Bli medlem
Bli medlem

Du är här

2016-03-14

Minerva Neurosciences Reports Fiscal 2015 Fourth Quarter and Year End Financial Results and Business Updates

Minerva Neurosciences, Inc.
Press release

Minerva Neurosciences Reports Fiscal 2015 Fourth Quarter and Year End Financial
Results and Business Updates

Clinical trial advancements during 2015 support multiple top line data readouts
in first half of 2016

Management to host conference call today at 8:30 a.m. Eastern Time

WALTHAM, Mass., 2016-03-14 12:30 CET (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,
2015.

“Minerva is positioned to deliver a series of significant clinical milestones
during the first half of 2016 with three first-in-class compounds to treat
schizophrenia (MIN-101), primary insomnia (MIN-202), comorbid insomnia in
patients suffering from major depressive disorder, or MDD, (MIN-202), and MDD
(MIN-117),” said Dr. Remy Luthringer, president and chief executive officer of
Minerva.

MIN-101:

-- The Company has completed enrollment of 244 patients in its ongoing Phase
IIb, double-blind, placebo controlled trial testing MIN-101, a
first-in-class 5-HT2a and sigma2 antagonist for the treatment of
schizophrenia. The primary objective of this trial is to evaluate the
efficacy of MIN-101 given at once-a-day doses of 32 and 64 milligrams (mg)
in the morning compared to placebo in improving the negative symptoms of
schizophrenic patients over 12 weeks of treatment, as measured by the
change from baseline in the Positive and Negative Syndrome Scale (PANSS).
Secondary objectives include assessment of the effect of MIN-101 on the
total PANSS score and sub-scores, cognition and sleep. Safety and
tolerability of the drug will also be monitored. Patients who respond
positively to treatment during the 12-week double-blind period of the trial
have the opportunity to enter an extension period of six months, during
which all patients will be on active treatment. Top line results for the
core 12-week treatment evaluation period are expected in the second quarter
of 2016.
-- The U.S. Food and Drug Administration (FDA) has accepted the Company’s
Investigational New Drug (IND) application for MIN-101. Acceptance of the
IND for MIN-101 supports the initiation of clinical testing of this
compound in the U.S.

MIN-202 (JNJ-42847922), under joint development with Janssen Pharmaceutica NV
(Janssen):

-- MIN-202, a selective orexin-2 receptor antagonist, has been evaluated in
three clinical trials, including a Phase IIa trial in insomnia disorder
conducted in the U.S. and Europe, a Phase Ib trial as an adjunctive
treatment to marketed antidepressants in patients suffering from MDD with
insomnia as a comorbid symptom conducted in Europe, and a Phase I trial in
healthy Japanese men.
-- The Phase IIa trial in patients suffering from insomnia disorder without
psychiatric comorbidity was a randomized, placebo-controlled double-blind,
two way cross-over study to evaluate treatment with MIN-202 (40 mg daily
given in the evening for five consecutive days) versus placebo in 28 study
participants. Patients treated with MIN-202 were observed to have
statistically significant improvements, as compared to placebo, in all key
sleep parameters assessing sleep induction and sleep maintenance. These
parameters, measured by objective polysomnography, include sleep efficiency
(SE), the primary endpoint of the trial, for which a positive and
statistically significant efficacy signal was detected versus placebo
(p<0.001). Additional statistically significant positive efficacy
signals were observed for key secondary parameters, including latency to
persistent sleep (LPS), wake after sleep onset (WASO), and total sleep time
(TST). MIN-202 did not affect deep sleep, an important sleep stage
affecting physiological functions such as memory consolidation. Compared to
placebo, MIN-202 was observed to significantly improve polysomnography
parameters (p<0.001) on Days 1 and 5. On Day 5, LPS and WASO were
reduced by 23.2 and 11 minutes and TST and SE increased by 39 minutes and
8.12 percent, respectively. No serious adverse events were observed in this
trial, and preliminary data indicate that MIN-202 was well tolerated by
patients.
-- The Phase Ib trial was a randomized, double-blind, parallel group, positive
diphenhydramine and placebo-controlled study to evaluate treatment with
MIN-202 in 48 subjects with a diagnosis of MDD and treated with marketed
antidepressants. The treatment duration was one month. Safety and
tolerability, as well as effects on mood, cognition and stress hormone
levels, were assessed. Consistently greater improvements in depressive
symptomatology were observed in patients randomized to receive MIN-202
compared to those randomized to receive placebo (PLA) or diphenhydramine
(DPH), as measured by clinician administered rating scales, including the
Hamilton Depression Rating Scale (HDRS17). Core symptoms of depression (as
measured by the HAM-D6) were observed to be significantly improved in the
MIN-202 arm when compared with the PLA arm. MIN-202 was observed to be well
tolerated by study participants over a one-month treatment duration, with
no new emerging safety signals and no serious adverse events.
-- The Phase I trial in 24 healthy Japanese adult male study participants was
a single center, double blind, placebo-controlled randomized single
ascending dose study to investigate the safety, tolerability and
pharmacokinetics of MIN-202. It was observed that single dose morning
administration of MIN-202 was well tolerated at 5 mg, 20 mg and 40 mg. The
observed plasma pharmacokinetic features were comparable to those observed
in previous studies carried out in healthy non-Asian study participants.
No clinically relevant safety concerns were observed based on the
assessment of multiple safety endpoints. Somnolence was the most
frequently reported adverse event at the two higher doses, an expected
finding as this compound is being developed as a treatment for patients
suffering from insomnia disorder and as adjunctive treatment for MDD.

