Minerva Neurosciences reports second quarter 2026 results and C19 trial progress

Minerva Neurosciences, Inc. (Nasdaq: NERV) reported financial and business updates for the second quarter ended June 30, 2026, in a release dated August 7, 2026. The release was filed as Exhibit 99.1 to a Form 8-K. Minerva reported GAAP net income of $17.5 million, or $0.36 per basic share and $(0.14) per diluted share, for the quarter. The company says the result was driven by a $27.6 million non-cash gain on the change in fair value of its warrant liability.

Corporate updates

The C19 Study, Minerva's confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia, is designed to enroll 380 patients across approximately 40 clinical sites worldwide. Minerva says the study follows productive discussions with the FDA on its design and efficacy assessments, and builds on the prior pivotal trials, C03 and C07. Phase A will evaluate roluperidone 64 mg against placebo on primary negative symptoms at 12 weeks. Phase B will evaluate longer-term relapse of positive symptoms against commonly prescribed antipsychotic medications over an additional 52-week period, with topline Phase B data expected in the second half of 2028.

Remy Luthringer, Ph.D., Chief Executive Officer, said: "Roluperidone is the only late-stage candidate targeting negative symptoms directly." He added: "We remain focused on execution and on track for topline efficacy data in the second half of 2027."

Second quarter results

Research and development expense was $7.2 million for the quarter, compared with $1.3 million a year earlier. Minerva attributes the increase mainly to expenses for the C19 trial and higher compensation costs. Excluding the warrant gain and stock-based compensation expense, the adjusted net loss for the quarter was $7.8 million, compared with $3.0 million a year earlier.

Six-month results and balance sheet

For the six months ended June 30, 2026, research and development expense was $12.4 million and general and administrative expense was $14.9 million. The G&A figure includes a $6.6 million one-time, non-cash charge for the modification of previously granted stock options, tied to a first-quarter severance agreement. Minerva recorded an $81.8 million non-cash loss on the warrant liability from the October 2025 private placement, and reported a GAAP net loss of $107.9 million, or $2.38 per basic and diluted share, compared with a net loss of $7.0 million, or $0.93 per share, a year earlier.

Total liabilities were $296.6 million at June 30, 2026, compared with $233.8 million at December 31, 2025. Cash, cash equivalents, marketable securities and restricted cash were approximately $75.4 million at June 30, 2026, compared with $82.4 million at December 31, 2025.

Background on funding

Minerva's annual report on Form 10-K, filed March 11, 2026, says the company expects to fund the C19 trial and its NDA resubmission in part with net proceeds from its October 2025 private placement. Cash, cash equivalents and restricted cash were $82.4 million at December 31, 2025, which the 10-K says will be sufficient to meet operating commitments for at least twelve months from the date the financial statements are issued.

What the quarter does not change

Roluperidone still has to clear the C19 study. The company says topline efficacy data are expected in the second half of 2027, and Phase B data in 2028. The 10-K describes C19 as a trial required by the FDA and ties it to a planned NDA resubmission, so approval has not been granted. The release says C19 builds on clinical success in the earlier C03 and C07 trials but reports none of those results, and it calls roluperidone the only late-stage candidate for this population without naming any competitor. The 10-K says there can be no assurances that the company will resubmit the NDA and obtain approval in a timely manner, on favorable terms, or at all. It also says Minerva will require additional capital that may not be available on acceptable terms, and that raising funds by issuing equity will cause dilution to existing stockholders. The quarter's profit came from a non-cash warrant gain, and the adjusted net loss was $7.8 million. Total liabilities of $296.6 million at June 30, 2026 compare with cash, cash equivalents, marketable securities and restricted cash of approximately $75.4 million, down from $82.4 million at the end of 2025.

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