Core Insights - The Phase 2b RewinD-LB trial of neflamapimod showed significant improvements in primary and key secondary outcomes, particularly in patients without Alzheimer's disease (AD) co-pathology [1][2] - Neflamapimod demonstrated a significant reduction in the neurodegeneration biomarker GFAP, indicating its potential to target the underlying mechanisms of dementia with Lewy bodies (DLB) [1][10] - CervoMed plans to initiate a Phase 3 registrational trial for neflamapimod in DLB patients in the second half of 2026 [1][9] Trial Results - The RewinD-LB trial included a randomized phase comparing neflamapimod to placebo, followed by an open-label extension phase [3][7] - In the extension phase, participants receiving a new batch of neflamapimod capsules achieved target plasma concentration levels, leading to significant improvements in clinical outcomes [4][5] - The primary endpoint, CDR-SB, showed a mean change that was 52% lower with the new batch compared to the initial batch, and 82% lower in patients without AD co-pathology [5][10] Safety and Tolerability - Neflamapimod was well-tolerated, with a low treatment discontinuation rate over 48 weeks [6][10] - Discontinuation due to liver enzyme elevation was 2.5% in the initial phase and 1.3% in the extension phase, with all events being reversible [6][10] Company Overview - CervoMed is a clinical-stage company focused on developing treatments for age-related brain disorders, with neflamapimod as its lead candidate [9][11] - The company aims to address critical disease processes underlying degenerative brain disorders through neflamapimod, which inhibits a key enzyme involved in neuroinflammation [9][11] Disease Context - Dementia with Lewy bodies (DLB) is the second most common progressive dementia after Alzheimer's, with no approved treatments available in the U.S. or EU [8][9] - DLB typically progresses more rapidly than Alzheimer's, often requiring nursing-home care within two years of diagnosis [8][9]

Core Insights - CervoMed Inc. presented data from the Phase 2b RewinD-LB trial at the CTAD Conference, showing that neflamapimod treatment significantly reduced plasma GFAP levels and increased the A42/40 ratio, indicating potential therapeutic effects in dementia with Lewy bodies (DLB) [1][2][3] Company Overview - CervoMed is a clinical-stage biotechnology company focused on developing treatments for age-related brain disorders, with neflamapimod as its lead candidate targeting neuroinflammation and neurodegeneration [9][10] Clinical Trial Details - The RewinD-LB Phase 2b study included a randomized phase comparing neflamapimod to placebo, followed by an open-label extension phase, with a total of 159 participants [7][5] - The trial was funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging [7] Biomarker Findings - The reduction in plasma GFAP levels during the extension phase was significant, with a median change of -16.0 pg/mL, and a correlation was found between GFAP reduction and clinical improvement as measured by CDR-SB [11] - The A42/40 ratio also significantly increased during treatment, suggesting a positive effect on neuroinflammation and amyloidogenesis [11] Disease Context - DLB is the second most common progressive dementia after Alzheimer's disease, affecting millions globally, with no approved treatments available in the U.S. or EU [8][3] - The disease progresses more rapidly than Alzheimer's, with an average time from diagnosis to nursing home care being two years [3] Future Directions - CervoMed plans to initiate a global Phase 3 trial for neflamapimod in DLB patients in the second half of 2026, building on the promising results from the Phase 2b trial [9][12]

Late-breaking oral presentation by a leading global authority in Dementia with Lewy bodies (DLB) to highlight updated data from Phase 2b study on neflamapimod treatment for DLB New data demonstrating the utility of neflamapimod and its effects on key neurodegeneration biomarkers in DLB will also be highlighted in poster session BOSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced ...

