BURLINGTON, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) — Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the second quarter ended June 30, 2023.
“In the second quarter, we completed an equity financing of $20.0 million, further strengthening our cash position. This investment from Boehringer Ingelheim and Federated Hermes Kaufman Funds comes as we continue to interact with the FDA in support of their review of our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia.”
“We remain committed to bringing roluperidone to patients and physicians, as we believe it has the potential to improve patients’ quality of life and expand the treatment options physicians can offer their patients. Roluperidone, if approved, would be the first medication for negative symptoms of schizophrenia, a recognized unmet clinical need,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.
Q2 2023 Business Highlights
- On June 30, 2023, the Company completed a private investment in public equity financing of $20 million in gross proceeds from Boehringer Ingelheim, a global biopharmaceutical company with a growing mental health pipeline that includes schizophrenia, and Federated Hermes Kaufmann Funds.
- On May 8, 2023, the FDA confirmed that they had assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024.
- On April 27, 2023, the FDA confirmed the filing of Minerva’s NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
Second Quarter 2023 Financial Results
- Research and development (“R&D”) expense: R&D expense was $1.9 million and $4.5 million for the three and six months ended June 30, 2023, respectively, as compared to $4.1 million and $9.1 million for the three and six months ended June 30, 2022, respectively. The decrease of $2.2 million and $4.6 million in R&D expense for the three and six months ended June 30, 2023 versus the prior year periods was primarily due to lower non-cash stock compensation costs and lower consultant fees related to the preparation of the Company’s NDA for roluperidone, which was submitted during 2022, partially offset by higher professional service fees and staffing related expenses during 2023. Non-cash stock compensation costs included in R&D expense was $0.3 million and $0.5 million for the three and six months ended June 30, 2023, respectively, as compared to $0.5 million and $1.0 million for the three and six months ended June 30, 2022, respectively.
- General and administrative (G&A) expense: G&A expense was $2.6 million and $5.3 million for the three and six months ended June 30, 2023, respectively, as compared to $2.8 million and $5.9 million for the three and six months ended June 30, 2022, respectively. The decrease of approximately $0.2 million and $0.6 million for the three and six months ended June 30, 2023 versus the prior year periods was primarily due to lower non-cash stock compensation expense and insurance costs, partially offset by higher staffing related expenses during 2023. Non-cash stock compensation costs included in G&A expense was $0.3 million and $0.5 million for the three and six months ended June 30, 2023, respectively, as compared to $0.6 million and $1.1 million for the three and six month periods ended June 30, 2022, respectively.
- Non-cash interest expense: For the three and six months ended June 30, 2023, we recognized non-cash interest expense of $2.0 million and $4.0 million, respectively, as compared to $1.8 million and $3.6 million for the three and six months ended June 30, 2022, respectively. The increase in non-cash interest expense for both periods was primarily due to an increase in the carrying value of the liability related to the sale of future royalties for seltorexant to Royalty Pharma, for which upfront milestone payments are being amortized under the interest method over the estimated life of the agreement.
- Net loss: Basic and diluted net loss for the three and six months ended June 30, 2023 was $6.2 million and $13.2 million, or a loss per share of $1.12 and $2.43, respectively, as compared to a net loss for the three and six months ended June 30, 2022 of $8.7 million and $18.5 million or a loss per share of $1.63 and $3.46, respectively.
- Cash Position: Cash, cash equivalents, and restricted cash as of June 30, 2023, were approximately $51.9 million, as compared to $36.2 million as of December 31, 2022. In June 2023, we issued approximately 1.4 million shares of common stock and approximately 0.6 million pre-funded warrants to purchase common shares to two investors for gross proceeds to the Company of $20.0 million.
About Minerva Neurosciences
Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system (CNS) diseases. Our goal is to transform the lives of patients with improved therapeutic options. Minerva’s portfolio of compounds includes roluperidone (MIN-101), for negative symptoms of schizophrenia, and MIN-301, for Parkinson’s disease. For more information, please visit our website.
