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 for the same period in 2025; the gain was driven by a $109.6 million non-cash gain on the change in fair value of warrant liability.
• Adjusted (non-GAAP) net loss for the three months ended September 30, 2026, was $5.6 million, compared to an adjusted net loss of $2.5 million in the prior-year period.
• GAAP net loss for the nine months ended September 30, 2026, was $7.2 million ($0.15 per basic share), compared to a net loss of $9.8 million ($1.29 per basic share) in the prior-year period.
• Adjusted (non-GAAP) net loss for the nine months ended September 30, 2026, 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 for the three months ended September 30, 2026, was $5.2 million, up from $0.9 million in 2025; for the nine months, R&D was $17.6 million, up from $3.6 million in 2025, primarily due to C19 trial expenses and higher compensation.
• General and administrative (G&A) expense for the three months ended September 30, 2026, was $4.3 million, up from $1.9 million in 2025; for the nine months, G&A was $19.1 million, up from $6.5 million in 2025, driven by professional service fees, compensation, and a $6.6 million one-time non-cash charge for stock option modifications.
• Investment income for the three months ended September 30, 2026, was $0.6 million, up from $0.1 million in 2025; for the nine months, investment income was $1.8 million, up from $0.4 million in 2025, due to higher cash equivalents and marketable securities balances.
• Total liabilities under GAAP were $184.1 million as of September 30, 2026, down from $233.8 million as of December 31, 2025; non-GAAP total liabilities (excluding warrant and royalty liabilities) 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, down from $82.4 million as of December 31, 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 the execution of the Phase 3 trial and the confirmation of roluperidone's effect on primary negative symptoms.

Business Segments and Product Lines:

• Roluperidone (MIN-101C19) is the only late-stage drug candidate targeting negative symptoms of schizophrenia.
• The C19 Study is a global Phase 3 trial 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 (risperidone, aripiprazole, or olanzapine) over an additional 52-week period.
• The trial design includes standardized assessments, intensive rater training, real-time monitoring, and structured caregiver outreach to minimize variability.
• CEO Remy Luthringer and CMO Michael Davidson published an article in Schizophrenia Research describing the need for non-dopaminergic mechanisms and improved clinical trial methodology for negative symptoms.
• The article characterizes roluperidone as an antagonist with high affinity for 5-HT2A and α1A receptors and very weak affinity for dopamine receptors.

Market and Competitive Landscape:

• Roluperidone remains the only late-stage drug candidate for the high-need population of patients with negative symptoms of schizophrenia.
• The psychiatry field is increasingly recognizing the importance of finding non-dopaminergic mechanisms in the treatment of schizophrenia.

Risks and Challenges:

• Forward-looking statements include risks regarding the inability to predict expenditures for the Phase 3 trial, potential delays in trials, and the possibility that trial results may not be satisfactory.
• Risks include the potential for the commercial opportunity to be smaller than anticipated, uncertainties in obtaining regulatory approvals, and the need for additional financing if cash resources are insufficient.
• The company notes that earlier trials may not be predictive of later trials and that enrollment rates or trial design may not enable successful completion.
• Risks also include patent protection uncertainties, litigation, and general economic conditions.

Management Commentary and Tone:

• CEO Remy Luthringer stated the company is "on track for topline efficacy data in the second half of 2027" and emphasized the focus on "execution."
• Management highlighted that the C19 study is designed to "separate signal from noise" and confirm effects seen in prior trials.
• The tone reflects confidence in the unique positioning of roluperidone as the sole late-stage candidate for this indication.

Other Key Points:

• The Company will host an in-person and virtual Key Opinion Leader (KOL) event on November 12, 2026, at 10:00 AM ET in New York.
• A $6.6 million one-time, non-cash charge was recorded in the first quarter of 2026 related to a severance agreement and the modification of previously granted stock options.
• The warrant liability gain of $109.6 million in the third quarter and $27.8 million in the nine months is related to warrants issued in conjunction with the October 2025 private placement.
• The company operates as a clinical-stage biopharmaceutical company focused on CNS disorders.