Minerva Neurosciences, Inc

Minerva Neurosciences Reports Fiscal 2018 Fourth Quarter and Year End Financial Results and Business Updates

Minerva Neurosciences Reports Fiscal 2018 Fourth Quarter and Year End Financial Results and Business Updates

Recruitment active in five late-stage trials with three compounds directed toward significant unmet medical needs

Target indications include schizophrenia, major depressive disorder and insomnia disorder

Five key data readouts expected in 2019 

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

WALTHAM, Mass., March 12, 2019 (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, 2018.

“Minerva is on track for the completion of patient enrollment and subsequent top-line data readouts in 2019 from five clinical trials with a diversified pipeline of product candidates, led by the Phase 3 trial with roluperidone for negative symptoms in patients with schizophrenia,” said Dr. Remy Luthringer, executive chairman and chief executive officer of Minerva.  “During the past year we have also published additional clinical data with roluperidone, expanded our understanding of its pharmacological effect through new pre-clinical studies, completed further safety testing, and initiated strategic development, market research and pre-commercialization activities.  These activities will be further informed by the data expected following the completion of the Phase 3 trial.” 

Roluperidone (MIN-101):

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

MIN-117:

Fourth Quarter and Year Ended 2018 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 these results and recent business activities.  To participate, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 4598906.

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: roluperidone (MIN-101), in Phase 3 clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922) in Phase 2b clinical development for insomnia and major depressive disorder (MDD); MIN-117, in clinical 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 scope of future clinical trials and results of clinical trials with roluperidone, seltorexant, 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 roluperidone, seltorexant, MIN-117 and MIN-301 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; 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 Annual Report on Form 10-K for the year ended December 31, 2018, filed with the Securities and Exchange Commission on March 12, 2019.  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.

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CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
 December 31,December 31,
 2018  2017 
 (in thousands)
ASSETS
Current Assets:  
Cash and cash equivalents$  50,235 $  26,052 
Marketable securities   37,763    102,109 
Restricted cash   100    80 
Prepaid expenses and other current assets   1,921    1,299 
Total current assets   90,019    129,540 
Marketable securities - noncurrent   -     5,023 
Equipment, net   33    51 
Other noncurrent assets   15    15 
In-process research and development   34,200    34,200 
Goodwill   14,869    14,869 
Total Assets$  139,136 $  183,698 
   
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:  
Notes payable$  -  $  3,962 
Accounts payable   1,799    1,436 
Accrued expenses and other current liabilities   1,810    1,439 
Total current liabilities   3,609    6,837 
Long-Term Liabilities:  
Deferred taxes   4,057    4,057 
Deferred revenue   41,176    41,176 
Other noncurrent liabilities   29    30 
Total liabilities   48,871    52,100 
Stockholders' Equity:  
Common stock   4    4 
Additional paid-in capital   304,814    295,975 
Accumulated deficit   (214,553)   (164,381)
Total stockholders' equity   90,265    131,598 
Total Liabilities and Stockholders' Equity$  139,136 $  183,698 
   

 

    
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS   
(Unaudited)     
 Three Months Ended December 31, Twelve Months Ended December 31,
 (in thousands, except per share amounts) (in thousands, except per share amounts)
  2018  2017   2018  2017 
      
Revenues$  -  $  -   $  -  $  -  
Operating expenses:     
Research and development   9,008    6,541     34,889    30,256 
General and administrative   4,620    2,991     16,841    10,914 
Total operating expenses   13,628    9,532     51,730    41,170 
      
Foreign exchange losses   (5)   (11)    (5)   (57)
Investment income   430    434     1,674    942 
Interest expense   -     (105)    (110)   (614)
Loss before income taxes   (13,203)   (9,214)    (50,171)   (40,899)
Benefit for income taxes   -     (9,376)    -     (9,376)
Net (loss) income $  (13,203)$  162  $  (50,171)$  (31,523)
Loss per share:     
Basic and diluted$  (0.34)$  0.00  $  (1.29)$  (0.83)
Weighted average shares:     
Basic and diluted   38,888    38,710     38,793    37,937 
      

 Contact:

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376