Group 1 - CervoMed Inc. will host a conference call and webcast on July 28, 2025, to share primary endpoint results from the Phase 2b RewinD-LB study of neflamapimod in dementia with Lewy bodies [1][2] - The RewinD-LB study is a randomized, 16-week, double-blind, placebo-controlled trial involving 159 patients, with a subsequent 32-week extension phase [4] - The study is primarily funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging [4] Group 2 - Neflamapimod is an investigational oral small molecule that inhibits p38 mitogen-activated protein kinase alpha, aimed at treating synaptic dysfunction in age-related neurologic disorders [5] - The primary outcome measure of the RewinD-LB study is the change in the Clinical Dementia Rating – Sum of Boxes, with secondary endpoints including various cognitive assessments [4] - The study excludes patients with Alzheimer's disease co-pathology, focusing on those with "pure" dementia with Lewy bodies [4]

Core Viewpoint - CervoMed Inc. is set to present new findings from its RewinD-LB Phase 2b study of neflamapimod for dementia with Lewy bodies at the Alzheimer's Association International Congress (AAIC) 2025, highlighting its focus on age-related neurologic disorders [1][3]. Group 1: Presentation Details - CervoMed will deliver both in-person and virtual poster presentations at AAIC 2025, scheduled for July 27 – 31, 2025, in Toronto, Canada [1]. - The in-person poster titled "Effects of neflamapimod (p38α kinase inhibitor) on clinical progression in patients with dementia with Lewy bodies (DLB) without Alzheimer's disease (AD) Co-Pathology" will be presented on July 27, 2025 [2]. - A virtual presentation titled "Impact of AD Co-Pathology on Response to Neflamapimod (p38α Kinase Inhibitor) in Patients with Dementia with Lewy Bodies" will also be featured [2]. Group 2: Company Overview - CervoMed is a clinical-stage company dedicated to developing treatments for age-related neurologic disorders, with a focus on neflamapimod, an investigational small molecule that inhibits p38 mitogen-activated protein kinase alpha [3]. - Neflamapimod aims to address synaptic dysfunction, a reversible aspect of neurodegenerative processes in DLB and other neurological disorders, and is currently undergoing evaluation in a Phase 2b study [3].

Clinical Trial Overview - The RewinD-LB phase 2b clinical trial investigated neflamapimod in dementia with Lewy bodies (DLB)[3] - The trial randomized 159 participants 1:1 to neflamapimod 40mg or placebo TID for 16 weeks, followed by a 32-week open-label extension[20] - The primary outcome measure was the Clinical Dementia Rating Sum of Boxes (CDR-SB)[20] Efficacy Results - The primary statistical analysis showed no discernible differences between the neflamapimod and placebo groups in change from baseline on CDR-SB (NFMD-Placebo Difference: 0.01)[29] - Secondary endpoint CGIC results showed Number of Participants in Each Category at Week 16[34] Safety and Tolerability - The study was generally well-tolerated, with no new safety signals[37] - There were 8 serious adverse events (SAEs) in the placebo group and 5 in the neflamapimod group[37] - The most common treatment emergent adverse event was falls, occurring in 18.8% of the placebo group and 15.2% of the neflamapimod group[38] Plasma Drug Concentrations - Mean trough plasma drug concentration (Ctrough) in RewinD-LB was 3.9 ng/mL[42, 43, 44] - This Ctrough level was similar to that seen with 40mg BID in earlier studies, lower than targeted[42, 43, 44] - Analysis suggests lower bioavailability related to the age of the capsules used during the double-blind phase[49] Open-Label Extension (OLE) and Future Directions - The open-label extension (OLE) of the study introduced a newer batch of capsules[44] - Week 16 OLE analysis is upcoming in March 2025[46] - A clinical study evaluating the safety and pharmacokinetics of 80mg BID in DLB is ongoing[49]

Core Insights - CervoMed is advancing the development of neflamapimod, targeting a Phase 3 trial in dementia with Lewy Bodies (DLB) set to begin in mid-2026 following discussions with regulatory authorities [1][3] Leadership Changes - Marco Verwijs, PhD, has been appointed as Executive Vice President of Technical Operations, bringing extensive experience in drug development and CMC functions from previous roles at notable biotech companies [2][3] Inducement Grants - On June 9, 2025, CervoMed granted Dr. Verwijs an option to purchase 54,000 shares of common stock at an exercise price of $7.74, with vesting over three years [4] Company Overview - CervoMed is focused on developing treatments for age-related neurologic disorders, with neflamapimod being an investigational small molecule aimed at treating synaptic dysfunction in DLB and other neurological disorders [5]

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]

