Minerva Neurosciences, Inc.
Nov 6, 2014

Minerva Neurosciences Reports Third Quarter 2014 Financial Results

- Advanced Lead Compound MIN-101 in Once-daily Formulation with Topline Results Expected in 4Q14; Phase 2b Study Expected to be Submitted in 4Q14 and Enrollment Expected to Begin in 1H15 -

- Phase 1 Bioavailability Study for MIN-202 in Insomnia in U.S. Ongoing after FDA Acceptance of IND Application; Topline Results Expected in 4Q14 -

- Management to Host Conference Call Today at 4:30 p.m. ET -

WALTHAM, Mass., Nov. 6, 2014 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq:NERV), a leader in the development of innovative therapies to treat neuropsychiatric diseases and disorders, today reported business highlights and financial results for the third quarter ended September 30, 2014.

"During the past quarter, we continued to make important progress in our clinical development programs for schizophrenia and insomnia and look forward to announcing multiple milestones across both programs before the end of the year," said Rogerio Vivaldi, M.D., Chief Executive Officer of Minerva Neurosciences. "Our once-daily dose formulation study of MIN-101 is on track and we will look to establish the optimal once-daily dose formulation for our Phase 2b trials in schizophrenia, slated to begin in the first half of next year. In addition, in July the U.S. Food and Drug Administration accepted the Investigational New Drug application for MIN-202, which we plan to develop for insomnia, and we look forward to continuing to work with Janssen on the ongoing Phase 1 studies for this potential important new therapy."

Q3 Business Highlights

Today, Minerva Neurosciences announced the promotion of Remy Luthringer, PhD, to President and Chief Scientific Officer. Dr. Luthringer was formerly Executive Vice President and Head of R&D and has worked for the Company since its inception. In his new role, Dr. Luthringer will report to Minerva Neurosciences CEO Rogerio Vivaldi, M.D. and will be responsible for the evaluation, design and implementation of strategies to advance the Company's pipeline and R&D efforts. Dr. Luthringer has been involved in the development of more than 150 active molecules advanced to clinical stage research in the treatment of a broad range of CNS diseases and disorders.

Upcoming Milestones:

MIN-101

MIN-202

Third Quarter 2014 Financial Results

Conference Call Information

Minerva Neurosciences will host a conference call and live audio webcast today at 4:30 p.m. EST to discuss the quarter and recent business activities. To participate in the conference call, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 27580305. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.minervaneurosciences.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event and will be archived for 30 days.

About Minerva

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat neuropsychiatric diseases. Minerva Neurosciences is developing a portfolio of first-in-class proprietary compounds, including lead compound MIN-101, which is in Phase 2 trials for schizophrenia, and additional candidates targeting MDD, insomnia and other CNS disorders. Minerva Neurosciences' common stock is listed on the NASDAQ Global Market where it trades 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 milestones, the timing of future clinical trials of and results of such clinical trials regarding MIN-101 and MIN-202, clinical and therapeutic potential of MIN-101 and MIN-202 and our ability to successfully develop and commercialize MIN-101 and MIN-202 and management's ability to successfully achieve its goals. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors including, without limitation, whether MIN-101, MIN-202 or any of our other 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 MIN-101, MIN-202 and our other therapeutic products will be successfully marketed if approved; whether any of our other 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, 2014, filed with the Securities and Exchange Commission on November 6, 2014. Copies of reports filed with the SEC are posted on our website. 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.

Minerva Neurosciences, Inc.
     
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
 September 30,December 31,
 20142013
 (in thousands)
ASSETS    
Current Assets:    
Cash and cash equivalents $23,640 $1,818
Prepaid expenses 584 1
Total current assets $24,224 $1,819
Equipment, net 35 3
In-process research and development 34,200 19,000
Goodwill 14,869 7,918
Deferred public offering costs ---- 434
Total Assets $73,328 $29,174
     
LIABILITIES AND STOCKHOLDERS' DEFICIT    
Current Liabilities:    
Accounts payable $942 $523
Accrued expenses and other current liabilities 2,237 815
Convertible promissory notes ---- 58
Derivative liability ---- 10
Total current liabilities $3,179 $1,406
Long-Term Liabilities:    
Deferred taxes 13,434 7,589
Total liabilities $16,613 $8,995
Stockholders' Deficit:    
Common stock 2 1
Additional paid-in capital 124,002 38,008
Accumulated deficit (67,289) (17,830)
Total stockholders' deficit $ 56,715 $ 20,179
Total Liabilities and Stockholders' Deficit $73,328 $29,174
     
     
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
         
 Three Months Ended September 30Nine Months Ended September 30
 (in thousands, except(in thousands, except
 per share amounts)per share amounts)
 2014201320142013
         
Revenues $ ---- $ ---- $ ---- $ ----
Operating expenses:        
Research and development 24,738 191 39,940 544
General and administrative 2,413 292 7,485 588
Total operating expenses 27,151 483 47,425 1,132
         
Foreign exchange (gains)/losses (11) 2 (15) 3
Interest expense, net 15 3 2,049 ------
Net loss $ 27,155 $488 $49,459 $1,135
Loss per share:        
Basic and diluted $1.53 $0.12 $4.58 $0.29
Weighted average shares:        
Basic and diluted 17,752 4,091 10,798 3,859
         
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