Minerva Neurosciences, Inc.: Minerva Neurosciences Reports Third Quarter 2017 Financial Results and Business Updates

WALTHAM, Mass., 2017-11-06 13:30 CET (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 September 30, 2017. 

"As we approach year-end, we are completing the final steps prior to the
initiation of a number of advanced-stage clinical efficacy trials with multiple
compounds targeting significant unmet needs in CNS, highlighted by our lead
product candidate, MIN-101 for the treatment of negative symptoms in
schizophrenia," said Dr. Remy Luthringer, president and chief executive officer
of Minerva.  "Our objective is to ensure rigorously conducted clinical trials
that support well-defined product profiles, timely data readouts and a smooth
transition to future regulatory review and commercialization." 

MIN-101:

  -- The Company is on schedule to initiate a pivotal Phase 3 trial of MIN-101
     to treat negative symptoms in patients diagnosed with schizophrenia in the
     fourth quarter of 2017.  Top-line results from the three-month double blind
     phase of this trial are expected in the first half of 2019.
  -- The final protocol for the Phase 3 trial has been submitted to the
     Investigational New Drug application (IND), and the first Institutional
     Review Board (IRB) approval has been received for the study in the U.S.  
     The trial will be a 12-week, double-blind, randomized, placebo-controlled,
     monotherapy study testing two doses of MIN-101 in schizophrenic patients
     with negative symptoms. These are the same two doses as those employed in
     the Phase 2b trial. After the double-blind phase, patients may enter a
     40-week open label extension phase in which all will receive active
     treatment. This multi-center, international trial is expected to enroll
     approximately 500 patients at approximately 60 clinical sites across the
     U.S. and Europe, with 30 percent of patients coming from the U.S.
  -- The Chemistry, Manufacturing and Controls (CMC) program has been initiated
     to ensure consistency between drug batches and its timely inclusion with
     the potential submission of a New Drug Application (NDA) pending a
     successful Phase 3 trial.

SELTOREXANT (MIN-202 OR JNJ-42847922):

  -- The first patient has been enrolled in a Phase 2b clinical trial of
     seltorexant as adjunctive therapy to antidepressants in adult patients with
     major depressive disorder (MDD) who have responded inadequately to
     antidepressant therapy.  Approximately 280 patients are planned to be
     enrolled at more than 85 clinical sites in the U.S., Europe, Russia and
     Japan.  Two additional clinical trials of seltorexant are planned for
     initiation in the fourth quarter of 2017. These include a second Phase 2b
     trial in MDD and a Phase 2b trial in insomnia.
  -- An amendment to the Company's co-development and license agreement with
     Janssen became effective on August 29, 2017 following approval of its terms
     by the European Commission.

MIN-117:

  -- The Company plans to initiate patient recruitment in a Phase 2b clinical
     trial with MIN-117 in MDD in early 2018. This trial is expected to include
     patients with MDD who also have symptoms of anxiety, building upon previous
     Phase 2a clinical results that showed effects in both depressive
     symptomatology and anxiety.
  -- In preparation for the Phase 2b trial, a food-effect study is currently
     ongoing with MIN-117 under the Company's IND.

MIN-301:

  -- The Company is continuing to conduct pre-clinical, toxicology and other
     IND-enabling studies with MIN-301 as a prelude to advancing this compound
     into the initial stage of clinical development.
  -- MIN-301 is a recombinant protein with the extra-cellular domain of
     neuregulin-1 beta primarily activating the ErbB4 receptor. Dysregulation of
     the NRG-1 signaling pathway has been linked to neurodevelopmental and
     neurodegenerative disorders including and beyond Parkinson's disease.

