Core Insights - CervoMed Inc. is advancing its clinical program for neflamapimod, targeting Dementia with Lewy Bodies (DLB), highlighted at the American Neurological Association conference [1][2] - The Phase 2b trial demonstrated a 74% risk reduction in clinically significant worsening of dementia symptoms compared to placebo in patients unlikely to have Alzheimer's disease co-pathology [2][4] - The company plans to initiate a Phase 3 trial in DLB patients, with alignment on trial design expected with the FDA in Q4 2025 [2] Company Overview - CervoMed is a clinical-stage company focused on treatments for age-related neurologic disorders, specifically developing neflamapimod, an investigational small molecule [5] - Neflamapimod targets synaptic dysfunction associated with neurodegenerative diseases, including DLB [5] Clinical Trial Details - The RewinD-LB Phase 2b trial was a randomized, double-blind, placebo-controlled study involving 159 DLB patients, assessing the efficacy of oral neflamapimod [4] - The trial was funded by a $21.3 million grant from the National Institutes of Health, with 43 sites across the U.S., U.K., and Netherlands [4] - The initial phase faced challenges in evaluating clinical activity due to issues with the drug formulation, but the Extension phase allowed for effective evaluation of the treatment [4]

Summary of CervoMed FY Conference Call (September 08, 2025) Company Overview - **Company**: CervoMed (NasdaqCM:CRVO) - **Focus**: Development of therapies for dementia with Lewy bodies (DLB) Industry Context - **Unmet Medical Need**: High unmet medical need for DLB with no approved therapies available, only symptomatic treatments that do not address the underlying disease process [2][3] - **Patient Population**: Approximately 175,000 patients diagnosed with pure DLB in the U.S. [1] Core Drug Mechanism and Clinical Evidence - **Drug Mechanism**: The drug is an inhibitor of P38 alpha MAP kinase, which is linked to neuroinflammation and cholinergic neuron dysfunction in DLB [3][4] - **Clinical Proof of Concept**: The drug has demonstrated efficacy against significant clinical endpoints, particularly in cognition and dementia severity [3][5] - **Phase IIa Study Results**: Showed translatable effects on cognition and dementia severity in humans, with a focus on patients without Alzheimer's disease (AD) co-pathology [5][6] Recent Clinical Trials - **Phase IIb Study (REWIND LB)**: Focused on patients with DLB, using a blood test to enrich for those without AD co-pathology [5][6] - **Initial Results**: The first sixteen-week placebo-controlled phase did not show an effect due to issues with a specific batch of capsules [6][7] - **Subsequent Analysis**: A new batch of capsules was introduced, leading to effective dosing and significant clinical effects observed in later phases [8][11] Key Findings from Clinical Trials - **Dementia Rating Scale (CDR Sum of Boxes)**: The primary endpoint showed significant improvement when therapeutic blood concentrations were achieved [10][11] - **Statistical Significance**: The results indicated a 65% reduction in the risk of progression against placebo, with a 74% reduction observed with the effective drug batch [15][16] - **Biomarker Evidence**: Plasma biomarkers indicated a significant clinical progression reduction, supporting the efficacy of the drug [16] Future Plans and Financial Considerations - **Regulatory Strategy**: Plans to present trial data to regulatory agencies, aiming for a 24-week clinical trial with approximately 300 patients [17] - **Financial Outlook**: The company is financed through Q3 of the following year, with an estimated $50 million to $75 million needed for the Phase III trial, likely closer to $70 million to $75 million [19][20] Conclusion - **Next Milestone**: The company is on track to meet with the FDA for feedback in Q4 of this year, which will inform the next steps in their clinical development program [17][18]