MIN-117:

-- The Company has completed enrollment of patients with MDD in its ongoing
Phase IIa, double-blind, parallel group design, placebo- and
active-controlled clinical trial in Europe of MIN-117, a compound that
targets multiple receptors known to be involved in mood disorders.
Eighty-four patients were enrolled across the four treatment arms of this
study (0.5 and 2.5 mg daily of MIN-117, placebo, and 20 mg daily of
paroxetine). The primary endpoint of the trial is the efficacy of MIN-117
versus placebo in reducing the symptoms of a major depressive episode as
measured by the Montgomery-Asberg Depression Rating Scale over six weeks of
treatment. Secondary endpoints include assessments of onset of mood
improvement, cognition, sexual function and sleep. Top-line results are
expected in the second quarter of 2016.

MIN-301:

-- Following a non-human primate study showing that treatment with an analog
of MIN-301 improved a range of symptoms associated with a Parkinson’s
disease model, the Company is pursuing the pre-clinical development of this
compound, which is the extra-cellular domain of neuregulin-1 beta primarily
activating Erb4. The next planned steps in this program are the filing of
an IND in the United States, 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 2015 Financial Results

-- Net Loss: Net loss was $8.4 million for the fourth quarter of 2015, or a
loss per share of $0.34 (basic and diluted), compared to a net loss of $7.4
million for the fourth quarter of 2014, or a loss per share of $0.40 (basic
and diluted). Net loss was $27.1 million for the year ended December 31,
2015, or a loss per share of $1.16 (basic and diluted), compared to a net
loss of $56.9 million, or a loss per share of $4.47 (basic and diluted),
for the year ended December 31, 2014.
-- R&D Expenses: Research and development (R&D) expenses were $6.3
million in the fourth quarter of 2015, compared to $3.0 million in the
fourth quarter of 2014. R&D expenses were $18.5 million for the year
ended December 31, 2015, compared to $42.9 million for the year ended
December 31, 2014. R&D expenses for the year ended December 31, 2014
included a $22.0 million license fee paid to Janssen pursuant to our
co-development agreement for MIN-202. R&D expenses for the years ended
December 31, 2015 and 2014 included non-cash stock-based compensation
expenses of $0.6 million and $13.1 million, respectively. Excluding
stock-based compensation and the $22.0 million license fee, total R&D
expenses related to drug development programs for the years ended December
31, 2015 and 2014 were $17.9 million and $7.8 million, respectively, an
increase of $10.1 million. This increase in R&D expenses primarily
reflects increased expenses related to our Phase IIb clinical trial of
MIN-101, our Phase IIa clinical trial of MIN-117 and the MIN-202 Phase IIa
and Ib clinical trials.
-- G&A Expenses: General and administrative (G&A) expenses were $1.9
million in the fourth quarter of 2015, compared to $4.5 million in the
fourth quarter of 2014. G&A expenses were $7.6 million for the year
ended December 31, 2015, compared to $12.0 million for the year ended
December 31, 2014. G&A expenses for the years ended December 31, 2015
and 2014 included non-cash stock-based compensation expenses of $1.6
million and $4.9 million, respectively. Excluding stock-based
compensation, G&A expenses for the years ended December 31, 2015 and
2014 were $6.0 million and $7.1 million, respectively.
-- Cash Position: Cash, cash equivalents and marketable securities as of
December 31, 2015 were approximately $32.2 million, compared to $18.5
million as of December 31, 2014. In the first quarter of 2016, the Company
received approximately $17.5 million in proceeds from the exercise by
certain existing stockholders of warrants granted in connection with a
private placement in March 2015. Warrants with respect to a total of
3,039,514 shares of common stock were exercised at an exercise price of
$5.77 per share. As a result, Minerva expects that its cash, cash
equivalents and marketable securities will be sufficient to fund its
operations into the second quarter of 2017.

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 49677445.

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 p...

Författare SSE

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.