Minerva Neurosciences Q2 2024 Financial Results and Business Updates

Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company based in Burlington, Massachusetts, has announced business updates and financial results for the second quarter of 2024, which ended on June 30, 2024.

During the first quarter of the year, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for roluperidone (formerly known as MIN-101). This drug is intended for the treatment of negative symptoms in patients with schizophrenia. Since the issuance of the CRL, Minerva has been actively engaged in discussions with the FDA to address the concerns and questions raised.

In terms of financial performance, Minerva reported that research and development (R&D) expenses for the three months ended June 30, 2024, were $3.9 million, up from $1.9 million in the same period in 2023. This increase was mainly attributed to higher subcontractor fees associated with their drug substance validation campaign. For the six-month period ending June 30, 2024, R&D expenses rose to $8.0 million from $4.5 million in the same period the previous year, driven by costs related to the drug substance validation campaign and the conduct of the MIN-101C18 study.

General and administrative (G&A) expenses for the three months ended June 30, 2024, were $2.4 million, a slight decrease from $2.6 million in the same quarter of 2023. For the six-month period ending June 30, 2024, G&A expenses stood at $4.9 million, down from $5.3 million in the comparable period in 2023. The reduction in G&A expenses was mainly due to lower compensation expenses and professional service fees.

Non-cash interest expense related to the sale of future royalties for the three and six months ended June 30, 2024, was $2.3 million and $4.6 million, respectively, compared to $2.0 million and $4.0 million for the same periods in 2023. The increase is primarily due to the amortization of non-cash interest expense related to the difference between the liability balance from the sale of future royalties and the estimated future royalties to be received.

Net loss for the three months ended June 30, 2024, was $8.2 million, or $1.09 per share, compared to a net loss of $6.2 million, or $1.12 per share, in the same period in 2023. For the six-month period ending June 30, 2024, net loss was $16.8 million, or $2.22 per share, compared to a net loss of $13.2 million, or $2.43 per share, in the first half of 2023.

As of June 30, 2024, Minerva reported cash, cash equivalents, and restricted cash totaling approximately $31.0 million, down from $41.0 million as of December 31, 2023.

Minerva Neurosciences is dedicated to developing therapies for central nervous system (CNS) disorders. The company aims to improve the lives of patients with innovative treatment options, including roluperidone for schizophrenia-related negative symptoms and MIN-301 for Parkinson’s disease.

In conclusion, despite facing challenges with the FDA regarding roluperidone, Minerva continues its efforts to resolve the issues. The financial results reflect increased R&D expenditures aimed at advancing their pipeline, while G&A expenses have decreased slightly. The company remains focused on its mission to develop effective therapies for CNS diseases.