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]

Core Insights - CervoMed Inc. announced positive results from the first 16 weeks of the extension phase of the Phase 2b RewinD-LB study of neflamapimod for dementia with Lewy bodies (DLB), showing significant improvements in clinical measures compared to both old capsules and placebo [1][2][10] Study Overview - The RewinD-LB study included 159 participants in the initial phase, with 152 completing it and 149 entering the extension phase where all received neflamapimod [3][4] - The study is funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging [14] Clinical Results - The new batch of neflamapimod capsules led to increased plasma drug concentrations, with a mean trough concentration of 5.1 ng/mL compared to 4.0 ng/mL for old capsules [8] - Significant improvement was observed in the Clinical Dementia Rating Sum of Boxes (CDR-SB) with a difference of -0.73 (p<0.001) between new and old capsules [10] - The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC) showed improved scores with new capsules (4.02 vs. 4.46, p=0.035) [10] Safety and Tolerability - Both old and new capsules demonstrated comparable tolerability profiles, with no new safety signals identified during the extension phase [10] - The incidence of falls was lower in participants receiving new capsules (7.4% vs. 14.5% for old capsules, p=0.025) [10] Future Plans - CervoMed plans to engage with regulatory authorities to discuss advancing neflamapimod through Phase 3 and the regulatory approval process [2][10] - The results from the extension phase will be presented at the International Conference on Alzheimer's and Parkinson's Diseases in April 2025 [11]

Core Insights - CervoMed Inc. is advancing its neflamapimod development program for dementia with Lewy bodies (DLB), with key data expected in Q1 2025 from the open-label extension phase of the RewinD-LB trial [1][3] - The company believes neflamapimod may have therapeutic potential for DLB, based on clinical and safety data from the double-blind phase of the study [3][5] - DLB affects approximately 700,000 individuals in both the U.S. and the European Union, and there are currently no FDA or EMA approved treatments for this condition [4] Company Overview - CervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders, specifically targeting synaptic dysfunction [8] - Neflamapimod is an investigational drug designed to inhibit the alpha isoform of p38MAP kinase, with previous studies indicating its potential to improve dementia severity and cognitive function in early-stage DLB patients [6][8] Clinical Trial Details - The RewinD-LB trial is a randomized, 16-week, double-blind, placebo-controlled study involving 159 early-stage DLB participants, with primary and secondary endpoints focused on cognitive and motor functions [7] - The trial is funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging, with data from the first 16 weeks of the open-label extension phase expected in Q1 2025 [7] Pharmacokinetic Findings - Recent pharmacokinetic data from a food-effect study in healthy volunteers indicates that newer capsules of neflamapimod achieved targeted mean plasma concentrations [1][5] - A within-subject comparison showed that participants receiving the newer batch of capsules achieved better plasma concentrations compared to those who received older capsules during the double-blind phase [1][5]

Core Insights - CervoMed Inc. is set to present topline results from the Phase 2b RewinD-LB study at the 8th International Lewy Body Dementia Conference in Amsterdam on January 31, 2025 [1] - The study focuses on the efficacy and safety of neflamapimod in treating dementia with Lewy bodies [2] - Neflamapimod is an investigational drug designed to inhibit p38 mitogen-activated protein kinase alpha, potentially addressing synaptic dysfunction in age-related neurologic disorders [3] Presentation Details - The presentation will be titled "Efficacy and safety results of the RewinD-LB phase 2b clinical trial of neflamapimod in dementia with Lewy bodies (DLB)" [2] - It will be delivered by John Alam, MD, who is the CEO of CervoMed and Co-Principal Investigator of the study [2] - The session is scheduled for January 31, 2025, at 13:30 CET / 7:30 ET [2] Company Overview - CervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders [3] - The company is currently advancing neflamapimod, which is an orally administered small molecule aimed at treating neurodegenerative processes [3]

