Minerva Neurosciences Reports First Quarter 2017 Financial Results and Business Updates
"We recently had a meeting with the
Clinical Development Updates
- An "end-of-Phase II meeting" with the
FDAtook place recently to review pre-clinical and clinical data generated to date with MIN-101 and to discuss Phase III and Phase IV clinical development of this compound to treat negative symptoms in patients with a diagnosis of schizophrenia, including pivotal trial design.
- Following the acceptance of the Investigational New Drug application (IND) for MIN-117 by the
FDAlate last year, Minerva is planning clinical trials with this compound in the U.S.and Europe. These trials will build upon the results from the Phase IIa trial with MIN-117, and they are expected to begin in late 2017.
MIN-202 (JNJ-42847922), under joint development with
- The planned indications for the next stage of clinical development with MIN-202 include insomnia without neuro-psychiatric comorbid symptoms and comorbid insomnia in patients suffering from depressive disorders. A number of supportive activities and clinical pharmacology studies are being conducted by Minerva and Janssen in preparation for trials in both indications.
First Quarter 2017 Financial Results
- Net Loss: Net loss was
$10.6 millionfor the first quarter of 2017, or a loss per share of $0.30(basic and diluted), compared to a net loss of $8.0 million, or a loss per share of $0.29(basic and diluted) for the first quarter of 2016.
- R&D Expenses: Research and development (R&D) expenses were
$7.6 millionin the first quarter of 2017, compared to $5.4 millionin the first quarter of 2016. R&D expense in the three month periods ended March 31, 2017and 2016 included non-cash stock based compensation expenses of $0.5 millionand $0.2 million, respectively. This increase in R&D 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. These amounts were partially offset by lower costs due to the completion of our Phase IIb clinical trial of MIN-101 and the completion of our Phase IIa clinical trial of MIN-117.
- G&A Expenses: General and administrative (G&A) expenses were
$2.9 millionin the first quarter of 2017, compared to $2.4 millionin the first quarter of 2016. G&A expense in the three month periods ended March 31, 2017and 2016 included non-cash stock-based compensation expenses of $0.8 millionand $0.6 million, respectively. This increase in general and administrative expenses was primarily due to an increase in legal and professional fees, an increase in non-cash stock-based compensation expenses, and increased personnel costs during the three months ended March 31, 2017.
- Cash Position: Cash, cash equivalents and marketable securities as of
March 31, 2017were approximately $85.4 million. The Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months.
Conference Call Information:
The live webcast can be accessed under "Events and Presentations" in the Investors and Media section of Minerva's website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and results of future clinical milestones with MIN-101, MIN-202 and MIN-117, including the planned Phase III trial of MIN-101, the timing and scope of future clinical trials and results of clinical trials with these compounds; the timing and outcomes of future interactions with
CONDENSED CONSOLIDATED BALANCE SHEET DATA
|Cash and cash equivalents||$||68,895||$||82,981|
|Prepaid expenses and other current assets||792||803|
|Total current assets||86,232||83,864|
|In-process research and development||34,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Notes payable - current portion||$||4,959||$||4,854|
|Accrued expenses and other current liabilities||1,673||816|
|Accrued collaborative expenses||3,078||2,548|
|Total current liabilities||12,986||9,685|
|Notes payable - noncurrent||2,601||3,841|
|Additional paid-in capital||249,785||238,837|
|Total stockholders' equity||106,286||105,983|
|Total Liabilities and Stockholders' Equity||$||135,307||$||132,943|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended |
|(in thousands, except per share amounts)|
|Research and development||7,614||5,375|
|General and administrative||2,871||2,382|
|Total operating expenses||10,485||7,757|
|Foreign exchange losses||(17||)||(9||)|
|Loss per share:|
|Basic and diluted||$||(0.30||)||$||(0.29||)|
|Weighted average shares:|
|Basic and diluted||35,370||27,203|
William B. BoniVP, Investor Relations/ Corp. Communications Minerva Neurosciences, Inc.(617) 600-7376
News Provided by Acquire Media