Minerva Neurosciences, Inc.
May 3, 2016

Minerva Neurosciences Reports First Quarter 2016 Financial Results and Business Updates

Positive top line results of trials with MIN-202 highlight first quarter

Last patient visits completed in trials with MIN-101 and MIN-117; 

data expected in second quarter

WALTHAM, Mass., May 03, 2016 (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, 2016.

"The first quarter of 2016 was highlighted by positive top line results from two clinical trials with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV," said Dr. Remy Luthringer, president and chief executive officer of Minerva. "These include positive findings from a Phase IIa trial in insomnia disorder and a Phase Ib trial in patients diagnosed with a major depressive disorder (MDD) that pave the way toward the next steps in the clinical development of this product.

"We remain on schedule in the final stages of our ongoing Phase IIb trial in schizophrenia with MIN-101 and our ongoing Phase IIa trial with MIN-117 in MDD," said Dr. Luthringer.  "Both trials recently reported last patient visits. Top line results from both trials are expected later in this quarter. Our objective for these trials is to support the potential of MIN-101 and MIN-117 to address significant unmet needs in the treatment of large numbers of patients with these diseases."

Clinical Trial Updates

MIN-101:

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

MIN-117:

First Quarter 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 74086869.

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 products to treat CNS diseases.  Minerva's proprietary compounds include: MIN-101, in Phase IIb development for schizophrenia; MIN-202 (JNJ-42847922), which recently completed Phase IIa and Phase Ib clinical trials for insomnia and major depressive disorder (MDD), respectively; MIN-117, in Phase IIa 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 results of future clinical and pre-clinical milestones with MIN-101, MIN-202, MIN-117 and MIN-301; the timing of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these 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 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-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission on May 3, 2016. 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, 
 2016  2015  
 (in thousands) 
ASSETS 
Current Assets:   
Cash and cash equivalents$  34,822 $  14,284  
Marketable securities   9,818    17,921  
Restricted cash   80    80  
Prepaid expenses   618    1,196  
Total current assets   45,338    33,481  
Equipment, net    22    26  
In-process research and development   34,200    34,200  
Goodwill   14,869    14,869  
Total Assets$  94,429 $  82,576  
    
LIABILITIES AND STOCKHOLDERS' DEFICIT 
Current Liabilities:   
Notes payable - current portion$  2,644 $  1,435  
Accounts payable   1,224    1,360  
Accrued expenses and other current liabilities   3,101    2,525  
Total current liabilities   6,969    5,320  
Long-Term Liabilities:   
Notes payable - noncurrent   7,376    8,503  
Deferred taxes   13,434    13,434  
Total liabilities   27,779    27,257  
Stockholders' Deficit:   
Common stock   3    2  
Additional paid-in capital   176,464    157,130  
Accumulated deficit   (109,817)   (101,813) 
Total stockholders' deficit   66,650    55,319  
Total Liabilities and Stockholders' Deficit$  94,429 $  82,576  
    

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)  
 Three Months Ended March 31,
 (in thousands, except per share amounts)
  2016  2015 
   
Revenues$  -  $  -  
Operating expenses:  
Research and development   5,375    3,961 
General and administrative   2,382    1,917 
Total operating expenses   7,757    5,878 
   
Foreign exchange (losses)/gains   (9)    16 
Investment income   32    -  
Interest expense   (270)   (231)
Net loss$  (8,004)$  (6,093)
Loss per share:  
Basic and diluted$  (0.29)$  (0.31)
Weighted average shares:  
Basic and diluted   27,203    19,417 
   
Contact:



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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