Minerva Neurosciences, Inc.
Mar 13, 2017

Minerva Neurosciences Reports Fiscal 2016 Fourth Quarter and Year End Financial Results and Business Updates

Multiple positive data readouts during 2016 provide foundation for initiation of advanced clinical trials with three product candidates in 2017  

Management to host conference call today at 8:30 a.m. Eastern Time

WALTHAM, Mass., March 13, 2017 (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, 2016.

"Multiple data readouts during 2016 marked significant progress along the clinical development pathways for MIN-101 in schizophrenia, MIN-202 in insomnia disorder and major depressive disorder (MDD) and MIN-117 in MDD," said Dr. Remy Luthringer, president and chief executive officer of Minerva.  "These accomplishments set the stage for the expected initiation of advanced-stage and pivotal clinical trials in 2017.  Our goal with each of these product candidates is to address unmet medical needs and thereby to expand the therapeutic options for patients suffering from these diseases."

MIN-101:

MIN-202 (JNJ-42847922), under joint development with Janssen Pharmaceutica NV (Janssen):

MIN-117:

MIN-301:

Fourth Quarter and Year Ended 2016 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 63111094.

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: MIN-101, in clinical development for schizophrenia; MIN-117, in clinical development for major depressive disorder (MDD); MIN-202 (JNJ-42847922), in clinical development for insomnia and 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 results of future clinical and pre-clinical milestones with MIN-101, MIN-202, 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 any of our 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-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 13, 2017. 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)
        December 31,   December 31,  
    2016 2015
      (in thousands)
ASSETS
Current Assets:        
Cash and cash equivalents       $ 82,981   $ 14,284  
Marketable securities         -     17,921  
Restricted cash         80     80  
Prepaid expenses and other current assets         803     1,196  
Total current assets         83,864     33,481  
Equipment, net         10     26  
In-process research and development         34,200     34,200  
Goodwill         14,869     14,869  
Total Assets       $ 132,943   $ 82,576  
         
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:        
Notes payable - current portion       $ 4,854   $ 1,435  
Accounts payable         1,467     1,360  
Accrued expenses and other current liabilities         816     2,525  
Accrued collaborative expenses         2,548     -  
Total current liabilities         9,685     5,320  
Long-Term Liabilities:        
Notes payable - noncurrent         3,841     8,503  
Deferred taxes         13,434     13,434  
Total liabilities         26,960     27,257  
Stockholders' Equity:        
Common stock         4     2  
Additional paid-in capital         238,837     157,130  
Accumulated deficit         (132,858)     (101,813)  
Total stockholders' equity         105,983     55,319  
Total Liabilities and Stockholders' Equity       $ 132,943   $ 82,576  
         


CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)          
        Year Ended December 31,
        (in thousands, except per share amounts)
          2016     2015  
           
Revenues       $   -    $   -   
Operating expenses:          
Research and development           20,440       18,533  
General and administrative           9,751       7,577  
Total operating expenses           30,191       26,110  
           
Foreign exchange losses           (23)      (16)  
Investment income           198       97  
Interest expense          (1,030)     (1,053)  
Net loss       $ (31,046)   $ (27,082)  
Loss per share:          
Basic and diluted       $ (0.99)   $ (1.16)  
Weighted average shares:          
Basic and diluted           31,514       23,412  
           


William B. Boni

VP, Investor Relations/

Corp. Communications

Minerva Neurosciences, Inc.

(617) 600-7376



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Source: Minerva Neurosciences, Inc. via Globenewswire

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