Financial Performance - As of September 30, 2025, CervoMed had approximately $27.3 million in cash, cash equivalents, and marketable securities, down from $38.9 million as of December 31, 2024, indicating a decrease of about 29.1%[4] - Grant revenue for the three months ended September 30, 2025, was approximately $0.3 million, a significant decrease of 84.2% compared to approximately $1.9 million for the same period in 2024[5] - The net loss for the three months ended September 30, 2025, was approximately $7.7 million, compared to a net loss of approximately $4.8 million for the same period in 2024, representing an increase of 60.4%[8] - Grant revenue for Q2 2025 was $322,569, compared to $1,939,751 in Q2 2024, representing a significant decline[17] - Net loss for Q2 2025 was $7,726,639, compared to a net loss of $4,753,541 in Q2 2024, indicating an increase in losses of about 62.5%[17] - Total comprehensive loss for the first half of 2025 was $18,929,450, compared to $9,461,619 in the first half of 2024, indicating a year-over-year increase of approximately 99.5%[17] Expenses - Research and Development (R&D) expenses for the quarter ended September 30, 2025, were approximately $6.0 million, an increase of 17.6% from approximately $5.1 million in the same period in 2024[7] - General and Administrative (G&A) expenses were approximately $2.3 million during the three months ended September 30, 2025, compared to approximately $2.2 million in the same period in 2024, reflecting a slight increase of 4.5%[8] - Total operating expenses increased to $8,366,768 in Q2 2025 from $7,336,024 in Q2 2024, a rise of approximately 14.1%[17] - Research and development expenses rose to $6,040,442 in Q2 2025 from $5,125,097 in Q2 2024, an increase of approximately 17.9%[17] - General and administrative expenses increased to $2,326,326 in Q2 2025 from $2,210,927 in Q2 2024, an increase of approximately 5.2%[17] Clinical Trials and Developments - CervoMed reported a 64% risk reduction in clinically significant worsening in patients treated with neflamapimod compared to control over 32 weeks, with a p-value of less than 0.001[6] - The company plans to initiate a global pivotal Phase 3 trial for neflamapimod in DLB patients in the second half of 2026, following alignment with the FDA on trial design[3] - Initial biomarker data from a Phase 2a trial in a subtype of frontotemporal dementia (FTD) and topline results from a Phase 2a trial in recovery after stroke are expected in 2026[1] - CervoMed's recent Phase 2b RewinD-LB trial demonstrated a durable beneficial effect on clinical progression and substantial reductions in plasma levels of a biomarker of neurodegeneration[2] Management Changes - The company appointed Matthew Winton, Ph.D., as Chief Commercial and Business Officer and David Quigley to its Board of Directors in October 2025[6] Shareholder Information - Net loss per share for Q2 2025 was $0.84, compared to $0.55 in Q2 2024, reflecting a deterioration in per-share performance[17] - Weighted average shares outstanding increased to 9,252,719 in Q2 2025 from 8,702,764 in Q2 2024, a growth of about 6.3%[17] Other Income - Interest income decreased to $318,787 in Q2 2025 from $646,172 in Q2 2024, a decline of about 50.7%[17] - Total other income, net for Q2 2025 was $317,560, down from $642,732 in Q2 2024, a decrease of about 50.6%[17]

Core Insights - CervoMed has aligned with the FDA on the design of a planned Phase 3 clinical trial for neflamapimod in patients with dementia with Lewy bodies (DLB), indicating progress in regulatory discussions and trial preparations [1][3] - The Phase 2b RewinD-LB trial results showed a 64% risk reduction in clinically significant worsening of DLB symptoms over 32 weeks, highlighting the drug's potential efficacy [2][3] - The company plans to initiate a global pivotal trial in the second half of 2026, with additional biomarker data from ongoing trials expected in 2026 [1][3] Clinical Development Updates - CervoMed reported that the 32-week treatment data from the RewinD-LB trial demonstrated a durable beneficial effect on clinical progression and significant reductions in plasma levels of a neurodegeneration biomarker [1][2] - The FDA's feedback on the trial design supports the proposed endpoints and patient enrichment strategy, which are crucial for a potential New Drug Application [3] - Initial biomarker data from a Phase 2a trial in frontotemporal dementia (FTD) and topline results from a recovery after stroke trial are anticipated in 2026 [1][3] Financial Performance - As of September 30, 2025, CervoMed had approximately $27.3 million in cash and equivalents, down from $38.9 million at the end of 2024, which is expected to fund operations into the third quarter of 2026 [5] - Grant revenue for the three months ended September 30, 2025, was approximately $0.3 million, a decrease from $1.9 million in the same period in 2024, attributed to the completion of the initial phase of the RewinD-LB trial [6] - Research and Development (R&D) expenses increased to approximately $6.0 million for the quarter, compared to $5.1 million in the same period in 2024, primarily due to higher personnel and consulting costs [7] Operational Highlights - CervoMed appointed Matthew Winton, Ph.D., as Chief Commercial and Business Officer and David Quigley to its Board of Directors in October 2025, indicating a strengthening of its leadership team [4] - The company’s lead drug candidate, neflamapimod, is designed to target neuroinflammation and neurodegeneration, with potential applications in DLB, recovery after ischemic stroke, and frontotemporal dementia [9][10]

Core Insights - CervoMed Inc. reported a quarterly loss of $0.84 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.68, and a decline from a loss of $0.55 per share a year ago, indicating a significant earnings surprise of -23.53% [1] - The company generated revenues of $0.32 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 69.24%, and a decrease from $1.94 million in the same quarter last year [2] - CervoMed Inc. shares have increased approximately 211.5% year-to-date, significantly outperforming the S&P 500's gain of 14.3% [3] Financial Performance - Over the last four quarters, CervoMed has surpassed consensus EPS estimates only once, while it has topped consensus revenue estimates three times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.65 on revenues of $0.9 million, and for the current fiscal year, it is -$2.58 on revenues of $5.12 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which CervoMed belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked using tools like the Zacks Rank [5][6]

