Minerva Neurosciences Reports Fiscal 2016 Fourth Quarter and Year End Financial Results and Business Updates
Multiple positive data readouts during 2016 provide foundation for initiation of advanced clinical trials with three product candidates in 2017
Management to host conference call today at
"Multiple data readouts during 2016 marked significant progress along the clinical development pathways for MIN-101 in schizophrenia, MIN-202 in insomnia disorder and major depressive disorder (MDD) and MIN-117 in MDD," said Dr.
- During 2016, the Company announced positive results from both the randomized, double blind, placebo controlled core phase and the open label extension phase of its Phase IIb trial with MIN-101 for the treatment of schizophrenia. Statistically significant, specific improvements were observed in negative symptoms, the primary endpoint of the trial, as well as in multiple secondary endpoints, resulting from treatment with MIN-101 as monotherapy. Results from this trial were presented at the 2016 Annual Meeting of the
American College of Neuropsychopharmacology(ACNP).
- Following recent interactions with the
U.S. Food and Drug Administration(FDA), an "end of Phase II" meeting has been scheduled with the FDAto take place early in the second quarter of 2017 to review the clinical and pre-clinical data with MIN-101 and to discuss the design of pivotal Phase III trials with this compound. A scientific advisory meeting will be scheduled thereafter with the European Medicines Agency(EMA). The Company expects to initiate Phase III testing of MIN-101 in schizophrenic patients with negative symptoms in the second half of 2017.
MIN-202 (JNJ-42847922), under joint development with
- Data from a randomized, two way, cross-over placebo controlled, double blind Phase IIa clinical trial of MIN-202 in insomnia disorder were announced in the first quarter of 2016. Patients treated with MIN-202 were observed to experience statistically significant improvements in key sleep parameters compared to patients treated with placebo, including sleep efficiency as measured by objective polysomnography, the primary endpoint. Additional significant positive efficacy signals were observed for key secondary parameters.
- Top line results from a randomized, double blind, parallel group Phase Ib clinical trial in MDD were announced in the first quarter of 2016. In this trial, consistently greater improvements in depressive symptomatology were observed in patients who received MIN-202 compared to those who received placebo or diphenhydramine, a positive control. Core symptoms of depression were also observed to significantly improve in patients treated with MIN-202, independent from its effect on sleep.
- A number of supportive activities and clinical pharmacology studies are being conducted in anticipation of the next phase of clinical development with this compound in insomnia and MDD.
- In a randomized, double blind, placebo and active controlled Phase IIa clinical trial in MDD, dose-dependent benefit of MIN-117 over placebo was observed. The trial was designed for signal detection and effect size estimation and not powered to demonstrate statistical significance. Improvement in depressive symptomatology was observed after two weeks of treatment with MIN-117, and data showed that 24 percent of patients treated with the higher tested dose achieved remission as prospectively defined.
FDAaccepted the Investigational New Drug application (IND) for MIN-117 as announced in September, 2016. Acceptance of the IND allows the Company to begin clinical trials with this compound in the U.S. Planning is underway for these trials, which are expected to begin in late 2017.
- The Company is pursuing the pre-clinical development of MIN-301 for the treatment of Parkinson's disease. MIN-301 is a peptide that targets the extra-cellular domain of neuregulin-1 beta-1 activating the ErbB4 receptor. The next planned steps in this program include the filing of an IND in the
U.S.or an Investigational Medicinal Product Dossier in Europe, and pending acceptance by regulatory authorities, the initiation of Phase I clinical testing thereafter.
Fourth Quarter and Year Ended 2016 Financial Results
- Net Loss: Net loss was
$9.4 millionfor the fourth quarter of 2016, or a loss per share of $0.27(basic and diluted), compared to a net loss of $8.4 millionfor the fourth quarter of 2015, or a loss per share of $0.34(basic and diluted). Net loss was $31.0 millionfor the year ended December 31, 2016, or a loss per share of $0.99(basic and diluted), compared to a net loss of $27.1 million, or a loss per share of $1.16(basic and diluted), for the year ended December 31, 2015.
- R&D Expenses: Research and development (R&D) expenses were
$6.5 millionin the fourth quarter of 2016, compared to $6.3 millionin the fourth quarter of 2015. R&D expenses were $20.4 millionfor the year ended December 31, 2016, compared to $18.5 millionfor the year ended December 31, 2015. This increase in research and development expenses primarily reflects higher development expenses under the MIN-202 program for Phase II clinical trial preparation, and an increase in non-cash stock-based compensation expenses. This increase was partially offset by decreased expenses due to the completion of our Phase IIb clinical trial of MIN-101.
- G&A Expenses: General and administrative (G&A) expenses were
$2.7 millionin the fourth quarter of 2016, compared to $1.9 millionin the fourth quarter of 2015. G&A expenses were $9.8 millionfor the year ended December 31, 2016, compared to $7.6 millionfor the year ended December 31, 2015. The increase in general and administrative expenses was primarily due to an increase in non-cash stock-based compensation expenses, personnel costs and professional fees during the year ended December 31, 2016.
- Cash Position: Cash, cash equivalents and marketable securities as of
December 31, 2016were approximately $83.0 million, compared to $32.2 millionas of December 31, 2015. During 2016, the Company received approximately $23.4 millionin proceeds from the exercise of warrants granted in connection with a private placement in March 2015, approximately $1 millionfrom a common stock purchase by a director of the Company, and net proceeds of approximately $53.7 millionfrom a public offering of common stock. Minerva presently expects that its existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months from today. The assumptions upon which this estimate is based are under constant review and subject to change. The actual amount and timing of the Company's research and development expenditures may vary depending upon a number of factors, including but not limited to those related to the design, timing and duration of future clinical trials.
Conference Call Information:
The live webcast can be accessed under "Events and Presentations" in the Investors and Media section of Minerva's website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and results of future clinical and pre-clinical milestones with MIN-101, MIN-202, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these
compounds; the clinical and therapeutic potential of these compounds; the timing and outcomes of future interactions with
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||82,981||$||14,284|
|Prepaid expenses and other current assets||803||1,196|
|Total current assets||83,864||33,481|
|In-process research and development||34,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Notes payable - current portion||$||4,854||$||1,435|
|Accrued expenses and other current liabilities||816||2,525|
|Accrued collaborative expenses||2,548||-|
|Total current liabilities||9,685||5,320|
|Notes payable - noncurrent||3,841||8,503|
|Additional paid-in capital||238,837||157,130|
|Total stockholders' equity||105,983||55,319|
|Total Liabilities and Stockholders' Equity||$||132,943||$||82,576|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
| Year Ended |
|(in thousands, except per share amounts)|
|Research and development||20,440||18,533|
|General and administrative||9,751||7,577|
|Total operating expenses||30,191||26,110|
|Foreign exchange losses||(23)||(16)|
|Loss per share:|
|Basic and diluted||$||(0.99)||$||(1.16)|
|Weighted average shares:|
|Basic and diluted||31,514||23,412|
William B. Boni
VP, Investor Relations/
Minerva Neurosciences, Inc.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
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