Minerva Neurosciences Reports Second Quarter 2024 Financial Results and Business Updates
Rhea-AI Summary
Minerva Neurosciences (Nasdaq: NERV) reported its Q2 2024 financial results and business updates. Key highlights include:
1. The FDA issued a Complete Response Letter (CRL) for roluperidone's NDA for treating negative symptoms in schizophrenia patients.
2. R&D expenses increased to $3.9 million in Q2 2024 from $1.9 million in Q2 2023.
3. G&A expenses decreased to $2.4 million in Q2 2024 from $2.6 million in Q2 2023.
4. Net loss for Q2 2024 was $8.2 million ($1.09 per share) compared to $6.2 million ($1.12 per share) in Q2 2023.
5. Cash position as of June 30, 2024, was $31.0 million, down from $41.0 million on December 31, 2023.
Positive
- Continued interactions with FDA to address CRL questions for roluperidone
- Lower G&A expenses due to reduced compensation and professional service fees
Negative
- FDA issued Complete Response Letter for roluperidone NDA
- R&D expenses doubled year-over-year in Q2 2024
- Net loss increased to $8.2 million in Q2 2024 from $6.2 million in Q2 2023
- Cash position decreased by $10 million in the first half of 2024
News Market Reaction
On the day this news was published, NERV gained 5.00%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
BURLINGTON, Mass., Aug. 06, 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 second quarter of 2024 ending June 30, 2024.
Roluperidone NDA Update
During the first quarter of this year, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Since receiving the CRL, the Company has continued to have interactions with the FDA with the goal of addressing questions raised in the CRL.
Second Quarter 2024 Financial Results
Research and development (R&D) expense: For the three months ended June 30, 2024 and 2023, R&D expense was
General and administrative (G&A) expense: For the three months ended June 30, 2024 and 2023, G&A expense was
Non-cash interest expense: For the three and six months ended June 30, 2024, non-cash interest expense for the sale of future royalties was
Net loss: Net loss for the three and six months ended June 30, 2024 was
Cash Position: Cash, cash equivalents and restricted cash at June 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 June 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) | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| (in thousands) | |||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 30,881 | $ | 40,913 | |||
| Restricted cash | 100 | 100 | |||||
| Prepaid expenses and other current assets | 428 | 989 | |||||
| Total current assets | 31,409 | 42,002 | |||||
| Equipment and capitalized software, net | 13 | 29 | |||||
| Goodwill | 14,869 | 14,869 | |||||
| Total assets | $ | 46,291 | $ | 56,900 | |||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 829 | $ | 1,805 | |||
| Accrued expenses and other current liabilities | 3,375 | 1,535 | |||||
| Total current liabilities | 4,204 | 3,340 | |||||
| Long-term liabilities: | |||||||
| Liability related to the sale of future royalties | 86,579 | 82,017 | |||||
| Total liabilities | 90,783 | 85,357 | |||||
| Stockholders' deficit: | |||||||
| Common stock | 1 | 1 | |||||
| Additional paid-in capital | 369,125 | 368,357 | |||||
| Accumulated deficit | (413,618 | ) | (396,815 | ) | |||
| Total stockholders' deficit | (44,492 | ) | (28,457 | ) | |||
| Total liabilities and stockholders' deficit | $ | 46,291 | $ | 56,900 | |||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, (in thousands, except per share amounts) | Six Months Ended June 30, (in thousands, except per share amounts) | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,860 | $ | 1,887 | $ | 8,028 | $ | 4,541 | ||||||||
| General and administrative | 2,417 | 2,633 | 4,932 | 5,327 | ||||||||||||
| Total operating expenses | 6,277 | 4,520 | 12,960 | 9,868 | ||||||||||||
| Loss from operations | (6,277 | ) | (4,520 | ) | (12,960 | ) | (9,868 | ) | ||||||||
| Foreign exchange (losses) gains | (5 | ) | (7 | ) | 1 | (16 | ) | |||||||||
| Investment income | 361 | 365 | 719 | 730 | ||||||||||||
| Non-cash interest expense for the sale of future royalties | (2,312 | ) | (2,030 | ) | (4,562 | ) | (4,008 | ) | ||||||||
| Net loss | $ | (8,233 | ) | $ | (6,192 | ) | $ | (16,802 | ) | $ | (13,162 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.09 | ) | $ | (1.12 | ) | $ | (2.22 | ) | $ | (2.43 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 7,569 | 5,511 | 7,569 | 5,426 | ||||||||||||
FAQ
What was Minerva Neurosciences' (NERV) net loss per share in Q2 2024?
How much cash did Minerva Neurosciences (NERV) have as of June 30, 2024?
What was the status of Minerva Neurosciences' (NERV) roluperidone NDA in Q2 2024?
How did Minerva Neurosciences' (NERV) R&D expenses change in Q2 2024 compared to Q2 2023?
