WALTHAM, Mass., Nov. 06, 2017 (GLOBE NEWSWIRE) --
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
September 30, 2017.
"As we approach year-end, we are completing the
final steps prior to the initiation of a number of advanced-stage
clinical efficacy trials with multiple compounds targeting
significant unmet needs in CNS, highlighted by our lead product
candidate, MIN-101 for the treatment of negative symptoms in
schizophrenia," said Dr. Remy Luthringer, president and chief
executive officer of Minerva. "Our objective is to ensure
rigorously conducted clinical trials that support well-defined
product profiles, timely data readouts and a smooth transition to
future regulatory review and commercialization."
MIN-101:
- The Company is on schedule to initiate a pivotal
Phase 3 trial of MIN-101 to treat negative symptoms in patients
diagnosed with schizophrenia in the fourth quarter of 2017.
Top-line results from the three-month double blind phase of this
trial are expected in the first half of 2019.
- The final protocol for the Phase 3 trial has been
submitted to the Investigational New Drug application (IND), and
the first Institutional Review Board (IRB) approval has been
received for the study in the U.S. The trial will be a
12-week, double-blind, randomized, placebo-controlled, monotherapy
study testing two doses of MIN-101 in schizophrenic patients with
negative symptoms. These are the same two doses as those employed
in the Phase 2b trial. After the double-blind phase, patients may
enter a 40-week open label extension phase in which all will
receive active treatment. This multi-center, international trial is
expected to enroll approximately 500 patients at approximately 60
clinical sites across the U.S. and Europe, with 30 percent of
patients coming from the U.S.
- The Chemistry, Manufacturing and Controls (CMC)
program has been initiated to ensure consistency between drug
batches and its timely inclusion with the potential submission of a
New Drug Application (NDA) pending a successful Phase 3 trial.
SELTOREXANT (MIN-202 OR
JNJ-42847922):
- The first patient has been enrolled in a Phase 2b
clinical trial of seltorexant as adjunctive therapy to
antidepressants in adult patients with major depressive disorder
(MDD) who have responded inadequately to antidepressant
therapy. Approximately 280 patients are planned to be
enrolled at more than 85 clinical sites in the U.S., Europe, Russia
and Japan. Two additional clinical trials of seltorexant are
planned for initiation in the fourth quarter of 2017. These include
a second Phase 2b trial in MDD and a Phase 2b trial in
insomnia.
- An amendment to the Company's co-development and
license agreement with Janssen became effective on August 29, 2017
following approval of its terms by the European Commission.
MIN-117:
- The Company plans to initiate patient recruitment
in a Phase 2b clinical trial with MIN-117 in MDD in early 2018.
This trial is expected to include patients with MDD who also have
symptoms of anxiety, building upon previous Phase 2a clinical
results that showed effects in both depressive symptomatology and
anxiety.
- In preparation for the Phase 2b trial, a
food-effect study is currently ongoing with MIN-117 under the
Company's IND.
MIN-301:
- The Company is continuing to conduct
pre-clinical, toxicology and other IND-enabling studies with
MIN-301 as a prelude to advancing this compound into the initial
stage of clinical development.
- MIN-301 is a recombinant protein with the
extra-cellular domain of neuregulin-1 beta primarily activating the
ErbB4 receptor. Dysregulation of the NRG-1 signaling pathway has
been linked to neurodevelopmental and neurodegenerative disorders
including and beyond Parkinson's disease.
Third Quarter 2017 Financial
Results
- Cash Position:
Cash, cash equivalents and marketable securities as of September
30, 2017 were approximately $143.3 million, compared to $83.0
million as of December 31, 2016. As previously stated,
Minerva expects that its cash, cash equivalents and marketable
securities will be sufficient to fund its operations for at least
the next 12 months.
- R&D Expenses:
Research and development (R&D) expenses were $9.0 million in
the third quarter of 2017, compared to $5.9 million in the third
quarter of 2016. R&D expense in the three months ended
September 30, 2017 and 2016 included non-cash stock-based
compensation expenses of $0.5 million and $0.3 million,
respectively. This increase in R&D expenses primarily reflects
higher development expenses under the MIN-202 program for the Phase
2 clinical trials, increased expenses for the MIN-101 program and
an increase in non-cash stock-based compensation
expenses.
For the nine months ended September 30, 2017, R&D expenses were
$23.7 million, compared to $13.9 million for the nine months ended
September 30, 2016. R&D expense in the nine months ended
September 30, 2017 and 2016 included non-cash stock-based
compensation expenses of $1.5 million and $0.7 million,
respectively. This increase in R&D expenses primarily reflects
higher development expenses under the MIN-202 program for the Phase
2 clinical trial, increased expenses for the MIN-101 program, an
increase in personnel costs and an increase in non-cash stock-based
compensation expenses. These amounts were partially offset by lower
costs due to the completion of the Phase 2a clinical trial of
MIN-117.