Core Insights - CervoMed Inc. has granted equity awards to two new employees as a material inducement for their employment [1][2] - The company is focused on developing treatments for age-related neurologic disorders, specifically through its investigational drug neflamapimod [3] Summary by Sections Equity Awards - On December 6, 2024, CervoMed granted options to purchase a total of 14,753 shares of common stock to two new employees, with an exercise price of $11.91, which is the closing price on the grant date [2] - The options will vest in 36 equal installments over three years, contingent on the employees' continued employment [2] Company Overview - CervoMed Inc. is a clinical-stage company dedicated to developing treatments for age-related neurologic disorders [3] - The company is currently working on neflamapimod, an orally administered small molecule designed to inhibit p38 mitogen-activated protein kinase alpha, which may address synaptic dysfunction in neurodegenerative diseases [3]

Core Insights - CervoMed Inc. has received Orphan Drug Designation from the FDA for its investigational drug neflamapimod, aimed at treating frontotemporal dementia (FTD), highlighting the significant unmet medical need in this area [1][2] - The company is preparing to report topline data from the RewinD-LB Phase 2b clinical trial for dementia with Lewy bodies (DLB) in December 2024, with plans to advance to a Phase 3 trial in mid-2025 [1][4] Company Overview - CervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders, specifically targeting synaptic dysfunction associated with neurodegenerative diseases [5][6] - The company is currently developing neflamapimod, an orally administered small molecule that inhibits p38MAP kinase alpha, which has shown promise in improving dementia severity and functional mobility in clinical studies [4][6] Disease Context - Frontotemporal dementia is a rare neurodegenerative disease affecting approximately 50,000 to 60,000 individuals in the U.S. and around 110,000 in the European Union, with no approved treatment options available [3] - FTD is characterized by significant neuronal loss in the frontal and temporal regions of the cortex, leading to behavioral changes and cognitive decline, typically manifesting in individuals in their 40s and 50s [3] Drug Development Insights - Neflamapimod has demonstrated positive results in preclinical and clinical studies, reversing synaptic dysfunction and improving cognitive test scores in patients with early-stage DLB [4][6] - The ongoing RewinD-LB Phase 2b study involves 159 patients and aims to evaluate the efficacy of neflamapimod, with topline results expected in December 2024 [4]

Financial Performance - CervoMed reported a net loss of approximately $4.8 million for Q3 2024, compared to a net income of approximately $2.2 million in Q3 2023[4]. - The net loss for the three months ended September 30, 2024, was $(4,753,541), a decrease from a net income of $2,150,362 in the same period of 2023[7]. - Net loss per share of common stock, diluted, was $(0.55) for the three months ended September 30, 2024, compared to $(0.70) for the same period in 2023[7]. - Total comprehensive loss for the three months ended September 30, 2024, was $(4,610,677), compared to a comprehensive income of $2,150,362 in the prior year[7]. Revenue and Income - Grant revenue for Q3 2024 was approximately $1.9 million, an increase from approximately $1.5 million in Q3 2023, attributed to more active trial sites[4]. - Grant revenue for the three months ended September 30, 2024, was $1,939,751, an increase of 27.1% compared to $1,526,482 for the same period in 2023[7]. - Interest income for the three months ended September 30, 2024, was $646,172, significantly higher than $47,667 in the same period of 2023[7]. - The company reported total other income, net, of $642,732 for the three months ended September 30, 2024, compared to $4,825,491 in the same period of 2023[7]. Expenses - Research and Development (R&D) expenses increased to approximately $5.1 million in Q3 2024, up from approximately $1.8 million in the same period in 2023[4]. - Total operating expenses for the three months ended September 30, 2024, were $7,336,024, up 74.5% from $4,201,611 in the prior year[7]. - Research and development expenses increased to $5,125,097 for the three months ended September 30, 2024, compared to $1,791,487 in the same period last year, reflecting a growth of 186.5%[7]. - Total operating expenses for the nine months ended September 30, 2024, were $18,562,282, an increase of 86.1% from $9,986,739 in the same period of 2023[7]. - General and Administrative (G&A) expenses were approximately $2.2 million in Q3 2024, slightly down from approximately $2.4 million in Q3 2023[4]. Cash and Liabilities - Cash position as of September 30, 2024, was approximately $46.7 million, down from approximately $50.9 million as of June 30, 2024[4]. - Total liabilities as of September 30, 2024, were approximately $3.2 million, compared to approximately $2.6 million at the end of 2023[6]. Clinical Trials and Recognition - CervoMed completed the last patient visit in its RewinD-LB Phase 2b clinical trial in October 2024, with topline data expected in December 2024[2]. - The RewinD-LB trial enrolled 159 patients and is funded by a $21.3 million grant from the NIA[5]. - CervoMed plans to initiate a Phase 2a trial for neflamapimod in ischemic stroke patients in Q1 2025[2]. - CervoMed was recognized as "Best Startup" in the 2024 Prix Galien USA Award by the Galien Foundation[3].

