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]

Core Insights - Neflamapimod has shown a clinically meaningful effect in slowing the progression of dementia with Lewy bodies (DLB) during the Extension phase of the RewinD-LB clinical study [1][2][3] - The study results will be presented at the AD/PD™ 2025 conference, highlighting improvements in cognitive fluctuations and working memory [1][2] - CervoMed Inc. is focused on developing neflamapimod as a transformative therapy for DLB, with plans for pivotal development following the completion of the study [2][7] Study Overview - The RewinD-LB study involved 159 participants, with 152 completing the initial phase and 149 entering the Extension phase where all received neflamapimod [3][6] - The study is a randomized, double-blind, placebo-controlled trial evaluating neflamapimod (40mg TID) over a total of 48 weeks [6][8] - The primary outcome measure is the change in Clinical Dementia Rating Sum of Boxes (CDR-SB), with secondary endpoints including the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC) [6][8] Results and Findings - The New Capsules of neflamapimod achieved target plasma drug concentrations, leading to significant clinical outcomes compared to the Old Capsules and placebo [4][9] - Participants receiving New Capsules showed a mean improvement of 0.73 points in CDR-SB compared to Old Capsules, and 0.81 points in those without Alzheimer's disease co-pathology [9] - The incidence of clinically meaningful worsening was 40% lower in New Capsule recipients compared to Old Capsules, and 62% lower in participants without Alzheimer's co-pathology [9] Safety and Tolerability - Both Old and New Capsules exhibited similar safety and tolerability profiles, with no new safety signals identified during the Extension phase [6][9] - The New Capsules resulted in a lower incidence of falls (4% vs. 15.2% with Old Capsules) during the Extension phase [9] Future Plans - CervoMed aims to complete the full 32-week Extension phase and engage with regulatory authorities to finalize Phase 3 plans for neflamapimod [7]

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].

Group 1 - Initial results from CervoMed's Phase 2b study in Dementia With Lewy Bodies did not show a statistically significant change on the study's primary endpoint [1] - The company attributed the lack of significant results to an old batch of neflamapimod [1]

Financial Performance - CervoMed reported a net loss of approximately $16.3 million for the year ended December 31, 2024, compared to a net loss of approximately $2.2 million for the same period in 2023, reflecting a significant increase in losses [9]. - The operating loss for 2024 was approximately $18.2 million, compared to an operating loss of approximately $7.8 million in 2023 [8]. - General and administrative (G&A) expenses increased to approximately $9.2 million in 2024 from approximately $6.5 million in 2023, driven by higher legal and public relations costs [7]. Research and Development - Research and development (R&D) expenses for 2024 were approximately $18.8 million, up from approximately $8.4 million in 2023, primarily due to increased costs associated with the RewinD-LB trial [6]. - CervoMed aims to initiate a Phase 2a trial for neflamapimod in frontotemporal dementia in mid-2025, following FDA Orphan Drug designation [3]. - The company plans to report 32-week results from the RewinD-LB trial in the second half of 2025, following positive 16-week results [3]. Revenue and Funding - Grant revenue for the year was approximately $9.7 million, an increase from approximately $7.1 million in 2023, attributed to a larger number of active trial sites [5]. - CervoMed's cash position improved to approximately $38.9 million as of December 31, 2024, compared to $7.8 million at the end of 2023, enabling funding for operations into mid-2026 [4]. Recognition and Leadership - The company received the 2024 Prix Galien USA Award as "Best Startup," highlighting its innovative contributions to life sciences [3]. - CervoMed's leadership team expanded with new appointments, enhancing its strategic capabilities [3].