- G&A Expenses:
General and administrative (G&A) expenses were $2.5 million in
the third quarter of 2017, compared to $2.4 million in the third
quarter of 2016. G&A expense in the three months ended
September 30, 2017 and 2016 included non-cash stock-based
compensation expenses of $0.8 million and $0.7 million,
respectively. This increase was primarily due to an increase in
professional fees during the three months ended September 30,
2017.
For the nine months ended September 30, 2017, G&A expenses were
$7.9 million, compared to $7.0 million for the same period in 2016.
G&A expense in the nine months ended September 30, 2017 and
2016 included non-cash stock-based compensation expenses of $2.3
million and $1.8 million, respectively. This increase was primarily
due to an increase in professional fees and an increase in non-cash
stock-based compensation expenses during the nine months ended
September 30, 2017.
- Net Loss:
Net loss was $11.3 million for the third quarter of 2017, or a loss
per share of $0.28 (basic and diluted), as compared to a net loss
of $8.4 million, or a loss per share of $0.24 (basic and diluted)
for the third quarter of 2016. Net loss was $31.7 million for
the first nine months of 2017, or a loss per share of $0.84 (basic
and diluted), as compared to a net loss of $21.6 million, or a loss
per share of $0.71 (basic and diluted) for the first nine months of
2016.
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 number 90294475.
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 products to treat CNS
diseases. Minerva's proprietary compounds include: 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 MIN-101, seltorexant,
MIN-117 and MIN-301. 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 MIN-101, seltorexant, MIN-117 and MIN-301 will
advance further in the clinical trials process; 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 Quarterly Report on Form 10-Q
for the quarter ended September 30, 2017, filed with
the Securities and Exchange Commission on November 6,
2017. 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) |
|
September 30, |
December 31, |
|
2017 |
|
|
2016 |
|
|
(in thousands) |
ASSETS |
Current Assets: |
|
|
Cash and cash equivalents |
$ |
36,255 |
|
$ |
82,981 |
|
Marketable securities |
|
96,675 |
|
|
- |
|
Restricted cash |
|
80 |
|
|
80 |
|
Prepaid expenses and other
current assets |
|
1,073 |
|
|
803 |
|
Total current assets |
|
134,083 |
|
|
83,864 |
|
Marketable securities -
noncurrent |
|
10,355 |
|
|
- |
|
Equipment, net |
|
- |
|
|
10 |
|
In-process research and
development |
|
34,200 |
|
|
34,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
193,507 |
|
$ |
132,943 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
Current Liabilities: |
|
|
Notes payable - current
portion |
$ |
5,194 |
|
$ |
4,854 |
|
Accounts payable |
|
1,504 |
|
|
1,467 |
|
Accrued expenses and other
current liabilities |
|
2,022 |
|
|
816 |
|
Accrued collaborative
expenses |
|
- |
|
|
2,548 |
|
Total current liabilities |
|
8,720 |
|
|
9,685 |
|
Long-Term Liabilities: |
|
|
Notes payable -
noncurrent |
|
- |
|
|
3,841 |
|
Deferred taxes |
|
13,434 |
|
|
13,434 |
|
Deferred revenue |
|
41,176 |
|
|
- |
|
Total liabilities |
|
63,330 |
|
|
26,960 |
|
Stockholders' Equity: |
|
|
Common stock |
|
4 |
|
|
4 |
|
Additional paid-in
capital |
|
294,717 |
|
|
238,837 |
|
Accumulated deficit |
|
(164,544 |
) |
|
(132,858 |
) |
Total stockholders'
equity |
|
130,177 |
|
|
105,983 |
|
Total Liabilities and
Stockholders' Equity |
$ |
193,507 |
|
$ |
132,943 |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
|
2017 |
|
|
2016 |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
Revenues |
|
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
8,956 |
|
|
5,852 |
|
|
|
23,715 |
|
|
13,941 |
|
General and
administrative |
|
|
2,451 |
|
|
2,380 |
|
|
|
7,923 |
|
|
7,012 |
|
Total operating expenses |
|
|
11,407 |
|
|
8,232 |
|
|
|
31,638 |
|
|
20,953 |
|
|
|
|
|
|
|
|
Foreign exchange losses |
|
|
(9 |
) |
|
(3 |
) |
|
|
(46 |
) |
|
(28 |
) |
Investment income |
|
|
294 |
|
|
70 |
|
|
|
508 |
|
|
137 |
|
Interest expense |
|
|
(138 |
) |
|
(259 |
) |
|
|
(510 |
) |
|
(797 |
) |
Net loss |
|
$ |
(11,260 |
) |
$ |
(8,424 |
) |
|
$ |
(31,686 |
) |
$ |
(21,641 |
) |
Loss per share: |
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.28 |
) |
$ |
(0.24 |
) |
|
$ |
(0.84 |
) |
$ |
(0.71 |
) |
Weighted average shares: |
|
|
|
|
|
|
Basic and diluted |
|
|
40,880 |
|
|
34,806 |
|
|
|
37,677 |
|
|
30,393 |
|
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376