Minerva Secures $60M Upfront to Fuel Phase 3 Roluperidone Amid FDA Dialogue

Introduction

Minerva Neurosciences, Inc. (NASDAQ: NERV) is a clinical-stage biopharmaceutical company headquartered in Waltham, Massachusetts. The company focuses on the development of therapies targeting central nervous system (CNS) disorders, with a portfolio that includes roluperidone (MIN-101) for negative symptoms of schizophrenia and MIN-301 for Parkinson’s disease.

Corporate Structure and Leadership

Founded in 2010, Minerva operates under an executive management team with extensive experience in CNS drug development and commercialization:

• Dr. Remy Luthringer, Executive Chairman & Chief Executive Officer since November 2014, has guided over 150 CNS molecules into clinical trials and holds a PhD in neurosciences and clinical pharmacology.
• Mr. Geoff Race, President and Chief Business Officer since January 2016, previously led Funxional Therapeutics and PanGenetics.
• Dr. Michael Davidson, Chief Medical Officer, has authored over 300 peer-reviewed publications in schizophrenia and Alzheimer’s research and has received numerous awards in neuroscience.
• Mr. Fred Ahlholm, Chief Financial Officer, joined in 2014 and previously served as Vice President of Finance and Chief Accounting Officer at Amarin Corporation.
• Mr. Joe Reilly, Senior Vice President and Chief Operating Officer, has over a decade of experience at Genzyme in several commercial and finance roles.
• Dr. Jay Saoud, Consultant, possesses more than 26 years of R&D experience in multiple therapeutic areas, including successful New Drug Application submissions.

CNS disorders by Pawel Czerwinski

Developments and News

On January 19, 2021, Minerva announced the sale of its royalty interest in seltorexant to Royalty Pharma plc for an upfront payment of $60 million and potential additional milestone payments of up to $95 million, contingent upon the achievement of specific clinical, regulatory, and commercialization milestones. Seltorexant is in Phase 3 development for major depressive disorder with insomnia, conducted by Janssen Pharmaceutica. The proceeds from this transaction are intended to support the Phase 3 development of roluperidone.

On March 17, 2025, Nasdaq confirmed Minerva's compliance with Listing Rule 5550(b)(3), allowing the company to maintain its listing on the Nasdaq Capital Market. Interactions with the U.S. Food and Drug Administration are ongoing to address the Complete Response Letter related to the New Drug Application for roluperidone.

On May 13, 2025, Minerva reported its first-quarter financial results for the period ending March 31, 2025.

Financial and Strategic Analysis

For the quarter ending March 31, 2025, research and development expenses totaled $1.4 million, a decrease from $4.2 million in the same period of 2024, primarily due to reduced costs associated with the FDA review of the NDA for roluperidone and the completion of the C18 study. General and administrative expenses remained constant at $2.5 million. Non-cash interest expense related to the sale of future royalties was zero, compared to $2.3 million in Q1 2024. The net loss for the quarter was $3.8 million, or $0.50 per share, compared to a net loss of $8.6 million, or $1.13 per share, in Q1 2024. Cash, cash equivalents, and restricted cash amounted to $17.4 million at March 31, 2025, down from $21.5 million at December 31, 2024.

The monetization of the seltorexant royalty stream has provided non-dilutive capital to advance the Phase 3 development of roluperidone. Ongoing dialogue with the FDA will determine the timeline for resubmission of roluperidone's NDA.

Market Position and Industry Context

Minerva operates within the CNS therapeutic sector alongside other companies developing treatments for schizophrenia, major depressive disorder, insomnia, and Parkinson’s disease. The emphasis on clinical endpoints that are directly tied to patient benefit is in line with a wider industry movement toward measurable outcomes. Minerva’s mid-stage pipeline and royalty agreement structure distinguish it from early-stage biotech firms and larger pharmaceutical entities, positioning it to leverage partnerships for later-stage funding and commercialization.

tl;dr

• On March 17, 2025, Minerva regained Nasdaq compliance and continues interactions with the FDA to resolve the Complete Response Letter for roluperidone’s NDA.
• First-quarter results (ending March 31, 2025) reported a net loss of $3.8 million ($0.50/share) and a cash position of $17.4 million.
• Proceeds from the $60 million upfront payment by Royalty Pharma support the ongoing Phase 3 program for roluperidone; potential future milestone payments of up to $95 million remain contingent on certain achievement criteria.
• Continued FDA engagement and cash resources will influence the timeline for key data updates and potential resubmissions for regulatory approval.