Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on central nervous system (CNS) diseases, reported a net loss of $293.4 million for the year ended December 31, 2025, compared to a net income of $1.4 million for the year ended December 31, 2024. The company's research and development expenses decreased to $5.8 million in 2025 from $11.9 million in 2024, primarily due to lower costs for a drug substance validation campaign, safety study, consultant fees, and compensation expenses. General and administrative expenses also saw a decrease, totaling $9.3 million in 2025 compared to $9.9 million in 2024, mainly due to lower professional service fees and insurance costs.
The significant shift in profitability was largely influenced by non-cash transactions. In 2024, the company recognized $26.6 million in other income due to an adjustment in the carrying amount of the liability related to the sale of future royalties, while in 2025, the company recorded a loss on issuance of convertible preferred stock and warrants of $321.5 million and a gain on the change in fair value of the warrant liability of $45.4 million. Investment income decreased from $1.3 million in 2024 to $0.9 million in 2025, reflecting lower cash and cash equivalents balances and interest rates. As of December 31, 2025, Minerva Neurosciences had cash, cash equivalents, and restricted cash totaling $82.4 million.
A key operational development for Minerva Neurosciences is the ongoing development of its lead product candidate, roluperidone, for the treatment of negative symptoms in schizophrenia. Following a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for roluperidone, the company is planning a new confirmatory Phase 3 trial (C19) to address the deficiencies cited by the FDA. The C19 trial is expected to initiate in the second quarter of 2026 and enroll 380 patients, with topline efficacy results anticipated in the second half of 2027 and relapse assessment data in the second half of 2028.
Looking ahead, Minerva Neurosciences anticipates increased clinical and administrative costs as it progresses with the Phase 3 trial of roluperidone and hires additional support staff. The company expects to fund these activities, in part, with the net proceeds from a private placement completed in October 2025. The company's strategy involves advancing roluperidone through clinical development, exploring collaborations with pharmaceutical companies, and leveraging its intellectual property portfolio to identify additional indications for roluperidone. As of December 31, 2025, the company had 7 full-time employees and relies on consultants and companies for expertise in key functions.
About Minerva Neurosciences, Inc.
Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing proprietary therapies for central nervous system disorders. Its key products include roluperidone for negative symptoms in schizophrenia, and in-licensed compounds like MIN-301 for Parkinson’s disease and seltorexant for insomnia and depression. The company targets high unmet medical needs globally, leveraging innovative mechanisms, clinical data, and strategic collaborations to advance novel CNS treatments.
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