Minerva Neurosciences Reports $3.8 Million Net Loss in Q1 2025, Focuses on Roluperidone Development

Minerva Neurosciences, Inc. reported a net loss of $3.8 million for the first quarter of 2025, a significant decrease from the $8.6 million loss recorded in the same period of 2024. The company's total expenses for the quarter were approximately $3.9 million, down from $6.7 million year-over-year. This reduction in expenses was primarily attributed to a decrease in research and development costs, which fell to $1.4 million from $4.2 million, reflecting lower costs associated with the FDA's review of the New Drug Application (NDA) for its lead product candidate, roluperidone.

As of March 31, 2025, Minerva's total assets were reported at $32.8 million, a decline from $37.1 million at the end of 2024. The company's cash and cash equivalents decreased to $17.3 million from $21.4 million, indicating a net cash used in operating activities of approximately $4.1 million during the quarter. The accumulated deficit increased to $399.1 million, up from $395.4 million at the end of the previous fiscal year. The company has not generated any revenue from product sales, as none of its product candidates have received regulatory approval.

In terms of strategic developments, Minerva continues to focus on its lead product candidate, roluperidone, which is being developed for the treatment of negative symptoms in schizophrenia. Following the FDA's issuance of a Complete Response Letter (CRL) in February 2024, the company has been engaged in ongoing discussions with the FDA to address the concerns raised in the CRL. These include the need for additional studies to demonstrate the safety and efficacy of roluperidone, particularly in conjunction with antipsychotic medications.

Minerva's operational metrics indicate that the company remains in a clinical development stage, with no approved products or revenue generation. The company has a total of 6,993,406 shares of common stock outstanding as of May 8, 2025. The company is also subject to compliance with Nasdaq listing requirements, having recently regained compliance with the Net Income Rule, which mandates a minimum net income from continuing operations. However, the company remains under a discretionary panel monitor for one year, and any future non-compliance could lead to delisting.

Looking ahead, Minerva anticipates the need for additional capital to fund its ongoing operations and product development efforts. The company believes its current cash reserves will be sufficient to meet its operating commitments for the next 12 months. However, it acknowledges the uncertainty surrounding the timing and outcomes of clinical trials, which could significantly impact its financial position and operational strategy. The company is exploring various financing options to support its future endeavors, including potential equity offerings and collaborations.