Announcement • Apr 13
Minerva Neurosciences, Inc., Annual General Meeting, Jun 03, 2026 Minerva Neurosciences, Inc., Annual General Meeting, Jun 03, 2026. Announcement • Apr 02
Minerva Neurosciences Announces First Patient Screened in Global Phase 3 Confirmatory Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia Minerva Neurosciences, Inc. announced that the first patient has been screened in its global, confirmatory Phase 3 clinical trial evaluating roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia. Negative symptoms, including avolition (severe lack of motivation), anhedonia (inability to experience pleasure) and social withdrawal can lead to profound personal and functional impairment and represent one of the greatest unmet needs in schizophrenia. There are currently no FDA-approved treatments with this indication. The Phase 3 trial will enroll approximately 380 patients across roughly 40 clinical sites worldwide, including the United States and multiple European countries. This confirmatory Phase 3 trial follows productive discussions with the FDA on the overall design and efficacy assessments. It builds directly on Minerva’s clinical success in the prior pivotal Phase 2b and Phase 3 trials (C03 and C07), both of which demonstrated consistent improvements in negative symptoms with the 64 mg dose of roluperidone. The global Phase 3 MIN-101C19 trial will enroll approximately 380 adults aged 18–55 with moderate to severe negative symptoms of schizophrenia, confirmed by a Positive and Negative Syndrome Scale (PANSS) negative subscale score greater than 20 and stable positive symptoms for at least six months. The trial utilizes a two-part design. The overall objective of the study is to confirm the effect of roluperidone on primary negative symptoms at 12 weeks compared to placebo and to evaluate longer-term relapse of positive symptoms compared with commonly prescribed antipsychotic medications for an additional 40 weeks. The trial is designed to minimize variability and maximize sensitivity to treatment effect, including standardized assessments, and comprehensive caregiver engagement. Topline data from the 12-week Phase A portion (i.e., primary efficacy endpoint) of the trial are expected in the second half of 2027. The trial’s operational model includes intensive rater training, real-time monitoring of scoring data, and structured caregiver outreach to support safety tracking, functional assessments, and adherence. Phase A is a 12-week, randomized, double-blind, placebo-controlled phase during which patients will receive 64 mg of roluperidone or placebo to evaluate the primary endpoint: change from baseline in the Marder Negative Symptoms Factor Score (NSFS), which is a factor-analytic composite created from selected PANSS items. The sole key secondary endpoint is the change from baseline in the Personal and Social Performance (PSP) total score. Other secondary endpoints include a broad set of additional clinical measures, including PANSS subscales, Clinical Global Impression – Severity (CGI-S), Clinical Global Impression – Improvement (CGI-I), the Calgary Depression Scale, avolition-specific analyses, and patient and caregiver treatment-satisfaction ratings. Phase B extends the trial for 40 weeks using a double-dummy, active-controlled, randomized design comparing continued roluperidone with three commonly prescribed antipsychotic medications (risperidone, aripiprazole, or olanzapine). This phase is designed to compare relapse rates between treatment groups. Relapses of positive symptoms will be evaluated using a rigorous, multi-component definition incorporating psychometric endpoints based on PANSS score worsening, and clinically meaningful events such as hospitalization or dangerous behavior. New Risk • Mar 23
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Negative equity (-US$136m). Shareholders have been substantially diluted in the past year (over 5x increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$43m net loss in 3 years). 
