Minerva Neurosciences — Third Quarter 2026 Earnings Summary

Financial Performance

• GAAP net income for the three months ended September 30, 2026, was $100.7 million ($1.94 per basic share), compared to a net loss of $2.7 million in the prior-year period; GAAP net loss for the nine months ended September 30, 2026, was $7.2 million, compared to a net loss of $9.8 million in the prior-year period.
• The quarter's GAAP net income was driven by a $109.6 million non-cash gain on the change in fair value of the warrant liability; excluding this gain and stock-based compensation, adjusted (non-GAAP) net loss for the quarter was $5.6 million, compared to an adjusted net loss of $2.5 million in the prior-year period.
• For the nine months ended September 30, 2026, excluding the $27.8 million non-cash gain on the warrant liability and stock-based compensation, adjusted (non-GAAP) net loss was $20.8 million, compared to an adjusted net loss of $8.9 million in the prior-year period.
• Research and development (R&D) expense was $5.2 million for the three months ended September 30, 2026, compared to $0.9 million in the prior-year period; for the nine months, R&D expense was $17.6 million compared to $3.6 million in the prior-year period, driven by C19 trial expenses and higher compensation.
• General and administrative (G&A) expense was $4.3 million for the three months ended September 30, 2026, compared to $1.9 million in the prior-year period; for the nine months, G&A expense was $19.1 million compared to $6.5 million in the prior-year period, driven by professional service fees, compensation, and a $6.6 million one-time non-cash charge for stock option modifications.
• Investment income was $0.6 million for the three months ended September 30, 2026, compared to $0.1 million in the prior-year period; for the nine months, investment income was $1.8 million compared to $0.4 million in the prior-year period.
• Total liabilities were $184.1 million as of September 30, 2026, compared to $233.8 million as of December 31, 2025; non-GAAP total liabilities (excluding warrant liability and royalty liability) were $2.5 million as of September 30, 2026, compared to $2.3 million as of December 31, 2025.
• Cash, cash equivalents, marketable securities, and restricted cash totaled approximately $77.0 million as of September 30, 2026, compared to $82.4 million as of December 31, 2025.
• The company recorded a non-cash gain of $109.6 million for the three months and $27.8 million for the nine months related to the change in fair value of the warrant liability issued in October 2025.

Guidance and Future Outlook

• Topline efficacy data from Phase A of the C19 Study is expected in the second half of 2027.
• Topline data from Phase B of the C19 Study is expected in the second half of 2028.
• Management remains focused on execution and is on track for the expected data timelines.

Business Segments and Product Lines

• The ongoing global Phase 3 clinical trial of roluperidone (C19 Study) is designed to enroll 380 patients across approximately 40 clinical sites worldwide, including the US and multiple European countries.
• Phase A evaluates roluperidone 64 mg versus placebo to confirm effects on primary negative symptoms at 12 weeks.
• Phase B evaluates longer-term relapse of positive symptoms for roluperidone versus commonly prescribed antipsychotic medications over an additional 52-week period.
• Roluperidone is described as the only late-stage drug candidate targeting negative symptoms of schizophrenia directly.
• The company published an article in Schizophrenia Research describing roluperidone as an antagonist with high affinity for 5-HT2A and α1A receptors and very weak affinity for dopamine receptors.
• The company will host a Key Opinion Leader (KOL) event on November 12, 2026, in New York to discuss the opportunity for roluperidone.

Market and Competitive Landscape

• The psychiatry field is increasingly recognizing the importance of non-dopaminergic mechanisms in treating schizophrenia, particularly for negative symptoms.
• Roluperidone remains the only late-stage drug candidate for the high-need population of patients with negative symptoms of schizophrenia.
• The company emphasizes the need to expand basic science beyond dopaminergic mechanisms and improve clinical trial methodology for negative symptoms.

Risks and Challenges

• Risks include the inability to predict expenditures and resources required for the Phase 3 trial, potential delays in trials, and the possibility that trials may not have satisfactory outcomes.
• There is a risk that expected cash runway may not be accurate, potentially requiring additional financing sooner than anticipated.
• Risks include uncertainties regarding regulatory approvals, patent protection, litigation, and the potential for the commercial opportunity to be smaller than anticipated.
• The design and enrollment rate of the confirmatory Phase 3 trial may not enable successful completion.

Management Commentary and Tone

• CEO Remy Luthringer stated the company is developing treatments for negative symptoms beyond dopaminergic mechanisms and testing them in trials designed to separate signal from noise.
• Management highlighted that the C19 study is designed to confirm the effect seen in prior trials and that they remain focused on execution.
• The tone reflects confidence in the trial design and the unique positioning of roluperidone as the only late-stage candidate for this indication.

Other Key Points

• A $6.6 million one-time, non-cash charge related to the modification of previously granted stock options was included in the first quarter G&A expenses.
• The warrant liability is a non-cash, mark-to-market obligation revalued each period based on the company's stock price and other inputs.
• Non-GAAP financial measures exclude non-cash items related to stock-based compensation and changes in fair value of the warrant liability.
• The company is a clinical-stage biopharmaceutical company focused on central nervous system (CNS) disorders.