CervoMed Announces Key Senior Leadership Appointments

Rhea-AI Summary

CervoMed (NASDAQ: CRVO) announced two key senior leadership appointments to advance the development of neflamapimod. Dr. Claudia Ordonez joined as Senior Vice President, Medical Science, bringing expertise from previous roles at Vertex and Biogen. Dr. Mark De Rosch was appointed Senior Vice President, Regulatory and Government Affairs and Program Management, contributing over 30 years of experience in regulatory and CMC functions. The company expects topline data from the RewinD-LB study in December 2024 and plans Phase 3 initiation in mid-2025 for dementia with Lewy Bodies treatment. The company also granted stock options to three new employees, including 32,000 shares to Dr. De Rosch at $12.53 per share.

Positive

• Strategic strengthening of leadership team with experienced executives in medical science and regulatory affairs
• Approaching important milestone with RewinD-LB study topline data in December 2024
• Clear timeline for Phase 3 initiation in mid-2025

Negative

• No approved therapies currently available for dementia with Lewy Bodies
• Potential dilution from new stock options granted to employees

Insights

Market Research Analyst

This management change news, while highlighting experienced additions to the leadership team, is not significantly impactful for immediate investor consideration. The appointments of Dr. Ordonez and Dr. De Rosch, though bringing valuable expertise, represent routine organizational development. The only tangible financial element is the modest inducement grant of 56,959 shares, which has minimal impact on the company's market cap of 103.9M.

The key catalyst to watch remains the upcoming topline data from the RewinD-LB study in December 2024, followed by potential Phase 3 initiation in mid-2025. These future events, rather than these appointments, will be more significant drivers of company value.

New hires in key scientific and regulatory roles to advance continued development of neflamapimod

BOSTON, Nov. 13, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today reported two senior leadership appointments to advance continued development of neflamapimod.

Claudia Ordonez, MD, joined CervoMed as Senior Vice President, Medical Science in October 2024. Dr. Ordonez was previously Chief Medical Officer at two biotech companies and has significant expertise with both early and late-stage drug development. She previously led clinical development programs in cystic fibrosis and multiple sclerosis at Vertex and Biogen, respectively. Additionally, Mark De Rosch, Ph.D., FRAPS, recently joined CervoMed as Senior Vice President, Regulatory and Government Affairs and Program Management. Dr. De Rosch brings over 30 years of experience having successfully built out regulatory, quality and chemistry, manufacturing and controls (CMC) functions at separate biotech organizations to support Phase 3 and commercialization readiness.

“We are pleased to welcome these seasoned executives to our leadership team at this critical juncture for CervoMed,” said John Alam, MD, Chief Executive Officer of CervoMed. “We believe both Claudia and Mark will play important roles in CervoMed’s future as we continue to evaluate neflamapimod’s potential and the role it could play in addressing the significant unmet need for patients suffering from dementia with Lewy Bodies (DLB), for whom no approved therapies are currently available. We look forward to leveraging their extensive experience as we approach topline data from the RewinD-LB study in December 2024 and prepare for regulatory discussions and Phase 3 initiation in mid-2025.”

Inducement Grants

On November 7, 2024, CervoMed granted options to purchase an aggregate of 56,959 shares of CervoMed Inc. (the “Company”) common stock to three new employees, including 32,000 shares granted to Dr. De Rosch. Each option has an exercise price of $12.53, the closing price of the Company’s common stock on the grant date, and each will vest in 36 equal installments on the last day of each month over a three-year period, subject to the employee’s continued employment with the Company on each such date. The awards were approved by the compensation committee of the Company’s board of directors as an inducement material to each new employee’s entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

About CervoMed
CervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that causes disease in DLB and certain other major neurological disorders. Neflamapimod is currently being evaluated in a Phase 2b study in patients with early-stage DLB.

Forward-Looking Statements
This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to, the Company’s financial position and cash runway, the therapeutic potential of neflamapimod, the anticipated timing and achievement of clinical and development milestones, including the completion and achievement of primary endpoints of the RewinD-LB Phase 2b clinical trial and the Company’s announcement of topline and other data therefrom, and any other expected or implied benefits or results, including that any initial clinical results observed with respect to neflamapimod in the AscenD-LB Trial or RewinD-LB Trial will be replicated in later trials, as well as the timing of the initiation of any potential future trials. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources and the availability of additional funds on acceptable terms; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the U.S. Food and Drug Administration; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (SEC) on March 29, 2024, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law.

Investor Contact:
PJ Kelleher
LifeSci Advisors
Investors@cervomed.com
617-430-7579

FAQ

When will CervoMed (CRVO) release topline data for the RewinD-LB study?

CervoMed expects to release topline data from the RewinD-LB study in December 2024.

What was the exercise price for stock options granted by CervoMed (CRVO) on November 7, 2024?

The stock options were granted with an exercise price of $12.53, which was the closing price of CervoMed's common stock on the grant date.

When does CervoMed (CRVO) plan to initiate Phase 3 trials for neflamapimod?

CervoMed plans to initiate Phase 3 trials for neflamapimod in mid-2025.