Minerva Neurosciences Reports First Quarter 2025 Financial Results and Business Updates
Rhea-AI Summary
• Regained Nasdaq compliance on March 17, 2025
• Ongoing FDA interactions regarding roluperidone NDA for schizophrenia negative symptoms
• Q1 2025 net loss of $3.8 million ($0.50 per share), improved from $8.6 million loss in Q1 2024
• R&D expenses decreased to $1.4 million from $4.2 million year-over-year
• G&A expenses remained stable at $2.5 million
• Cash position of $17.4 million as of March 31, 2025, down from $21.5 million at end of 2024
Positive
- Net loss improved significantly to $3.8M in Q1 2025 from $8.6M in Q1 2024
- Regained Nasdaq listing compliance, ensuring continued market presence
- R&D expenses reduced by 67% year-over-year
- Maintained stable G&A expenses at $2.5M
Negative
- Cash position declined by $4.1M in Q1 2025
- FDA Complete Response Letter issues for roluperidone NDA remain unresolved
- Continued operating losses with no revenue generation
News Market Reaction 1 Alert
On the day this news was published, NERV declined 0.07%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
BURLINGTON, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter of 2025 ended on March 31, 2025.
Corporate Update
On March 17, 2025, we were formally notified by Nasdaq that we had regained compliance with Nasdaq Listing Rule 5550(b)(3), and as such, will continue to be listed on the Nasdaq Capital Market.
Interactions with the FDA continue with the goal of addressing questions raised in the Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia as first disclosed in the first quarter of 2024.
First Quarter 2025 Financial Results
Research and development (R&D) expense: For the three months ended March 31, 2025 and 2024, R&D expense was
General and administrative (G&A) expense: For both the three months ended March 31, 2025 and 2024, G&A expense was
Non-cash interest expense: For the three months ended March 31, 2025 and 2024, non-cash interest expense for the sale of future royalties was zero and
Net loss: Net loss was
Cash Position: Cash, cash equivalents and restricted cash at March 31, 2025 were approximately
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia and MIN-301 for Parkinson’s disease. For more information, please visit the Company’s website.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to Minerva’s ability to remediate or otherwise resolve issues and deficiencies identified in the CRL and the outcome of its interactions with the FDA; and Minerva’s expectation that it will maintain compliance with Nasdaq’s listing standards and will be able to continue its listing on the Nasdaq Capital Market. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, Minerva’s ability to address FDA’s feedback and timing thereof; uncertainties associated with regulatory processes, including the content and timing of decisions by the FDA; general risks associated with developing biopharmaceutical product candidates; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund its clinical development plans, operations and corporate objectives on terms acceptable to Minerva; general economic conditions; and other factors that are described under the caption “Risk Factors” in Minerva’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 25, 2025, as updated by its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. Copies of reports filed with the SEC are posted on Minerva’s website at http://ir.minervaneurosciences.com/. The forward-looking statements in this press release are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law.
Contact:
Investor inquiries:
Frederick Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
info@minervaneurosciences.com
Media inquiries:
Helen Shik
Principal
Shik Communications LLC
helen@shikcommunications.com
| CONDENSED CONSOLIDATED BALANCE SHEET DATA | ||||||
| (Unaudited) | ||||||
| March 31, 2025 | December 31, 2024 | |||||
| (in thousands) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 17,290 | $ | 21,362 | ||
| Restricted cash | 100 | 100 | ||||
| Prepaid expenses and other current assets | 535 | 807 | ||||
| Total current assets | 17,925 | 22,269 | ||||
| Equipment and capitalized software, net | 4 | 6 | ||||
| Goodwill | 14,869 | 14,869 | ||||
| Total assets | $ | 32,798 | $ | 37,144 | ||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 640 | $ | 1,608 | ||
| Accrued expenses and other current liabilities | 1,307 | 1,229 | ||||
| Total current liabilities | 1,947 | 2,837 | ||||
| Long-term liabilities: | ||||||
| Liability related to the sale of future royalties | 60,000 | 60,000 | ||||
| Total liabilities | 61,947 | 62,837 | ||||
| Stockholders' deficit: | ||||||
| Common stock | 1 | 1 | ||||
| Additional paid-in capital | 369,980 | 369,683 | ||||
| Accumulated deficit | (399,130 | ) | (395,377 | ) | ||
| Total stockholders' deficit | (29,149 | ) | (25,693 | ) | ||
| Total liabilities and stockholders' deficit | $ | 32,798 | $ | 37,144 | ||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||
| (Unaudited) | ||||||
| Three Months Ended March 31, (in thousands, except per share amounts) | ||||||
| 2025 | 2024 | |||||
| Operating expenses: | ||||||
| Research and development | $ | 1,362 | $ | 4,167 | ||
| General and administrative | 2,541 | 2,515 | ||||
| Total operating expenses | 3,903 | 6,682 | ||||
| Loss from operations | (3,903 | ) | (6,682 | ) | ||
| Foreign exchange (losses) gains | (8 | ) | 5 | |||
| Investment income | 158 | 358 | ||||
| Non-cash interest expense for the sale of future royalties | - | (2,250 | ) | |||
| Net loss | $ | (3,753 | ) | $ | (8,569 | ) |
| Net loss per share, basic and diluted | $ | (0.50 | ) | $ | (1.13 | ) |
| Weighted average shares outstanding, basic and diluted | 7,569 | 7,569 | ||||
FAQ
What were Minerva Neurosciences (NERV) Q1 2025 financial results?
How did NERV's Q1 2025 performance compare to Q1 2024?
What is the status of Minerva's roluperidone FDA application?
Has Minerva Neurosciences resolved its Nasdaq listing compliance issues?
What is Minerva's current cash position as of Q1 2025?
