Minerva Neurosciences, Inc.
Nov 3, 2016

Minerva Neurosciences Reports Third Quarter 2016 Financial Results and Business Updates

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

WALTHAM, Mass., Nov. 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 third quarter ended September 30, 2016.

"Recent highlights for Minerva include the completion and analyses of positive data from the 24-week open label extension phase of our Phase IIb trial with MIN-101 for schizophrenia announced on October 26 and the acceptance of four abstracts for presentation at the 55th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), including a featured oral presentation of data from the MIN-101 trial," said Dr. Remy Luthringer, president and chief executive officer of Minerva.

"Combined with the statistically significant data from the randomized, double-blind, placebo-controlled 12-week core phase of the Phase IIb trial announced earlier this year, the extension data help shape the Phase III clinical strategy with MIN-101 as a differentiated treatment for schizophrenia patients with negative symptoms," said Dr. Luthringer.  "With these data in hand, we intend to meet with the U.S. Food and Drug Administration (FDA) to determine the late stage clinical strategy and more specifically the design of the next clinical trials with MIN-101.  Our objective is to initiate these trials in mid-2017."

MIN-101:

MIN-117:

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

MIN-301:

Third 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 90389179.

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 has completed a Phase IIb clinical trial for schizophrenia; MIN-117, which has completed a Phase IIa clinical trial development for MDD; MIN-202 (JNJ-42847922), which has 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 September 30, 2016, filed with the Securities and Exchange Commission on November 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)
 September 30,December 31,
 2016  2015 
 (in thousands)
ASSETS
Current Assets:  
Cash and cash equivalents$  91,853 $  14,284 
Marketable securities   -     17,921 
Restricted cash   80    80 
Prepaid expenses and other current assets   703    1,196 
Total current assets   92,636    33,481 
Equipment, net   13    26 
In-process research and development   34,200    34,200 
Goodwill   14,869    14,869 
Total Assets$   141,718 $  82,576 
   
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:  
Notes payable - current portion$  4,751 $  1,435 
Accounts payable   832    1,360 
Accrued expenses and other current liabilities   981    2,525 
Accrued collaborative expenses   3,534    -  
Total current liabilities   10,098    5,320 
Long-Term Liabilities:  
Notes payable - noncurrent   5,049    8,503 
Deferred taxes   13,434    13,434 
Total liabilities   28,581    27,257 
Stockholders' Equity:  
Common stock   3    2 
Additional paid-in capital   236,588    157,130 
Accumulated deficit   (123,454)   (101,813)
Total stockholders' equity   113,137    55,319 
Total Liabilities and Stockholders' Equity$  141,718 $  82,576 
   

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS   
(Unaudited)     
 Three Months Ended September 30, Nine Months Ended September 30,
 (in thousands, except
per share amounts)
 (in thousands, except
per share amounts)
  2016  2015   2016  2015 
      
Revenues$  -  $  -   $  -  $  -  
Operating expenses:     
Research and development   5,852    3,828     13,941    12,274 
General and administrative   2,380    1,877     7,012    5,641 
Total operating expenses   8,232    5,705     20,953    17,915 
      
Foreign exchange losses   (3)   (2)    (28)   (15)
Investment income   70    38     137    64 
Interest expense   (259)   (270)    (797)   (776)
Net loss$  (8,424)$  (5,939 ) $  (21,641)$  (18,642)
Loss per share:     
Basic and diluted$  (0.24)$  (0.24) $  (0.71)$  (0.81)
Weighted average shares:     
Basic and diluted   34,806    24,721     30,393    22,972 
      
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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