Minerva Neurosciences, Inc.
Aug 4, 2016

Minerva Neurosciences Reports Second Quarter 2016 Financial Results and Business Updates

Positive clinical data advance development with MIN-101 in schizophrenia and MIN-117 in major depressive disorder

Additional trials also planned with MIN-202 in insomnia disorder and major depressive disorder

WALTHAM, Mass., Aug. 04, 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 June 30, 2016.

"Positive data announced during the second quarter of 2016 reinforced the differentiated product profiles of MIN-101 and MIN-117 that have the potential to address substantial unmet needs in schizophrenia and major depressive disorder (MDD)," said Dr. Remy Luthringer, president and chief executive officer of Minerva.  "Minerva is now planning the next steps in the clinical development pathways for both of these product candidates, as well as for MIN-202, under development with Janssen Pharmaceutica NV, for which positive data were announced earlier this year in both insomnia disorder and major depressive disorder."

The Company also completed a public offering of shares of common stock on June 17, 2016 that resulted in net proceeds of approximately $53.7 million.  These resources will support the continued clinical development of MIN-101, MIN-117 and MIN-202, as well as the pre-clinical development of MIN-301 for Parkinson's disease. 

MIN-101:

MIN-117:

MIN-202:

MIN-301:

Second 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 48847859.

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, which recently completed a Phase IIb clinical trial for schizophrenia; MIN-117, which recently completed a Phase IIa clinical trial development for MDD;  MIN-202 (JNJ-42847922), which recently completed Phase IIa and Phase Ib clinical trials for insomnia and MDD, respectively; 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 June 30, 2016, filed with the Securities and Exchange Commission on August 4, 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) 
 June 30,December 31, 
  2016  2015  
 (in thousands) 
ASSETS 
Current Assets:   
Cash and cash equivalents$  88,670  $  14,284  
Marketable securities   8,387    17,921  
Restricted cash   80    80   
Prepaid expenses and other current assets   278    1,196  
Total current assets   97,415    33,481  
Equipment, net   18    26  
In-process research and development    34,200    34,200  
Goodwill   14,869    14,869  
Total Assets$  146,502 $  82,576  
    
LIABILITIES AND STOCKHOLDERS' EQUITY 
Current Liabilities:   
Notes payable - current portion$  3,879 $  1,435  
Accounts payable   877    1,360  
Accrued expenses and other current liabilities   1,483    2,525  
Total current liabilities   6,239    5,320  
Long-Term Liabilities:   
Notes payable - noncurrent   6,225    8,503  
Deferred taxes   13,434    13,434  
Total liabilities   25,898    27,257  
Stockholders' Equity:   
Common stock   3    2  
Additional paid-in capital   235,632    157,130  
Accumulated deficit   (115,031)   (101,813) 
Total stockholders' equity   120,604    55,319  
Total Liabilities and Stockholders' Equity$  146,502 $  82,576  
    

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
(Unaudited)     
 Three Months Ended June 30, Six Months Ended June 30,
 (in thousands, except per share
amounts)
 (in thousands, except per share
amounts)
  2016  2015   2016   2015 
      
Revenues$  -  $  -   $  -  $  -  
Operating expenses:     
Research and development   2,714    4,485     8,089    8,446 
General and administrative   2,250    1,847     4,632    3,765 
Total operating expenses   4,964    6,332     12,721    12,211 
      
Foreign exchange (losses)/gains   (16)   (29)    (25)   (13)
Investment income   35    27     67    27 
Interest expense   (268)   (276)     (539)   (506)
Net loss$  (5,213)$  (6,610) $  (13,218)$  (12,703)
Loss per share:      
Basic and diluted$  (0.18)$  (0.27) $  (0.47)$  (0.58)
Weighted average shares:     
Basic and diluted   29,122    24,721     28,163    22,084 
      


Contact:



William B. Boni

VP, Investor Relations/

Corp. Communications

Minerva Neurosciences, Inc.

(617) 600-7376

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Source: Minerva Neurosciences, Inc.

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