Minerva Neurosciences Reports Fiscal 2016 Fourth Quarter and Year End Financial Results and Business Updates
March 13 2017 - 7:30AM
Multiple positive
data readouts during 2016 provide foundation for initiation of
advanced clinical trials with three product candidates in
2017
Management to host
conference call today at 8:30 a.m. Eastern Time
WALTHAM, Mass., March 13, 2017 (GLOBE NEWSWIRE) --
Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage
biopharmaceutical company focused on the development of innovative
therapies to treat unmet medical needs of central nervous system
(CNS) disorders, today reported key business updates and financial
results for the fourth quarter and fiscal year ended December 31,
2016.
"Multiple data readouts during 2016 marked
significant progress along the clinical development pathways for
MIN-101 in schizophrenia, MIN-202 in insomnia disorder and major
depressive disorder (MDD) and MIN-117 in MDD," said Dr. Remy
Luthringer, president and chief executive officer of Minerva.
"These accomplishments set the stage for the expected initiation of
advanced-stage and pivotal clinical trials in 2017. Our goal
with each of these product candidates is to address unmet medical
needs and thereby to expand the therapeutic options for patients
suffering from these diseases."
MIN-101:
-
During 2016, the Company announced
positive results from both the randomized, double blind, placebo
controlled core phase and the open label extension phase of its
Phase IIb trial with MIN-101 for the treatment of
schizophrenia. Statistically significant, specific
improvements were observed in negative symptoms, the primary
endpoint of the trial, as well as in multiple secondary endpoints,
resulting from treatment with MIN-101 as monotherapy. Results from
this trial were presented at the 2016 Annual Meeting of the
American College of Neuropsychopharmacology (ACNP).
-
Following recent interactions with the
U.S. Food and Drug Administration (FDA), an "end of Phase II"
meeting has been scheduled with the FDA to take place early in the
second quarter of 2017 to review the clinical and pre-clinical data
with MIN-101 and to discuss the design of pivotal Phase III trials
with this compound. A scientific advisory meeting will be
scheduled thereafter with the European Medicines Agency
(EMA). The Company expects to initiate Phase III testing of
MIN-101 in schizophrenic patients with negative symptoms in the
second half of 2017.
MIN-202 (JNJ-42847922), under
joint development with Janssen Pharmaceutica NV (Janssen):
-
Data from a randomized, two way,
cross-over placebo controlled, double blind Phase IIa clinical
trial of MIN-202 in insomnia disorder were announced in the first
quarter of 2016. Patients treated with MIN-202 were observed
to experience statistically significant improvements in key sleep
parameters compared to patients treated with placebo, including
sleep efficiency as measured by objective polysomnography, the
primary endpoint. Additional significant positive efficacy
signals were observed for key secondary parameters.
-
Top line results from a randomized,
double blind, parallel group Phase Ib clinical trial in MDD were
announced in the first quarter of 2016. In this trial, consistently
greater improvements in depressive symptomatology were observed in
patients who received MIN-202 compared to those who received
placebo or diphenhydramine, a positive control. Core symptoms
of depression were also observed to significantly improve in
patients treated with MIN-202, independent from its effect on
sleep.
-
A number of supportive activities and
clinical pharmacology studies are being conducted in anticipation
of the next phase of clinical development with this compound in
insomnia and MDD.
MIN-117:
-
In a randomized, double blind, placebo
and active controlled Phase IIa clinical trial in MDD,
dose-dependent benefit of MIN-117 over placebo was observed.
The trial was designed for signal detection and effect size
estimation and not powered to demonstrate statistical significance.
Improvement in depressive symptomatology was observed after two
weeks of treatment with MIN-117, and data showed that 24 percent of
patients treated with the higher tested dose achieved remission as
prospectively defined.
-
The FDA accepted the Investigational
New Drug application (IND) for MIN-117 as announced in September,
2016. Acceptance of the IND allows the Company to begin
clinical trials with this compound in the U.S. Planning is
underway for these trials, which are expected to begin in late
2017.
MIN-301:
-
The Company is pursuing the
pre-clinical development of MIN-301 for the treatment of
Parkinson's disease. MIN-301 is a peptide that targets the
extra-cellular domain of neuregulin-1 beta-1 activating the ErbB4
receptor. The next planned steps in this program include the
filing of an IND in the U.S. or an Investigational Medicinal
Product Dossier in Europe, and pending acceptance by regulatory
authorities, the initiation of Phase I clinical testing
thereafter.
Fourth Quarter and Year Ended
2016 Financial Results
-
Net Loss:
Net loss was $9.4 million for the fourth quarter of 2016, or a loss
per share of $0.27 (basic and diluted), compared to a net loss of
$8.4 million for the fourth quarter of 2015, or a loss per share of
$0.34 (basic and diluted). Net loss was $31.0 million for the
year ended December 31, 2016, or a loss per share of $0.99 (basic
and diluted), compared to a net loss of $27.1 million, or a loss
per share of $1.16 (basic and diluted), for the year ended December
31, 2015.
-
R&D
Expenses: Research and development (R&D) expenses were
$6.5 million in the fourth quarter of 2016, compared to $6.3
million in the fourth quarter of 2015. R&D expenses were
$20.4 million for the year ended December 31, 2016, compared to
$18.5 million for the year ended December 31, 2015. This
increase in research and development expenses primarily reflects
higher development expenses under the MIN-202 program for Phase II
clinical trial preparation, and an increase in non-cash stock-based
compensation expenses. This increase was partially
offset by decreased expenses due to the completion of our Phase IIb
clinical trial of MIN-101.
