CervoMed Reports First Quarter 2024 Financial Results and Provides Corporate Updates
CervoMed, a clinical-stage company developing treatments for age-related neurological disorders, reported its Q1 2024 financial results. The company is on track to complete enrollment for its RewinD-LB Phase 2b trial evaluating neflamapimod in DLB patients by 2Q 2024, with topline data expected in 4Q 2024.
CervoMed completed a private placement of up to $149.4 million in early 2Q 2024, with $50 million received upfront. Cash and cash equivalents as of March 31, 2024, were $6.4 million, excluding the private placement proceeds.
Grant revenue increased to $2.3 million for Q1 2024, while R&D expenses rose to $2.8 million due to the RewinD-LB trial. G&A expenses increased to $2.1 million due to higher operational costs following a reverse merger in August 2023. The company reported an operating loss of $2.6 million but net income of $2.5 million for Q1 2024.
- Completion of enrollment for the RewinD-LB Phase 2b trial on track for 2Q 2024.
- Topline data from the RewinD-LB trial expected in 4Q 2024.
- Private placement of up to $149.4 million completed, with $50 million upfront.
- Grant revenue increased to $2.3 million for Q1 2024, up from $1.4 million in Q1 2023.
- Net income of $2.5 million for Q1 2024, compared to a net loss of $0.5 million in Q1 2023.
- Cash and cash equivalents decreased to $6.4 million as of March 31, 2024, down from $7.8 million as of December 31, 2023.
- R&D expenses increased to $2.8 million in Q1 2024 from $1.8 million in Q1 2023.
- G&A expenses rose to $2.1 million in Q1 2024 from $1.0 million in Q1 2023.
- Operating loss increased to $2.6 million for Q1 2024, up from $1.4 million for Q1 2023.
Insights
CervoMed's latest financial results reveal a significant net income increase to
CervoMed's progress on its RewinD-LB Phase 2b clinical trial for neflamapimod in patients with dementia with Lewy bodies (DLB) is promising. Completion of enrollment is expected in 2Q 2024, with topline data anticipated in 4Q 2024. The Phase 2b trial is critically designed to enroll DLB patients most likely to benefit from neflamapimod, potentially positioning it as a first-to-market treatment. Additionally, neflamapimod's ability to modulate cholinergic dysfunction, as demonstrated in preclinical and clinical studies, is significant. It offers a potential breakthrough in treating DLB, a condition with limited treatment options. The publication of Phase 2a results in a respected journal like Neurology and presentations at major conferences further underscores the drug’s potential. Long-term, if successful, this could create substantial value for both patients and investors.
The recent private placement involving leading healthcare investors indicates strong market confidence in CervoMed's clinical programs and financial health. The upfront proceeds of
- CervoMed on track to complete enrollment in 2Q 2024 in its RewinD-LB Phase 2b clinical trial evaluating neflamapimod in patients with dementia with Lewy bodies (DLB); topline data expected in 4Q 2024-
- Completed up to
BOSTON, May 15, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today reported its financial results for the first quarter ended March 31, 2024.
“Building on a year of high operational and clinical achievement, already in 2024, we have strengthened our financial resources and published data that further positions our lead clinical program, neflamapimod, as a highly differentiated, potential first-to-market treatment option for patients with DLB,” said John Alam, MD, Chief Executive Officer of CervoMed. “In preclinical and clinical studies, neflamapimod has demonstrated the potential to modulate cholinergic dysfunction and degeneration, thereby reversing the underlying disease process in the basal forebrain and improving performance on cognitive and motor tasks. Our RewinD-LB Phase 2b clinical trial builds on these results, is well powered, designed to include DLB patients most likely to benefit from neflamapimod, and is expected to provide a path to market in this high value indication. We remain on track to complete enrollment in the RewinD-LB trial during the second quarter of this year, followed by topline efficacy results expected in the fourth quarter of 2024. In parallel, without distracting from our core focus on DLB, we also plan to explore opportunities to expand the therapeutic applications of neflamapimod to overcome existing challenges in additional cholinergic dysfunction driven neurological disorders.”
Recent Highlights and Anticipated Milestones
- Enrollment in the randomized, controlled Phase 2b RewinD-LB clinical trial evaluating oral neflamapimod in patients with DLB continues to progress and CervoMed remains on track to complete enrollment in the second quarter of 2024.