Financial Position - The company has approximately $27.3 million in cash and cash equivalents and marketable securities as of September 30, 2025[120]. - As of September 30, 2025, the company does not believe its existing cash and cash equivalents will fund operations for at least twelve months, raising substantial doubt about its ability to continue as a going concern[154]. - The company completed a private placement in April 2024, raising approximately $50.0 million, with potential additional proceeds of up to $99.4 million from warrant exercises[150]. Revenue and Grant Funding - The accumulated deficit as of September 30, 2025, is $89.6 million, with a net loss of $18.9 million for the nine months ended September 30, 2025[121]. - Grant funding recognized for the nine months ended September 30, 2025, was $4.0 million, compared to $7.6 million for the same period in 2024[123]. - Grant revenue decreased to $0.3 million for the three months ended September 30, 2025, down from $1.9 million in 2024, representing an 83% decline[132]. - For the nine months ended September 30, 2025, grant revenue was $4.0 million, down 47% from $7.6 million in 2024[141]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, increased to $8.4 million, a 14% rise from $7.3 million in 2024[131]. - Total operating expenses for the nine months ended September 30, 2025, were $24.0 million, a 29% increase from $18.6 million in 2024[140]. - Research and development expenses rose to $6.0 million for the three months ended September 30, 2025, an 18% increase from $5.1 million in 2024[135]. - Research and development expenses for the nine months ended September 30, 2025, totaled $16.0 million, a 37% increase from $11.7 million in 2024[145]. Net Loss - Net loss for the three months ended September 30, 2025, was $7.7 million, a 63% increase compared to a net loss of $4.8 million in 2024[131]. - The net loss for the nine months ended September 30, 2025, was $18.9 million, up from a net loss of $9.6 million in the same period of 2024, indicating a 97% increase in losses[158][159]. Cash Flow - For the nine months ended September 30, 2025, net cash used in operating activities was $16.9 million, compared to $8.5 million for the same period in 2024, representing a 99% increase in cash outflow[157][158]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $4.6 million, a significant decrease from $46.4 million in the same period of 2024, reflecting a decline of 90%[161]. - Cash used in investing activities for the nine months ended September 30, 2025, was $12.7 million, down from $38.0 million in the same period of 2024, showing a reduction of 66%[160]. Clinical Trials and Research - The RewinD-LB Trial demonstrated a 54% risk reduction in clinically significant worsening compared to control at Week 32 of Batch B neflamapimod treatment (p=0.0037)[116]. - Neflamapimod has shown statistically significant improvements in primary and secondary endpoints in the RewinD-LB Trial (p < 0.001 for primary endpoint)[114]. - The company plans to initiate a Phase 3 clinical trial for neflamapimod in approximately 300 patients with DLB in the second half of 2026[117]. - The company expects topline data from the ongoing RESTORE Trial, evaluating neflamapimod in ischemic stroke recovery, in the second half of 2026[118]. - Manufacturing improvements are being implemented to ensure the stability of the drug product for the planned Phase 3 trial[119]. Future Outlook - Research and development expenses are expected to increase substantially as the company continues to invest in clinical trials and regulatory approvals[126]. - The company anticipates continued increases in research and development expenses, general and administrative expenses, and capital expenditures in the foreseeable future[153]. - The company plans to finance its cash needs through equity offerings, debt financings, or other capital sources, which may dilute existing stockholders' ownership[154]. - The company is focused on advancing its product candidates through clinical development and may require additional funds to meet operational needs[155]. Accounting Policies - There were no material changes to the company's critical accounting policies and estimates during the nine months ended September 30, 2025[165]. - The company has no off-balance sheet arrangements that could materially affect its financial condition[164].

