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Minerva Neurosciences Provides First Quarter 2026 Financial Results and Business Updates

NERV
  • Minerva Neurosciences initiated its global confirmatory Phase 3 trial for roluperidone to treat negative symptoms of schizophrenia in the first quarter of 2026, with the first patient screened in March 2026.
  • The trial will enroll approximately 380 patients across 40 sites worldwide, including the US and Europe, to evaluate roluperidone 64 mg versus placebo for primary negative symptoms at 12 weeks.
  • Topline efficacy data for the 12-week Phase A portion of the trial is expected in the second half of 2027.
  • Phase B will extend the trial for 40 weeks to compare roluperidone with three common antipsychotics (risperidone, aripiprazole, olanzapine) regarding relapse rates of positive symptoms.
  • Previous open-label data presented at SIRS 2026 showed no safety concerns or drug-drug interactions between roluperidone and olanzapine.
  • Roluperidone remains the only late-stage drug candidate for patients with negative symptoms of schizophrenia, a population with no approved treatments in the US or Europe.
  • Minerva announced a leadership transition in Q1 2026, appointing Jim O'Connor as Chief Business Officer and General Counsel effective April 21, 2026.
  • R&D expenses for Q1 2026 were $5.3 million, while G&A expenses reached $11.4 million, largely due to an $8.0 million non-cash stock compensation charge including a $6.6 million one-time settlement cost.
  • The company recorded a $109.4 million non-cash expense for the change in fair value of warrant liability during the quarter.
  • GAAP net loss for Q1 2026 was $125.4 million ($2.86 per share), compared to a non-GAAP adjusted net loss of $7.3 million ($0.17 per share).
  • Minerva's cash position as of March 31, 2026, stood at approximately $78.2 million.