[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) 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](index=1&type=section&id=Q2%202025%20Key%20Updates) 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](index=1&type=chunk) - 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](index=1&type=chunk) - 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](index=1&type=chunk) [CEO Statement](index=1&type=section&id=CEO%20Statement) 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](index=2&type=chunk) - 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](index=2&type=chunk) - 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](index=2&type=chunk) [Clinical Development Updates](index=1&type=section&id=Clinical%20Development%20Updates) 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](index=1&type=section&id=RewinD-LB%20Phase%202b%20Trial%20Extension%20Data) 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) [Recent Highlights and Anticipated Milestones](index=1&type=section&id=Recent%20Highlights%20and%20Anticipated%20Milestones) 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](index=6&type=chunk) - 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](index=6&type=chunk) - 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](index=6&type=chunk) [About the RewinD-LB Phase 2b Trial](index=3&type=section&id=About%20the%20RewinD-LB%20Phase%202b%20Trial) 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](index=9&type=chunk) - 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](index=9&type=chunk) - 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](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) CervoMed's Q2 2025 financial results show cash position, grant revenue, R&D and G&A expenses, and net loss [Cash Position](index=2&type=section&id=Cash%20Position) 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](index=4&type=chunk) [Grant Revenue](index=2&type=section&id=Grant%20Revenue) 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](index=5&type=chunk) [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) 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](index=7&type=chunk) - 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](index=7&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) 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](index=8&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) 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](index=3&type=section&id=About%20CervoMed) CervoMed is a clinical-stage company developing neflamapimod for age-related neurologic disorders, targeting synaptic dysfunction [Company Profile and Neflamapimod](index=3&type=section&id=Company%20Profile%20and%20Neflamapimod) 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](index=10&type=chunk) - The Company is currently developing **neflamapimod**, an investigational, **orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha**[10](index=10&type=chunk) - 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](index=10&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines standard forward-looking statements regarding future plans and expectations, emphasizing inherent risks and uncertainties [Disclaimer and Risk Factors](index=4&type=section&id=Disclaimer%20and%20Risk%20Factors) 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](index=11&type=chunk) - 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](index=11&type=chunk) - 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](index=11&type=chunk) [Investor Contact](index=4&type=section&id=Investor%20Contact) This section provides contact information for investor relations inquiries [Contact Information](index=4&type=section&id=Contact%20Information) 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](index=12&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents CervoMed's condensed consolidated balance sheets and statements of operations and comprehensive loss [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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) |

Core Insights - CervoMed Inc. reported significant findings from the Phase 2b RewinD-LB trial, indicating that neflamapimod treatment led to a 54% risk reduction in clinically significant worsening of Dementia with Lewy Bodies (DLB) at week 32 compared to the control group, with an improved 64% reduction among patients with minimal Alzheimer's disease co-pathology [1][3][9] - The company plans to engage with the U.S. Food and Drug Administration (FDA) in Q4 2025 to align on the design of the Phase 3 trial for DLB, with the trial expected to start in mid-2026, contingent on funding [1][3][5] Clinical Trial Results - The 32-week Extension phase of the Phase 2b RewinD-LB trial showed a statistically significant reduction in plasma levels of glial fibrillary acidic protein (GFAP) in patients treated with neflamapimod, with a mean change of -18.4±4.0 pg/mL for all participants and -21.2±4.4 pg/mL for those with ptau181 < 2.2 pg/mL [1][3][2] - The trial's primary endpoint was the Clinical Dementia Rating Sum of Boxes (CDR-SB), which demonstrated a significant reduction in clinical progression for patients receiving neflamapimod [3][9] Financial Overview - As of June 30, 2025, CervoMed had approximately $33.5 million in cash and cash equivalents, down from $38.9 million at the end of 2024, which is expected to fund operations into Q3 2026 [5][6] - Grant revenue for Q2 2025 was approximately $1.8 million, a decrease from $3.3 million in the same period in 2024, attributed to the transition from the initial double-blind phase to the Extension phase of the trial [6][8] - Research and Development (R&D) expenses increased to approximately $5.1 million in Q2 2025 from $3.8 million in Q2 2024, primarily due to rising costs associated with clinical trials and CMC activities [7][8] Corporate Developments - In June 2025, Marco Verwijs, PhD, joined CervoMed as Executive Vice President, Technical Operations, to oversee the Chemistry, Manufacturing, and Controls (CMC) division [3] - The company is also conducting Phase 2a trials of neflamapimod in patients recovering from acute stroke and in those with the nonfluent/agrammatic variant of primary progressive aphasia (PPA) [3][4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ______________. Commission file number: 001-37942 CervoMed Inc. (Exact name of registrant as specified in its charter) Delaware 30-0645032 (State o ...

