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 June
30, 2019.
“In the first half of 2019, we presented positive data from two
Phase 2b clinical trials with seltorexant,” said Dr. Remy
Luthringer, Executive Chairman and Chief Executive Officer of
Minerva. “In addition, in a recent biomarker study with
seltorexant, we demonstrated mood improvements in MDD patients when
seltorexant was given as monotherapy. Taken together, the
data from these studies point to the unique ability of seltorexant
to address unmet medical needs in both depression and insomnia as
an adjunctive treatment or in monotherapy.”
Key data reported in the Second Quarter and today include:
- Statistically significant and clinically meaningful improvement
in symptoms of depression in MDD patients not responding adequately
to first line anti-depressant therapies (MDD2001);
- Statistically significant and clinically meaningful improvement
in symptoms of depression in MDD patients treated with seltorexant
administered as monotherapy (MDD1009);
- In both studies the improvement in mood was greater in patients
with associated insomnia;
- Statistically significant and clinically meaningful effect in
adult and elderly patients suffering from insomnia, with a
favorable tolerability profile (ISM2005);
- Primary and multiple secondary endpoints were also improved
versus zolpidem (ISM2005).
Clinical Pipeline Update
Seltorexant
Seltorexant is a novel, oral, investigational highly selective
Orexin-2 antagonist that is currently being evaluated in
major depressive disorder (MDD) and insomnia. Minerva is
co-developing seltorexant with Janssen Pharmaceutica NV
(Janssen).
- Study MDD1009: The Company recently analyzed data from an
exploratory, biomarker, multicenter, placebo-controlled,
randomized, double-blind Phase 1b trial of seltorexant,
administered at doses of 20 and 40 milligrams (mg) as monotherapy
in 128 subjects with moderate to severe MDD. The primary objective
of this study was to analyze the treatment effect of seltorexant
versus placebo on symptoms of depression as measured by the
Hamilton Rating Scale for Depression (HDRS17) . The presence
of subjective sleep disturbance (subjective sleep assessment,
Insomnia Severity Index (ISI), and Ruminative Response Scale [RRS])
as a possible indicator of hyper-arousal was used as a
stratification factor in patient randomization.The primary endpoint
analysis showed a significant treatment effect at week 5 for
seltorexant versus placebo. The efficacy signal for the 20 mg
dose was statistically significant (p=0.0049) and more pronounced
in the MDD population with sleep disorder, measured as having an
ISI >15 and subjective sleep onset latency >30 min during at
least 3 nights over 7 recorded days and in MDD patients with higher
rumination (RRS ≥ 50).Seltorexant 40 mg dose did not show a
statistically significant effect at week 5, although the efficacy
signal was also more pronounced in the subgroups (MDD patients with
presence of subjective sleep disorder, ISI >15 or RRS ≥50).These
new findings show that seltorexant administered as monotherapy
improves depressive symptoms and that the improvement is more
pronounced when patients present with insomnia. Importantly,
they also support the relationship between mood disorders,
insomnia, hyper-arousal, clinical efficacy and the mechanism of
action of seltorexant.
- Study MDD2001: On May 13, 2019, Minerva announced positive top
line results from a Phase 2b clinical trial of seltorexant as
adjunctive therapy to antidepressants in adult patients with MDD
who are not responding adequately to selective serotonin reuptake
inhibitors (SSRIs) and/or serotonin-norepinephrine reuptake
inhibitors (SNRIs).In this dose finding study, the 20 mg dose of
seltorexant showed a statistically significant improvement in the
Montgomery-Asberg Depression Rating Scale (MADRS) score compared to
placebo at week 6. Seltorexant was also observed to have even
greater improvement over placebo in patients with clinically
significant insomnia and a favorable tolerability profile.
- Study ISM2005: On June 24, 2019, the Company announced positive
top line results from a Phase 2b clinical trial of seltorexant in
patients with insomnia disorder that demonstrated highly
statistically significant and clinically meaningful improvement in
the primary endpoint, Latency to Persistent Sleep (LPS) at Night 1
after treatment with 10 and 20 mg doses of seltorexant.In addition
to the primary endpoint, multiple secondary endpoints were improved
with seltorexant versus placebo and standard of care zolpidem,
available under the brand name Ambien. Furthermore, the
beneficial effects of seltorexant on elderly patients, in
conjunction with a favorable safety profile, suggest its potential
benefit in the large and growing population of elderly patients
whose prevalence of insomnia is higher than in younger
patients.
Roluperidone
Roluperidone is a novel, oral, investigational 5-HT2A and Sigma2
receptor antagonist that is currently being evaluated in patients
diagnosed with schizophrenia presenting with negative symptoms.
