Minerva Neurosciences Reports Third Quarter 2020 Financial Results And Business Updates

11/2/20

WALTHAM, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended September 30, 2020.

Clinical program update

Roluperidone

The U.S. Food and Drug Administration (FDA) has granted Minerva a Type C meeting scheduled to take place via teleconference on November 10, 2020. This meeting will provide an opportunity for the Company to review clinical data generated to date with roluperidone, including the recently completed double-blind part of the Phase 3 trial for the treatment of negative symptoms in schizophrenia, and to solicit recommendations from the FDA regarding these data and the readiness of the roluperidone data package to support a New Drug Application submission. The Company expects to provide an update in mid-late December 2020 following receipt of the official minutes of the meeting.

“The objective of our upcoming meeting with the FDA is to discuss and define a path forward for roluperidone, Minerva’s lead product,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “Negative symptoms continue to represent the leading unmet need in the treatment of schizophrenia, as well as significant symptoms in a number of other psychiatric disorders. Our analyses of the recently announced Phase 3 trial top line results, in conjunction with the database we have generated to date, support our confidence in roluperidone’s potential to be a novel treatment in this space.”

Third Quarter 2019 Financial Results

  • Cash Position: Cash, cash equivalents and restricted cash as of September 30, 2020 were approximately $32.6 million.
  • R&D Expenses: Research and development (R&D) expenses for the three and nine months ended September 30, 2020 were $4.6 million and $18.5 million, respectively, compared to $9.7 million and $29.6 million for the same periods in 2019. The decreases in R&D expenses primarily reflect lower development expenses for the Phase 3 clinical trial of roluperidone and the completion of the Phase 2b clinical trial of MIN-117 in December 2019. The Company expects R&D expenses to decrease during 2020 as compared to 2019 following the completion of the MIN-117 clinical trial as well as the 12-week, double-blind portion of the Phase 3 clinical trial of roluperidone.
  • G&A Expenses: General and administrative (G&A) expenses for the three and nine months ended September 30, 2020 were $3.5 million and $13.5 million, respectively, compared to $4.6 million and $13.9 million for the same periods in 2019. The decrease in G&A expenses in the three-month period was primarily due to a decrease in non-cash stock-based compensation expenses and lower commercial expenses, and the decrease in G&A expenses in the nine-month period was primarily due to lower commercial expenses.
  • Net Loss/Income: Net loss for the three months ended September 20, 2020 was $8.1 million, or a loss per share of $0.19 basic and diluted, compared to a net loss of $14.0 million, or a loss per share of $0.36 basic and diluted for the three months ended September 30, 2019. For the nine months ended September 30, 2020, net income was $9.3 million, or $0.23 basic and diluted, compared to a net loss of $42.3 million, or net loss per share of $1.08 basic and diluted for the nine months ended September 30, 2019.

Collaborative revenue was $41.2 million for the nine months ended September 30, 2020 compared to zero for the same period in 2019, an increase of $41.2 million. The increase in collaborative revenue was the result of the Company’s opting out of its co-development and license agreement with Janssen for seltorexant. That revenue was recognized during the second quarter of 2020 as there are no future performance obligations under the agreement.

About Minerva Neurosciences:

Minerva’s portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia; a potential royalty stream from seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and major depressive disorder; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.