Core Viewpoint - CervoMed has received FDA feedback that aligns with its proposed Phase 3 clinical trial design for neflamapimod, a drug targeting dementia with Lewy bodies (DLB), marking a significant step towards a potential New Drug Application submission [1][4] Phase 3 Trial Design and Regulatory Alignment - The Phase 3 trial will be a global, randomized, double-blind, placebo-controlled study involving approximately 300 DLB patients, set to begin in the second half of 2026 [2] - Patients with historical evidence of Alzheimer's disease will be excluded, and further enrichment will be achieved through a validated blood plasma test [2] - Participants will be randomized 1:1 to receive either neflamapimod or placebo for 32 weeks, followed by an additional 48-week extension with neflamapimod only [2] Primary and Secondary Endpoints - The primary endpoint will be the change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB), consistent with the recently completed Phase 2b trial [3] - Secondary endpoints will include the percentage of participants with a greater than 1.5-point increase in CDR-SB and other established cognitive and motor function measures [3] Advancing Toward Registration - CervoMed's CEO expressed satisfaction with the FDA's alignment on the trial design, emphasizing the potential of neflamapimod to transform care for DLB patients [4] - The company anticipates feedback from other global regulators and plans to provide further details on the Phase 3 trial design in early 2026 [4] About Dementia with Lewy Bodies - DLB is the second most common progressive dementia after Alzheimer's disease, affecting millions globally, with no approved treatments available in the U.S. or EU [5] About Neflamapimod - Neflamapimod is an investigational oral drug that inhibits a key enzyme involved in neuroinflammation and synaptic dysfunction, showing promise in restoring synaptic function and improving neuron health [6][7] - Clinical trials have demonstrated that neflamapimod is generally well tolerated and has shown efficacy in improving dementia severity and functional mobility in DLB patients [8]

Core Insights - CervoMed Inc. has appointed David Quigley to its Board of Directors, bringing extensive experience in business strategy and life sciences [1][2] - The appointment is strategic as CervoMed prepares for Phase 3 trials and commercialization of its lead drug candidate, neflamapimod, targeting dementia with Lewy bodies (DLB) [1][2] - DLB is a significant health issue with no approved treatments in the U.S. or EU, affecting millions globally [3][4] Company Overview - CervoMed is a clinical-stage biotechnology company focused on developing treatments for age-related brain disorders [4] - The lead drug candidate, neflamapimod, aims to restore communication between brain cells by inhibiting a key enzyme involved in inflammation and neurodegeneration [4] - The company recently completed a successful Phase 2b trial for neflamapimod in DLB patients and plans to initiate a global Phase 3 trial in mid-2026 [4] Industry Context - DLB is the second most common progressive dementia after Alzheimer's disease, characterized by cognitive decline, visual hallucinations, and motor symptoms similar to Parkinson's disease [3] - Current standard-of-care therapies for DLB only provide temporary symptom relief, highlighting the need for effective treatments [3]

Summary of CervoMed Inc. Conference Call Company Overview - **Company Name**: CervoMed Inc. - **Ticker Symbol**: CRBO - **Industry**: Clinical-stage biotechnology focused on neurological diseases - **Lead Product**: Neflamapimod, an investigational orally administered small molecule targeting p38 MAP kinase alpha Key Points and Arguments 1. **Market Opportunity**: Neflamapimod is entering phase three trials for dementia with Lewy bodies (DLB), a significant market with no approved therapies currently available [2][3] 2. **Disease Impact**: DLB is the third most common neurodegenerative disease, more impactful than Alzheimer's, with rapid progression leading to nursing home care within two years [3][4] 3. **Patient Population**: Approximately 50% of DLB patients are classified as pure DLB, representing a target population of 150,000 to 180,000 in the US, 280,000 to 420,000 in Europe, and 100,000 to 250,000 in Japan [6] 4. **Clinical Data**: Phase 2 studies showed significant improvements in dementia rating scales, gait, motor function, and biomarkers indicative of neurodegeneration [7][8] 5. **Phase 2b Study Design**: A larger phase 2b study with 159 patients is underway, focusing on the CDR-Sum of Boxes as the primary endpoint, which is a well-established measure for dementia severity [8][9] 6. **Drug Efficacy**: Batch B of the drug showed a 52% reduction in clinical progression on the CDR-Sum of Boxes scale compared to batch A, which was ineffective [13][15] 7. **Safety Profile**: Safety data has been favorable, with no severe adverse events leading to discontinuation, and minimal liver enzyme elevation observed [19] 8. **FDA Engagement**: Ongoing discussions with the FDA regarding phase three trial design, aiming for a 24-week placebo-controlled study with around 300 patients [19][26] Additional Important Insights 1. **Differentiation from Alzheimer's**: DLB symptoms occur earlier and are potentially reversible, making it an optimal target for intervention compared to Alzheimer's, where significant cell death complicates treatment [30][31] 2. **Biomarker Correlation**: The decrease in GFAP, a biomarker for neurodegeneration, correlates with clinical improvements, reinforcing the drug's efficacy [17][18] 3. **Future Directions**: CervoMed is also exploring treatments for recovery after stroke and frontotemporal dementia, indicating a broader pipeline beyond DLB [21][22] This summary encapsulates the critical aspects of CervoMed's conference call, highlighting the company's focus on DLB, the potential of neflamapimod, and the strategic direction moving forward.