CervoMed Reports Second Quarter 2024 Financial Results and Provides Corporate Updates
- Completed enrollment 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
- Completed private placement for up to
- Added to the Russell 2000® and Russell 3000® Indexes effective
“In the second quarter, we continued to deliver on key milestones, highlighted by completing enrollment in RewinD-LB, our Phase 2b trial evaluating neflamapimod in patients with early-stage DLB, and we remain on track to report topline data from the study in December 2024,” said
Recent Highlights and Anticipated Milestones
- Completed enrollment in Phase 2b RewinD-LB clinical trial evaluating oral neflamapimod in patients with early-stage DLB in
June 2024 and remain on track to report topline data from the study inDecember 2024 . - 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’s website. - Completed a private placement for proceeds of up to
$149.4 million with leading institutional healthcare investors inApril 2024 , with upfront gross proceeds of$50.0 million extending CervoMed’s cash runway through 2025. - 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.
Second Quarter 2024 Financial Results
Cash Position: As of
Grant Revenue: In
Research and Development (R&D) Expenses: R&D expenses for the second 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 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 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 CervoMed
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, and 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 data therefrom. 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
Investors@cervomed.com
617-430-7579
| Condensed Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 10,009,217 | $ | 7,792,846 | ||||
| Marketable securities, current | 35,082,502 | — | ||||||
| Prepaid expenses and other current assets | 2,236,436 | 1,256,501 | ||||||
| Grant receivable | — | 915,404 | ||||||
| Total current assets | 47,328,155 | 9,964,751 | ||||||
| Marketable securities, non-current | 5,806,260 | — | ||||||
| Other assets | 56,234 | 7,770 | ||||||
| Total assets | $ | 53,190,649 | $ | 9,972,521 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 725,854 | $ | 662,471 | ||||
| Deferred grant revenue | 1,401,501 | — | ||||||
| Accrued expenses and other current liabilities | 1,086,381 | 1,933,276 | ||||||
| Total liabilities | 3,213,736 | 2,595,747 | ||||||
| Commitments and Contingencies (Note 9) | ||||||||
| Stockholders’ Equity: | ||||||||
| Common stock, |
8,253 | 5,674 | ||||||
| Additional paid-in capital | 109,260,391 | 61,811,889 | ||||||
| Accumulated other comprehensive loss | (19,702 | ) | — | |||||
| Accumulated deficit | (59,272,029 | ) | (54,440,789 | ) | ||||
| Total stockholders' equity | 49,976,913 | 7,376,774 | ||||||
| Total liabilities and stockholders' equity | $ | 53,190,649 | $ | 9,972,521 | ||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (As Restated) | (As Restated) | |||||||||||||||
| Grant revenue | $ | 3,288,971 | $ | 1,719,944 | $ | 5,636,221 | $ | 3,127,812 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,772,391 | 1,958,388 | 6,586,649 | 3,791,662 | ||||||||||||
| General and administrative | 2,511,679 | 992,553 | 4,639,609 | 1,993,466 | ||||||||||||
| Total operating expenses | 6,284,070 | 2,950,941 | 11,226,258 | 5,785,128 | ||||||||||||
| Loss from operations | (2,995,099 | ) | (1,230,997 | ) | (5,590,037 | ) | (2,657,316 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Other income (expense) | (247 | ) | (212,211 | ) | (277 | ) | 644,368 | |||||||||
| Interest income | 678,441 | 17,707 | 759,074 | 53,111 | ||||||||||||
| Total other income, net | 678,194 | (194,504 | ) | 758,797 | 697,479 | |||||||||||
| Net loss | $ | (2,316,905 | ) | $ | (1,425,501 | ) | $ | (4,831,240 | ) | $ | (1,959,837 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.27 | ) | $ | (2.75 | ) | $ | (0.65 | ) | $ | (3.78 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 8,702,764 | 518,140 | 7,436,633 | 518,140 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net unrealized loss on marketable securities | (19,702 | ) | — | (19,702 | ) | — | ||||||||||
| Total comprehensive loss | $ | (2,336,607 | ) | $ | (1,425,501 | ) | $ | (4,850,942 | ) | $ | (1,959,837 | ) | ||||
Source: CervoMed Inc.