Merger and Acquisition - 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.[4] - Each outstanding share of EIP capital stock was converted into the right to receive 0.1151 shares of CervoMed common stock as part of the merger[4]. - The merger is treated as a reverse recapitalization under US GAAP, with EIP's historical results considered the Company's historical results prior to the merger[4]. - The Company completed the Merger of EIP and Merger Sub on August 16, 2023, with EIP security holders owning approximately 76% of the Company post-Merger[64]. - Total net assets assumed in the Merger amounted to $10,339,114 after deducting transaction costs of $1,548,643[65]. Financial Performance - Total current assets increased significantly to $48,809,930 as of September 30, 2024, compared to $9,964,751 on December 31, 2023[14]. - Grant revenue for the three months ended September 30, 2024, was $1,939,751, up from $1,526,482 for the same period in 2023, representing a year-over-year increase of 27.1%[15]. - Total operating expenses for the nine months ended September 30, 2024, were $18,562,282, compared to $9,986,739 for the same period in 2023, reflecting an increase of 86.2%[15]. - The net loss for the three months ended September 30, 2024, was $(4,753,541), compared to a net income of $2,150,362 for the same period in 2023[15]. - The accumulated deficit increased to $(64,025,570) as of September 30, 2024, from $(54,440,789) at the end of 2023[14]. - Total stockholders' equity rose to $45,637,496 as of September 30, 2024, compared to $7,376,774 on December 31, 2023[14]. - The net loss for the nine months ended September 30, 2024, was $9,584,781, compared to a net income of $190,525 for the same period in 2023[22]. - The company generated negative cash flows from operations, with net cash used in operating activities amounting to $8,479,909 for the nine months ended September 30, 2024[22]. - The company reported a net unrealized gain on marketable securities of $142,864 for the three months ended September 30, 2024[15]. - The company reported stock-based compensation expense of $1,068,011 for the nine months ended September 30, 2024[22]. Research and Development - 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 and an additional $0.3 million in August 2024[7]. - The company initiated the Phase 2b clinical trial, RewinD-LB, in the second quarter of 2023, evaluating neflamapimod for Early-Stage DLB[9]. - Research and development expenses for the nine months ended September 30, 2024, were $11,711,746, significantly higher than $5,583,149 for the same period in 2023, indicating a focus on innovation[15]. - The company is focused on developing its lead drug candidate, neflamapimod, which is currently in a Phase 2b study funded by a $21.3 million grant from the NIA[24]. - Research and development costs are expensed as incurred, primarily for new product development, including salaries, benefits, and third-party fees[40]. Risks and Uncertainties - CervoMed's future performance may be influenced by various risks, including regulatory approvals and market acceptance of its product candidates[10]. - The company is subject to risks that could materially affect its financial condition and future operations, including the success of its research and development efforts[26]. - The company anticipates ongoing clinical trials and research and development activities to enhance its product pipeline and market position[9]. - CervoMed's financial condition and liquidity are subject to various risks and uncertainties, including market conditions and regulatory developments[10]. Funding and Capital Structure - CervoMed's 2024 Private Placement raised approximately $149.4 million, consisting of 2,532,285 units, each including one share of common stock or one Pre-Funded Warrant and one Series A Warrant[6]. - The company raised $46,398,606 from the sale of common stock and warrants during the financing activities[22]. - The company has a plan to fund operations for at least twelve months based on existing cash and marketable securities, but will require additional financing for ongoing development[25]. - The company intends to seek funds through equity offerings, debt financings, or other capital sources to support its operations[25]. Stock and Equity - The weighted average shares outstanding for basic net loss per share was 8,702,764 for the three months ended September 30, 2024, compared to 3,308,302 for the same period in 2023[15]. - The diluted net loss per share for the three months ended September 30, 2024 was $(0.55), while it was $(0.70) for the same period in 2023[57]. - The company had 2,532,285 Series A Warrants outstanding with an exercise price of $39.24, set to expire upon the fulfillment of certain conditions[91]. - As of September 30, 2024, the company had 533,159 stock options outstanding with a weighted average exercise price of $21.23[98]. - Stock-based compensation expense for the nine months ended September 30, 2024, totaled $1,068,011, significantly higher than $242,660 for the same period in 2023, indicating a substantial increase of 341.5%[97]. Compliance and Internal Controls - The company aims to maintain compliance with Nasdaq listing requirements and other regulatory obligations[10]. - The company is actively working to remediate previously disclosed material weaknesses in its internal controls over financial reporting[10]. - The company has fully offset its net deferred tax assets with a valuation allowance due to historical operating performance and cumulative net losses[53].

