CervoMed Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
Rhea-AI Summary
CervoMed Inc. (NASDAQ: CRVO) reported Q3 2024 financial results and corporate updates. The company completed the last patient visit in its RewinD-LB Phase 2b trial for neflamapimod in early-stage dementia with Lewy bodies, with topline data expected in December 2024. Financial highlights include cash position of $46.7 million as of September 30, 2024, grant revenue of $1.9 million, R&D expenses of $5.1 million, and a net loss of $4.8 million. The company expects current funding to support operations through 2025.
Positive
- Secured $21.3 million in total NIA grants for RewinD-LB trial
- Strong cash position of $46.7 million, sufficient through 2025
- Grant revenue increased to $1.9M from $1.5M year-over-year
- Selected as 'Best Startup' in 2024 Prix Galien USA Award
Negative
- Net loss increased to $4.8M from $2.2M net income year-over-year
- R&D expenses increased significantly to $5.1M from $1.8M year-over-year
- Operating loss doubled to $5.4M from $2.7M year-over-year
- Cash decreased from $50.9M in Q2 2024 to $46.7M in Q3 2024
News Market Reaction – CRVO
On the day this news was published, CRVO declined 2.55%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Reported last patient, last visit in its RewinD-LB Phase 2b clinical trial evaluating neflamapimod in patients with early-stage dementia with Lewy bodies (DLB) in October 2024; topline data expected in December 2024 –
- Hosted a virtual key opinion leader event in July 2024 highlighting neflamapimod’s potential for patients with early-stage DLB –
BOSTON, Nov. 12, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results for the third quarter ended September 30, 2024.
“In the third quarter, we conducted the final patient visits in RewindD-LB, our Phase 2b trial evaluating neflamapimod in patients with early-stage DLB and began to prepare for database lock in the fourth quarter. We remain on track to report topline data from the study in December 2024,” said John Alam, MD, Chief Executive Officer of CervoMed. “Additionally, we carried out important chemistry, manufacturing and controls (CMC) activities to prepare for Phase 3 trial initiation in mid-2025 after a planned end-of-Phase 2 meeting with the FDA. While our core focus remains on the opportunity in DLB, we also plan to initiate a Phase 2a trial to evaluate neflamapimod’s potential to promote recovery from ischemic stroke in the first quarter of 2025, for which we recently obtained ethics committee approval.”
Recent Highlights and Anticipated Milestones
- In November 2024, CervoMed was selected as “Best Startup” in the 2024 Prix Galien USA Award by the Galien Foundation, a premier global institution dedicated to honoring innovators in life sciences.
- Delivered two oral presentations at the recent Clinical Trials on Alzheimer’s Disease Conference (CTAD) showing neflamapimod demonstrated a treatment effect on plasma glial fibrillary acid protein, a robust measure of neurogenerative disease activity in DLB, and that the RewinD-LB study enrolled a population that is optimized to show the treatment effect. Full details on the CTAD presentation can be found here.
- Reported last patient, last visit had occurred in the Phase 2b RewinD-LB clinical trial evaluating oral neflamapimod in patients with early-stage DLB in October 2024 and remain on track to report topline data from the study in December 2024.
- Plasma biomarker data from the AscenD-LB Phase 2a trial of neflamapimod in patients with DLB were featured in a poster presentation at the Alzheimer's Association International Conference®, held in Philadelphia on July 29, 2024. A PDF copy of the poster presentation is available on the “Presentations and Publications” section of the CervoMed website.
- Hosted a virtual key opinion leader event on clinical disease expression of DLB, the role of the cholinergic system and neflamapimod’s potential for patients with early-stage DLB in July 2024. The call featured presentations from John-Paul Taylor, MBBS (hons), MRCPsych, PhD (Newcastle University) and Ralph A. Nixon, MD, PhD (New York University Grossman School of Medicine). A replay is accessible on CervoMed’s website.
- On July 1, 2024, CervoMed was added to the Russell 2000® and Russell 3000® Indexes as part of the 2024 Russell U.S. Indexes annual reconstitution.
