Core Viewpoint - CervoMed Inc. is advancing its clinical trial for neflamapimod in early-stage dementia with Lewy bodies (DLB), with topline data expected in December 2024, while also preparing for a Phase 3 trial and exploring additional indications for the drug [1][2][10]. Clinical Development - The final patient visits in the RewinD-LB Phase 2b trial were conducted in October 2024, with database lock planned for the fourth quarter [2][3]. - A Phase 2a trial to evaluate neflamapimod's potential for ischemic stroke recovery is set to begin in Q1 2025 following ethics committee approval [2]. - CervoMed hosted a virtual event in July 2024 to discuss neflamapimod's potential in treating early-stage DLB, featuring expert presentations [3]. Financial Performance - As of September 30, 2024, CervoMed reported approximately $46.7 million in cash and equivalents, down from $50.9 million as of June 30, 2024, but up from $7.8 million at the end of 2023 [4]. - Grant revenue for Q3 2024 was approximately $1.9 million, an increase from $1.5 million in Q3 2023, attributed to more active trial sites [5]. - Research and development expenses surged to approximately $5.1 million in Q3 2024, compared to $1.8 million in the same period in 2023, due to increased costs associated with the RewinD-LB trial [6]. - General and administrative expenses slightly decreased to approximately $2.2 million in Q3 2024 from $2.4 million in Q3 2023 [7]. - The operating loss for Q3 2024 was approximately $5.4 million, compared to $2.7 million in Q3 2023, while the net loss was approximately $4.8 million, a significant drop from a net income of $2.2 million in the prior year [8][9]. Research Highlights - CervoMed was recognized as "Best Startup" at the 2024 Prix Galien USA Award, highlighting its innovative contributions to life sciences [3]. - Presentations at the Clinical Trials on Alzheimer's Disease Conference indicated that neflamapimod positively affected plasma glial fibrillary acid protein levels, a key marker in neurodegenerative diseases [3]. - The RewinD-LB study involved 159 patients and is funded by a $21.3 million grant from the National Institute on Aging [10].

The Prix Galien USA Best Startup category recognizes outstanding innovation by therapeutics-focused life science companies that have not yet received their first product approval The award to CervoMed recognizes the advances made by the company towards developing the first treatment for Dementia with Lewy bodies (DLB) BOSTON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related neurologic disorders, announced today it was a ...

Data from the AscenD-LB Phase 2a trial in DLB confirm recent scientific literature indicating that plasma glial fibrillary acid protein (GFAP) is a robust measure of neurodegenerative disease activity in DLB Neflamapimod treatment previously led to significant reduction in plasma GFAP levels (p=0.015 versus placebo) and these reductions were associated with an improvement in clinical outcomes The RewinD-LB Phase 2b clinical study successfully enrolled a DLB patient population that is optimized to show the t ...

Topline data from the RewinD-LB Phase 2b study on track for December 2024 Detailed safety and efficacy data from RewinD-LB Phase 2b study to be featured in an oral presentation at the ILBDC conference in January 2025 BOSTON, Oct. 29, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related neurologic disorders, today announced that it will deliver an oral presentation providing detailed safety and efficacy results from its completed Rew ...

CervoMed Inc. (CRVO) shares ended the last trading session 10.6% higher at $17.47. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 2.3% loss over the past four weeks. Last month, the company reported robust financial results for the second quarter of 2024. The phase IIb study evaluating CervoMed's pipeline candidate, neflamapimod, for treating Dementia with Lewy Bodies is also progressing well. This might have driv ...

BOSTON, Aug. 27, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced that the Company's management will participate in the following investor conferences during the month of September: Morgan Stanley 22nd Annual Global Healthcare Conference Format: Fireside Chat Date: Friday, September 6, 2024 Time: 1:50 PM ET Webcast Link: click here H.C. Wainwright 26th Annual Global Investment Conference For ...

BOSTON, Aug. 22, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced its recent feature in Fortune magazine. In the article, titled "A New Hope for Dementia Treatment", CervoMed was recognized for its pioneering work in developing neflamapimod, a potentially transformative treatment for patients suffering from dementia with Lewy bodies (DLB). "We are honored to be featured in Fortune and to hav ...

Clinical Trials - CervoMed completed enrollment in its RewinD-LB Phase 2b clinical trial for neflamapimod in early-stage dementia with Lewy bodies (DLB) in June 2024, with topline data expected in December 2024 [2]. - Approximately two-thirds of screened patients met the exclusion criteria for plasma ptau181, indicating that half or more of diagnosed DLB individuals are still in early stages [2]. Financial Performance - The company raised up to $149.4 million through a private placement with institutional healthcare investors in April 2024, providing cash runway through 2025 [3]. - As of June 30, 2024, CervoMed had approximately $50.9 million in cash, cash equivalents, and marketable securities, up from $7.8 million as of December 31, 2023 [4]. - Grant revenue for the six months ended June 30, 2024, was approximately $5.6 million, an increase from $3.1 million for the same period in 2023, due to more active trial sites [5]. - Grant revenue for Q2 2024 was $3,288,971, up 91.1% from $1,719,944 in Q2 2023 [12]. - Total operating expenses for Q2 2024 were $6,284,070, an increase of 112.5% compared to $2,950,941 in Q2 2023 [12]. - Interest income for Q2 2024 was $678,441, a substantial increase from $17,707 in Q2 2023 [12]. Expenses - Research and Development (R&D) expenses for Q2 2024 were approximately $3.8 million, compared to $2.0 million in Q2 2023, primarily due to increased costs related to the RewinD-LB Trial [6]. - Research and development expenses in Q2 2024 reached $3,772,391, a 92.5% increase from $1,958,388 in Q2 2023 [12]. - General and Administrative (G&A) expenses were approximately $2.5 million in Q2 2024, up from $1.0 million in Q2 2023, driven by increased public company costs [7]. - General and administrative expenses for Q2 2024 were $2,511,679, up 153.5% from $992,553 in Q2 2023 [12]. Losses - The operating loss for Q2 2024 was approximately $3.0 million, compared to $1.2 million for the same period in 2023 [7]. - The net loss for Q2 2024 was approximately $2.3 million, compared to a net loss of approximately $1.4 million for the same period in 2023 [7]. - Loss from operations for Q2 2024 was $(2,995,099), compared to $(1,230,997) in Q2 2023 [12]. - Net loss for Q2 2024 was $(2,316,905), an increase from $(1,425,501) in Q2 2023 [12]. - Net loss per share for Q2 2024 was $(0.27), compared to $(2.75) in Q2 2023 [12]. - Total comprehensive loss for Q2 2024 was $(2,336,607), compared to $(1,425,501) in Q2 2023 [12]. Market Position - CervoMed was added to the Russell 2000® and Russell 3000® Indexes effective July 1, 2024, as part of the annual reconstitution [3]. - Weighted average shares outstanding for Q2 2024 were 8,702,764, significantly higher than 518,140 in Q2 2023 [12].

