Minerva Neurosciences Reports Fiscal 2019 Fourth Quarter and Year End Financial Results and Business Updates
Company confirms timing of expected top-line results from Phase 3 roluperidone trial in Q2 2020
Management to host conference call today at
Clinical Program Updates
The Company is pleased to confirm its previous guidance that top-line results from the Phase 3 trial with roluperidone are expected in the second quarter of 2020. As announced in February, enrollment of 515 patients has been achieved in the 12-week core phase of a pivotal trial for the treatment of negative symptoms, the leading unmet medical need in schizophrenia.
This trial is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, 12-week trial to evaluate the efficacy and safety of 32 milligram (mg) and 64 mg doses of roluperidone as measured by the Positive and Negative Syndrome Scale. The primary endpoint is the Marder negative symptoms factor score. The core 12-week study, which the Company expects to read out in the second quarter, will be followed by an optional 40-week, open-label extension period during which patients on the drug continue receiving their original dose and patients on placebo receive one of the two doses of roluperidone.
The Company announced positive data readouts in 3 Phase 2b studies and one Phase 1b trial with seltorexant (MIN-202) during 2019. Three of these trials were in major depressive disorder (MDD) and one was in insomnia disorder.
The Company is currently in discussions with its partner,
The Company is developing MIN-301, a pre-clinical candidate for the potential treatment of Parkinson’s disease and other neurodegenerative disorders. Building upon positive data in non-primate pre-clinical models, the Company is continuing to conduct pre-clinical studies in preparation for regulatory filings leading toward entry into humans.
“We are on track to read out top-line results of the roluperidone Phase 3 study in the second quarter of 2020,” said Dr.
Fourth Quarter and Year Ended 2019 Financial Results
- Net (Loss) Income: Net loss was
$29.9 millionfor the fourth quarter of 2019, or loss per share of $0.77(basic and diluted), compared to net loss of $13.2 millionfor the fourth quarter of 2018, or loss per share of $0.34(basic and diluted). Net loss was $72.2 millionfor the year ended December 31, 2019, or loss per share of $1.85(basic and diluted), compared to a net loss of $50.2 million, or loss per share of $1.29(basic and diluted) for the year ended December 31, 2018.
- R&D Expenses: Research and development (R&D) expenses were
$28.5 millionin the fourth quarter of 2019, compared to $9.0 millionin the fourth quarter of 2018. R&D expenses were $58.1 millionfor the year ended December 31, 2019, compared to $34.9 millionfor the year ended December 31, 2018. The increase in R&D expenses during the fourth quarter and year ended December 31, 2019primarily reflects a $19.0 millionnon-cash impairment expense for the discontinued development of MIN-117 and higher development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117.
- G&A Expenses: General and administrative (G&A) expenses were
$3.8 millionin the fourth quarter of 2019, compared to $4.6 millionin the fourth quarter of 2018. G&A expenses were $17.7 millionfor the year ended December 31, 2019, compared to $16.8 millionfor the year ended December 31, 2018. This increase in G&A expenses during the fourth quarter and year ended December 31, 2019was primarily due to an increase in non-cash stock-based compensation expenses and higher professional fees to support pre-commercial activities.
- Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of
December 31, 2019were approximately $46.0 million, compared to $88.1 millionas of December 31, 2018.
Conference Call Information:
The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Minerva’s proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone (MIN-101), seltorexant (MIN-202) and MIN-301; the clinical and therapeutic potential of these compounds; the timing and outcomes of future interactions with
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||21,413||$||50,235|
|Prepaid expenses and other current assets||1,182||1,921|
|Total current assets||47,137||90,019|
|Other noncurrent assets||15||15|
|Operating lease right-of-use assets||262||-|
|In-process research and development||15,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||4,139||1,810|
|Total current liabilities||6,629||3,609|
|Other noncurrent liabilities||-||29|
|Noncurrent operating leases||111||-|
|Additional paid-in capital||314,512||304,814|
|Total stockholders' equity||27,780||90,265|
|Total Liabilities and Stockholders' Equity||$||77,499||$||139,136|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended
||Twelve Months Ended
|(in thousands, except per share
|(in thousands, except per share
|Research and development||28,524||9,008||58,123||34,889|
|General and administrative||3,843||4,620||17,741||16,841|
|Total operating expenses||32,367||13,628||75,864||51,730|
|Foreign exchange losses||(11||)||(5||)||(29||)||(5||)|
|Loss before income taxes||(32,172||)||(13,203||)||(74,437||)||(50,171||)|
|Benefit for income taxes||(2,254||)||-||(2,254||)||-|
|Net (loss) income||$||(29,918||)||$||(13,203||)||$||(72,183||)||$||(50,171||)|
|Loss per share:|
|Basic and diluted||$||(0.77||)||$||(0.34||)||$||(1.85||)||$||(1.29||)|
|Weighted average shares:|
|Basic and diluted||39,037||38,888||39,014||38,793|
VP, Investor Relations/
Source: Minerva Neurosciences, Inc