CervoMed Reports Second Quarter 2024 Financial Results and Provides Corporate Updates
Rhea-AI Summary
CervoMed Inc. (NASDAQ: CRVO) reported its Q2 2024 financial results and provided corporate updates. Key highlights include:
1. Completed enrollment in the RewinD-LB Phase 2b trial for neflamapimod in early-stage dementia with Lewy bodies (DLB), with topline data expected in December 2024.
2. Raised up to $149.4 million in a private placement, extending cash runway through 2025.
3. Added to Russell 2000® and Russell 3000® Indexes.
4. Q2 2024 financials: $50.9 million cash on hand, $5.6 million grant revenue for H1 2024, R&D expenses of $3.8 million, G&A expenses of $2.5 million, and a net loss of $2.3 million.
The company remains focused on developing treatments for age-related neurologic disorders, with neflamapimod showing potential in DLB and other neurological conditions.
Positive
- Completed enrollment in RewinD-LB Phase 2b trial for neflamapimod in early-stage DLB
- Raised up to $149.4 million in private placement, extending cash runway through 2025
- Added to Russell 2000® and Russell 3000® Indexes
- Increased grant revenue to $5.6 million for H1 2024, up from $3.1 million in H1 2023
- Cash position increased to $50.9 million as of June 30, 2024, from $7.8 million at end of 2023
Negative
- Net loss increased to $2.3 million in Q2 2024, compared to $1.4 million in Q2 2023
- R&D expenses increased to $3.8 million in Q2 2024, up from $2.0 million in Q2 2023
- G&A expenses rose to $2.5 million in Q2 2024, compared to $1.0 million in Q2 2023
- Operating loss increased to $3.0 million in Q2 2024, up from $1.2 million in Q2 2023
News Market Reaction – CRVO
In the trading session that priced this news, CRVO gained 7.54%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Completed enrollment in its RewinD-LB Phase 2b clinical trial evaluating neflamapimod in patients with early-stage dementia with Lewy bodies (DLB) in June 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 –
- Completed private placement for up to
- Added to the Russell 2000® and Russell 3000® Indexes effective July 1, 2024, as part of the 2024 Russell U.S. Indexes annual reconstitution -
BOSTON, Aug. 12, 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 second quarter ended June 30, 2024.
“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 John Alam, MD, Chief Executive Officer of CervoMed. “Approximately two-thirds of the patients screened met the exclusion criteria for plasma ptau181—that is, they did not have advanced DLB—affirming our expectation that half or more of individuals with diagnosed DLB are still in the early stages of their disease. This, together with the high level of engagement across our clinical trial sites and the execution of our clinical team and partners, contributed to our ability to complete enrollment as planned. We look forward to building on the encouraging data from our Phase 2a AscenD-LB trial demonstrating neflamapimod’s potential to improve the lives of patients by targeting synaptic dysfunction in the basal forebrain cholinergic system to address cognitive, functional and motor aspects of the disease, and we believe a positive result in RewinD-LB will bring us one step closer to the market in this high value indication. Beyond DLB, we continue to explore additional opportunities to capitalize on neflamapimod’s potential to overcome existing challenges in neurological disorders driven by cholinergic dysfunction. This includes progressing early-stage clinical activities evaluating neflamapimod’s potential to promote recovery from ischemic stroke and improve clinical outcomes in certain forms of frontotemporal dementia.”
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 in December 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 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.
- Completed a private placement for proceeds of up to
$149.4 million with leading institutional healthcare investors in April 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 Russell U.S. Indexes annual reconstitution.
Second Quarter 2024 Financial Results
Cash Position: As of June 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 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
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 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, 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 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) | ||||||||
| June 30, | December 31, | |||||||
| 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 | ||||
| CervoMed Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 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 | ) | ||||
