Minerva Neurosciences Secures $200M Funding for Roluperidone Phase 3 Trials

Minerva Neurosciences, Inc. has successfully secured a substantial funding initiative aimed at supporting the clinical development of roluperidone, specifically targeting the negative symptoms of schizophrenia. The company announced that this private placement could yield up to $200 million in gross capital.

Details of Funding Arrangement

The financing arrangement comprises an initial upfront investment of $80 million through the sale of Series A preferred stock. Additionally, there is potential for up to $80 million via the exercise of Tranche A warrants. An extra $40 million may also be secured contingent upon achieving specific milestones relating to Tranche B warrant cash exercises.

Use of Proceeds

• Funding confirmatory Phase 3 clinical trials of roluperidone.
• Resubmission of the New Drug Application (NDA) to regulatory authorities.
• Preparation for the commercial launch of roluperidone in the U.S. market.
• General corporate purposes and working capital.

Minerva has projected that the closing of this placement will occur around October 23, 2025, pending customary conditions being met. A strategic board expansion is also expected, with up to three investor-designated directors being appointed to enhance the management of clinical operations.

Clinical Trial Focus

The funding is intended to facilitate a clinical trial designed to assess the efficacy of roluperidone in alleviating the severe negative symptoms associated with schizophrenia. Negative symptoms can severely diminish an individual’s quality of life, making this area a significant target for therapeutic intervention.

Regulatory Alignment and Future Prospects

Minerva has made noteworthy advancements alongside the FDA concerning the design and execution of the Phase 3 trial. The trial will focus on patients diagnosed with stable, impairing negative symptoms of schizophrenia. There is an emphasis on achieving a diverse patient recruitment strategy to adequately represent the affected population in the U.S.

In summary, the $200 million funding secured by Minerva Neurosciences is poised to make significant strides in addressing the unmet needs in the treatment of schizophrenia’s negative symptoms through the development of roluperidone. Investors have expressed confidence in Minerva’s ability to navigate the complexities of clinical trials and regulatory frameworks, aiming to provide effective solutions for millions affected by this disorder.