CervoMed (CRVO) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights CervoMed reported Q2 2025 results, highlighting positive 32-week RewinD-LB trial data and plans for FDA engagement on Phase 3 design Q2 2025 Key Updates CervoMed reported Q2 2025 results, highlighting positive 32-week RewinD-LB trial data showing reduced clinical worsening and GFAP levels, with FDA discussions planned for Q4 2025 on Phase 3 design - 32-week data from Phase 2b RewinD-LB Trial Extension showed neflamapimod treatment resulted in a substantial reduction in clinically significant worsening compared to control arm over 32 weeks, which improved further among patients with minimal evidence of Alzheimer's disease (AD) co-pathology[1] - At week 32 of the Extension phase, patients treated with neflamapimod demonstrated a significant reduction from baseline in plasma levels of glial fibrillary acidic protein (GFAP)[1] - CervoMed plans to engage with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025 to align on trial design for the Phase 3 program in Dementia with Lewy Bodies (DLB)[1] CEO Statement CEO John Alam expressed increased confidence in neflamapimod for DLB, citing 16- and 32-week data showing slowed clinical progression and reduced GFAP, with FDA discussions for Phase 3 planned in Q4 2025 - CEO John Alam stated that 16- and 32-week Extension phase data from the Phase 2b RewinD-LB trial solidified evidence for slowing clinical progression in DLB associated with neflamapimod treatment[2] - The proof-of-concept, combined with notable reductions in plasma levels of GFAP, an important blood-based biomarker, increases confidence in Phase 3 success and neflamapimod's potential[2] - The company is actively preparing for discussions with the FDA, expected in Q4 2025, to align on the design of the planned Phase 3 trial[2] Clinical Development Updates CervoMed provided updates on the RewinD-LB Phase 2b trial extension data, recent milestones, and future development plans for neflamapimod RewinD-LB Phase 2b Trial Extension Data CervoMed presented 32-week RewinD-LB extension data in July 2025, showing a 54% risk reduction in clinical worsening, improving to 64% in minimal AD co-pathology patients, alongside significant GFAP reduction - At Week 32 of treatment, patients treated with neflamapimod showed 54% risk reduction in clinically significant worsening (CDR-SB) compared to control (p=0.0037), improving to 64% (p=0.0001) among patients with minimal AD co-pathology[3] - At Week 32 of the Phase 2b RewinD-LB Extension phase, there was a statistically significant reduction (p<0.0001) from baseline in GFAP plasma levels in patients who received active neflamapimod, with a mean change of -18.4±4.0 pg/mL in all participants[3] - In contrast, placebo-recipients in the initial double-blind phase had a mean increase from baseline to Week 16 of +1.1±3.0 pg/mL in GFAP[3] Recent Highlights and Anticipated Milestones CervoMed announced personnel additions, presented 16-week RewinD-LB data, and outlined future plans including a Q4 2025 FDA meeting for Phase 3 design, 80mg BID data, and new Phase 2a trials for acute stroke and PPA - In June 2025, Marco Verwijs, PhD, joined CervoMed as Executive Vice President, Technical Operations, to oversee CMC and advance neflamapimod development[6] - The Company plans to meet with the FDA in Q4 2025 to align on the design of its planned Phase 3 trial, which it plans to initiate in mid-2026 subject to available funding[6] - In Q2 2025, CervoMed enrolled the first patients in a Phase 2a trial of neflamapimod in acute stroke recovery and initiated a Phase 2a trial in patients with the nonfluent/agrammatic variant of primary progressive aphasia (PPA), following Orphan Drug designation for FTD in November 2024[6] About the RewinD-LB Phase 2b Trial The RewinD-LB trial was a 16-week randomized, double-blind study of neflamapimod (40mg TID) in 159 DLB patients, followed by a 32-week open-label extension, primarily funded by a $21.3 million NIA grant - The initial phase of RewinD-LB was a randomized, 16-week, double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg TID) in 159 patients with DLB, followed by a 32-week neflamapimod-only treatment Extension phase, excluding patients with AD co-pathology[9] - The initial phase did not effectively evaluate clinical activity due to a capsule batch that did not lead to expected plasma drug concentrations; however, the Extension phase utilized a more recently manufactured batch that achieved targeted concentrations, allowing effective evaluation[9] - The RewinD-LB trial is primarily funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging[9] Second Quarter 2025 Financial Results CervoMed's Q2 2025 financial results show cash position, grant revenue, R&D and G&A expenses, and net loss Cash Position CervoMed's cash, cash equivalents, and marketable securities totaled $33.5 million as of June 30, 2025, projecting funds into Q3 2026 Cash, Cash Equivalents, and Marketable Securities | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $8,320,713 | $8,999,496 | | Marketable securities | $25,210,453 | $29,922,523 | | Total cash, cash equivalents and marketable securities | $33,531,166 | $38,922,019 | - Based on its current operating plan, CervoMed believes its cash, cash equivalents and marketable securities on hand as of June 30, 2025, along with remaining funds from the NIA grant, will enable the Company to fund its planned operating expenses and capital expenditure requirements into the third quarter of 2026[4] Grant Revenue Grant revenue for Q2 2025 was $1.8 million, a decrease from $3.3 million in Q2 2024, due to the completion of the RewinD-LB Trial's initial phase Grant Revenue (Three Months Ended June 30) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :------------ | :------------------------------- | :------------------------------- | :----------- | | Grant revenue | $1,757,724 | $3,288,971 | -$1,531,247 | - The decrease in grant revenue is due to the completion of the initial, double-blind phase of the RewinD-LB Trial and transition to the Extension phase in December 2024[5] Research and Development (R&D) Expenses R&D