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NERV Reports 1st Quarter Results

Minerva Neurosciences Reports First Quarter 2018 Financial Results and Business Updates
WALTHAM, Mass., May 03, 2018 (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 March 31, 2018.

"Minerva now has five late-stage clinical efficacy trials ongoing with three compounds," said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. "These include our lead product, roluperidone (MIN-101) for schizophrenia, MIN-117 for MDD and seltorexant (MIN-202) for insomnia disorder and MDD.

"In schizophrenia, the leading unmet medical need as ranked by psychiatrists is negative symptoms, the target indication for roluperidone," said Dr. Luthringer. "Based on the improvement in negative symptoms measured in clinical tests with roluperidone to date, combined with the observed stability in positive symptoms and a favorable side effect profile, we believe this compound has the potential to be a differentiated therapy in schizophrenia, and we are working on commercialization strategies that address this significant commercial opportunity."

Clinical Development Updates

Roluperidone (MIN-101):

The Company's clinical sites in the U.S. are actively enrolling patients in the pivotal Phase 3 trial with roluperidone. The Company has prioritized the initiation of U.S. sites, and now European sites have been initiated. Target enrollment in this trial is approximately 500 patients. Top-line results are expected in the first half of 2019.
MIN-117:

As announced on April 9, 2018, the Company has enrolled the first patient in a Phase 2b trial of MIN-117 to treat the symptoms of patients diagnosed with MDD. Approximately 324 patients will be enrolled at clinical sites in the U.S. and Europe. Top-line results are expected in the first half of 2019.
Seltorexant (MIN-202 or JNJ-42847922), under joint development with Janssen Pharmaceutica NV (Janssen):

Three Phase 2b clinical trials are ongoing with seltorexant, including two in MDD and one in insomnia disorder. In the first MDD trial, approximately 280 patients are planned to be enrolled at clinical sites in the U.S., Europe and Japan. In the second MDD trial, approximately 100 patients are planned to be randomized at clinical sites in the U.S. The insomnia trial is expected to enroll a total of approximately 360 patients at clinical sites in the U.S., Europe and Japan. These trials are planned for completion in 2019.
First Quarter 2018 Financial Results

Net Loss: Net loss was $12.4 million for the first quarter of 2018, or a loss per share of $0.32 (basic and diluted), compared to a net loss of $10.6 million for the first quarter of 2017, or a loss per share of $0.30 (basic and diluted).

R&D Expenses: Research and development (R&D) expenses were $8.4 million in the first quarter of 2018, compared to $7.6 million in the first quarter of 2017. The increase in R&D expenses primarily reflects higher development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117. These amounts were partially offset by lower development expenses for the seltorexant program due to the amendment to the Company's Co-Development and License Agreement with Janssen. R&D expenses are expected to increase during 2018 with increased patient enrollment and related support activities for the roluperidone and MIN-117 clinical trials.

G&A Expenses: General and administrative (G&A) expenses were $4.3 million in the first quarter of 2018, compared to $2.9 million in the first quarter of 2017. This increase in G&A expenses was primarily due to an increase in non-cash stock-based compensation expenses and salary costs from increased staffing to support the Company's pre-commerical activities. G&A expenses are expected to increase during 2018 with investment in the infrastructure necessary to support the Company's growth.

Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2018 were approximately $121.1 million.
Conference Call Information:

Minerva Neurosciences will host a conference call and live audio webcast today at 8:30 a.m. Eastern Time to discuss the quarter and recent business activities. To participate, please dial [phone] (domestic) or [phone] (international) and refer to conference ID 8885379.

The live webcast can be accessed under "Events and Presentations" in the Investors and Media section of Minerva's website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.

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