Core Insights - CervoMed Inc. is participating in the CG 45 Annual Growth Conference from August 12 to August 14, 2025, where management will engage in a fireside chat and one-on-one investor meetings [1][2] Company Overview - CervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders [3] - The company is developing neflamapimod, an investigational orally administered small molecule that inhibits p38 mitogen-activated protein kinase alpha [3] - Neflamapimod aims to address synaptic dysfunction associated with neurodegenerative processes in disorders such as Dementia with Lewy Bodies (DLB) [3] - Currently, neflamapimod is being evaluated in a Phase 2b trial for patients with DLB [3]

Core Insights - CervoMed Inc. presented 32-week data from the Extension phase of its Phase 2b RewinD-LB trial, focusing on oral neflamapimod for patients with Dementia with Lewy Bodies (DLB) [1][2] Group 1: Trial Results - The Extension phase demonstrated that neflamapimod continued to slow disease progression and positively affected a key plasma marker of neurodegeneration in DLB patients [2] - At Week 32, there was a statistically significant reduction in GFAP plasma levels in patients receiving New Capsules, with a mean change of -18.4±4.0 pg/mL for all participants (N=107) and -21.2±4.4 pg/mL for those with screening plasma ptau181 below 2.2 pg/mL (N=91) [4][5] - Placebo recipients in the initial phase showed a mean increase in GFAP levels of +1.1±3.0 pg/mL for all participants (N=74) and +1.1±3.3 pg/mL for the subset with screening plasma ptau181 below 2.2 pg/mL (N=65) [5] Group 2: Safety and Tolerability - Both Old and New Capsules exhibited comparable tolerability profiles, with no new safety signals identified during the Extension phase [5] - A lower incidence of falls was observed in participants with screening ptau181 < 2.2 pg/mL who received New Capsules compared to those receiving Old Capsules or placebo, with significant p-values indicating statistical relevance (p=0.025 vs. Old Capsules; p=0.007 vs. placebo) [5] Group 3: Market Reaction - Following the announcement of the trial results, CRVO stock increased by 29.4%, reaching $11.62 [6]

Group 1 - CervoMed Inc. (CRVO) shares increased by 11.6% to close at $8.98, with notable trading volume compared to typical sessions, and a 13.3% gain over the past four weeks [1][2] - The price rise is linked to growing investor optimism regarding the company's pipeline candidate, neflamapimod, aimed at treating Dementia with Lewy Bodies and other neurological disorders [2] - The company is expected to report a quarterly loss of $0.57 per share, reflecting a year-over-year change of -111.1%, with revenues projected at $1.11 million, down 66.3% from the previous year [2] Group 2 - The consensus EPS estimate for CervoMed has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] - CervoMed currently holds a Zacks Rank of 3 (Hold), while another company in the same industry, Qiagen, has a Zacks Rank of 2 (Buy) and closed 1.1% higher at $51.79 [5][6] - Qiagen's consensus EPS estimate for the upcoming report is $0.6, representing a +5.3% change from the previous year [6]

