Minerva reports first quarter 2026 results and starts its Phase 3 trial

Minerva Neurosciences, Inc. (Nasdaq: NERV) reported financial and business updates for the quarter ended March 31, 2026, in a release dated May 5, 2026. Under GAAP, the company reported a net loss of $125.4 million, or $2.86 per basic and diluted share, compared with a net loss of $3.8 million, or $0.50 per share, a year earlier. On a non-GAAP basis, adjusted net loss was $7.3 million, or $0.17 per share, compared with $3.5 million, or $0.46 per share, in the prior-year period. The release was furnished with a Form 8-K filed the same day.

The confirmatory Phase 3 trial

Minerva initiated its global confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia during the first quarter, and screened the first patient in March 2026. The trial will enroll approximately 380 patients at roughly 40 clinical sites worldwide, including the United States and several European countries. It will test roluperidone 64 mg against placebo for its effect on primary negative symptoms at 12 weeks. It will also evaluate, on an informational basis, the longer-term relapse rate of positive symptoms compared with several commonly prescribed antipsychotics over an additional 40 weeks.

The company says the design follows productive discussions with the FDA on the overall design and efficacy assessments, and builds directly on its earlier pivotal Phase 2b and Phase 3 trials, C03 and C07. Topline data from the 12-week Phase A portion are expected in the second half of 2027.

Dr. Remy Luthringer, Executive Chairman and CEO, said that "the initiation of our confirmatory Phase 3 trial and the screening of the first patient represent meaningful milestones for Minerva that underscore the progress of our lead program." The company also presented open-label safety data at the Schizophrenia International Research Society 2026 Annual Congress in March. The data showed no clinically meaningful safety concerns, no significant pharmacokinetic interactions and no pharmacodynamic effects when roluperidone was given with olanzapine.

Operating expenses and the balance sheet

Research and development expenses were $5.3 million, compared with $1.4 million a year earlier. The company attributes the increase mainly to costs of starting the C19 trial and higher compensation. General and administrative expenses were $11.4 million, compared with $2.5 million. That $8.9 million increase came mainly from non-cash stock compensation of $8.0 million, including a one-time charge of $6.6 million to modify previously granted stock options under the settlement agreement with Geoff Race, who was president and elected to leave the company.

The company recorded a non-cash expense of $109.4 million for the change in fair value of its warrant liability and for losses recognized on warrant exercises during 2026. Total liabilities were $343.1 million at March 31, 2026, compared with $233.8 million at December 31, 2025. Minerva had approximately $78.2 million in cash, cash equivalents, marketable securities and restricted cash at March 31, 2026, compared with $82.4 million at December 31, 2025.

Leadership

Jim O'Connor became Chief Business Officer and General Counsel effective April 21, 2026. Geoff Race will continue to be involved with the company as a consultant.

What the numbers and the data do not show

The first quarter net loss of $125.4 million came mostly from a non-cash warrant charge, but adjusted net loss still rose to $7.3 million from $3.5 million. Cash, cash equivalents, marketable securities and restricted cash fell to approximately $78.2 million from $82.4 million, while total liabilities reached $343.1 million. The olanzapine safety data are open-label, meaning unblinded, and the "no clinically meaningful safety concerns" finding is the company's description. Screening the first patient says nothing yet about efficacy, and the 10-K's reference to an NDA resubmission shows roluperidone is not approved. The 10-K says Minerva will require additional capital that may not be available on acceptable terms, and that raising funds by issuing equity will cause dilution. The company says topline efficacy data from the confirmatory trial are expected in the second half of 2027.

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