Minerva is currently enrolling a pivotal Phase 3 clinical trial
of roluperidone (Study MIN-101C07) as monotherapy for negative
symptoms in patients diagnosed with schizophrenia. The trial
is a multicenter, randomized, double-blind, parallel-group,
placebo-controlled, 12-week study to evaluate the efficacy and
safety of 32 mg and 64 mg of roluperidone in adult patients with
negative symptoms of schizophrenia. The 12-week study will be
followed by a 40-week, open-label extension period during which
patients on drug will continue receiving their original dose and
patients on placebo will receive either 32 mg or 64 mg of
roluperidone.
The 500 patients expected to be enrolled in this trial at
clinical sites in the U.S. and Europe will be initially randomized
equally to receive one of the two doses of roluperidone or placebo
for 12 weeks. Thereafter, all patients will continue
treatment with roluperidone for the 40-week extension period.
Top-line results from the 12-week double blind phase of this trial
are expected in the first half of 2019.
The primary endpoint of this trial will be improvement in
negative symptoms in patients treated with roluperidone compared to
placebo as measured by the change in the Positive and Negative
Syndrome Scale, or PANSS, Marder negative symptoms factor score, or
NSFS, over the 12-week double-blind treatment period. The key
secondary endpoint will be the effect of roluperidone compared to
placebo as measured by the Personal and Social Performance, or PSP,
total score over the same period. Additional secondary
endpoints will be the effect of roluperidone compared to placebo on
the Clinical Global Impression of Severity, or CGI-S, score and
safety and tolerability.
MIN-117
MIN-117 is a novel, oral, investigational drug with a multimodal
mechanism of action in development for the treatment of MDD and
specifically for patients suffering with MDD and anxiety.
Minerva is currently enrolling a Phase 2b trial in MDD in the
U.S. and Europe. The primary objective of the trial is to evaluate
the efficacy of two fixed doses of MIN-117, 5.0 mg and 2.5 mg,
compared with placebo in reducing the symptoms of major depression
as measured by the change in the MADRS total score over six weeks
of treatment. Secondary objectives include: (1) assessment of
the change from baseline in symptoms of anxiety using the Hamilton
Anxiety Scale (HAM-A); (2) the change in severity of illness using
the CGI-S and the Clinical Global Impression of Improvement Scale
(CGI-I); and (3) safety over six weeks of treatment.
Approximately 324 patients are expected to be enrolled at
approximately 40 sites in the U.S. and Europe. Patients will
be randomized to one of three arms, including placebo and the two
dosage arms, in a 2:1:1 ratio, resulting in approximately 162
patients in the placebo group and 81 patients in each of the two
MIN-117 treatment groups.
Second Quarter 2019 Financial Results
- Cash Position: Cash, cash equivalents,
restricted cash and marketable securities as of June 30, 2019 were
approximately $69.4 million, compared to $88.1 million as of
December 31, 2018.
- R&D Expenses: Research and development
(R&D) expenses were $8.3 million in the second quarter of 2019,
compared to $9.1 million in the second quarter of 2018, a decrease
of $0.8 million. This decrease primarily reflects decreased
non-clinical and clinical pharmacology expenses, partially offset
by increased costs for the Phase 3 clinical trial of roluperidone
and the Phase 2b clinical trial of MIN-117.For the six months ended
June 30, 2019, R&D expenses were $19.9 million, compared to
$17.5 million for the six months ended June 30, 2018, an increase
of $2.4 million. This increase primarily reflects higher
development expenses for the Phase 3 clinical trial of roluperidone
and the Phase 2b clinical trial of MIN-117.The Company expects
R&D expenses to increase during 2019 associated with patient
enrollment and related support activities for the roluperidone and
MIN-117 clinical trials.
- G&A Expenses: General and administrative
(G&A) expenses were $4.6 million in the second quarter of 2019,
compared to $3.9 million in the second quarter of 2018, an increase
of approximately $0.7 million. For the six months ended June 30,
2019, G&A expenses were $9.3 million, compared to $8.2 million
for the same period in 2018, an increase of approximately $1.1
million. These increases in G&A expenses were primarily
due to an increase in non-cash stock-based compensation expenses
and salary costs from increased staffing to support pre-commercial
activities. The Company expects G&A expenses to increase
during 2019 as it prepares for the transition of roluperidone from
clinical development to commercialization.
- Net Loss: Net loss was $12.5 million for the
second quarter of 2019, or a loss per share of $0.32 (basic and
diluted), as compared to a net loss of $12.5 million, or a loss per
share of $0.32 (basic and diluted) for the second quarter of
2018. Net loss was $28.3 million for the first six months of
2019, or a loss per share of $0.73 (basic and diluted), as compared
to a net loss of $24.9 million, or a loss per share of $0.64 (basic
and diluted) for the first six months of 2018.
