Minerva Neurosciences Reports Third Quarter 2019 Financial Results and Business Updates
November 04 2019 - 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, 2019.
Clinical program updates
Roluperidone
The Company is currently enrolling patients in the U.S. and
Europe into a Phase 3 trial of roluperidone for the treatment of
negative symptoms in schizophrenia. The Company expects to complete
patient enrollment at approximately year-end 2019, and top line
results from the 12-week, double-blind part of the trial are
expected to be available in the first half of 2020. Following
the most recent meeting of the Data Safety Monitoring Board (DSMB)
in July, the DSMB recommended continuation of the study with no
changes to the protocol.
This trial is a multicenter, randomized, double-blind, parallel
group, placebo-controlled, 12-week trial to evaluate the efficacy
and safety of 32 mg and 64 mg doses of roluperidone as measured by
the Positive and Negative Syndrome Scale (PANSS) Marder negative
symptoms factor score. The core 12-week study is followed by
a 40-week, open-label extension period during which patients on the
drug continue receiving their original dose and patients on placebo
receive one of the two doses of roluperidone.
In September, 2019, the Company entered into a long-term
commercial supply agreement with Catalent under which Catalent will
manufacture and package the finished dose form of the drug.
The Company is working with Catalent to enable the tech transfer
from pilot to commercial-scale production.
MIN-117
Enrollment has been completed in a Phase 2b trial of MIN-117 in
the U.S. and Europe, with a total of 360 adult patients enrolled
with moderate or severe major depressive disorder (MDD) with
anxious distress and without psychotic features. The Company
expects top-line results from this trial in the fourth quarter of
2019.
This trial is a 6-week, 3-arm, randomized, double-blind,
placebo-controlled study to investigate the safety and efficacy of
MIN-117. The primary efficacy endpoint is the change in the
Montgomery-Asberg Depression Rating Scale (MADRS) total score from
baseline (the start of double-blind treatment) to the end of the
double-blind treatment period (week 6), and the key secondary
endpoint is the change in the Hamilton-Anxiety Rating Scale (HAM-A)
over the same period.
Seltorexant
During 2019, the Company completed and announced top-line
results from three Phase 2b trials and one Phase 1b trial with
seltorexant (MIN-202). Three of these trials were in MDD and
one was in insomnia disorder.
Key conclusions following data analyses from these trials
include the following.
- Seltorexant shows clinically meaningful and consistent
improvements in mood and sleep symptoms.
- In depressed patients, seltorexant shows improvement in mood as
monotherapy and as add-on therapy to SSRIs or SNRIs, and its effect
on mood is stronger in patients with insomnia.
- Among the doses of seltorexant tested, 20 mg shows the most
robust and consistent effect on mood.
- In both adult and elderly subjects, seltorexant improves both
sleep induction and sleep maintenance compared to zolpidem.
- Seltorexant shows a safety and tolerability profile similar to
placebo.
These findings are expected to help define a Phase 3 clinical
development program for seltorexant that potentially will encompass
both MDD and insomnia.
Third Quarter 2019 Financial Results
- Cash Position: Cash, cash equivalents,
marketable securities and restricted cash as of September 30, 2019
were approximately $60.0 million, compared to $88.1 million as of
December 31, 2018.
- R&D Expenses: Research and development
(R&D) expenses for the three and nine months ended September
30, 2019 were $9.7 million and $29.6 million, respectively,
compared to $8.4 million and $25.9 million for the same periods in
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.
- G&A Expenses: General and administrative
(G&A) expenses for the three and nine months ended September
30, 2019 were $4.6 million and $13.9 million, respectively,
compared to $4.1 million and $12.2 million for the same periods in
2018. The increase in G&A expenses during the three-month
period was primarily due to higher professional fees to support
pre-commercial activities. The increase in G&A expenses during
the nine-month period was primarily due to an increase in non-cash
stock-based compensation expenses, increased salary costs and
professional fees to support pre-commercial activities.
