Minerva Neurosciences (NERV) investor relations material

Strategic focus and clinical rationale

• Targeting unmet needs in psychiatry, specifically negative symptoms in schizophrenia, which affect at least 60% of patients and are linked to poor functional outcomes.

• Roluperidone is designed as a monotherapy to address primary negative symptoms, avoiding confounding effects of antipsychotics and aiming for a paradigm shift in treatment.

• The approach is supported by consensus with the FDA and reflects evolving clinical practice toward individualized, function-focused care.

• Patients and prescribers are expected to favor roluperidone due to its side effect profile and potential to improve daily functioning.

• The strategy involves switching stabilized patients from antipsychotics to roluperidone, with the option to revert if positive symptoms recur.

Clinical development and trial design

• A confirmatory phase III trial began in March, following $200 million in PIPE financing, with 12-week efficacy data expected in the second half of 2027.

• The trial is powered at over 90% to detect a 1.8-point placebo-adjusted change, with robust controls for dropout and variability.

• The study population is characterized by stable positive symptoms and significant negative symptoms, with prior studies showing a four-point improvement over placebo at 12 weeks and up to eight to nine points at one year.

• Functional improvements on the PSP scale exceeded clinically meaningful thresholds, and relapse rates in prior studies were notably low (9–14%).

• No interim analysis for futility is planned, but ongoing monitoring of dropout and data variability is in place.

Regulatory and market outlook

• FDA engagement is ongoing, with the possibility of filing based on 12-week data while awaiting longer-term relapse data.

• The relapse phase (Phase B) is focused on safety, aiming for relapse rates comparable to or below those seen with antipsychotics (<20%).

• The patient population for the trial is well-defined and reproducible, with consistent baseline characteristics across studies.

• Intellectual property protection extends to at least 2038 via a sophisticated formulation patent, with ongoing efforts to further strengthen and extend IP.

• Broader indications may be pursued post-approval, leveraging the transdiagnostic relevance of negative symptoms.