Minerva Neurosciences Reports First Quarter 2018 Financial Results and Business Updates
“Minerva now has five late-stage clinical efficacy trials ongoing with three compounds,” said Dr.
“In schizophrenia, the leading unmet medical need as ranked by psychiatrists is negative symptoms, the target indication for roluperidone,” said Dr. Luthringer. “Based on the improvement in negative symptoms measured in clinical tests with roluperidone to date, combined with the observed stability in positive symptoms and a favorable side effect profile, we believe this compound has the potential to be a differentiated therapy in schizophrenia, and we are working on commercialization strategies that address this significant commercial opportunity.”
Clinical Development Updates
- The Company’s clinical sites in the U.S. are actively enrolling patients in the pivotal Phase 3 trial with roluperidone. The Company has prioritized the initiation of U.S. sites, and now European sites have been initiated.
Targetenrollment in this trial is approximately 500 patients. Top-line results are expected in the first half of 2019.
- As announced on
April 9, 2018, the Company has enrolled the first patient in a Phase 2b trial of MIN-117 to treat the symptoms of patients diagnosed with MDD. Approximately 324 patients will be enrolled at clinical sites in the U.S. and Europe. Top-line results are expected in the first half of 2019.
Seltorexant (MIN-202 or JNJ-42847922), under joint development with
- Three Phase 2b clinical trials are ongoing with seltorexant, including two in MDD and one in insomnia disorder. In the first MDD trial, approximately 280 patients are planned to be enrolled at clinical sites in the U.S.,
Europeand Japan. In the second MDD trial, approximately 100 patients are planned to be randomized at clinical sites in the U.S. The insomnia trial is expected to enroll a total of approximately 360 patients at clinical sites in the U.S., Europeand Japan. These trials are planned for completion in 2019.
First Quarter 2018 Financial Results
- Net Loss: Net loss was
$12.4 millionfor the first quarter of 2018, or a loss per share of $0.32(basic and diluted), compared to a net loss of $10.6 millionfor the first quarter of 2017, or a loss per share of $0.30(basic and diluted).
- R&D Expenses: Research and development (R&D) expenses were
$8.4 millionin the first quarter of 2018, compared to $7.6 millionin the first quarter of 2017. The increase in R&D expenses primarily reflects higher development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117. These amounts were partially offset by lower development expenses for the seltorexant program due to the amendment to the Company’s Co-Development and License Agreement with Janssen. R&D expenses are expected to increase during 2018 with increased patient enrollment and related support activities for the roluperidone and MIN-117 clinical trials.
- G&A Expenses: General and administrative (G&A) expenses were
$4.3 millionin the first quarter of 2018, compared to $2.9 millionin the first quarter of 2017. This increase in G&A expenses was primarily due to an increase in non-cash stock-based compensation expenses and salary costs from increased staffing to support the Company's pre-commerical activities. G&A expenses are expected to increase during 2018 with investment in the infrastructure necessary to support the Company’s growth.
- Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of
March 31, 2018were approximately $121.1 million.
Conference Call Information:
The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of current clinical trials and results of clinical trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether roluperidone, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|March 31,||December 31,|
|Cash and cash equivalents||$||45,126||$||26,052|
|Prepaid expenses and other current assets||4,243||1,299|
|Total current assets||125,340||129,540|
|Marketable securities - noncurrent||-||5,023|
|Other noncurrent assets||15||15|
|In-process research and development||34,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||2,393||1,439|
|Total current liabilities||7,915||6,837|
|Other noncurrent liabilities||30||30|
|Additional paid-in capital||298,089||295,975|
|Total stockholders' equity||121,293||131,598|
|Total Liabilities and Stockholders' Equity||$||174,471||$||183,698|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended March 31,|
|(in thousands, except per share amounts)|
|Research and development||8,449||7,614|
|General and administrative||4,294||2,871|
|Total operating expenses||12,743||10,485|
|Foreign exchange losses||(18||)||(17||)|
|Net income (loss)||$||(12,418||)||$||(10,645||)|
|Loss per share:|
|Basic and diluted||$||(0.32||)||$||(0.30||)|
|Weighted average shares:|
|Basic and diluted||38,749||35,370|
VP, Investor Relations/
Source: Minerva Neurosciences, Inc