- Net Loss: The Company reported a net loss for
the three and nine months ended September 30, 2019 of $14.0 million
and $42.3 million respectively, or $0.36 and $1.08 per share,
respectively, compared to $12.0 million and $37.0 million,
respectively, or $0.31and $0.95 per share, respectively, for the
same period in 2018.
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 5277094.
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;
MIN-117, in clinical development for major depressive disorder
(MDD); seltorexant (MIN-202 or 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
scope of future clinical trials and results of clinical trials with
roluperidone, seltorexant, MIN-117 and MIN-301; 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 Quarterly Report on Form 10-Q for the quarter
ended September 30, 2019, filed with the Securities and
Exchange Commission on November 4, 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) |
|
|
|
September 30, |
|
December 31, |
|
|
2019 |
|
2018 |
|
|
(in thousands) |
|
ASSETS |
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
$ |
37,906 |
|
$ |
50,235 |
|
Marketable securities |
22,027 |
|
37,763 |
|
Restricted cash |
100 |
|
100 |
|
Prepaid expenses and other current assets |
1,377 |
|
1,921 |
|
Total current assets |
61,410 |
|
90,019 |
|
Equipment, net |
20 |
|
33 |
|
Other noncurrent assets |
15 |
|
15 |
|
Operating lease right-of-use assets |
299 |
|
- |
|
In-process research and development |
34,200 |
|
34,200 |
|
Goodwill |
14,869 |
|
14,869 |
|
Total Assets |
$ |
110,813 |
|
$ |
139,136 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
$ |
5,330 |
|
$ |
1,799 |
|
Accrued expenses and other current liabilities |
4,398 |
|
1,810 |
|
Operating leases |
167 |
|
- |
|
Total current liabilities |
9,895 |
|
3,609 |
|
Long-Term Liabilities: |
|
|
|
|
Deferred taxes |
4,057 |
|
4,057 |
|
Deferred revenue |
41,176 |
|
41,176 |
|
Other noncurrent liabilities |
- |
|
29 |
|
Noncurrent operating leases |
157 |
|
- |
|
Total liabilities |
55,285 |
|
48,871 |
|
Stockholders' Equity: |
|
|
|
|
Common stock |
4 |
|
4 |
|
Additional paid-in capital |
312,342 |
|
304,814 |
|
Accumulated deficit |
(256,818 |
) |
(214,553 |
) |
Total stockholders' equity |
55,528 |
|
90,265 |
|
Total Liabilities and Stockholders' Equity |
$ |
110,813 |
|
$ |
139,136 |
|
|
|
|
|
|
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) |
|
|
|
|
|
|
|
|
2019 |
|
2018 |
|
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
9,674 |
|
8,369 |
|
|
29,600 |
|
25,881 |
|
General and administrative |
4,608 |
|
4,055 |
|
|
13,898 |
|
12,221 |
|
Total operating expenses |
14,282 |
|
12,424 |
|
|
43,498 |
|
38,102 |
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange losses |
(5 |
) |
(11 |
) |
|
(18 |
) |
- |
|
Investment income |
325 |
|
418 |
|
|
1,250 |
|
1,244 |
|
Interest expense |
- |
|
(4 |
) |
|
- |
|
(110 |
) |
Loss before income taxes |
(13,962 |
) |
(12,021 |
) |
|
(42,266 |
) |
(36,968 |
) |
Benefit for income taxes |
- |
|
- |
|
|
- |
|
- |
|
Net (loss) income |
$ |
(13,962 |
) |
$ |
(12,021 |
) |
|
$ |
(42,266 |
) |
$ |
(36,968 |
) |
Loss per share: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.36 |
) |
$ |
(0.31 |
) |
|
$ |
(1.08 |
) |
$ |
(0.95 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
39,025 |
|
38,782 |
|
|
39,007 |
|
38,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact:
William B. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc. (617) 600-7376
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