Inducement Grants Strengthening CMC leadership to prepare for scaled up neflamapimod manufacturing On track to initiate Phase 3 trial of neflamapimod in DLB in mid-2026 following meeting with regulatory authorities BOSTON, June 10, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported a key senior leadership hire to oversee the Company's Chemistry, Manufacturing, and Cont ...

Financial Data and Key Metrics Changes - CervoMed's lead asset, Neflumab vimode, is progressing into Phase 3 trials after showing robust clinical activity in dementia with Lewy bodies (DLB) [4][6] - The market opportunity for DLB is estimated to be comfortably over $5 billion, targeting a patient population of approximately 175,000 in the US [10] Business Line Data and Key Metrics Changes - The Phase 2 REWIND DLB study demonstrated a 52% reduction in clinical worsening on the CDR Sum of Boxes scale over 16 weeks, with a 67% reduction in a more precisely defined patient population [20][21] - The study also indicated a clinically significant treatment effect with a p-value of 0.033 on the Clinical Global Impression of Change [22] Market Data and Key Metrics Changes - DLB is the second most common dementia after Alzheimer's, with distinct symptoms that include cognitive deficits and motor components, leading to a significant impact on quality of life [7][8] - The company aims to position Neflumab vimode in a specialty market similar to multiple sclerosis, with pricing expectations in the range of $40,000 to $50,000 per patient annually [48] Company Strategy and Development Direction - CervoMed plans to initiate a Phase 3 trial in mid-2026, contingent on FDA feedback and completion of necessary assays [40][41] - The company is open to partnerships but believes it can self-commercialize the drug, depending on market conditions and strategic considerations [43][45] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway, noting that the Phase 3 trial would likely be sufficient for approval given the high unmet medical need in DLB [27][29] - The company highlighted the unique opportunity in DLB, emphasizing that the drug targets underlying disease processes, which may lead to better outcomes compared to Alzheimer's treatments [51] Other Important Information - The company is preparing for additional FDA interactions to clarify the clinical development path for Neflumab vimode [25][26] - Management noted that the variability in patient responses in previous studies could affect the power of certain endpoints, but overall positive trends were observed [39] Q&A Session Summary Question: What is the expected size of the field sales force for DLB? - Management indicated that the sales force would be similar to that used for multiple sclerosis, focusing on neurologists who manage DLB patients [47] Question: What is the pricing paradigm for Neflumab in DLB? - The expected pricing for Neflumab is in the range of $40,000 to $50,000 annually, which is comparable to other specialty diseases [48]

LEERINK PARTNERS LLC 1301 Avenue of the Americas, 5th Floor New York, New York 10019 Ladies and Gentlemen: CervoMed Inc., a Delaware corporation (the "Company"), confirms its agreement (this "Agreement") with Leerink Partners LLC (the "Agent"), as follows: CervoMed Inc. Shares of Common Stock ($0.001 par value per share) SALES AGREEMENT May 12, 2025 Exhibit 1.1 1. Issuance and Sale of Shares. The Company agrees that, from time to time during the term of this Agreement, on the terms and subject to the condit ...

Group 1 - CervoMed Inc. reported a quarterly loss of $0.56 per share, which was better than the Zacks Consensus Estimate of a loss of $0.60, but worse than the loss of $0.41 per share from the previous year, indicating a 36.6% increase in loss year-over-year [1] - The company achieved revenues of $1.92 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 66.70%, although this represents a decline from $2.35 million in revenues a year ago [2] - CervoMed Inc. shares have increased approximately 262.8% since the beginning of the year, contrasting with a decline of 3.8% in the S&P 500 [3] Group 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 trend for estimate revisions for CervoMed Inc. is currently unfavorable, resulting in a Zacks Rank of 4 (Sell), indicating expected underperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.57 on revenues of $0.81 million, and for the current fiscal year, it is -$2.17 on revenues of $2.8 million [7] Group 3 - The Medical - Biomedical and Genetics industry, to which CervoMed Inc. belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting that stocks in the top 50% of Zacks-ranked industries tend to outperform those in the bottom 50% by more than a factor of 2 to 1 [8]

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ______________. Commission file number: 001-37942 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symb ...

Reported positive 16-week results from the extension phase of the Phase 2b RewinD-LB trial, demonstrating proof-of-concept for neflamapimod as a potential treatment for dementia with Lewy bodies (DLB) Plan to initiate Phase 3 trial of neflamapimod in DLB in mid-2026 following meeting with regulatory authorities Initiating separate Phase 2a trials to evaluate neflamapimod in patients with primary progressive aphasia and patients in the recovery phase after ischemic stroke BOSTON, May 12, 2025 (GLOBE NEWSWIRE ...

Company Overview - CervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders [3] - The company is currently developing neflamapimod, an investigational orally administered small molecule that inhibits p38 mitogen-activated protein kinase alpha [3] - Neflamapimod has the potential to treat synaptic dysfunction associated with neurodegenerative processes in disorders such as Dementia with Lewy Bodies (DLB) [3] - The drug is currently being evaluated in a Phase 2b study in patients with DLB [3] Upcoming Events - Company management will participate in a fireside chat and one-on-one investor meetings at the H.C. Wainwright 3rd Annual BioConnect Investor Conference [1] - The fireside chat is scheduled for May 20, 2025, from 5:00 to 5:30 PM ET [2] - A webcast of the fireside chat will be accessible on the Investor section of the CervoMed website [2]

During the first 16 weeks of the Extension phase of the RewinD-LB clinical study neflamapimod slowed clinical progression compared to controls, as assessed by Clinical Dementia Rating Sum of Boxes (CDR-SB) and Clinical Global Impression of Change (CGIC) Neflamapimod was associated with a reduced incidence of falls in the Extension phase of the study and new data to be presented at AD/PD™ 2025 demonstrates improvements on endpoints measuring cognitive fluctuations and working memory The results demonstrate p ...

Group 1 - CervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders, specifically presenting at the upcoming AP/PD™ conference [1][2][3] - The company will present detailed analyses from the Extension Phase of the RewinD-LB Phase 2b study of neflamapimod in dementia with Lewy bodies (DLB) [1][2] - Neflamapimod is an investigational orally administered small molecule that inhibits p38 mitogen-activated protein kinase alpha, with potential applications in treating synaptic dysfunction associated with neurodegenerative processes [3] Group 2 - The oral presentation will take place on April 5th, 2025, from 18:25 to 18:40 CET, featuring key figures from CervoMed and Harvard Medical School [2] - The abstract of the presentation will be made available in the Investor section of CervoMed's website following the event [2]

Core Viewpoint - CervoMed Inc. is set to present findings from the RewinD-LB Phase 2b study of neflamapimod for dementia with Lewy bodies at the upcoming AP/PD™ conference in Vienna, highlighting its focus on age-related neurologic disorders [1][2]. Company Overview - CervoMed is a clinical-stage company dedicated to developing treatments for age-related neurologic disorders, specifically through its investigational drug neflamapimod, which targets synaptic dysfunction associated with neurodegenerative diseases [3]. Presentation Details - The oral presentation will cover the efficacy and safety results of the RewinD-LB Phase 2b clinical trial of neflamapimod in dementia with Lewy bodies, scheduled for April 5, 2025 [2]. - The presentation will be led by John Alam, CEO of CervoMed, and Stephen Gomperts, a prominent neurologist [2].