expenses increased to $5.1 million in Q2 2025 from $3.8 million in Q2 2024, driven by higher CMC, non-clinical, headcount, CRO costs, and new Phase 2a trials Research and Development Expenses (Three Months Ended June 30) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :---------------------- | :------------------------------- | :------------------------------- | :----------- | | Research and development | $5,108,625 | $3,772,391 | +$1,336,234 | - The increase of $1.3 million was primarily due to an increase in costs related to CMC activities, increased non-clinical studies, increased headcount costs, and outsourced CRO costs related to clinical work for neflamapimod[7] - The increase also includes costs related to the Phase 2a clinical trials of neflamapimod in recovery from acute stroke and with the nonfluent/agrammatic variant of PPA, both initiated in Q2 2025[7] General and Administrative (G&A) Expenses G&A expenses rose to $3.3 million in Q2 2025 from $2.5 million in Q2 2024, primarily due to increased headcount costs and outsourced services General and Administrative Expenses (Three Months Ended June 30) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :-------------------------- | :------------------------------- | :------------------------------- | :----------- | | General and administrative | $3,265,374 | $2,511,679 | +$753,695 | - The increase of $0.8 million was primarily due to headcount costs and outsourced services[8] Net Loss CervoMed reported a net loss of $6.3 million for Q2 2025, significantly higher than the $2.3 million net loss for Q2 2024, due to increased operating expenses and decreased grant revenue Net Loss (Three Months Ended June 30) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :------- | :------------------------------- | :------------------------------- | :----------- | | Net loss | $(6,258,404) | $(2,316,905) | $(3,941,499) | About CervoMed CervoMed is a clinical-stage company developing neflamapimod for age-related neurologic disorders, targeting synaptic dysfunction Company Profile and Neflamapimod CervoMed is a clinical-stage company developing neflamapimod, an orally administered small molecule inhibiting p38 mitogen-activated protein kinase alpha, for age-related neurologic disorders like DLB - CervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders[10] - The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha[10] - Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in DLB and certain other major neurological disorders[10] Forward-Looking Statements This section outlines standard forward-looking statements regarding future plans and expectations, emphasizing inherent risks and uncertainties Disclaimer and Risk Factors This section contains forward-looking statements about future plans, cash runway, and clinical milestones, noting that actual results may differ due to various risks and uncertainties - This press release includes express and implied forward-looking statements regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including cash runway, therapeutic potential of neflamapimod, and timing of clinical and development milestones[11] - Forward-looking statements by their nature involve risks and uncertainties, many of which are beyond the Company's control, and actual results could differ materially from those expressed or implied[11] - Particular risks and uncertainties include those related to the Company's available cash resources, clinical trial results (including RewinD-LB), likelihood and timing of regulatory approval, and the ability to implement business plans[11] Investor Contact This section provides contact information for investor relations inquiries Contact Information This section provides the name, affiliation, email, and phone number for investor relations contact - Investor contact is PJ Kelleher of LifeSci Advisors, reachable at Investors@cervomed.com or 617-430-7579[12] Condensed Consolidated Financial Statements This section presents CervoMed's condensed consolidated balance sheets and statements of operations and comprehensive loss Condensed Consolidated Balance Sheets The balance sheet shows CervoMed's financial position as of June 30, 2025, with total assets decreasing from $43.1 million to $38.1 million, and total stockholders' equity decreasing Condensed Consolidated Balance Sheets | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $8,320,713 | $8,999,496 | | Marketable securities | $25,210,453 | $29,922,523 | | Total current assets | $38,081,399 | $43,081,610 | | Total assets | $38,081,399 | $43,081,610 | | Total liabilities | $4,641,620 | $3,879,282 | | Total stockholders' equity | $33,439,779 | $39,202,328 | Condensed Consolidated Statements of Operations and Comprehensive Loss The income statement details CervoMed's financial performance for Q2 2025 and YTD, showing a significant increase in net loss due to decreased grant revenue and increased operating expenses Condensed Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended June 30) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------- | | Grant revenue | $1,757,724 | $3,288,971 | -$1,531,247 | | Research and development | $5,108,625 | $3,772,391 | +$1,336,234 | | General and administrative | $3,265,374 | $2,511,679 | +$753,695 | | Total operating expenses | $8,373,999 | $6,284,070 | +$2,089,929 | | Loss from operations | $(6,616,275) | $(2,995,099) | $(3,621,176) | | Net loss | $(6,258,404) | $(2,316,905) | $(3,941,499) | | Net loss per share (basic and diluted) | $(0.70) | $(0.27) | $(0.43) | Condensed Consolidated Statements of Operations and Comprehensive Loss (Six Months Ended June 30) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------- | | Grant revenue | $3,675,215 | $5,636,221 | -$1,961,006 | | Research and development | $9,946,423 | $6,586,649 | +$3,359,774 | | General and administrative | $5,647,951 | $4,639,609 | +$1,008,342 | | Total operating expenses | $15,594,374 | $11,226,258 | +$4,368,116 | | Loss from operations | $(11,919,159) | $(5,590,037) | $(6,329,122) | | Net loss | $(11,152,438) | $(4,831,240) | $(6,321,198) | | Net loss per share (basic and diluted) | $(1.26) | $(0.65) | $(0.61) |