Full Press Release Details
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, MA (November 6, 2014) 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:
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.
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
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.
Berry & Company Public Relations
Stern Investor Relations, Inc.
Minerva Neurosciences, Inc.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
| September 30, 2014 | December 31, 2013 | |||||||
| (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
| Three Months Ended September 30 (in thousands, except per share amounts) | Nine Months Ended September 30 (in thousands, except per share amounts) | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| 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 |