Minerva Neurosciences Reports First Quarter 2020 Financial Results and Business Updates
“We are pleased to report that we are approaching the conclusion of the double-blind, 12-week phase of our pivotal Phase 3 trial with roluperidone and reiterate our previous guidance that we expect to report top line results in the second quarter,” said Dr.
“Finally, the prominent role of negative symptoms in schizophrenia has been increasingly highlighted by the key opinion leader (KOL) community since we initiated the Phase 3 trial,” said
Clinical Development Updates
Following the completion of enrollment in a pivotal Phase 3 trial with roluperidone (clinicaltrials.gov identifier: NCT033971340) to treat negative symptoms in schizophrenia in
The Company and its co-development and co-commercialization partner,
First Quarter 2020 Financial Results
- Net Loss: Net loss was
$12.2 millionfor the first quarter of 2020, or a loss per share of $0.31(basic and diluted), compared to a net loss of $15.8 millionfor the first quarter of 2019, or a loss per share of $0.41(basic and diluted).
- R&D Expenses: Research and development (R&D) expenses were
$8.1 millionin the first quarter of 2020, compared to $11.6 millionin the first quarter of 2019. The decrease in R&D expenses primarily reflects lower development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117. R&D expenses are expected to decrease during 2020 with the completion of the Phase 2b trial of MIN-117 and the 12-week, double-blind portion of the Phase 3 clinical trial of roluperidone.
- G&A Expenses: General and administrative (G&A) expenses were
$4.2 millionin the first quarter of 2020, compared to $4.7 millionin the first quarter of 2019. This decrease in G&A expenses was primarily due to a decrease in non-cash stock-based compensation expenses and a decrease in professional fees.
- Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of
March 31, 2020were approximately $37.6 million.
Conference Call Information:
The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Minerva’s proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone (MIN-101) and seltorexant (MIN-202); the clinical and therapeutic potential of these compounds; the timing and outcomes of future interactions with
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||30,036||$||21,413|
|Prepaid expenses and other current assets||852||1,182|
|Total current assets||38,466||47,137|
|Other noncurrent assets||15||15|
|Operating lease right-of-use assets||224||262|
|In-process research and development||15,200||15,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||3,936||4,139|
|Total current liabilities||7,118||6,629|
|Noncurrent operating leases||64||111|
|Additional paid-in capital||317,508||314,512|
|Total stockholders' equity||18,625||27,780|
|Total Liabilities and Stockholders' Equity||$||68,786||$||77,499|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended
|(in thousands, except per share amounts)|
|Research and development||8,083||11,606|
|General and administrative||4,189||4,706|
|Total operating expenses||12,272||16,312|
|Foreign exchange losses||(9||)||(6||)|
|Net (loss) income||$||(12,151||)||$||(15,827||)|
|Loss per share:|
|Basic and diluted||$||(0.31||)||$||(0.41||)|
|Weighted average shares:|
|Basic and diluted||39,178||38,968|
VP, Investor Relations/
Source: Minerva Neurosciences, Inc