Third Quarter 2024 Financial Results
Cash Position: As of September 30, 2024, CervoMed had approximately
Grant Revenue: In January 2023, CervoMed was awarded a
Research and Development (R&D) Expenses: R&D expenses for the three months ended September 30, 2024, were approximately
General and Administrative (G&A) Expenses: G&A expenses were approximately
Operating Loss: Operating loss was approximately
Net Loss: Net loss was approximately
About the RewinD-LB Phase 2b Study in Dementia with Lewy Bodies
CervoMed’s ongoing Phase 2b study, RewinD-LB, is a randomized, 16-week, double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg TID) in 159 patients with early-stage DLB. In early-stage DLB patients – who are estimated to comprise approximately
About CervoMed
CervoMed 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
| CervoMed Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,743,667 | $ | 7,792,846 | ||||
| Marketable securities, current | 38,913,236 | — | ||||||
| Prepaid expenses and other current assets | 1,888,879 | 1,256,501 | ||||||
| Grant receivable | 264,148 | 915,404 | ||||||
| Total current assets | 48,809,930 | 9,964,751 | ||||||
| Other assets | 73,937 | 7,770 | ||||||
| Total assets | $ | 48,883,867 | $ | 9,972,521 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,082,435 | $ | 662,471 | ||||
| Accrued expenses and other current liabilities | 2,163,936 | 1,933,276 | ||||||
| Total liabilities | 3,246,371 | 2,595,747 | ||||||
| Commitments and Contingencies (Note 10) | ||||||||
| Stockholders’ Equity: | ||||||||
| Common stock, | 8,253 | 5,674 | ||||||
| Additional paid-in capital | 109,531,651 | 61,811,889 | ||||||
| Accumulated other comprehensive income | 123,162 | — | ||||||
| Accumulated deficit | (64,025,570 | ) | (54,440,789 | ) | ||||
| Total stockholders' equity | 45,637,496 | 7,376,774 | ||||||
| Total liabilities and stockholders' equity | $ | 48,883,867 | $ | 9,972,521 | ||||
| CervoMed Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Grant revenue | $ | 1,939,751 | $ | 1,526,482 | $ | 7,575,972 | $ | 4,654,294 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,125,097 | 1,791,487 | 11,711,746 | 5,583,149 | ||||||||||||
| General and administrative | 2,210,927 | 2,410,124 | 6,850,536 | 4,403,590 | ||||||||||||
| Total operating expenses | 7,336,024 | 4,201,611 | 18,562,282 | 9,986,739 | ||||||||||||
| Loss from operations | (5,396,273 | ) | (2,675,129 | ) | (10,986,310 | ) | (5,332,445 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Other income (expense) | (3,440 | ) | 4,777,824 | (3,717 | ) | 5,422,192 | ||||||||||
| Interest income | 646,172 | 47,667 | 1,405,246 | 100,778 | ||||||||||||
| Total other income, net | 642,732 | 4,825,491 | 1,401,529 | 5,522,970 | ||||||||||||
| Net (loss) income | $ | (4,753,541 | ) | $ | 2,150,362 | $ | (9,584,781 | ) | $ | 190,525 | ||||||
| Per share information: | ||||||||||||||||
| Net (loss) income per share of common stock, basic and diluted | $ | (0.55 | ) | $ | 0.65 | $ | (1.22 | ) | $ | 0.13 | ||||||
| Weighted average shares outstanding, basic and diluted | 8,702,764 | 3,308,302 | 7,861,757 | 1,458,415 | ||||||||||||
| Net loss per share of common stock, diluted | $ | (0.55 | ) | $ | (0.70 | ) | $ | (1.22 | ) | $ | (2.37 | ) | ||||
| Weighted average shares outstanding, diluted | 8,702,764 | 3,766,700 | 7,861,757 | 2,209,407 | ||||||||||||
| Comprehensive (loss) income: | ||||||||||||||||
| Net unrealized gain on marketable securities | 142,864 | — | 123,162 | — | ||||||||||||
| Total comprehensive (loss) income | $ | (4,610,677 | ) | $ | 2,150,362 | $ | (9,461,619 | ) | $ | 190,525 | ||||||
FAQ
When will CervoMed (CRVO) release topline data for the RewinD-LB Phase 2b trial?
What was CervoMed's (CRVO) cash position in Q3 2024?
What was CervoMed's (CRVO) Q3 2024 net loss?
How much grant funding did CervoMed (CRVO) receive from NIA?
