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]

Group 1 - CervoMed Inc. will host a conference call and webcast on July 28, 2025, to share primary endpoint results from the Phase 2b RewinD-LB study of neflamapimod in dementia with Lewy bodies [1][2] - The RewinD-LB study is a randomized, 16-week, double-blind, placebo-controlled trial involving 159 patients, with a subsequent 32-week extension phase [4] - The study is primarily funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging [4] Group 2 - Neflamapimod is an investigational oral small molecule that inhibits p38 mitogen-activated protein kinase alpha, aimed at treating synaptic dysfunction in age-related neurologic disorders [5] - The primary outcome measure of the RewinD-LB study is the change in the Clinical Dementia Rating – Sum of Boxes, with secondary endpoints including various cognitive assessments [4] - The study excludes patients with Alzheimer's disease co-pathology, focusing on those with "pure" dementia with Lewy bodies [4]

Core Viewpoint - CervoMed Inc. is set to present new findings from its RewinD-LB Phase 2b study of neflamapimod for dementia with Lewy bodies at the Alzheimer's Association International Congress (AAIC) 2025, highlighting its focus on age-related neurologic disorders [1][3]. Group 1: Presentation Details - CervoMed will deliver both in-person and virtual poster presentations at AAIC 2025, scheduled for July 27 – 31, 2025, in Toronto, Canada [1]. - The in-person poster titled "Effects of neflamapimod (p38α kinase inhibitor) on clinical progression in patients with dementia with Lewy bodies (DLB) without Alzheimer's disease (AD) Co-Pathology" will be presented on July 27, 2025 [2]. - A virtual presentation titled "Impact of AD Co-Pathology on Response to Neflamapimod (p38α Kinase Inhibitor) in Patients with Dementia with Lewy Bodies" will also be featured [2]. Group 2: Company Overview - CervoMed is a clinical-stage company dedicated to developing treatments for age-related neurologic disorders, with a focus on neflamapimod, an investigational small molecule that inhibits p38 mitogen-activated protein kinase alpha [3]. - Neflamapimod aims to address synaptic dysfunction, a reversible aspect of neurodegenerative processes in DLB and other neurological disorders, and is currently undergoing evaluation in a Phase 2b study [3].

Clinical Trial Overview - The RewinD-LB phase 2b clinical trial investigated neflamapimod in dementia with Lewy bodies (DLB)[3] - The trial randomized 159 participants 1:1 to neflamapimod 40mg or placebo TID for 16 weeks, followed by a 32-week open-label extension[20] - The primary outcome measure was the Clinical Dementia Rating Sum of Boxes (CDR-SB)[20] Efficacy Results - The primary statistical analysis showed no discernible differences between the neflamapimod and placebo groups in change from baseline on CDR-SB (NFMD-Placebo Difference: 0.01)[29] - Secondary endpoint CGIC results showed Number of Participants in Each Category at Week 16[34] Safety and Tolerability - The study was generally well-tolerated, with no new safety signals[37] - There were 8 serious adverse events (SAEs) in the placebo group and 5 in the neflamapimod group[37] - The most common treatment emergent adverse event was falls, occurring in 18.8% of the placebo group and 15.2% of the neflamapimod group[38] Plasma Drug Concentrations - Mean trough plasma drug concentration (Ctrough) in RewinD-LB was 3.9 ng/mL[42, 43, 44] - This Ctrough level was similar to that seen with 40mg BID in earlier studies, lower than targeted[42, 43, 44] - Analysis suggests lower bioavailability related to the age of the capsules used during the double-blind phase[49] Open-Label Extension (OLE) and Future Directions - The open-label extension (OLE) of the study introduced a newer batch of capsules[44] - Week 16 OLE analysis is upcoming in March 2025[46] - A clinical study evaluating the safety and pharmacokinetics of 80mg BID in DLB is ongoing[49]

Core Insights - CervoMed is advancing the development of neflamapimod, targeting a Phase 3 trial in dementia with Lewy Bodies (DLB) set to begin in mid-2026 following discussions with regulatory authorities [1][3] Leadership Changes - Marco Verwijs, PhD, has been appointed as Executive Vice President of Technical Operations, bringing extensive experience in drug development and CMC functions from previous roles at notable biotech companies [2][3] Inducement Grants - On June 9, 2025, CervoMed granted Dr. Verwijs an option to purchase 54,000 shares of common stock at an exercise price of $7.74, with vesting over three years [4] Company Overview - CervoMed is focused on developing treatments for age-related neurologic disorders, with neflamapimod being an investigational small molecule aimed at treating synaptic dysfunction in DLB and other neurological disorders [5]

Financial Data and Key Metrics Changes - CervoMed's lead asset, Neflumab vimode, is progressing into Phase 3 trials after showing robust clinical activity in dementia with Lewy bodies (DLB) [4][6] - The market opportunity for DLB is estimated to be comfortably over $5 billion, targeting a patient population of approximately 175,000 in the US [10] Business Line Data and Key Metrics Changes - The Phase 2 REWIND DLB study demonstrated a 52% reduction in clinical worsening on the CDR Sum of Boxes scale over 16 weeks, with a 67% reduction in a more precisely defined patient population [20][21] - The study also indicated a clinically significant treatment effect with a p-value of 0.033 on the Clinical Global Impression of Change [22] Market Data and Key Metrics Changes - DLB is the second most common dementia after Alzheimer's, with distinct symptoms that include cognitive deficits and motor components, leading to a significant impact on quality of life [7][8] - The company aims to position Neflumab vimode in a specialty market similar to multiple sclerosis, with pricing expectations in the range of $40,000 to $50,000 per patient annually [48] Company Strategy and Development Direction - CervoMed plans to initiate a Phase 3 trial in mid-2026, contingent on FDA feedback and completion of necessary assays [40][41] - The company is open to partnerships but believes it can self-commercialize the drug, depending on market conditions and strategic considerations [43][45] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway, noting that the Phase 3 trial would likely be sufficient for approval given the high unmet medical need in DLB [27][29] - The company highlighted the unique opportunity in DLB, emphasizing that the drug targets underlying disease processes, which may lead to better outcomes compared to Alzheimer's treatments [51] Other Important Information - The company is preparing for additional FDA interactions to clarify the clinical development path for Neflumab vimode [25][26] - Management noted that the variability in patient responses in previous studies could affect the power of certain endpoints, but overall positive trends were observed [39] Q&A Session Summary Question: What is the expected size of the field sales force for DLB? - Management indicated that the sales force would be similar to that used for multiple sclerosis, focusing on neurologists who manage DLB patients [47] Question: What is the pricing paradigm for Neflumab in DLB? - The expected pricing for Neflumab is in the range of $40,000 to $50,000 annually, which is comparable to other specialty diseases [48]