Core Viewpoint - CervoMed Inc. is advancing its clinical trial for neflamapimod in early-stage dementia with Lewy bodies (DLB), with topline data expected in December 2024, while also preparing for a Phase 3 trial and exploring additional indications for the drug [1][2][10]. Clinical Development - The final patient visits in the RewinD-LB Phase 2b trial were conducted in October 2024, with database lock planned for the fourth quarter [2][3]. - A Phase 2a trial to evaluate neflamapimod's potential for ischemic stroke recovery is set to begin in Q1 2025 following ethics committee approval [2]. - CervoMed hosted a virtual event in July 2024 to discuss neflamapimod's potential in treating early-stage DLB, featuring expert presentations [3]. Financial Performance - As of September 30, 2024, CervoMed reported approximately $46.7 million in cash and equivalents, down from $50.9 million as of June 30, 2024, but up from $7.8 million at the end of 2023 [4]. - Grant revenue for Q3 2024 was approximately $1.9 million, an increase from $1.5 million in Q3 2023, attributed to more active trial sites [5]. - Research and development expenses surged to approximately $5.1 million in Q3 2024, compared to $1.8 million in the same period in 2023, due to increased costs associated with the RewinD-LB trial [6]. - General and administrative expenses slightly decreased to approximately $2.2 million in Q3 2024 from $2.4 million in Q3 2023 [7]. - The operating loss for Q3 2024 was approximately $5.4 million, compared to $2.7 million in Q3 2023, while the net loss was approximately $4.8 million, a significant drop from a net income of $2.2 million in the prior year [8][9]. Research Highlights - CervoMed was recognized as "Best Startup" at the 2024 Prix Galien USA Award, highlighting its innovative contributions to life sciences [3]. - Presentations at the Clinical Trials on Alzheimer's Disease Conference indicated that neflamapimod positively affected plasma glial fibrillary acid protein levels, a key marker in neurodegenerative diseases [3]. - The RewinD-LB study involved 159 patients and is funded by a $21.3 million grant from the National Institute on Aging [10].