Financial Performance - The net loss for the six months ended June 30, 2024, was $4.8 million, compared to a net loss of $2.0 million for the same period in 2023[106]. - Net loss for the three months ended June 30, 2024, was $2.3 million, a 63% increase from a net loss of $1.4 million in 2023[114]. - The company has not generated any revenue from product sales and does not expect to do so in the near future[108]. - The company expects to continue incurring losses and will require additional financing to support ongoing operations and product development[131]. Cash and Funding - As of June 30, 2024, the company had cash and cash equivalents of approximately $50.9 million and an accumulated deficit of $59.3 million[105][106]. - The company raised approximately $50.0 million in a private placement in April 2024, with potential additional proceeds of up to $99.4 million if Series A Warrants are fully exercised[96]. - Cash provided by financing activities for the six months ended June 30, 2024, was $46.4 million, resulting from the sale of common stock[138]. - The net increase in cash and cash equivalents for the six months ended June 30, 2024, was $2.2 million, compared to a decrease of $3.4 million in the same period of 2023[135]. - Cash used in investing activities for the six months ended June 30, 2024, was $40.6 million due to the purchase of marketable securities following a private placement[138]. Grant Funding - Grant funding recognized for the six months ended June 30, 2024, was $5.6 million, up from $3.1 million in the same period in 2023[108]. - Grant revenue increased to $3.3 million for the three months ended June 30, 2024, up 91% from $1.7 million in the same period of 2023, driven by the $21.0 million NIA Grant for the RewinD-LB Trial[115]. - For the six months ended June 30, 2024, grant revenue was $5.6 million, an 80% increase from $3.1 million in 2023, attributed to increased services for the RewinD-LB Trial[123]. Expenses - Research and development expenses are expected to increase substantially as the company continues to invest in clinical trials and regulatory approvals for neflamapimod[110]. - Research and development expenses rose to $3.8 million for the three months ended June 30, 2024, a 93% increase from $2.0 million in 2023, primarily due to outsourced CRO and related site expenses for the RewinD-LB Trial[116]. - Research and development expenses for the six months ended June 30, 2024, were $6.6 million, a 74% increase from $3.8 million in 2023[124]. - General and administrative expenses are anticipated to rise due to increased headcount and compliance costs associated with being a public company[112]. - General and administrative expenses surged to $2.5 million for the three months ended June 30, 2024, a 153% increase from $1.0 million in 2023, mainly due to costs associated with being a public company post-merger[118]. - General and administrative expenses for the six months ended June 30, 2024, reached $4.6 million, a 133% increase from $2.0 million in 2023[125]. - Total operating expenses for the three months ended June 30, 2024, were $6.3 million, reflecting a 113% increase from $3.0 million in 2023[114]. Clinical Trials - Enrollment in the RewinD-LB Trial was completed in June 2024, with topline data expected in December 2024, funded by a $21.0 million grant from the NIA[96]. - The RewinD-LB Trial enrolled 159 patients with Early-Stage DLB, with an estimated 66% of these patients being Early-Stage DLB based on screening data[100]. - The RewinD-LB Trial is designed to have greater than 95% statistical power to demonstrate improvement relative to placebo on change in CDR-SB, a global measure of dementia severity[100]. Operational Insights - The company experienced a cash outflow from operations primarily due to a net loss and changes in operating assets and liabilities[136]. - For the six months ended June 30, 2024, net cash used in operating activities was $3.6 million, compared to $3.4 million for the same period in 2023, reflecting an increase of approximately 5.9%[136]. - The company has no off-balance sheet arrangements that could materially affect its financial condition or results of operations[140]. - The company is not exposed to significant financing, liquidity, market, or credit risk from off-balance sheet arrangements[140]. - There were no material changes to critical accounting policies and estimates during the six months ended June 30, 2024[141]. - The company may enter into additional collaborative research and manufacturing agreements in the future, which could require upfront payments or long-term cash commitments[139].

BOSTON, July 30, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced that Company's Management will participate in a fireside chat at the Canaccord Genuity 44th Annual Growth Conference, to be held in Boston, MA, and participate in one-on-one investor meetings. Presentation Details Format: Fireside Chat Date: Tuesday, August 13, 2024 Time: 12:30 PM ET Webcast Link: https://wsw.com/webcast/canac ...