MIN-101 Phase 2b trial for schizophrenia on track with enrollment underway; new regulatory approvals to conduct trials in Europe
MIN-117 Phase 2a study in Major Depressive Disorder (MDD) on track and expected to begin enrollment in second quarter; additional study arm planned
Management to host conference call today at 8:30 a.m. ET
WALTHAM, Mass., May 7, 2015 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq:NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) diseases and disorders, today reported key business updates and financial results for the first quarter ended March 31, 2015.
"We significantly strengthened our balance sheet by successfully completing equity capital and debt financing in the first quarter of 2015," said Dr. Remy Luthringer, president and chief executive officer of Minerva. "We also made important progress advancing our clinical development programs and achieving several clinical and regulatory milestones for our pipeline, including regulatory approval to begin our Phase 2b study of our lead product candidate MIN-101. We remain on track with our clinical programs as we approach several upcoming milestones in 2015 and key data readouts in the first half of 2016, which I believe will bring us closer to our goal of building a CNS company with innovative therapeutics to help patients with significant unmet needs."
First Quarter 2015 Key Business Updates:
MIN-101:
MIN-202:
MIN-117:
MIN-301:
Financings:
First Quarter 2015 Financial Results:
Conference Call Information:
Minerva Neurosciences will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss the quarter and recent business activities. To participate in the conference call, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 29475035. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.minervaneurosciences.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event and will be archived for 30 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 is developing proprietary compounds, including its lead program MIN-101 in development for the treatment of schizophrenia, MIN-202 in development for primary and comorbid insomnia, MIN-117 in development for the treatment of major depressive disorder and MIN-301 in development for the treatment of Parkinson's disease. Minerva's common stock is listed on the NASDAQ Global Market where it trades 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 results of future clinical milestones; the timing of future clinical trials and results of clinical trials; the clinical and therapeutic potential of our compounds; 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 only predictions and may differ materially from actual results due to a variety of factors including, without limitation, whether any of our other therapeutic products 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; our ability to achieve the results contemplated by our co-development agreements; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, filed with the Securities and Exchange Commission on May 7, 2015. 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 | ||
(Unaudited) | ||
March 31, | December 31, | |
2015 | 2014 | |
(in thousands) | ||
ASSETS | ||
Current Assets: | ||
Cash and cash equivalents | $ 52,201 | $ 18,546 |
Restricted cash | 40 | 35 |
Prepaid expenses | 503 | 757 |
Total current assets | $ 52,744 | $ 19,338 |
Equipment, net | 34 | 44 |
In-process research and development | 34,200 | 34,200 |
Goodwill | 14,869 | 14,869 |
Total Assets | $ 101,847 | $ 68,451 |
LIABILITIES AND STOCKHOLDERS' DEFICIT | ||
Current Liabilities: | ||
Notes payable - current portion | $ 158 | $ -- |
Accounts payable | 1,035 | 642 |
Accrued expenses and other current liabilities | 1,771 | 1,645 |
Accrued collaborative expenses | 1,461 | 1,222 |
Total current liabilities | $ 4,425 | $ 3,509 |
Long-Term Liabilities: | ||
Notes payable - noncurrent | 9,547 | -- |
Deferred taxes | 13,434 | 13,434 |
Other non-current liabilities | 5 | 8 |
Total liabilities | $ 27,411 | $ 16,951 |
Stockholders' Deficit: | ||
Common stock | 2 | 2 |
Additional paid-in capital | 155,258 | 126,229 |
Accumulated deficit | (80,824) | (74,731) |
Total stockholders' deficit | $ 74,436 | $ 51,500 |
Total Liabilities and Stockholders' Deficit | $ 101,847 | $ 68,451 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||
(Unaudited) | ||
Three months ended March 31, | ||
(in thousands, except per share amounts) |
||
2015 | 2014 | |
Revenues | $ -- | $ -- |
Operating expenses: | ||
Research and development | 3,961 | 586 |
General and administrative | 1,917 | 2,037 |
Total operating expenses | 5,878 | 2,623 |
Foreign exchange (gains)/losses | 16 | (6) |
Interest expense, net | (231) | (309) |
Net loss | $ (6,093) | $ (2,938) |
Loss per share: | ||
Basic and diluted | $ (0.31) | $ (0.43) |
Weighted average shares: | ||
Basic and diluted | 19,417 | 6,903 |