Minerva Neurosciences Reports First Quarter 2019 Financial Results and Business Updates
Minerva has five late-stage clinical efficacy trials ongoing with three product candidates, including a Phase 3 trial with roluperidone (MIN-101) for negative symptoms in patients with schizophrenia, a Phase 2b trial with MIN-117 for major depressive disorder (MDD) associated with anxiety and three Phase 2b trials with seltorexant (MIN-202) for insomnia disorder and MDD.
“I am very pleased to provide an update and insights into the progress we are making in all of our studies,” said Dr.
“Our three seltorexant studies will now read out sooner than anticipated, with patient enrollment completed in all three,” said Dr. Luthringer. “We expect to report top-line results from both our first MDD trial and our insomnia trial in the second quarter of 2019, and we expect top-line results from our second MDD trial in the third quarter of 2019.
“The new timelines reflect the latest information available from our sites, as well as the care that we are taking both in recruiting subjects who meet stringent entry criteria and in engaging well-trained clinical investigators to evaluate the therapeutic benefit of our product candidates,” said Dr. Luthringer. “I am pleased to report that patient selection to date has met these standards and the investigators are performing well. Our focus continues to be on trial conduct and data quality.”
- The Company is actively enrolling patients in the pivotal Phase 3 trial with roluperidone (clinicaltrials.gov identifier: NCT03397134). Approximately 60 sites in the U.S. and
Europeare participating in this trial, and target enrollment is approximately 500 patients. Completion of full enrollment is now expected in the second half of 2019, and top-line results from the 12-week, double-blind portion of the trial are expected in the fourth quarter of 2019.
- In parallel with advancing its Phase 3 study, Minerva is continuing preparatory work for regulatory filing and commercialization. These activities include clinical pharmacology studies and manufacturing of registration batches.
- Pre-clinical data presented at the 2019
Congressof the Schizophrenia International Research Societysuggest a mechanistic role for roluperidone in addressing negative symptoms. Presenters also indicated the potential of roluperidone for disease modification and improved neuroplasticity.
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, designated as the 2001 trial (Clinicaltrials.gov Identifier: NCT03227224), patient enrollment has been completed, with 287 patients enrolled at clinical sites in the U.S.,
Europeand Japan. Top-line results from this trial are expected in the second quarter of 2019.
- Enrollment has also been completed in the insomnia trial, designated as the 2005 trial (Clinicaltrials.gov Identifier: NCT03375203), with approximately 360 patients enrolled at clinical sites in the U.S.,
Europeand Japan. Top-line results are expected in the second quarter of 2019.
- In the second MDD trial, designated as the 2002 trial (Clinicaltrials.gov Identifier NCT03321526), patient enrollment has also been completed, with 100 patients enrolled at clinical sites in the U.S. Top-line results from this trial are expected in the third quarter of 2019.
- A Phase 2b trial is ongoing with MIN-117 to treat patients diagnosed with MDD and associated anxiety disorders (Clinicaltrials.gov Identifier: NCT03446846). Approximately 324 patients are expected to be enrolled at 40 clinical sites in the U.S. and
Europe. Completion of enrollment is now expected in the third quarter of 2019, with top-line results expected to be available in the fourth quarter of 2019.
First Quarter 2019 Financial Results
- Net Loss: Net loss was
$15.8 millionfor the first quarter of 2019, or a loss per share of $0.41(basic and diluted), compared to a net loss of $12.4 millionfor the first quarter of 2018, or a loss per share of $0.32(basic and diluted).
- R&D Expenses: Research and development (R&D) expenses were
$11.6 millionin the first quarter of 2019, compared to $8.4 millionin the first quarter of 2018. 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. R&D expenses are expected to increase during 2019 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
$4.7 millionin the first quarter of 2019, compared to $4.3 millionin the first quarter of 2018. 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-commercial activities.
- Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of
March 31, 2019were approximately $79.3 million.
Conference Call Information:
The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether roluperidone, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the
|CONDENSED CONSOLIDATED BALANCE SHEET DATA|
|March 31,||December 31,|
|Cash and cash equivalents||$||30,608||$||50,235|
|Prepaid expenses and other current assets||1,054||1,921|
|Total current assets||80,319||90,019|
|Marketable securities - noncurrent||-||-|
|Other noncurrent assets||15||15|
|Operating lease right-of-use assets||371||-|
|In-process research and development||34,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||3,721||1,810|
|Total current liabilities||6,903||3,609|
|Other noncurrent liabilities||-||29|
|Noncurrent operating leases||243||-|
|Additional paid-in capital||307,800||304,814|
|Total stockholders' equity||77,424||90,265|
|Total Liabilities and Stockholders' Equity||$||129,803||$||139,136|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended March 31,
|(in thousands, except per share amounts)
|Research and development||11,606||8,449|
|General and administrative||4,706||4,294|
|Total operating expenses||16,312||12,743|
|Foreign exchange losses||(6||)||(18||)|
|Loss before income taxes||(15,827||)||(12,418||)|
|Benefit for income taxes||-||-|
|Net (loss) income||$||(15,827||)||$||(12,418||)|
|Loss per share:|
|Basic and diluted||$||(0.41||)||$||(0.32||)|
|Weighted average shares:|
|Basic and diluted||38,968||38,749|
VP, Investor Relations/
Source: Minerva Neurosciences, Inc