Third Quarter 2017 Financial Results

  -- Cash Position: Cash, cash equivalents and marketable securities as of
     September 30, 2017 were approximately $143.3 million, compared to $83.0
     million as of December 31, 2016.  As previously stated, Minerva expects
     that its cash, cash equivalents and marketable securities will be
     sufficient to fund its operations for at least the next 12 months.
  -- R&D Expenses: Research and development (R&D) expenses were $9.0
     million in the third quarter of 2017, compared to $5.9 million in the third
     quarter of 2016.  R&D expense in the three months ended September 30,
     2017 and 2016 included non-cash stock-based compensation expenses of $0.5
     million and $0.3 million, respectively. This increase in R&D expenses
     primarily reflects higher development expenses under the MIN-202 program
     for the Phase 2 clinical trials, increased expenses for the MIN-101 program
     and an increase in non-cash stock-based compensation expenses.
     For the nine months ended September 30, 2017, R&D expenses were $23.7
     million, compared to $13.9 million for the nine months ended September 30,
     2016. R&D expense in the nine months ended September 30, 2017 and 2016
     included non-cash stock-based compensation expenses of $1.5 million and
     $0.7 million, respectively. This increase in R&D expenses primarily
     reflects higher development expenses under the MIN-202 program for the
     Phase 2 clinical trial, increased expenses for the MIN-101 program, an
     increase in personnel costs and an increase in non-cash stock-based
     compensation expenses. These amounts were partially offset by lower costs
     due to the completion of the Phase 2a clinical trial of MIN-117.
  -- G&A Expenses: General and administrative (G&A) expenses were $2.5
     million in the third quarter of 2017, compared to $2.4 million in the third
     quarter of 2016.  G&A expense in the three months ended September 30,
     2017 and 2016 included non-cash stock-based compensation expenses of $0.8
     million and $0.7 million, respectively. This increase was primarily due to
     an increase in professional fees during the three months ended September
     30, 2017.
     For the nine months ended September 30, 2017, G&A expenses were $7.9
     million, compared to $7.0 million for the same period in 2016. G&A
     expense in the nine months ended September 30, 2017 and 2016 included
     non-cash stock-based compensation expenses of $2.3 million and $1.8
     million, respectively. This increase was primarily due to an increase in
     professional fees and an increase in non-cash stock-based compensation
     expenses during the nine months ended September 30, 2017.
  -- Net Loss:
  Net loss was $11.3 million for the third quarter of 2017, or a loss per
     share of $0.28 (basic and diluted), as compared to a net loss of $8.4
     million, or a loss per share of $0.24 (basic and diluted) for the third
     quarter of 2016.  Net loss was $31.7 million for the first nine months of
     2017, or a loss per share of $0.84 (basic and diluted), as compared to a
     net loss of $21.6 million, or a loss per share of $0.71 (basic and diluted)
     for the first nine months of 2016.

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 [phone] (domestic) or (765)
507-2618 (international) and refer to conference ID number 90294475. 

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
clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922),
in 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 MIN-101, seltorexant,
MIN-117 and MIN-301.  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 MIN-101, seltorexant, MIN-117
and MIN-301 will advance further in the clinical trials process; 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, 2017, filed with the Securities and Exchange
Commission on November 6, 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)                                                                     
                                              September 30,       December 31,  
                                            2017               2016            
                                                       (in thousands)           
ASSETS                                                                          
Current Assets:                                                                 
Cash and cash equivalents                      $    36,255        $    82,981   
Marketable securities                               96,675                  -   
Restricted cash                                         80                 80   
Prepaid expenses and other current assets            1,073                803   
Total current assets                               134,083             83,864   
Marketable securities - noncurrent                  10,355                  -   
Equipment, net                                           -                 10   
In-process research and development                 34,200             34,200   
Goodwill                                            14,869             14,869   
Total Assets                                   $   193,507        $   132,943   
                                                                                
LIABILITIES AND STOCKHOLDERS' EQUITY                                            
Current Liabilities:                                                            
Notes payable - current portion                $     5,194        $     4,854   
Accounts payable                                     1,504              1,467   
Accrued expenses and other current                   2,022                816   
 liabilities                                                                    
Accrued collaborative expenses                           -              2,548   
Total current liabilities                            8,720              9,685   
Long-Term Liabilities:                                                          
Notes payable - noncurrent                               -              3,841   
Deferred taxes                                      13,434             13,434   
Deferred revenue                                    41,176                  -   
Total liabilities                                   63,330             26,960   
Stockholders' Equity:                                                           
Common stock                                             4                  4   
Additional paid-in capital                         294,717            238,837   
Accumulated deficit                               (164,544  )        (132,858  )
Total stockholders' equity                         130,177            105,983   
Total Liabilities and Stockholders' Equity     $   193,507        $   132,943   

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS                                 
(Unaudited)                                                                     
                            Three Months Ended       Nine Months Ended September
                              September 30,                      30,            
                        (in thousands, except per    (in thousands, except per  
                              share amounts)               share amounts)       
                             2017          2016           2017           2016   
                                                                                
Revenues               $        -     $       -     $        -     $        -   
Operating expenses:                                                             
Research and                8,956         5,852         23,715         13,941   
 development                                                                    
General and                 2,451         2,380          7,923          7,012   
 administrative                                                                 
Total operating            11,407         8,232         31,638         20,953   
 expenses                                                                       
                                                                                
Foreign exchange               (9  )         (3  )         (46  )         (28  )
 losses                                                                         
Investment income             294            70            508            137   
Interest expense             (138  )       (259  )        (510  )        (797  )
Net loss               $  (11,260  )  $  (8,424  )  $  (31,686  )  $  (21,641  )
Loss per share:                                                                 
Basic and diluted      $    (0.28  )  $   (0.24  )  $    (0.84  )  $    (0.71  )
Weighted average                                                                
 shares:                                                                        
Basic and diluted          40,880        34,806         37,677         30,393   

Contact:

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
[phone]