Minerva Neurosciences Reports First Quarter 2019 Financial Results and Business Updates
May 06 2019 - 7:30AM
Minerva Neurosciences Reports First Quarter 2019 Financial Results
and Business Updates
Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system (CNS) disorders, today reported key
business updates and financial results for the quarter ended March
31, 2019.
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. Remy
Luthringer, Executive Chairman and Chief Executive Officer of
Minerva. “We have updated forecast timelines for the
roluperidone Phase 3 study and the MIN-117 Phase 2b study, both of
which we now expect to read out in the fourth quarter of this year.
“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.”
Development Updates
Roluperidone (MIN-101):
- 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 Europe
are 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 Congress of the
Schizophrenia International Research Society suggest 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 Janssen Pharmaceutica NV (Janssen):
- 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., Europe and 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., Europe and 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.
MIN-117:
- 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 million for
the first quarter of 2019, or a loss per share of $0.41 (basic and
diluted), compared to a net loss of $12.4 million for 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 million in the first quarter of 2019,
compared to $8.4 million in 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 million in the first quarter of 2019,
compared to $4.3 million in 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, 2019 were
approximately $79.3 million.
Conference Call Information:
Minerva Neurosciences will host a conference call and live audio
webcast today at 8:30 a.m. Eastern Time to discuss the quarter and
recent business activities. To participate, please dial (877)
312-5845 (domestic) or (765) 507-2618 (international) and refer to
conference ID 5697837.
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.
About Minerva Neurosciences:
Minerva Neurosciences, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of a portfolio of product candidates to treat CNS
diseases. 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 major depressive disorder (MDD); MIN-117, in clinical
development for 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, 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 U.S. Food and Drug Administration
or equivalent foreign regulatory agencies and for which
indications; whether any of our therapeutic products will be
successfully marketed if approved; whether any of our therapeutic
product discovery and development efforts will be successful;
management’s ability to successfully achieve its goals; our ability
to raise additional capital to fund our operations on terms
acceptable to us; and general economic conditions. These and
other potential risks and uncertainties that could cause actual
results to differ from the results predicted are more fully
detailed under the caption “Risk Factors” in our filings with the
Securities and Exchange Commission, including our Annual Report on
Form 10-Q for the quarter ended March 31, 2019, filed with
the Securities and Exchange Commission on March 6, 2019.
Copies of reports filed with the SEC are posted on our
website at www.minervaneurosciences.com. The forward-looking
statements in this press release are based on information available
to us as of the date hereof, and we disclaim any obligation to
update any forward-looking statements, except as required by
law.
CONDENSED
CONSOLIDATED BALANCE SHEET DATA |
(Unaudited) |
|
March
31, |
December 31, |
2019 |
2018 |
|
(in
thousands) |
ASSETS |
Current
Assets: |
|
|
Cash and cash equivalents |
$ |
30,608 |
|
$ |
50,235 |
|
Marketable securities |
|
48,557 |
|
|
37,763 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Prepaid
expenses and other current assets |
|
1,054 |
|
|
1,921 |
|
Total
current assets |
|
80,319 |
|
|
90,019 |
|
Marketable securities - noncurrent |
|
- |
|
|
- |
|
Equipment, net |
|
29 |
|
|
33 |
|
Other
noncurrent assets |
|
15 |
|
|
15 |
|
Operating
lease right-of-use assets |
|
371 |
|
|
- |
|
In-process research and development |
|
34,200 |
|
|
34,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total
Assets |
$ |
129,803 |
|
$ |
139,136 |
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
Current
Liabilities: |
|
|
Notes
payable |
$ |
- |
|
$ |
- |
|
Accounts
payable |
|
3,026 |
|
|
1,799 |
|
Accrued
expenses and other current liabilities |
|
3,721 |
|
|
1,810 |
|
Operating
leases |
|
156 |
|
|
- |
|
Total
current liabilities |
|
6,903 |
|
|
3,609 |
|
Long-Term
Liabilities: |
|
|
Deferred
taxes |
|
4,057 |
|
|
4,057 |
|
Deferred
revenue |
|
41,176 |
|
|
41,176 |
|
Other
noncurrent liabilities |
|
- |
|
|
29 |
|
Noncurrent operating leases |
|
243 |
|
|
- |
|
Total
liabilities |
|
52,379 |
|
|
48,871 |
|
Stockholders' Equity: |
|
|
Common
stock |
|
4 |
|
|
4 |
|
Additional paid-in capital |
|
307,800 |
|
|
304,814 |
|
Accumulated deficit |
|
(230,380 |
) |
|
(214,553 |
) |
Total
stockholders' equity |
|
77,424 |
|
|
90,265 |
|
Total
Liabilities and Stockholders' Equity |
$ |
129,803 |
|
$ |
139,136 |
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
|
|
Three Months
Ended March 31, |
|
|
(in
thousands, except per share amounts) |
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
Revenues |
|
$ |
- |
|
$ |
- |
|
Operating
expenses: |
|
|
|
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 |
) |
Investment income |
|
|
491 |
|
|
414 |
|
Interest
expense |
|
|
- |
|
|
(71 |
) |
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 |
|
Contact:
William B. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
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