Merger and Corporate Structure - On August 16, 2023, the merger between Diffusion Pharmaceuticals Inc. and EIP Pharma, Inc. was completed, resulting in the formation of CervoMed Inc.[16] - The merger between Diffusion Pharmaceuticals Inc. and EIP Pharma, Inc. was completed on August 16, 2023, with EIP becoming a wholly-owned subsidiary of the newly named CervoMed Inc.[16] - Following the merger, a reverse stock split was executed at a ratio of 1-for-1.5, affecting the common stock of the company[16] - A reverse stock split was executed at a ratio of 1-for-1.5, retroactively affecting share and per share figures based on the exchange ratio of 0.1151[16][18]. Clinical Trials and Research - The ongoing RewinD-LB Trial, evaluating neflamapimod for treating dementia with Lewy bodies, was initiated in the second quarter of 2023[21]. - The RewinD-LB Trial, an ongoing Phase 2b clinical trial evaluating neflamapimod for dementia with Lewy bodies, was initiated in the second quarter of 2023[21]. - The company plans to initiate the Restore Trial, a Phase 2 clinical trial for patients recovering from ischemic stroke, in the second quarter of 2025[21]. - The Restore Trial, a Phase 2 clinical trial for patients recovering from ischemic stroke, is expected to begin in the second quarter of 2025[21]. - The company anticipates that the results of the RewinD-LB Trial will be reported in December 2024[21]. Financial Support and Planning - The company 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 and an additional $0.3 million in August 2024[21]. - Future obligations under the Vertex Agreement are a consideration for the company's financial planning[25]. - The company is actively managing its cash balances and exploring additional financing options to support its operations and growth[25]. Regulatory and Operational Considerations - The company is focused on obtaining and maintaining regulatory approval for its product candidates, which is critical for future commercialization[25]. - The company emphasizes the importance of obtaining and maintaining regulatory approval for its product candidates[25]. - The performance of third parties, including contract research organizations and manufacturers, is critical to the company's operational success[25]. - The company acknowledges the risks associated with forward-looking statements, including uncertainties in clinical trial outcomes and regulatory approvals[23]. - The company acknowledges that actual results may differ materially from forward-looking statements due to known and unknown factors[26]. - The company has no obligation to update forward-looking statements unless required by law, highlighting the inherent risks and uncertainties in its projections[23]. - There is no obligation to update forward-looking statements after the date of the Annual Report, except as required by law[27]. - Historical data comparisons are not intended to indicate future performance trends unless explicitly stated[27]. - The company anticipates challenges in recruiting participants for clinical trials and maintaining adequate drug supply[25].

Core Insights - CervoMed Inc. reported positive results from the 16-week extension phase of the Phase 2b RewinD-LB trial for neflamapimod in dementia with Lewy bodies (DLB), indicating proof-of-concept for the treatment [1][2] - The company plans to initiate a Phase 3 trial in mid-2026 after discussions with regulatory authorities [1] - CervoMed was awarded the 2024 Prix Galien USA Award as "Best Startup" by the Galien Foundation [1] Financial Performance - As of December 31, 2024, CervoMed had approximately $38.9 million in cash, cash equivalents, and marketable securities, a significant increase from $7.8 million as of December 31, 2023, primarily due to proceeds from a private placement [4] - Grant revenue for the twelve months ended December 31, 2024, was approximately $9.7 million, up from $7.1 million in 2023, attributed to increased services performed during the RewinD-LB trial [6] - Research and Development (R&D) expenses rose to approximately $18.8 million in 2024 from $8.4 million in 2023, driven by increased costs related to the RewinD-LB trial [7] - General and Administrative (G&A) expenses increased to approximately $9.2 million in 2024 from $6.5 million in 2023, due to various factors including increased headcount and public company expenses [8] - The operating loss for the twelve months ended December 31, 2024, was approximately $18.2 million, compared to $7.8 million in 2023 [9] - The net loss for the same period was approximately $16.3 million, significantly higher than the net loss of approximately $2.2 million in 2023 [10] Clinical Development and Milestones - The 16-week results from the RewinD-LB trial will be presented at the 19th International Conference on Alzheimer's and Parkinson's Diseases in April 2025 [5] - The company expects to report results from the 32-week extension phase of the RewinD-LB trial in the second half of 2025 [5] - Initial safety and pharmacokinetic data from an ongoing trial in patients with mild-to-moderate DLB is anticipated in the fourth quarter of 2025 [5] - CervoMed plans to advance neflamapimod development in additional diseases, including initiating a Phase 2a trial for frontotemporal dementia in mid-2025 and a Phase 2 Restore Trial for ischemic stroke recovery in the second quarter of 2025 [5]