Minerva Neurosciences Reports Fiscal 2018 Fourth Quarter and Year End Financial Results and Business Updates
March 12 2019 - 7:30AM
Minerva Neurosciences Reports Fiscal 2018 Fourth Quarter and Year
End Financial Results and Business Updates
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,
2018.
“Minerva is on track for the completion of patient enrollment
and subsequent top-line data readouts in 2019 from five clinical
trials with a diversified pipeline of product candidates, led by
the Phase 3 trial with roluperidone for negative symptoms in
patients with schizophrenia,” said Dr. Remy Luthringer, executive
chairman and chief executive officer of Minerva. “During the
past year we have also published additional clinical data with
roluperidone, expanded our understanding of its pharmacological
effect through new pre-clinical studies, completed further safety
testing, and initiated strategic development, market research and
pre-commercialization activities. These activities will be
further informed by the data expected following the completion of
the Phase 3 trial.”
Roluperidone (MIN-101):
- Enrollment continues in the Phase 3 clinical trial
(ClinicalTrials.gov Identifier: NCT03397134) of roluperidone as
monotherapy for negative symptoms in patients diagnosed with
schizophrenia. This multicenter, randomized, double-blind,
parallel-group, placebo-controlled, 12-week trial is being followed
by a 40-week, open-label extension period. Approximately 500
patients are expected to be enrolled in the U.S. and Europe.
The Company expects completion of enrollment during the
first half of 2019 and top-line results from the 12-week, double
blind period in mid-2019.
- Results announced on November 19, 2018 from a dose escalation
study of roluperidone administered at supra-therapeutic doses in
healthy volunteers suggest an expanded therapeutic window and
significantly improved cardiovascular safety margin for the
drug. The data from this study also suggest the potential for
future testing of roluperidone in schizophrenic patients with an
exacerbation of psychosis at higher doses than those being used in
the Phase 3 trial.
- On August 22, 2018, pre-clinical findings with roluperidone
were announced, providing evidence of its effect on Brain-Derived
Neurotrophic Factor (BDNF). BDNF has been associated with
neurogenesis, neuroplasticity, neuroprotection, synapse regulation,
learning and memory. Its involvement in schizophrenia has
also been described. These findings, along with the
previously announced Phase 2b results with roluperidone, suggest
the potential of this compound to change the overall course of the
disease.
- On May 17, 2018, the Company announced that the Journal of
Clinical Psychiatry had published online results showing cognitive
improvements in patients with schizophrenia treated with
roluperidone. These improvements correlated with improvements
in negative symptoms. Currently available dopamine-blocking
antipsychotic drugs have little impact on cognitive impairment, and
these data suggest that roluperidone, which combines 5HT2A
and sigma2 antagonism without dopamine blockade, may improve
cognitive deficits in these patients.
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 major depressive disorder (MDD) and one in
insomnia disorder. Enrollment in the MDD trial designated as
the 2001 trial (ClinicalTrials.gov Identifier: NCT03227224) has
been completed, with 287 patients enrolled at sites in the U.S.,
Europe, Russia and Japan. The Company expects top-line
results in the second quarter of 2019.
- In the MDD trial designated as the 2002 trial
(ClinicalTrials.gov Identifier: NCT03321526), approximately 100
patients have been enrolled at clinical sites in the U.S. The
Company expects top-line results in mid-2019.
- The insomnia trial, designated as the 2005 trial,
(ClinicalTrials.gov Identifier: NCT03375203) is expected to enroll
approximately 360 patients at sites in the U.S., Europe and
Japan. The Company expects top-line results in
mid-2019.
MIN-117:
- Patients with MDD who also have symptoms of anxiety are being
enrolled in a Phase 2b trial of MIN-117 (ClinicalTrials.gov
Identifier: NCT03446846). A total of approximately 324
patients are expected to be enrolled at clinical sites in the U.S.
and Europe. The Company expects top-line results in the first
half of 2019.
- The Company expanded the patent estate for MIN-117 with the
filing of a U.S. patent application for the use of MIN-117 to treat
pain. The pre-clinical data supporting this application
suggest that this compound may be investigated beyond mood and
anxiety disorders to include chronic pain, which is often a symptom
of several neuro-psychiatric disorders.
Fourth Quarter and Year Ended 2018 Financial
Results
- Net (Loss) Income: Net loss was $13.2
million for the fourth quarter of 2018, or loss per share of $0.34
(basic and diluted), compared to net income of $0.2 million for the
fourth quarter of 2017, or income per share of $0.00 (basic and
diluted). Net loss was $50.2 million for the year ended
December 31, 2018, or loss per share of $1.29 (basic and diluted),
compared to a net loss of $31.5 million, or loss per share of $0.83
(basic and diluted) for the year ended December 31,
2017.