Anticipated Clinical Milestones
Roluperidone: Phase 3 trial to treat negative symptoms in
patients diagnosed with schizophrenia (monotherapy); completion of
enrollment in this trial is expected during the second half of
2019, with top line results from the 12-week double blind phase of
this trial expected in the fourth quarter of 2019.
Seltorexant: Phase 2 positive-controlled MDD2002 trial to treat
patients with MDD (adjunctive therapy); enrollment has been
completed, with top-line results expected in the third quarter of
2019.
MIN-117: Phase 2b trial to treat patients with MDD who also have
symptoms of anxiety (monotherapy); completion of enrollment in this
trial is expected in the third quarter of 2019, with top-line
results expected in the fourth quarter of 2019.
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 7559419.
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 Annual Report on
Form 10-Q for the quarter ended June 30, 2019, filed with
the Securities and Exchange Commission on August 5,
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) |
|
June 30, |
December 31, |
2019 |
2018 |
|
(in thousands) |
ASSETS |
Current Assets: |
|
|
Cash and cash equivalents |
$ |
27,845 |
|
$ |
50,235 |
|
Marketable securities |
|
41,449 |
|
|
37,763 |
|
Restricted cash |
|
100 |
|
|
100 |
|
Prepaid expenses and other current assets |
|
1,453 |
|
|
1,921 |
|
Total current assets |
|
70,847 |
|
|
90,019 |
|
Marketable securities - noncurrent |
|
- |
|
|
- |
|
Equipment, net |
|
25 |
|
|
33 |
|
Other noncurrent assets |
|
15 |
|
|
15 |
|
Operating lease right-of-use assets |
|
336 |
|
|
- |
|
In-process research and development |
|
34,200 |
|
|
34,200 |
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
Total Assets |
$ |
120,292 |
|
$ |
139,136 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
Current Liabilities: |
|
|
Notes payable |
$ |
- |
|
$ |
- |
|
Accounts payable |
|
2,941 |
|
|
1,799 |
|
Accrued expenses and other current liabilities |
|
4,486 |
|
|
1,810 |
|
Operating leases |
|
162 |
|
|
- |
|
Total current liabilities |
|
7,589 |
|
|
3,609 |
|
Long-Term Liabilities: |
|
|
Deferred taxes |
|
4,057 |
|
|
4,057 |
|
Deferred revenue |
|
41,176 |
|
|
41,176 |
|
Other noncurrent liabilities |
|
- |
|
|
29 |
|
Noncurrent operating leases |
|
201 |
|
|
- |
|
Total liabilities |
|
53,023 |
|
|
48,871 |
|
Stockholders' Equity: |
|
|
Common stock |
|
4 |
|
|
4 |
|
Additional paid-in capital |
|
310,121 |
|
|
304,814 |
|
Accumulated deficit |
|
(242,856 |
) |
|
(214,553 |
) |
Total stockholders' equity |
|
67,269 |
|
|
90,265 |
|
Total Liabilities and Stockholders' Equity |
$ |
120,292 |
|
$ |
139,136 |
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
2019 |
2018 |
|
2019 |
2018 |
|
|
|
|
|
|
|
Revenues |
|
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
8,320 |
|
|
9,062 |
|
|
|
19,926 |
|
|
17,512 |
|
General and administrative |
|
|
4,584 |
|
|
3,873 |
|
|
|
9,290 |
|
|
8,167 |
|
Total operating expenses |
|
|
12,904 |
|
|
12,935 |
|
|
|
29,216 |
|
|
25,679 |
|
|
|
|
|
|
|
|
Foreign exchange losses |
|
|
(7 |
) |
|
29 |
|
|
|
(13 |
) |
|
11 |
|
Investment income |
|
|
434 |
|
|
412 |
|
|
|
925 |
|
|
826 |
|
Interest expense |
|
|
- |
|
|
(36 |
) |
|
|
- |
|
|
(106 |
) |
Loss before income taxes |
|
|
(12,477 |
) |
|
(12,530 |
) |
|
|
(28,304 |
) |
|
(24,948 |
) |
Benefit for income taxes |
|
|
- |
|
|
- |
|
|
|
- |
|
|
- |
|
Net (loss) income |
|
$ |
(12,477 |
) |
$ |
(12,530 |
) |
|
$ |
(28,304 |
) |
$ |
(24,948 |
) |
Loss per share: |
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.32 |
) |
$ |
(0.32 |
) |
|
$ |
(0.73 |
) |
$ |
(0.64 |
) |
Weighted average shares: |
|
|
|
|
|
|
Basic and diluted |
|
|
39,025 |
|
|
38,749 |
|
|
|
38,997 |
|
|
38,749 |
|
|
|
|
|
|
|
|
Contact:William B. BoniVP, Investor
Relations/Corp. CommunicationsMinerva Neurosciences, Inc.(617)
600-7376
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