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.

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]

Stock Issuance and Sales - The Company plans to issue and sell up to $50,000,000 of common stock through Leerink Partners LLC as the Agent[1] - The registration statement for the common stock was filed with the SEC on October 3, 2024, and declared effective on October 10, 2024[2] - The Company will provide the Agent with copies of the base prospectus and the prospectus supplement related to the Placement Shares[2] - Each Placement will require a Placement Notice specifying the maximum number of shares, time period for sales, and any minimum price[4] - The Agent will use commercially reasonable efforts to sell the Placement Shares as per the terms of the Placement Notice[6] - Settlement for sales of Placement Shares will occur on the first Trading Day following the date of sale[10] - The Net Proceeds delivered to the Company will be the gross sales price minus the Agent's commission and any transaction fees[10] - The Company must deliver the Placement Shares electronically on or before each Settlement Date[11] - If the Company defaults on delivering shares, it must return any Net Proceeds received and indemnify the Agent for any losses incurred[11] - The Company and the Agent may suspend sales if the Company possesses material non-public information[9] - The Company has filed a Registration Statement with the Commission, which has been declared effective prior to the issuance of any Placement Notices[13] - The Company has not received any notice from the Commission objecting to the use of the shelf registration statement form[13] - The Placement Shares have been duly authorized for issuance and will be validly issued, fully paid, and nonassessable[26] - The Company has filed a Notification of Listing of Additional Shares with Nasdaq regarding the Placement Shares[21] - The Company has the authorized and outstanding capitalization as set forth in its most recent Annual Report on Form 10-K[25] - The Company has not distributed any offering material other than the Registration Statement and the Prospectus in connection with the offering of the Placement Shares[19] - The Company is not considered an "ineligible issuer" as defined in Rule 405[16] - The issuance and sale of the Placement Shares will not be subject to any preemptive rights or similar rights[26] Financial Condition and Compliance - The Company has not experienced any material adverse change in its financial condition or operations since the last reporting period[33] - The financial statements included in the Registration Statement and Prospectus present fairly the consolidated financial position of the Company and its Subsidiaries[36] - The Company has filed all required federal income tax returns and paid all taxes due, with no material tax deficiencies expected[42] - There are no ongoing or threatened labor disputes that could have a material adverse effect on the Company[43] - The Company is not classified as an "investment company" under the Investment Company Act of 1940[29] - The Company has not incurred any material liabilities or obligations outside the ordinary course of business[33] - All necessary consents and approvals for the execution of agreements have been obtained[30] - The Company has not received any communications regarding the termination or non-renewal of any significant contracts[27] - The Company is in compliance with all applicable laws and regulations, with no violations that would have a material adverse effect[39] - The Company has engaged RSM US LLP as its independent registered public accounting firm, which is in compliance with all regulatory requirements[40] - The Company and its Subsidiaries are insured by reputable institutions with adequate coverage for risks including theft, damage, and clinical trial liability claims[45] - The Company holds good and marketable title to all real and personal property material to its business, free of significant liens or encumbrances[46] - The Company possesses all necessary permits required by regulatory agencies to conduct its business, with no material violations reported[47] - The Company maintains accurate books and records, ensuring compliance with GAAP and internal accounting controls[48] - The Company has established effective disclosure controls and procedures, with no material weaknesses reported in internal control over financial reporting[50] - The Company is in compliance with the Sarbanes-Oxley Act and has not failed to comply with any applicable provisions[54] - The Company and its Subsidiaries have not engaged in any unlawful payments or actions that would violate anti-corruption laws[55] - The Company has conducted its operations in compliance with financial recordkeeping and money laundering laws, with no pending investigations[58] - The Company is not owned or controlled by any individual or entity subject to sanctions, ensuring compliance with relevant sanctions authorities[59] - The Company and its Subsidiaries possess all necessary intellectual property rights for their business operations and product commercialization, with no known legal challenges that could have a Material Adverse Effect[60] - The Company is in full compliance with all applicable laws and regulations regarding the development and distribution of pharmaceuticals, with no adverse findings from regulatory authorities[62] - There are no ongoing legal proceedings that could materially affect the Company or its Subsidiaries, and no claims have been received alleging violations of applicable laws[63] - Clinical trials and studies conducted by the Company are in compliance with protocols and applicable laws, with no material unexpected adverse events reported[65] Market and Financial Projections - As of May 9, 2025, the market value of the Company's outstanding common equity held by non-affiliates was approximately $82.8 million[69] - The Company has not defaulted on any preferred stock dividends or payments on borrowed money, which could result in a Material Adverse Effect[73] - All financial projections included in the Registration Statement were made in good faith and are accompanied by cautionary statements regarding potential risks[74] - The Company is not involved in any bankruptcy or insolvency proceedings[76] - The Company and its Subsidiaries are in compliance with all applicable laws and regulations related to workplace safety[78] - There are no material outstanding loans or guarantees involving the Company or its Subsidiaries[75] Agreement and Legal Matters - The Company has filed all necessary patents and trademarks and is in compliance with the PTO's duty of candor[80] - The Company will make available an earnings statement covering a 12-month period within 15 months after the end of the current fiscal quarter[88] - The Company will pay all expenses related to the offering of Placement