- R&D Expenses: Research and development
(R&D) expenses were $9.0 million in the fourth quarter of 2018,
compared to $6.5 million in the fourth quarter of 2017. R&D
expenses were $34.9 million for the year ended December 31,
2018, compared to $30.3 million for the year ended December 31,
2017. The increase in R&D expenses during the
fourth quarter and year ended December 31, 2018 primarily reflects
higher development expenses for the Phase 3 clinical trial of
roluperidone and the Phase 2b clinical trial of MIN-117. During the
year ended December 31, 2018, these amounts were partially offset
by lower development expenses for the seltorexant program due to
the Amendment to our Co-Development and License Agreement with
Janssen.
- G&A Expenses: General and administrative
(G&A) expenses were $4.6 million in the fourth quarter of 2018,
compared to $3.0 million in the fourth quarter of 2017.
G&A expenses were $16.8 million for the year ended December 31,
2018, compared to $10.9 million for the year ended December 31,
2017. 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
pre-commercial activities.
- Cash Position: Cash, cash equivalents,
restricted cash and marketable securities as of December 31, 2018
were approximately $88.1 million, compared to $133.2 million as of
December 31, 2017. 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 routinely evaluated and may be subject to change.
Conference Call Information:
Minerva Neurosciences will host a conference call and live audio
webcast today at 8:30 a.m. Eastern Time to discuss these results
and recent business activities. To participate, please dial
(877) 312-5845 (domestic) or (765) 507-2618 (international) and
refer to conference ID 4598906.
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 Phase 3 clinical development for
schizophrenia; seltorexant (MIN-202 or JNJ-42847922) in Phase 2b
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-K for the year ended December 31, 2018, filed with
the Securities and Exchange Commission on March 12,
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) |
|
December 31, |
December 31, |
|
2018 |
|
|
2017 |
|
|
(in thousands) |
ASSETS |
Current Assets: |
|
|
Cash and cash equivalents |
$ |
50,235 |
|
$ |
26,052 |
|
Marketable securities |
|
37,763 |
|
|
102,109 |
|
Restricted cash |
|
100 |
|
|
80 |
|
Prepaid expenses and other current assets |
|
1,921 |
|
|
1,299 |
|
Total current assets |
|
90,019 |
|
|
129,540 |
|
Marketable securities - noncurrent |
|
- |
|
|
5,023 |
|
Equipment, net |
|
33 |
|
|
51 |
|
Other noncurrent assets |
|
15 |
|
|
15 |
|
In-process research and development |
|
34,200 |
|
|
34,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
139,136 |
|
$ |
183,698 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
Current Liabilities: |
|
|
Notes payable |
$ |
- |
|
$ |
3,962 |
|
Accounts payable |
|
1,799 |
|
|
1,436 |
|
Accrued expenses and other current liabilities |
|
1,810 |
|
|
1,439 |
|
Total current liabilities |
|
3,609 |
|
|
6,837 |
|
Long-Term Liabilities: |
|
|
Deferred taxes |
|
4,057 |
|
|
4,057 |
|
Deferred revenue |
|
41,176 |
|
|
41,176 |
|
Other noncurrent liabilities |
|
29 |
|
|
30 |
|
Total liabilities |
|
48,871 |
|
|
52,100 |
|
Stockholders' Equity: |
|
|
Common stock |
|
4 |
|
|
4 |
|
Additional paid-in capital |
|
304,814 |
|
|
295,975 |
|
Accumulated deficit |
|
(214,553 |
) |
|
(164,381 |
) |
Total stockholders' equity |
|
90,265 |
|
|
131,598 |
|
Total Liabilities and Stockholders' Equity |
$ |
139,136 |
|
$ |
183,698 |
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
|
(Unaudited) |
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
2018 |
|
|
2017 |
|
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
9,008 |
|
|
6,541 |
|
|
|
34,889 |
|
|
30,256 |
|
General and administrative |
|
4,620 |
|
|
2,991 |
|
|
|
16,841 |
|
|
10,914 |
|
Total operating expenses |
|
13,628 |
|
|
9,532 |
|
|
|
51,730 |
|
|
41,170 |
|
|
|
|
|
|
|
Foreign exchange losses |
|
(5 |
) |
|
(11 |
) |
|
|
(5 |
) |
|
(57 |
) |
Investment income |
|
430 |
|
|
434 |
|
|
|
1,674 |
|
|
942 |
|
Interest expense |
|
- |
|
|
(105 |
) |
|
|
(110 |
) |
|
(614 |
) |
Loss before income taxes |
|
(13,203 |
) |
|
(9,214 |
) |
|
|
(50,171 |
) |
|
(40,899 |
) |
Benefit for income taxes |
|
- |
|
|
(9,376 |
) |
|
|
- |
|
|
(9,376 |
) |
Net (loss) income |
$ |
(13,203 |
) |
$ |
162 |
|
|
$ |
(50,171 |
) |
$ |
(31,523 |
) |
Loss per share: |
|
|
|
|
|
Basic and diluted |
$ |
(0.34 |
) |
$ |
0.00 |
|
|
$ |
(1.29 |
) |
$ |
(0.83 |
) |
Weighted average shares: |
|
|
|
|
|
Basic and diluted |
|
38,888 |
|
|
38,710 |
|
|
|
38,793 |
|
|
37,937 |
|
|
|
|
|
|
|
Contact:
William B. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
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