Minerva Neurosciences Q1 2024 Financial Results and Business Updates

BURLINGTON, Mass., May 01, 2024 – Minerva Neurosciences, Inc. (Nasdaq: NERV), a biopharmaceutical company in the clinical-stage phase, has provided updates on its business activities and financial performance for the first quarter of 2024, ending March 31, 2024.

The company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of roluperidone, a treatment aimed at alleviating negative symptoms in schizophrenia patients. Minerva Neurosciences is actively engaging in discussions with the FDA to address the issues highlighted in the CRL.

In the first quarter of 2024, Minerva completed a Phase 1b clinical trial (MIN-101C18) which began in October 2023. This trial focused on the safety, tolerability, pharmacodynamics, and pharmacokinetics of administering roluperidone in combination with olanzapine to adults exhibiting moderate to severe negative symptoms of schizophrenia. The trial, registered under NCT06107803, enrolled 17 patients, of which 13 completed the 17-day daily regimen of 64 mg roluperidone. The study reported no new safety concerns, with only a few mild treatment-emergent adverse events (TEAEs) that were resolved without any lasting effects. No significant electrocardiogram or laboratory abnormalities emerged, and there was no worsening of symptoms during the period when roluperidone was administered alone or in combination with olanzapine. Pharmacokinetic interactions between the drugs were found to be non-relevant.

Financially, Minerva reported an increase in research and development (R&D) expenses for the quarter, rising to $4.2 million from $2.7 million in the same period the previous year. This hike was mainly due to the costs associated with the FDA's review of the NDA and the clinical trial MIN-101C18. General and administrative (G&A) expenses saw a slight decrease, totaling $2.5 million compared to $2.7 million in the previous year, primarily due to reduced professional service fees.

Non-cash interest expense related to the sale of future royalties increased to $2.3 million from $2.0 million year-over-year. This increase is attributed to the amortization of differences between the liability balance for future royalties and the estimated future royalty amounts.

Minerva reported a net loss of $8.6 million for the first quarter of 2024, with a net loss per share of $1.13, compared to a net loss of $7.0 million and a net loss per share of $1.31 for the first quarter of 2023. As of March 31, 2024, the company's cash, cash equivalents, and restricted cash stood at approximately $34.9 million, down from $41.0 million at the end of December 2023.

Minerva Neurosciences continues to focus on developing new therapies for central nervous system (CNS) disorders. The company's goal is to improve the lives of patients through innovative treatments, including roluperidone for the negative symptoms of schizophrenia and MIN-301 for Parkinson’s disease.

In summary, Minerva Neurosciences remains committed to advancing its clinical programs and addressing regulatory feedback from the FDA. Despite the financial challenges evidenced by the increased R&D expenditures and net loss for the quarter, the company continues to pursue its mission to develop effective treatments for CNS disorders.