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Recruitment active in five late-stage trials with three compounds directed toward significant unmet medical needs
Target indications include schizophrenia, major depressive disorder and insomnia disorder
Five key data readouts expected in 2019
Management to host conference call today at 8:30 a.m. Eastern Time
WALTHAM, Mass., March 12, 2019 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat unmet medical needs of central nervous system (CNS) disorders, today reported key business updates and financial results for the fourth quarter and fiscal year ended December 31, 2018.
“Minerva is on track for the completion of patient enrollment and subsequent top-line data readouts in 2019 from five clinical trials with a diversified pipeline of product candidates, led by the Phase 3 trial with roluperidone for negative symptoms in patients with schizophrenia,” said Dr. Remy Luthringer, executive chairman and chief executive officer of Minerva. “During the past year we have also published additional clinical data with roluperidone, expanded our understanding of its pharmacological effect through new pre-clinical studies, completed further safety testing, and initiated strategic development, market research and pre-commercialization activities. These activities will be further informed by the data expected following the completion of the Phase 3 trial.”
Seltorexant (MIN-202 or JNJ-42847922), under joint development with Janssen Pharmaceutica NV (Janssen):
Fourth Quarter and Year Ended 2018 Financial Results
Conference Call Information:
Minerva Neurosciences will host a conference call and live audio webcast today at 8:30 a.m. Eastern Time to discuss these results and recent business activities. To participate, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 4598906.
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.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva’s proprietary compounds include: roluperidone (MIN-101), in Phase 3 clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922) in Phase 2b clinical development for insomnia and major depressive disorder (MDD); MIN-117, in clinical development for MDD; 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.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether roluperidone, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the Securities and Exchange Commission on March 12, 2019. Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|December 31,||December 31,|
|Cash and cash equivalents||$||50,235||$||26,052|
|Prepaid expenses and other current assets||1,921||1,299|
|Total current assets||90,019||129,540|
|Marketable securities - noncurrent||-||5,023|
|Other noncurrent assets||15||15|
|In-process research and development||34,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||1,810||1,439|
|Total current liabilities||3,609||6,837|
|Other noncurrent liabilities||29||30|
|Additional paid-in capital||304,814||295,975|
|Total stockholders' equity||90,265||131,598|
|Total Liabilities and Stockholders' Equity||$||139,136||$||183,698|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|(in thousands, except per share amounts)||(in thousands, except per share amounts)|
|Research and development||9,008||6,541||34,889||30,256|
|General and administrative||4,620||2,991||16,841||10,914|
|Total operating expenses||13,628||9,532||51,730||41,170|
|Foreign exchange losses||(5||)||(11||)||(5||)||(57||)|
|Loss before income taxes||(13,203||)||(9,214||)||(50,171||)||(40,899||)|
|Benefit for income taxes||-||(9,376||)||-||(9,376||)|
|Net (loss) income||$||(13,203||)||$||162||$||(50,171||)||$||(31,523||)|
|Loss per share:|
|Basic and diluted||$||(0.34||)||$||0.00||$||(1.29||)||$||(0.83||)|
|Weighted average shares:|
|Basic and diluted||38,888||38,710||38,793||37,937|
William B. Boni
VP, Investor Relations/
Minerva Neurosciences, Inc.