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Minerva Neurosciences Provides Third Quarter 2026 Financial Results and Business Updates

  • Minerva Neurosciences reported Q3 2026 financial results & confirmed roluperidone Phase 3 trial (C19) is ongoing with topline efficacy data expected in 2H 2027.
  • Roluperidone remains the only late-stage drug candidate targeting negative symptoms of schizophrenia via non-dopaminergic mechanisms.
  • The C19 Study enrolls 380 patients across ~40 global sites; Phase A evaluates 64 mg roluperidone vs. placebo at 12 weeks with data expected 2H 2027.
  • Phase B of the C19 Study evaluates long-term relapse of positive symptoms over 52 weeks vs. antipsychotics with data expected 2H 2028.
  • A new Schizophrenia Research article co-authored by CEO Remy Luthringer & CMO Michael Davidson advocates expanding basic science beyond dopaminergic mechanisms.
  • The company will host an in-person & virtual Key Opinion Leader event on November 12, 2026, at 10:00 AM ET in New York.
  • R&D expenses for the three months ended September 30, 2026, were $5.2 million, driven by C19 trial costs & higher compensation.
  • G&A expenses for the three months ended September 30, 2026, were $4.3 million due to higher professional fees, compensation, & a $6.6 million non-cash stock option charge.
  • GAAP net income for the quarter was $100.7 million driven by a $109.6 million non-cash gain on warrant liability changes; adjusted non-GAAP net loss was $5.6 million.
  • GAAP net loss for the nine months ended September 30, 2026, was $7.2 million; adjusted non-GAAP net loss was $20.8 million.
  • Cash, cash equivalents, marketable securities, & restricted cash totaled approximately $77.0 million as of September 30, 2026.
  • Total GAAP liabilities were $184.1 million as of September 30, 2026, while non-GAAP total liabilities excluding warrant & royalty liabilities were $2.5 million.
  • Roluperidone is described as an antagonist with high affinity for σ-2, 5-HT2A, & α1A receptors but very weak affinity for dopamine receptors.
  • The Phase 3 trial design includes standardized assessments, intensive rater training, & caregiver outreach to minimize variability & maximize treatment effect sensitivity.