Minerva Neurosciences Reports Fiscal 2019 Fourth Quarter and Year End Financial Results and Business Updates
March 09 2020 - 7:30AM
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,
2019.
Clinical Program Updates
Roluperidone
The Company is pleased to confirm its previous guidance that
top-line results from the Phase 3 trial with roluperidone are
expected in the second quarter of 2020. As announced in
February, enrollment of 515 patients has been achieved in the
12-week core phase of a pivotal trial for the treatment of negative
symptoms, the leading unmet medical need in schizophrenia.
This trial is a multicenter, randomized, double-blind,
parallel-group, placebo-controlled, 12-week trial to evaluate the
efficacy and safety of 32 milligram (mg) and 64 mg doses of
roluperidone as measured by the Positive and Negative Syndrome
Scale. The primary endpoint is the Marder negative symptoms factor
score. The core 12-week study, which the Company expects to
read out in the second quarter, will be followed by an optional
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.
Seltorexant
The Company announced positive data readouts in 3 Phase 2b
studies and one Phase 1b trial with seltorexant (MIN-202) during
2019. Three of these trials were in major depressive disorder
(MDD) and one was in insomnia disorder.
The Company is currently in discussions with its partner,
Janssen Pharmaceutica NV, regarding the Phase 3 strategic
development program for seltorexant, with a target indication of
adjunctive treatment of MDD (aMDD) in patients with insomnia
symptoms. The Company and Janssen are also currently consulting
with the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency about this target indication and these trials, and
they have recently attended the end-of-Phase 2 meeting with FDA to
discuss the design of Phase 3 studies.
MIN-301
The Company is developing MIN-301, a pre-clinical candidate for
the potential treatment of Parkinson’s disease and other
neurodegenerative disorders. Building upon positive data in
non-primate pre-clinical models, the Company is continuing to
conduct pre-clinical studies in preparation for regulatory filings
leading toward entry into humans.
“We are on track to read out top-line results of the
roluperidone Phase 3 study in the second quarter of 2020,” said Dr.
Remy Luthringer, Executive Chairman and Chief Executive Officer of
Minerva, “and we continue to expand our understanding of this
exciting agent as a treatment for negative symptoms in
schizophrenia and beyond. In parallel, we are in discussions with
Janssen about moving forward into Phase 3 with seltorexant in
2020.”
Fourth Quarter and Year Ended 2019 Financial
Results
- Net (Loss) Income: Net loss was $29.9
million for the fourth quarter of 2019, or loss per share of $0.77
(basic and diluted), compared to net loss of $13.2 million for the
fourth quarter of 2018, or loss per share of $0.34 (basic and
diluted). Net loss was $72.2 million for the year ended
December 31, 2019, or loss per share of $1.85 (basic and diluted),
compared to a net loss of $50.2 million, or loss per share of $1.29
(basic and diluted) for the year ended December 31,
2018.
- R&D Expenses: Research and development
(R&D) expenses were $28.5 million in the fourth quarter of
2019, compared to $9.0 million in the fourth quarter of 2018.
R&D expenses were $58.1 million for the year ended December 31,
2019, compared to $34.9 million for the year ended December 31,
2018. The increase in R&D expenses during the
fourth quarter and year ended December 31, 2019 primarily reflects
a $19.0 million non-cash impairment expense for the discontinued
development of MIN-117 and 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 were $3.8 million in the fourth quarter of 2019,
compared to $4.6 million in the fourth quarter of 2018.
G&A expenses were $17.7 million for the year ended December 31,
2019, compared to $16.8 million for the year ended December 31,
2018. This increase in G&A expenses during the
fourth quarter and year ended December 31, 2019 was primarily due
to an increase in non-cash stock-based compensation expenses and
higher professional fees to support pre-commercial
activities.
- Cash Position: Cash, cash equivalents,
restricted cash and marketable securities as of December 31, 2019
were approximately $46.0 million, compared to $88.1 million as of
December 31, 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 these results
and recent business activities. To participate, please dial
(877) 312-5845 (domestic) or (765) 507-2618 (international) and
refer to conference ID 7176196.