-
G&A
Expenses: General and administrative (G&A) expenses
were $2.7 million in the fourth quarter of 2016, compared to $1.9
million in the fourth quarter of 2015. G&A expenses were
$9.8 million for the year ended December 31, 2016, compared to $7.6
million for the year ended December 31, 2015. The increase in
general and administrative expenses was primarily due to an
increase in non-cash stock-based compensation expenses, personnel
costs and professional fees during the year ended December 31,
2016.
-
Cash
Position: Cash, cash equivalents and marketable securities
as of December 31, 2016 were approximately $83.0 million, compared
to $32.2 million as of December 31, 2015. During 2016, the
Company received approximately $23.4 million in proceeds from the
exercise of warrants granted in connection with a private placement
in March 2015, approximately $1 million from a common stock
purchase by a director of the Company, and net proceeds of
approximately $53.7 million from a public offering of common
stock. Minerva presently expects that its existing cash and
cash equivalents will be sufficient to meet its anticipated capital
requirements for at least the next 12 months from today. The
assumptions upon which this estimate is based are under constant
review and subject to change. The actual amount and timing of
the Company's research and development expenditures may vary
depending upon a number of factors, including but not limited to
those related to the design, timing and duration of future clinical
trials.
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 63111094.
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: MIN-101, in
clinical development for schizophrenia; MIN-117, in clinical
development for major depressive disorder (MDD); MIN-202
(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 results of future clinical
and pre-clinical milestones with MIN-101, MIN-202, 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
any of our therapeutic products 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; our
ability to achieve the results contemplated by our co-development
agreements; 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-K for the year ended December 31, 2016,
filed with the Securities and Exchange
Commission on March 13, 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) |
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2016 |
2015 |
|
|
|
(in thousands) |
ASSETS |
Current Assets: |
|
|
|
|
Cash and cash
equivalents |
|
|
|
$ |
82,981 |
|
$ |
14,284 |
|
Marketable
securities |
|
|
|
|
- |
|
|
17,921 |
|
Restricted cash |
|
|
|
|
80 |
|
|
80 |
|
Prepaid expenses and
other current assets |
|
|
|
|
803 |
|
|
1,196 |
|
Total current
assets |
|
|
|
|
83,864 |
|
|
33,481 |
|
Equipment, net |
|
|
|
|
10 |
|
|
26 |
|
In-process research
and development |
|
|
|
|
34,200 |
|
|
34,200 |
|
Goodwill |
|
|
|
|
14,869 |
|
|
14,869 |
|
Total Assets |
|
|
|
$ |
132,943 |
|
$ |
82,576 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
Current
Liabilities: |
|
|
|
|
Notes payable -
current portion |
|
|
|
$ |
4,854 |
|
$ |
1,435 |
|
Accounts payable |
|
|
|
|
1,467 |
|
|
1,360 |
|
Accrued expenses and
other current liabilities |
|
|
|
|
816 |
|
|
2,525 |
|
Accrued collaborative
expenses |
|
|
|
|
2,548 |
|
|
- |
|
Total current
liabilities |
|
|
|
|
9,685 |
|
|
5,320 |
|
Long-Term
Liabilities: |
|
|
|
|
Notes payable -
noncurrent |
|
|
|
|
3,841 |
|
|
8,503 |
|
Deferred taxes |
|
|
|
|
13,434 |
|
|
13,434 |
|
Total liabilities |
|
|
|
|
26,960 |
|
|
27,257 |
|
Stockholders'
Equity: |
|
|
|
|
Common stock |
|
|
|
|
4 |
|
|
2 |
|
Additional paid-in
capital |
|
|
|
|
238,837 |
|
|
157,130 |
|
Accumulated
deficit |
|
|
|
|
(132,858) |
|
|
(101,813) |
|
Total stockholders'
equity |
|
|
|
|
105,983 |
|
|
55,319 |
|
Total Liabilities and
Stockholders' Equity |
|
|
|
$ |
132,943 |
|
$ |
82,576 |
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Year Ended
December 31, |
|
|
|
|
(in thousands, except per share amounts) |
|
|
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
Revenues |
|
|
|
$ |
- |
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
Research and
development |
|
|
|
|
20,440 |
|
|
18,533 |
|
General and
administrative |
|
|
|
|
9,751 |
|
|
7,577 |
|
Total operating
expenses |
|
|
|
|
30,191 |
|
|
26,110 |
|
|
|
|
|
|
|
Foreign exchange
losses |
|
|
|
|
(23) |
|
|
(16) |
|
Investment income |
|
|
|
|
198 |
|
|
97 |
|
Interest expense |
|
|
|
|
(1,030) |
|
|
(1,053) |
|
Net loss |
|
|
|
$ |
(31,046) |
|
$ |
(27,082) |
|
Loss per share: |
|
|
|
|
|
Basic and diluted |
|
|
|
$ |
(0.99) |
|
$ |
(1.16) |
|
Weighted average
shares: |
|
|
|
|
|
Basic and diluted |
|
|
|
|
31,514 |
|
|
23,412 |
|
|
|
|
|
|
|
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Minerva Neurosciences, Inc. via Globenewswire
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