Minerva Neurosciences Reports Third Quarter 2017 Financial Results and Business Updates
November 06 2017 - 7:30AM
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. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Minerva Neurosciences (NASDAQ:NERV)
Historical Stock Chart
From Apr 2023 to Apr 2024