, with potential applications in DLB and other degenerative brain disorders [4][7] - Clinical trials have shown that neflamapimod is generally well tolerated and has demonstrated efficacy in improving cognitive and functional outcomes in patients with DLB [5][6]