Minerva Neurosciences Reports Third Quarter Financial Results and Updates on Roluperidone Trial
News related to:Minerva Neurosciences · 3 min read
BURLINGTON, Mass., Nov. 06, 2026 /CourierPR/ -- Minerva Neurosciences, a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system (CNS) disorders, reported financial and business updates for the third quarter ended September 30, 2026. The company's ongoing Phase 3 trial of roluperidone (MIN-101C19) for the treatment of negative symptoms of schizophrenia is progressing, with topline efficacy data expected in the second half of 2027.
According to the company, the recent publication in Schizophrenia Research emphasizes the need to expand basic science beyond dopaminergic mechanisms and improve clinical trial methodology for negative symptoms. Roluperidone, the company's lead drug candidate, remains the only late-stage drug targeting negative symptoms directly. The C19 Study, an ongoing global Phase 3 clinical trial, is designed to enroll 380 patients across approximately 40 clinical sites worldwide, including the United States and multiple European countries.
The C19 Study follows discussions with the FDA on the overall design and efficacy assessments and builds directly on Minerva’s prior Phase 2b and Phase 3 trials (C03 and C07). Phase A of the C19 Study is evaluating roluperidone 64 mg versus placebo to confirm the effect of roluperidone on primary negative symptoms at 12 weeks. The topline data from Phase A is expected in the second half of 2027. Phase B of the C19 Study is evaluating longer-term relapse of positive symptoms for roluperidone versus commonly prescribed antipsychotic medications for an additional 52-week period. The topline data from Phase B is expected in the second half of 2028.
In the third quarter of 2026, Minerva Neurosciences reported research and development (R&D) expenses of $5.2 million, up from $0.9 million in the same period of 2025. For the nine months ended September 30, 2026, R&D expenses were $17.6 million, compared to $3.6 million in the same period of 2025. General and administrative (G&A) expenses for the third quarter of 2026 were $4.3 million, up from $1.9 million in the same period of 2025. For the nine months ended September 30, 2026, G&A expenses were $19.1 million, compared to $6.5 million in the same period of 2025. The increase in G&A expenses is attributed to higher professional service fees and compensation costs, as well as costs related to a severance agreement in the first quarter, which included a $6.6 million one-time, non-cash charge for the modification of the terms of previously granted stock options.
Other income and expense for the third quarter of 2026 was $0.6 million, up from $0.1 million in the same period of 2025. For the nine months ended September 30, 2026, investment income was $1.8 million, compared to $0.4 million in the same period of 2025. The increase is primarily due to higher cash equivalents and marketable securities balances.
Minerva Neurosciences also recorded a non-cash gain of $109.6 million related to the change in fair value of the warrant liability for the three months ended September 30, 2026. For the nine months ended September 30, 2026, the company recorded a non-cash gain of $27.8 million related to the change in fair value of the warrant liability. The gain on the changes in fair value of the warrant liability is related to the warrants issued in conjunction with the October 2025 private placement.
As of September 30, 2026, the company's cash, cash equivalents, marketable securities, and restricted cash position was approximately $77.0 million, down from $82.4 million at the end of 2025.
Minerva Neurosciences will host a Key Opinion Leader (KOL) event on November 12, 2026, at 10:00 AM ET, featuring several key opinion leaders and company management focused on the opportunity for roluperidone in treating the negative symptoms of schizophrenia.