Minerva Neurosciences Reports Second Quarter 2020 Financial Results and Business Updates
Clinical Pipeline Update
Although limited inferences can be drawn from these data, unadjusted statistically significant separations from placebo were observed in NSFS at Week 4 for both doses and at Week 8 for the 64 mg dose. The 64 mg dose was statistically significantly different from placebo as measured by change in PSP at all other assessment timepoints.
The patients receiving active treatment showed numerically superior improvements in NSFS to placebo, and a higher number of responders as measured by NSFS and total PANSS scores was observed in the roluperidone treatment groups. The reduction in negative symptoms scores in the 64 mg arm of roluperidone translated into functional improvement as measured by PSP.
Roluperidone was generally well tolerated, and Phase 3 safety data were consistent with such data from the Phase 2b trial.
“We continue our in-depth analyses of the Phase 3 trial with roluperidone and will be contacting the
“The integrated analysis of the Phase 2b and Phase 3 data show a highly significant separation between the two doses of roluperidone and placebo throughout the treatment period,” said
“With respect to seltorexant, the decision to opt out of our agreement with Janssen at this stage of the program enables us to retain a meaningful financial interest in the future revenue stream of a compound with significant commercial potential while eliminating the Company’s financial obligations to a substantial Phase 3 program encompassing major depressive disorder and insomnia,” said
Second Quarter 2020 Financial Results
- Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of
June 30, 2020were approximately $35.3 million.
- R&D Expenses: Research and development (R&D) expenses were
$5.8 millionin the second quarter of 2020, compared to $8.3 million in the second quarter of 2019, a decrease of approximately $2.5 million.
For the six months ended
June 30, 2020, R&D expenses were $13.8 million, compared to $19.9 millionfor the six months ended June 30, 2019, a decrease of approximately $6.1 million.
The decreases in R&D expenses during the quarter and six months ended
June 30, 2020primarily reflect lower development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117.
The Company expects R&D expenses to decrease during 2020, as it has completed the MIN-117 clinical trial 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
$5.9 millionin the second quarter of 2020, compared to $4.6 millionin the second quarter of 2019, an increase of approximately $1.3 million.
For the six months ended
June 30, 2020, G&A expenses were $10.1 million, compared to $9.3 millionfor the same period in 2019, an increase of approximately $0.8 million.
The increases in G&A expenses during the quarter and six months ended
June 30, 2020were primarily due to increases in non-cash stock-based compensation expenses and severance benefits.
- Net Income/Loss: Net income was
$29.5 millionfor the second quarter of 2020, or net income per share of $0.75and $0.73basic and diluted, respectively, as compared to a net loss of $12.5 million, or a loss per share of $0.32basic and diluted for the second quarter of 2019. Net income was $17.4 millionfor the first six months of 2020, or net income per share of $0.44and $0.43basic and diluted, respectively, as compared to a net loss of $28.3 million, or a loss per share of $0.73basic and diluted for the first six months of 2019.
As a result of opting out of the agreement with Janssen, the Company recognized
$41.2 millionin collaborative revenue during the second quarter of 2020 which had previously been included on the balance sheet under deferred revenue. This amount represents the $30 millionpayment made by Janssen in 2017 and $11.2 millionin previously accrued collaborative expenses forgiven by Janssen upon the effective date of the Amendment. The Company does not have any future performance obligations under the agreement and will recognize any future royalty revenues in the periods of the sale of products related to the Agreement.
Conference Call Information:
The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Minerva’s portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia; a potential royalty stream from seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone (MIN-101); the clinical and therapeutic potential of this compound; the likelihood of future sales and a royalty stream from seltorexant; the timing and outcomes of future interactions with
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||32,252||$||21,413|
|Prepaid expenses and other current assets||543||1,182|
|Total current assets||35,891||47,137|
|Other noncurrent assets||15||15|
|Operating lease right-of-use assets||184||262|
|In-process research and development||15,200||15,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||4,080||4,139|
|Total current liabilities||7,403||6,629|
|Noncurrent operating leases||16||111|
|Additional paid-in capital||326,298||314,512|
|Total stockholders' equity||56,944||27,780|
|Total Liabilities and Stockholders' Equity||$||66,166||$||77,499|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|Three Months Ended
||Six Months Ended
|(in thousands, except per share amounts)||(in thousands, except per share amounts)|
|Research and development||5,767||8,320||13,849||19,926|
|General and administrative||5,901||4,584||10,090||9,290|
|Total operating expenses||11,668||12,904||23,939||29,216|
|Gain (loss) from operations||29,508||12,904||17,237||29,216|
|Foreign exchange losses||(4||)||(7||)||(13||)||(13||)|
|Net income (loss)||29,529||(12,477||)||17,378||(28,304||)|
|Net income (loss) per share, basic||$||0.75||$||(0.32||)||$||0.44||$||(0.73||)|
|Weighted average shares outstanding, basic||39,483||39,025||39,330||38,997|
|Net income (loss) per share, diluted||$||0.73||$||(0.32||)||$||0.43||$||(0.73||)|
|Weighted average shares outstanding, diluted||40,278||39,025||40,145||38,997|
VP, Investor Relations/
Source: Minerva Neurosciences, Inc