Summary of CervoMed Conference Call Company and Industry - **Company**: CervoMed - **Industry**: Neurology, specifically focusing on treatments for dementia with Lewy bodies (DLB) Core Points and Arguments 1. **Clinical Trial Results**: CervoMed announced 32-week data from the Phase 2b REWIND DLB trial, showing that neflamapimod has the potential to slow disease progression in DLB patients, building on previous 16-week results [3][15][23] 2. **Disease Overview**: DLB is a progressive brain disorder characterized by cognitive decline and movement problems, with no approved treatments in the US or EU, representing a significant unmet medical need [6][7][10] 3. **Mechanism of Action**: Neflamapimod targets the hyperactivation of P38 MAP kinase, which is linked to neuroinflammation and cognitive decline in DLB [10][11] 4. **Clinical Endpoint**: The primary endpoint for the REWIND LB trial is the CDR Sum of Boxes, with a clinically meaningful worsening defined as a 0.5 increase [13][19] 5. **Statistical Analysis**: A Kaplan Meier analysis showed a 54% reduction in the risk of clinical progression with new capsules compared to old capsules, with a 64% reduction in patients with low plasma pTau levels [19][20][23] 6. **Biomarker Data**: Plasma GFAP levels, a marker of neurodegeneration, decreased by approximately 18% in patients receiving new capsules, indicating a positive treatment effect [21][24] 7. **Regulatory Path**: CervoMed plans to meet with the FDA in 2025 to discuss the Phase III trial design, which is expected to be similar to the Phase IIb trial [26][29] Additional Important Information 1. **Patient Population**: The initial target population for neflamapimod is approximately 175,000 diagnosed patients with DLB, highlighting the market potential [9] 2. **Treatment Duration**: The Phase III trial is anticipated to last 24 weeks, compared to the 16-week duration of the Phase IIb trial [27] 3. **Market Potential**: The first disease-modifying therapy for DLB could have multibillion-dollar potential, given the high unmet need in this area [29] 4. **Compliance and Adherence**: Patient adherence to the treatment regimen has been reported as very good, with minimal missed doses [44] 5. **International Licensing**: CervoMed is open to regional licensing deals in Europe, Japan, or East Asia to maximize opportunities and potentially secure non-dilutive financing [48] This summary encapsulates the key points discussed during the CervoMed conference call, focusing on the company's advancements in treating DLB and the implications for future clinical trials and market opportunities.

Core Insights - CervoMed Inc. announced positive results from the 32-week Extension phase of the Phase 2b RewinD-LB trial, showing that oral neflamapimod led to a 54% risk reduction in clinically significant worsening of dementia symptoms compared to control, improving to 64% for patients with minimal Alzheimer's Disease co-pathology [1][2][11] - The trial results were presented at the Alzheimer's Association International Congress 2025, highlighting the potential of neflamapimod as a treatment for Dementia with Lewy Bodies (DLB) [1][2] Clinical Trial Results - The primary endpoint, Clinical Dementia Rating Sum of Boxes (CDR-SB), showed a significant reduction in disease progression for patients treated with neflamapimod [1][2] - At Week 32, patients receiving neflamapimod demonstrated a statistically significant reduction in plasma levels of glial fibrillary acidic protein (GFAP), indicating a positive effect on neurodegeneration [1][10] - The analysis indicated that patients treated with new capsules of neflamapimod had a statistically significant slower disease progression compared to those treated with older capsules [5][10] Statistical Data - The hazard ratio for patients with ptau181 < 2.4 pg/mL was 0.46 (p=0.0037), and for those with ptau181 < 2.2 pg/mL, it was 0.36 (p=0.0001), indicating a strong correlation between lower ptau181 levels and reduced risk of clinical worsening [4][10] - A mean change in GFAP plasma levels was recorded as -18.4±4.0 pg/mL for all participants and -21.2±4.4 pg/mL for those with ptau181 < 2.2 pg/mL [10] Future Plans - CervoMed is preparing to initiate a Phase 3 trial and plans to meet with the U.S. Food and Drug Administration in Q4 2025 to discuss trial design [2][11] - The company aims to provide a meaningful treatment option for DLB patients, addressing the significant unmet needs in this area [2][11] Company Background - CervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders, with neflamapimod being an investigational oral small molecule targeting neurodegenerative processes [12]