Stock Issuance and Sales - The Company plans to issue and sell up to $50,000,000 of common stock through Leerink Partners LLC as the Agent[1] - The registration statement for the common stock was filed with the SEC on October 3, 2024, and declared effective on October 10, 2024[2] - The Company will provide the Agent with copies of the base prospectus and the prospectus supplement related to the Placement Shares[2] - Each Placement will require a Placement Notice specifying the maximum number of shares, time period for sales, and any minimum price[4] - The Agent will use commercially reasonable efforts to sell the Placement Shares as per the terms of the Placement Notice[6] - Settlement for sales of Placement Shares will occur on the first Trading Day following the date of sale[10] - The Net Proceeds delivered to the Company will be the gross sales price minus the Agent's commission and any transaction fees[10] - The Company must deliver the Placement Shares electronically on or before each Settlement Date[11] - If the Company defaults on delivering shares, it must return any Net Proceeds received and indemnify the Agent for any losses incurred[11] - The Company and the Agent may suspend sales if the Company possesses material non-public information[9] - The Company has filed a Registration Statement with the Commission, which has been declared effective prior to the issuance of any Placement Notices[13] - The Company has not received any notice from the Commission objecting to the use of the shelf registration statement form[13] - The Placement Shares have been duly authorized for issuance and will be validly issued, fully paid, and nonassessable[26] - The Company has filed a Notification of Listing of Additional Shares with Nasdaq regarding the Placement Shares[21] - The Company has the authorized and outstanding capitalization as set forth in its most recent Annual Report on Form 10-K[25] - The Company has not distributed any offering material other than the Registration Statement and the Prospectus in connection with the offering of the Placement Shares[19] - The Company is not considered an "ineligible issuer" as defined in Rule 405[16] - The issuance and sale of the Placement Shares will not be subject to any preemptive rights or similar rights[26] Financial Condition and Compliance - The Company has not experienced any material adverse change in its financial condition or operations since the last reporting period[33] - The financial statements included in the Registration Statement and Prospectus present fairly the consolidated financial position of the Company and its Subsidiaries[36] - The Company has filed all required federal income tax returns and paid all taxes due, with no material tax deficiencies expected[42] - There are no ongoing or threatened labor disputes that could have a material adverse effect on the Company[43] - The Company is not classified as an "investment company" under the Investment Company Act of 1940[29] - The Company has not incurred any material liabilities or obligations outside the ordinary course of business[33] - All necessary consents and approvals for the execution of agreements have been obtained[30] - The Company has not received any communications regarding the termination or non-renewal of any significant contracts[27] - The Company is in compliance with all applicable laws and regulations, with no violations that would have a material adverse effect[39] - The Company has engaged RSM US LLP as its independent registered public accounting firm, which is in compliance with all regulatory requirements[40] - The Company and its Subsidiaries are insured by reputable institutions with adequate coverage for risks including theft, damage, and clinical trial liability claims[45] - The Company holds good and marketable title to all real and personal property material to its business, free of significant liens or encumbrances[46] - The Company possesses all necessary permits required by regulatory agencies to conduct its business, with no material violations reported[47] - The Company maintains accurate books and records, ensuring compliance with GAAP and internal accounting controls[48] - The Company has established effective disclosure controls and procedures, with no material weaknesses reported in internal control over financial reporting[50] - The Company is in compliance with the Sarbanes-Oxley Act and has not failed to comply with any applicable provisions[54] - The Company and its Subsidiaries have not engaged in any unlawful payments or actions that would violate anti-corruption laws[55] - The Company has conducted its operations in compliance with financial recordkeeping and money laundering laws, with no pending investigations[58] - The Company is not owned or controlled by any individual or entity subject to sanctions, ensuring compliance with relevant sanctions authorities[59] - The Company and its Subsidiaries possess all necessary intellectual property rights for their business operations and product commercialization, with no known legal challenges that could have a Material Adverse Effect[60] - The Company is in full compliance with all applicable laws and regulations regarding the development and distribution of pharmaceuticals, with no adverse findings from regulatory authorities[62] - There are no ongoing legal proceedings that could materially affect the Company or its Subsidiaries, and no claims have been received alleging violations of applicable laws[63] - Clinical trials and studies conducted by the Company are in compliance with protocols and applicable laws, with no material unexpected adverse events reported[65] Market and Financial Projections - As of May 9, 2025, the market value of the Company's outstanding common equity held by non-affiliates was approximately $82.8 million[69] - The Company has not defaulted on any preferred stock dividends or payments on borrowed money, which could result in a Material Adverse Effect[73] - All financial projections included in the Registration Statement were made in good faith and are accompanied by cautionary statements regarding potential risks[74] - The Company is not involved in any bankruptcy or insolvency proceedings[76] - The Company and its Subsidiaries are