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Minerva Neurosciences Reports First Quarter 2025 Financial Results and Business Updates

1. Minerva regained Nasdaq compliance on March 17, ensuring continued listing. 2. Q1 2025 R&D expenses decreased to $1.4 million from $4.2 million in Q1 2024. 3. Net loss reduced to $3.8 million, down from $8.6 million year-over-year. 4. Ongoing interactions with FDA over questions on roluperidone's NDA process. 5. Cash position decreased to $17.4 million from $21.5 million at year-end.

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Why Neutral?

While improved compliance and reduced losses are positives, the FDA's concerns are still pending.

How important is it?

The article reflects financial stability and regulatory challenges but lacks definitive positive news.

Why Short Term?

FDA interactions and immediate financial metrics are relevant for the near future.

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NERV
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 $1.4 million and $4.2 million, respectively. R&D expense was lower versus the prior year period primarily due to costs associated with the FDA’s review of our NDA for roluperidone, costs for the C18 study, and lower compensation expenses. General and administrative (G&A) expense: For both the three months ended March 31, 2025 and 2024, G&A expense was $2.5 million. 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 $2.3 million, respectively. Non-cash interest expense was lower versus the prior year period due to revising our estimates for the timing and amount of future royalty payments to be received under the royalty arrangement. During the third quarter of 2024, we adjusted the carrying amount of our liability related to the sale of future royalties to the initial payment of $60 million. This adjustment resulted in the recognition of $26.6 million in other income during the third quarter of 2024, representing the amount of non-cash interest expense amortized through June 30, 2024. Net loss: Net loss was $3.8 million for the three months ended March 31, 2025, or a basic and diluted net loss per share of $0.50, as compared to net loss of $8.6 million for the three months ended March 31, 2024, or a basic and diluted net loss per share of $1.13. Cash Position: Cash, cash equivalents and restricted cash at March 31, 2025 were approximately $17.4 million, as compared to $21.5 million at December 31, 2024. 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 AhlholmChief Financial OfficerMinerva Neurosciences, Inc.info@minervaneurosciences.com Media inquiries: Helen ShikPrincipalShik Communications LLChelen@shikcommunications.com CONDENSED CONSOLIDATED BALANCE SHEET DATA(Unaudited) March 31, 2025December 31, 2024 (in thousands)ASSETSCurrent 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' DEFICITCurrent 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    

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