Minerva Neurosciences Reports Third Quarter 2024 Financial Results and Business Updates
Rhea-AI Summary
Minerva Neurosciences (NERV) reported Q3 2024 financial results with notable changes in expenses and income. R&D expenses decreased to $1.9 million from $3.4 million in Q3 2023, while G&A expenses slightly decreased to $2.5 million from $2.6 million. The company reported net income of $22.5 million for Q3 2024, compared to a net loss of $7.8 million in Q3 2023. Cash position stood at $26.6 million as of September 30, 2024. The FDA previously issued a Complete Response Letter for roluperidone's NDA for treating negative symptoms in schizophrenia patients, and the company continues interactions with the FDA to address raised questions.
Positive
- Net income of $22.5 million in Q3 2024 vs net loss of $7.8 million in Q3 2023
- Reduction in R&D expenses from $3.4M to $1.9M in Q3 2024
- Decrease in G&A expenses from $2.6M to $2.5M in Q3 2024
- Strong cash position of $26.6 million as of September 30, 2024
Negative
- FDA Complete Response Letter rejection for roluperidone NDA
- Cash position decreased from $41.0M (Dec 2023) to $26.6M (Sep 2024)
- Higher nine-month R&D expenses: $9.9M in 2024 vs $8.0M in 2023
News Market Reaction
On the day this news was published, NERV gained 1.72%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
BURLINGTON, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the third quarter of 2024 ending September 30, 2024.
Roluperidone NDA Update
As announced in February 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Interactions with the FDA continue with the goal of addressing questions raised in the CRL.
Third Quarter 2024 Financial Results
Research and development (R&D) expense: For the three months ended September 30, 2024 and 2023, R&D expense was
General and administrative (G&A) expense: For the three months ended September 30, 2024 and 2023, G&A expense was
Non-cash interest expense: For the three and nine months ended September 30, 2024, non-cash interest expense for the sale of future royalties was zero and
Other income: For the three and nine months ended September 30, 2024 and 2023, other income was
Net income (loss): Net income for the three and nine months ended September 30, 2024 was
Cash Position: Cash, cash equivalents and restricted cash at September 30, 2024 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 expectations concerning Minerva’s ability to remediate or otherwise resolve issues and deficiencies identified in the CRL and the timing and outcome of its interactions with the FDA. 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 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, 2023, filed with the Securities and Exchange Commission on February 22, 2024, as updated by its Quarterly Report on Form 10-Q for the quarter ended September 30, 3024. 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) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| (in thousands) | |||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 26,529 | $ | 40,913 | |||
| Restricted cash | 100 | 100 | |||||
| Prepaid expenses and other current assets | 1,307 | 989 | |||||
| Total current assets | 27,936 | 42,002 | |||||
| Equipment and capitalized software, net | 7 | 29 | |||||
| Goodwill | 14,869 | 14,869 | |||||
| Total assets | $ | 42,812 | $ | 56,900 | |||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 553 | $ | 1,805 | |||
| Accrued expenses and other current liabilities | 3,930 | 1,535 | |||||
| Total current liabilities | 4,483 | 3,340 | |||||
| Long-term liabilities: | |||||||
| Liability related to the sale of future royalties | 60,000 | 82,017 | |||||
| Total liabilities | 64,483 | 85,357 | |||||
| Stockholders' deficit: | |||||||
| Common stock | 1 | 1 | |||||
| Additional paid-in capital | 369,433 | 368,357 | |||||
| Accumulated deficit | (391,105 | ) | (396,815 | ) | |||
| Total stockholders' deficit | (21,671 | ) | (28,457 | ) | |||
| Total liabilities and stockholders' deficit | $ | 42,812 | $ | 56,900 | |||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Three Months Ended September 30, (in thousands, except per share amounts) | Nine Months Ended September 30, (in thousands, except per share amounts) | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 1,888 | $ | 3,444 | $ | 9,916 | $ | 7,985 | |||||||
| General and administrative | 2,479 | 2,635 | 7,410 | 7,963 | |||||||||||
| Total operating expenses | 4,367 | 6,079 | 17,326 | 15,948 | |||||||||||
| Loss from operations | (4,367 | ) | (6,079 | ) | (17,326 | ) | (15,948 | ) | |||||||
| Foreign exchange losses | (13 | ) | (5 | ) | (12 | ) | (21 | ) | |||||||
| Investment income | 314 | 349 | 1,032 | 1,079 | |||||||||||
| Non-cash interest expense for the sale of future royalties | - | (2,085 | ) | (4,562 | ) | (6,093 | ) | ||||||||
| Other income | 26,579 | - | 26,579 | - | |||||||||||
| Net income (loss) | $ | 22,513 | $ | (7,820 | ) | $ | 5,711 | $ | (20,983 | ) | |||||
| Net income (loss) per share, basic | $ | 2.97 | $ | (1.03 | ) | $ | 0.75 | $ | (3.41 | ) | |||||
| Weighted average shares outstanding, basic | 7,569 | 7,569 | 7,569 | 6,148 | |||||||||||
| Net income (loss) per share, diluted | $ | 2.97 | $ | (1.03 | ) | $ | 0.75 | $ | (3.41 | ) | |||||
| Weighted average shares outstanding, diluted | 7,569 | 7,569 | 7,578 | 6,148 | |||||||||||
FAQ
What was Minerva Neurosciences (NERV) Q3 2024 net income?
How much cash does NERV have as of September 30, 2024?
What happened with NERV's roluperidone FDA application in 2024?