- During the first quarter of 2024, an integrated summary of results from the AscenD-LB Phase 2a clinical trial was published in a major peer-reviewed journal (Neurology®) and presentations at a major scientific conference (AD/PD™ 2024) further highlighted the potential of neflamapimod in “pure” DLB and the probability of success in RewinD-LB.
- On April 1, 2024, CervoMed completed a private placement of up to
$149.4 million joined by leading healthcare investors. The gross upfront proceeds from the offering were approximately$50.0 million , with up to an additional$99.4 million if the warrants issued in connection with the offering are exercised in full. Cash and cash equivalents from the upfront proceeds of the offering, together with the CervoMed’s cash and cash equivalents as of March 31, 2024, and remaining funds to be received from its NIA grant, are expected to provide runway through the end of 2025 based on CervoMed’s current operating plan.
First Quarter 2024 Financial Results
Cash Position: As of March 31, 2024, CervoMed had approximately
Grant Revenue: In January 2023, CervoMed was awarded a
Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2024 were approximately
General and Administrative (G&A) Expenses: G&A expenses were approximately
Operating Loss: Operating loss was approximately
Net Loss: Net income 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 up to 160 patients with very mild or mild dementia due to DLB. Patients completing the 16-week placebo-controlled study period will be able to continue in the study while receiving open label neflamapimod treatment for an additional 32 weeks. Patients with Alzheimer’s Disease-related co-pathology, assessed by a blood biomarker (plasma ptau181), will be excluded. The primary endpoint in the study is change in the Clinical Dementia Rating Sum of Boxes, and secondary endpoints include the Timed Up and Go test, a cognitive test battery, and the Clinician’s Global Impression of Change. The RewinD-LB study is funded by a
About CervoMed
CervoMed Inc. (the “Company”) 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 p38MAP 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 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 therapeutic potential of neflamapimod, the anticipated timing and achievement of clinical and development milestones, including the completion and achievement of primary endpoints of the Company’s Phase 2b clinical trial , the potential receipt of additional proceeds from the Company’s private placement transaction completed in April 2024 upon the exercise of outstanding warrants, and the Company’s projected cash runway. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential” or other words that convey uncertainty of future events or outcomes 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; 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) | ||||||||
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,369,172 | $ | 7,792,846 | ||||
| Deferred offering costs | 247,671 | — | ||||||
| Prepaid expenses | 1,348,679 | 1,256,501 | ||||||
| Grant receivable | — | 915,404 | ||||||
| Total current assets | 7,965,522 | 9,964,751 | ||||||
| Other assets | 31,926 | 7,770 | ||||||
| Total assets | $ | 7,997,448 | $ | 9,972,521 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 679,739 | 662,471 | ||||||
| Deferred grant revenue | 572,475 | — | ||||||
| Accrued expenses and other current liabilities | 1,408,856 | 1,933,276 | ||||||
| Total liabilities | 2,661,070 | 2,595,747 | ||||||
| Commitments and Contingencies (Note 8) | ||||||||
| Stockholders’ Equity: | ||||||||
| Series A preferred stock March 31, 2024 and December 31, 2023, 0 shares issued and outstanding at March 31, 2024 and December 31, 2023 | — | — | ||||||
| Common stock, 6,170,479 and 5,674,520 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 6,170 | 5,674 | ||||||
| Additional paid-in capital | 62,285,332 | 61,811,889 | ||||||
| Accumulated deficit | (56,955,124 | ) | (54,440,789 | ) | ||||
| Total stockholders' equity | 5,336,378 | 7,376,774 | ||||||
| Total liabilities and stockholders' equity | $ | 7,997,448 | $ | 9,972,521 | ||||
| CervoMed Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| (As Restated) | ||||||||
| Grant revenue | $ | 2,347,250 | $ | 1,407,868 | ||||
| Operating expenses: | ||||||||
| Research and development | 2,814,258 | 1,833,274 | ||||||
| General and administrative | 2,127,930 | 1,000,913 | ||||||
| Total operating expenses | 4,942,188 | 2,834,187 | ||||||
| Loss from operations | (2,594,938 | ) | (1,426,319 | ) | ||||
| Other income (expense): | ||||||||
| Other income (expense) | (30 | ) | 856,579 | |||||
| Interest income | 80,633 | 35,404 | ||||||
| Total other income, net | 80,603 | 891,983 | ||||||
| Net loss | $ | (2,514,335 | ) | $ | (534,336 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.41 | ) | $ | (1.03 | ) | ||
| Weighted average shares outstanding, basic and diluted | 6,170,501 | 518,140 | ||||||
FAQ
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