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WALTHAM, Mass., May 06, 2019 (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, 2019.
Minerva has five late-stage clinical efficacy trials ongoing with three product candidates, including a Phase 3 trial with roluperidone (MIN-101) for negative symptoms in patients with schizophrenia, a Phase 2b trial with MIN-117 for major depressive disorder (MDD) associated with anxiety and three Phase 2b trials with seltorexant (MIN-202) for insomnia disorder and MDD.
“I am very pleased to provide an update and insights into the progress we are making in all of our studies,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “We have updated forecast timelines for the roluperidone Phase 3 study and the MIN-117 Phase 2b study, both of which we now expect to read out in the fourth quarter of this year.
“Our three seltorexant studies will now read out sooner than anticipated, with patient enrollment completed in all three,” said Dr. Luthringer. “We expect to report top-line results from both our first MDD trial and our insomnia trial in the second quarter of 2019, and we expect top-line results from our second MDD trial in the third quarter of 2019.
“The new timelines reflect the latest information available from our sites, as well as the care that we are taking both in recruiting subjects who meet stringent entry criteria and in engaging well-trained clinical investigators to evaluate the therapeutic benefit of our product candidates,” said Dr. Luthringer. “I am pleased to report that patient selection to date has met these standards and the investigators are performing well. Our focus continues to be on trial conduct and data quality.”
Seltorexant (MIN-202 or JNJ-42847922), under joint development with Janssen Pharmaceutica NV (Janssen):
First Quarter 2019 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 the quarter and recent business activities. To participate, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 5697837.
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 clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in 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-Q for the quarter ended March 31, 2019, filed with the Securities and Exchange Commission on March 6, 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|
|March 31,||December 31,|
|Cash and cash equivalents||$||30,608||$||50,235|
|Prepaid expenses and other current assets||1,054||1,921|
|Total current assets||80,319||90,019|
|Marketable securities - noncurrent||-||-|
|Other noncurrent assets||15||15|
|Operating lease right-of-use assets||371||-|
|In-process research and development||34,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||3,721||1,810|
|Total current liabilities||6,903||3,609|
|Other noncurrent liabilities||-||29|
|Noncurrent operating leases||243||-|
|Additional paid-in capital||307,800||304,814|
|Total stockholders' equity||77,424||90,265|
|Total Liabilities and Stockholders' Equity||$||129,803||$||139,136|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
Three Months Ended March 31,
(in thousands, except per share amounts)
|Research and development||11,606||8,449|
|General and administrative||4,706||4,294|
|Total operating expenses||16,312||12,743|
|Foreign exchange losses||(6||)||(18||)|
|Loss before income taxes||(15,827||)||(12,418||)|
|Benefit for income taxes||-||-|
|Net (loss) income||$||(15,827||)||$||(12,418||)|
|Loss per share:|
|Basic and diluted||$||(0.41||)||$||(0.32||)|
|Weighted average shares:|
|Basic and diluted||38,968||38,749|
William B. Boni
VP, Investor Relations/
Minerva Neurosciences, Inc.