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’s proprietary compounds include: roluperidone (MIN-101),
in clinical development for schizophrenia; 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 (MIN-101), seltorexant (MIN-202) 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 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, 2019, filed with the Securities and
Exchange Commission on March 9, 2020. 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.
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CONDENSED CONSOLIDATED BALANCE SHEET DATA |
|
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(Unaudited) |
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December 31, |
|
December 31, |
|
2019 |
|
2018 |
|
(in thousands) |
ASSETS |
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Current Assets: |
|
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|
|
|
Cash and cash equivalents |
$ |
21,413 |
|
$ |
50,235 |
|
Marketable securities |
|
24,442 |
|
|
37,763 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Prepaid expenses and other current assets |
|
1,182 |
|
|
1,921 |
|
Total current assets |
|
47,137 |
|
|
90,019 |
|
Equipment, net |
|
16 |
|
|
33 |
|
Other noncurrent assets |
|
15 |
|
|
15 |
|
Operating lease right-of-use assets |
|
262 |
|
|
- |
|
In-process research and development |
|
15,200 |
|
|
34,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
77,499 |
|
$ |
139,136 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current Liabilities: |
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Accounts payable |
$ |
2,317 |
|
$ |
1,799 |
|
Accrued expenses and other current liabilities |
|
4,139 |
|
|
1,810 |
|
Operating leases |
|
173 |
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|
- |
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Total current liabilities |
|
6,629 |
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|
3,609 |
|
Long-Term Liabilities: |
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|
|
|
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Deferred taxes |
|
1,803 |
|
|
4,057 |
|
Deferred revenue |
|
41,176 |
|
|
41,176 |
|
Other noncurrent liabilities |
|
- |
|
|
29 |
|
Noncurrent operating leases |
|
111 |
|
|
- |
|
Total liabilities |
|
49,719 |
|
|
48,871 |
|
Stockholders' Equity: |
|
|
|
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Common stock |
|
4 |
|
|
4 |
|
Additional paid-in capital |
|
314,512 |
|
|
304,814 |
|
Accumulated deficit |
|
(286,736 |
) |
|
(214,553 |
) |
Total stockholders' equity |
|
27,780 |
|
|
90,265 |
|
Total Liabilities and Stockholders' Equity |
$ |
77,499 |
|
$ |
139,136 |
|
|
|
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CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
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(Unaudited) |
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Three Months Ended December 31, |
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Twelve Months Ended December 31 |
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(in thousands, except per share amounts) |
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(in thousands, except per share amounts) |
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2019 |
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2018 |
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2019 |
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2018 |
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Revenues |
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
28,524 |
|
|
9,008 |
|
|
|
58,123 |
|
|
34,889 |
|
General and administrative |
|
3,843 |
|
|
4,620 |
|
|
|
17,741 |
|
|
16,841 |
|
Total operating expenses |
|
32,367 |
|
|
13,628 |
|
|
|
75,864 |
|
|
51,730 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange losses |
|
(11 |
) |
|
(5 |
) |
|
|
(29 |
) |
|
(5 |
) |
Investment income |
|
206 |
|
|
430 |
|
|
|
1,456 |
|
|
1,674 |
|
Interest expense |
|
- |
|
|
- |
|
|
|
- |
|
|
(110 |
) |
Loss before income taxes |
|
(32,172 |
) |
|
(13,203 |
) |
|
|
(74,437 |
) |
|
(50,171 |
) |
Benefit for income taxes |
|
(2,254 |
) |
|
- |
|
|
|
(2,254 |
) |
|
- |
|
Net (loss) income |
$ |
(29,918 |
) |
$ |
(13,203 |
) |
|
$ |
(72,183 |
) |
$ |
(50,171 |
) |
Loss per share: |
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|
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|
|
|
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Basic and diluted |
$ |
(0.77 |
) |
$ |
(0.34 |
) |
|
$ |
(1.85 |
) |
$ |
(1.29 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
39,037 |
|
|
38,888 |
|
|
|
39,014 |
|
|
38,793 |
|
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Contact:
William B. BoniVP, Investor Relations/Corp.
CommunicationsMinerva Neurosciences, Inc.(617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
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