in compliance with all applicable laws and regulations related to workplace safety[78] - There are no material outstanding loans or guarantees involving the Company or its Subsidiaries[75] Agreement and Legal Matters - The Company has filed all necessary patents and trademarks and is in compliance with the PTO's duty of candor[80] - The Company will make available an earnings statement covering a 12-month period within 15 months after the end of the current fiscal quarter[88] - The Company will pay all expenses related to the offering of Placement Shares, including legal and filing fees[89] - The Company will use commercially reasonable efforts to list the Placement Shares on Nasdaq[86] - The Company will notify the Agent promptly of any stop orders or requests for amendments from the Commission[84] - The Company is not subject to any non-competition or non-solicitation agreements that could affect its directors or officers[79] - The Company has not been notified of any inventorship challenges regarding its patents[80] - The Company will use the Net Proceeds as described in the Prospectus for its intended purposes[91] - The Company will not offer to sell or dispose of any shares of Common Stock during specified trading days without prior written consent from the Agent[91] - The Company will cooperate with due diligence reviews conducted by the Agent and provide necessary information and documents[94] - The Company agrees to file a prospectus supplement detailing the number of Placement Shares sold and the Net Proceeds to the Company[95] - The Company will maintain insurance covering risks that are reasonable and customary for its business[102] - The Company will ensure compliance with all applicable laws and maintain necessary permits[103] - The Company will conduct its affairs to avoid being classified as an "investment company" under the Investment Company Act[104] - The Company will maintain accurate books and records and internal accounting controls in accordance with GAAP[109] - The Company will provide Comfort Letters from its independent registered public accounting firm as required[99] - The Company will not engage in activities that could manipulate the price of its securities[101] - The Company will file a new shelf registration statement if any Placement Shares remain unsold by the third anniversary of the initial effective date[110] - The Company must notify the Agent if it is no longer eligible to use Form S-3 and file a new prospectus supplement within two business days[111] - The Company will indemnify the Agent against any documentary, stamp, or similar issue tax related to the sale of Placement Shares[113] - The Registration Statement must be effective for all offers and sales of Placement Shares issued pursuant to prior Placement Notices[114] - The Company is required to file the Prospectus Supplement with the Commission no later than the close of business on the second business day following the date of the Agreement[115] - The Company must ensure that no material adverse changes occur that could affect the offering of Placement Shares[119] - The Agent must receive legal opinions and comfort letters from Company Counsel and Agent's Counsel as required[120][121][122] - The Common Stock must be duly listed and authorized for trading on Nasdaq without any suspension[124] - All required filings with the Commission must be made prior to the issuance of any Placement Notice[127] - The Placement Shares must be approved for listing on Nasdaq or an application must be filed prior to the First Placement Notice Date[128] - The Company reported a Material Adverse Effect that may impair the ability to sell Placement Shares[138] - The Company must deliver required certifications and opinions within 15 calendar days to avoid termination by the Agent[138] - The Agent has the right to terminate the Agreement if trading in Placement Shares is suspended or limited on Nasdaq[138] - The Company can terminate the Agreement at its discretion with 10 days' prior notice[139] - The Agreement will automatically terminate upon the issuance and sale of all Placement Shares[142] - The Company is obligated to reimburse the Agent's expenses even after termination[144] - All indemnity and contribution agreements will survive regardless of investigations or delivery of Placement Shares[137] - The Agent is not liable for any settlement without its written consent[135] - The Company and the Agent will contribute to losses in proportion to the benefits received from the sale of Placement Shares[135] - Notices must be delivered in writing and can be sent electronically to specified addresses[145] - The Company will pay Leerink Partners a cash compensation equal to 3.0% of the gross proceeds from the sales of Placement Shares[175] - The Agreement constitutes the entire agreement and supersedes all prior agreements regarding the subject matter[151] - The Agent may assign its rights and obligations to an affiliate without the Company's consent, provided the affiliate is a registered broker-dealer[148] - All stock-related numbers in the Agreement will be adjusted for any stock split or similar event[149] - The Agreement is governed by the laws of the State of New York[152] - The Company acknowledges that no fiduciary or advisory relationship has been created with the Agent[160] - The Company is capable of evaluating and understanding the terms, risks, and conditions of the transactions contemplated by the Agreement[160] - The Agent may not provide any information gained in connection with the Agreement to any third party without the Company's written consent[163] - The Agreement may be executed in multiple counterparts, each of which is deemed an original[162] - The Company waives any claims against the Agent for breach of fiduciary duty in connection with the transactions contemplated by the Agreement[160] - The Company has complied with all agreements and satisfied all conditions under the Sales Agreement as of the date hereof[178] - There has been no material adverse change in the Company's financial condition or prospects since the date of the Prospectus[180] - The maximum amount of Placement Shares authorized for sale has been duly approved by the Company's board of directors[181]

