CervoMed Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
CRVO 11.12.2024
Drug:neflamapimod-unknown neflamapimod
Diseases:Dementia with Lewy Bodies
Diseases:Ischemic Stroke
Date of Upcoming Event:2024-10-01
Name of Upcoming Event:Clinical Trials on Alzheimer’s Disease Conference (CTAD)
About Gravity Analytica
Recent News
- 12.12.2024 - CervoMed Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
- 12.10.2024 - CervoMed Announces Topline Data from RewinD-LB Phase 2b Clinical Trial in Patients with Dementia with Lewy Bodies
- 11.27.2024 - CervoMed Announces Orphan Drug Designation Granted to Neflamapimod by U.S. Food and Drug Administration for the Treatment of Frontotemporal Dementia
Recent Filings
- 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
- Hosted a virtual key opinion leader event in
“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
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 foundhere.
- 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 inDecember 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 fromJohn-Paul Taylor , MBBS (hons), MRCPsych, PhD (Newcastle University ) andRalph A. Nixon , MD, PhD (New York University Grossman School of Medicine ). A replay is accessible on CervoMed’swebsite. - On
July 1, 2024 , CervoMed was added to the Russell 2000® and Russell 3000® Indexes as part of the 2024 RussellU.S. Indexes annual reconstitution.
Third Quarter 2024 Financial Results
Cash Position:As of
Grant Revenue:In
Research and Development (R&D) Expenses:R&D expenses for the three months ended
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 BodiesCervoMed’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 50% of the total diagnosed DLB patient population at any given time – the disease has not progressed to a point where the patient has significant neuronal loss in the hippocampus. Patients with advanced DLB – in whom there is significant, irreversible neuronal loss in the hippocampus and associated Alzheimer’s Disease co-pathology – as assessed by a blood biomarker (plasma ptau181), were excluded from the study. 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 CervoMedCervoMed 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 StatementsThis 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
Investor Contact:PJ Kelleher
| Condensed Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| 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 | ||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 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 | ||||||
Source: CervoMed Inc.