Shares, including legal and filing fees[89] - The Company will use commercially reasonable efforts to list the Placement Shares on Nasdaq[86] - The Company will notify the Agent promptly of any stop orders or requests for amendments from the Commission[84] - The Company is not subject to any non-competition or non-solicitation agreements that could affect its directors or officers[79] - The Company has not been notified of any inventorship challenges regarding its patents[80] - The Company will use the Net Proceeds as described in the Prospectus for its intended purposes[91] - The Company will not offer to sell or dispose of any shares of Common Stock during specified trading days without prior written consent from the Agent[91] - The Company will cooperate with due diligence reviews conducted by the Agent and provide necessary information and documents[94] - The Company agrees to file a prospectus supplement detailing the number of Placement Shares sold and the Net Proceeds to the Company[95] - The Company will maintain insurance covering risks that are reasonable and customary for its business[102] - The Company will ensure compliance with all applicable laws and maintain necessary permits[103] - The Company will conduct its affairs to avoid being classified as an "investment company" under the Investment Company Act[104] - The Company will maintain accurate books and records and internal accounting controls in accordance with GAAP[109] - The Company will provide Comfort Letters from its independent registered public accounting firm as required[99] - The Company will not engage in activities that could manipulate the price of its securities[101] - The Company will file a new shelf registration statement if any Placement Shares remain unsold by the third anniversary of the initial effective date[110] - The Company must notify the Agent if it is no longer eligible to use Form S-3 and file a new prospectus supplement within two business days[111] - The Company will indemnify the Agent against any documentary, stamp, or similar issue tax related to the sale of Placement Shares[113] - The Registration Statement must be effective for all offers and sales of Placement Shares issued pursuant to prior Placement Notices[114] - The Company is required to file the Prospectus Supplement with the Commission no later than the close of business on the second business day following the date of the Agreement[115] - The Company must ensure that no material adverse changes occur that could affect the offering of Placement Shares[119] - The Agent must receive legal opinions and comfort letters from Company Counsel and Agent's Counsel as required[120][121][122] - The Common Stock must be duly listed and authorized for trading on Nasdaq without any suspension[124] - All required filings with the Commission must be made prior to the issuance of any Placement Notice[127] - The Placement Shares must be approved for listing on Nasdaq or an application must be filed prior to the First Placement Notice Date[128] - The Company reported a Material Adverse Effect that may impair the ability to sell Placement Shares[138] - The Company must deliver required certifications and opinions within 15 calendar days to avoid termination by the Agent[138] - The Agent has the right to terminate the Agreement if trading in Placement Shares is suspended or limited on Nasdaq[138] - The Company can terminate the Agreement at its discretion with 10 days' prior notice[139] - The Agreement will automatically terminate upon the issuance and sale of all Placement Shares[142] - The Company is obligated to reimburse the Agent's expenses even after termination[144] - All indemnity and contribution agreements will survive regardless of investigations or delivery of Placement Shares[137] - The Agent is not liable for any settlement without its written consent[135] - The Company and the Agent will contribute to losses in proportion to the benefits received from the sale of Placement Shares[135] - Notices must be delivered in writing and can be sent electronically to specified addresses[145] - The Company will pay Leerink Partners a cash compensation equal to 3.0% of the gross proceeds from the sales of Placement Shares[175] - The Agreement constitutes the entire agreement and supersedes all prior agreements regarding the subject matter[151] - The Agent may assign its rights and obligations to an affiliate without the Company's consent, provided the affiliate is a registered broker-dealer[148] - All stock-related numbers in the Agreement will be adjusted for any stock split or similar event[149] - The Agreement is governed by the laws of the State of New York[152] - The Company acknowledges that no fiduciary or advisory relationship has been created with the Agent[160] - The Company is capable of evaluating and understanding the terms, risks, and conditions of the transactions contemplated by the Agreement[160] - The Agent may not provide any information gained in connection with the Agreement to any third party without the Company's written consent[163] - The Agreement may be executed in multiple counterparts, each of which is deemed an original[162] - The Company waives any claims against the Agent for breach of fiduciary duty in connection with the transactions contemplated by the Agreement[160] - The Company has complied with all agreements and satisfied all conditions under the Sales Agreement as of the date hereof[178] - There has been no material adverse change in the Company's financial condition or prospects since the date of the Prospectus[180] - The maximum amount of Placement Shares authorized for sale has been duly approved by the Company's board of directors[181]

Group 1 - CervoMed Inc. reported a quarterly loss of $0.56 per share, which was better than the Zacks Consensus Estimate of a loss of $0.60, but worse than the loss of $0.41 per share from the previous year, indicating a 36.6% increase in loss year-over-year [1] - The company achieved revenues of $1.92 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 66.70%, although this represents a decline from $2.35 million in revenues a year ago [2] - CervoMed Inc. shares have increased approximately 262.8% since the beginning of the year, contrasting with a decline of 3.8% in the S&P 500 [3] Group 2 - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The trend for estimate revisions for CervoMed Inc. is currently unfavorable, resulting in a Zacks Rank of 4 (Sell), indicating expected underperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.57 on revenues of $0.81 million, and for the current fiscal year, it is -$2.17 on revenues of $2.8 million [7] Group 3 - The Medical - Biomedical and Genetics industry, to which CervoMed Inc. belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting that stocks in the top 50% of Zacks-ranked industries tend to outperform those in the bottom 50% by more than a factor of 2 to 1 [8]