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]

Financial Performance - The company reported grant revenue of $1.9 million for the three months ended March 31, 2025, a decrease of 18% from $2.3 million in the same period of 2024[128]. - The total operating expenses for the three months ended March 31, 2025, were $7.2 million, reflecting a 46% increase from $4.9 million in the prior year[128]. - The net loss for the three months ended March 31, 2025, was $4.9 million, a 95% increase from a net loss of $2.5 million in the same period of 2024[128]. - Interest income for the three months ended March 31, 2025, was $0.4 million, a 407% increase from $0.1 million in the same period of 2024[133]. - For the three months ended March 31, 2025, net cash used in operating activities was $3.9 million, compared to $1.4 million for the same period in 2024, reflecting an increase in operational losses[140][142]. - The net cash outflow from operations for the three months ended March 31, 2025, was primarily due to a net loss of $4.9 million[141]. Research and Development - Research and development expenses increased by 72% to $4.8 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024[130]. - The ongoing RewinD-LB Trial is a Phase 2b study involving 159 participants with DLB, primarily funded by a $21.3 million grant from the NIA[114]. - The company expects to report 32-week results from the Extension of the RewinD-LB Trial in the second half of 2025[114]. - The company plans to initiate a Phase 2 trial evaluating neflamapimod in up to 90 participants recovering from ischemic stroke in the second quarter of 2025[115]. - The company anticipates continued increases in research and development expenses, general and administrative expenses, and capital expenditures, with ongoing losses expected for the foreseeable future[137]. Financial Position - As of March 31, 2025, the company had cash and cash equivalents and marketable securities of approximately $35.2 million[116]. - The accumulated deficit as of March 31, 2025, was $75.6 million, with the company having never been profitable[117]. - Cash used in investing activities for the three months ended March 31, 2025, was $5.4 million due to the purchase of marketable securities[144]. - The company expects to fund its operations and capital expenditures for at least twelve months from March 31, 2025, based on current cash and marketable securities[138]. Financing and Commitments - The company completed a private placement on April 1, 2024, raising approximately $50.0 million, with potential additional gross proceeds of up to $99.4 million from Series A Warrants[135]. - The company will continue to seek additional financing through equity offerings, debt financings, or other capital sources to support its operations and product development[138]. - The company has entered into contracts for clinical trials and manufacturing, with potential future commitments based on service timing[147]. - The company has no off-balance sheet arrangements that could materially affect its financial condition[148]. Accounting Policies - The company does not expect any material changes to its critical accounting policies and estimates for the three months ended March 31, 2025[149].

Core Insights - CervoMed Inc. reported positive 16-week results from the extension phase of the Phase 2b RewinD-LB trial, indicating proof-of-concept for neflamapimod as a potential treatment for dementia with Lewy bodies (DLB) [1][2] - The company plans to initiate a Phase 3 trial of neflamapimod in DLB in mid-2026 after discussions with regulatory authorities [1][2] - CervoMed is also starting separate Phase 2a trials to evaluate neflamapimod in patients with primary progressive aphasia and those recovering from ischemic stroke [1][2] Recent Highlights and Anticipated Milestones - The 16-week results from the RewinD-LB trial showed a significant improvement in the Clinical Dementia Rating Sum of Boxes (CDR-SB) with p<0.001 compared to old capsules and p=0.003 versus placebo [4] - Full results were presented at the 19th International Conference on Alzheimer's and Parkinson's Diseases in April 2025, with 32-week results expected in the second half of 2025 [4] - Initial safety and pharmacokinetic data from an ongoing trial in patients with mild-to-moderate DLB are anticipated in Q4 2025 [4] Financial Overview - As of March 31, 2025, CervoMed had approximately $35.2 million in cash and marketable securities, down from $38.9 million at the end of 2024 [4][5] - Grant revenue for Q1 2025 was approximately $1.9 million, a decrease from $2.3 million in the same period in 2024, attributed to the transition of the RewinD-LB trial [6] - Research and development expenses increased to approximately $4.8 million in Q1 2025 from $2.8 million in 2024, driven by various clinical activities [7] Operational Metrics - General and administrative expenses rose to approximately $2.4 million in Q1 2025 from $2.1 million in the same period in 2024 [8] - The net loss for Q1 2025 was approximately $4.9 million, compared to a net loss of approximately $2.5 million in Q1 2024 [8][16] - The company reported a net loss per share of $0.56 for Q1 2025, compared to $0.41 for the same period in 2024 [16]

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]