FDA feedback
on clinical trial design and completion of bridging study with new
formulation enable initiation of Phase 3 trial with MIN-101 to
treat negative symptoms of schizophrenia in second half of
2017
Amended
agreement with Janssen supports dual focus of clinical development
with MIN-202 in insomnia and major depressive disorder
Extended
financial runway allows for timely advancement of clinical
development with multiple product candidates
WALTHAM, Mass., Aug. 03, 2017 (GLOBE NEWSWIRE) --
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, 2017.
"A highly productive second quarter of 2017
included progress on a number of fronts related to clinical trial
preparation, business development and financing activities," said
Dr. Remy Luthringer, president and chief executive officer of
Minerva. "This progress will support the timely initiation of five
late-stage clinical efficacy trials with three product candidates
by the end of 2017."
MIN-101:
· Following an "end-of-Phase 2 meeting" with the
U.S. Food and Drug Administration (FDA), the Company is finalizing
the design of a pivotal Phase 3 trial of MIN-101 to treat negative
symptoms in patients with a diagnosis of schizophrenia. Key
elements in this design include:
- A three-month randomized, double
blind placebo controlled core stage followed by a nine-month
extension phase;
- Monotherapy administration of
MIN-101;
- Testing of the same daily doses, 32
milligrams (mg) and 64 mg, as those used in the successfully
completed Phase 2b study;
- Primary outcome of improvement in
negative symptoms;
- Recruitment of approximately 500
patients from approximately 60 clinical sites, one third of whom
will come from the U.S.;
- Recruitment of patients who have
been symptomatically stable in terms of positive and negative
symptoms for six months, with moderate to severe negative
symptoms.
· The Company has recently completed a
bridging study to identify a new, improved formulation of MIN-101
to be used in the Phase 3 trial. The improved formulation is
designed to provide bioequivalent exposures with the Phase 2b
formulation while enhancing the safety profile of the
compound.
· The Phase 3 trial is planned to be
initiated on schedule in the second half of 2017, and we expect to
release top-line results from the three-month double blind phase of
the trial in the first half of 2019.
MIN-202
(JNJ-42847922):
· The Company announced on May 31, 2017 that
it entered into an amended agreement with Janssen, conditional upon
final approval by the European Commission, whereby Minerva will
gain strategic control of the development of MIN-202 to treat
insomnia. Janssen will forego its right to royalties on
MIN-202 insomnia sales in Minerva territories. Minerva will retain
all of its current rights to MIN-202 in all indications.
· Key financial terms of the amended
agreement include payments to Minerva by Janssen of $30 million on
final approval by the European Commission, $20 million at the start
of a Phase 3 insomnia trial and $20 million when 50% of the
patients are enrolled in this trial. Janssen will waive all
remaining costs payable by Minerva (approximately $13 million) to
completion of Phase 2 development of this compound. Minerva will
assume all responsibility for Phase 3 development costs in insomnia
and contribute 40% of Phase 3 development costs in other
indications, including major depressive disorder (MDD).
· All Minerva stock currently owned by
Johnson & Johnson Innovation - JJDC, Inc., totaling
approximately 3.9 million shares and representing approximately 10%
of total Minerva shares outstanding at June 30, 2017 will be
repurchased by Minerva at par value of $.0001 per share or
approximately $389 in total.
· Three Phase 2b trials with MIN-202 are
planned for initiation before the end of 2017, including two trials
in patients suffering from MDD and one in insomnia
disorder without neuropsychiatric comorbid symptoms.
MIN-117:
· A Phase 2b clinical trial with MIN-117 in
MDD is planned for initiation in late 2017 and expected to include
patients who have both mood and anxiety disorders.
· The Company currently plans to define a
primary endpoint of MDD and a secondary endpoint of anxiety in this
trial, building upon previous Phase 2a clinical results that showed
effects in both depressive symptomatology and anxiety, as well
pharmacodynamic effects showing the preservation of sleep
continuity and architecture with no detrimental effects on rapid
eye movement sleep distribution and duration.
MIN-301:
· Minerva is planning to advance its
pre-clinical stage compound, MIN-301, into the initial stage of
clinical development as a treatment for Parkinson's disease.
· MIN-301 is a recombinant protein with the
extra-cellular domain of neuregulin-1 beta primarily activating the
ErbB4 receptor. Pre-clinically, MIN-301 has been shown to cross the
blood-brain barrier and to have neuro-protective and
neuro-restorative effects.
· The next planned steps in the MIN-301
program, after completion of the regular toxicology studies and
final production of the GMP batch, will include filing an
Investigational New Drug application (IND) and/or Investigational
Medicinal Product Dossier (IMPD).
FINANCING:
· The Company completed a public offering of
5,750,000 shares of common stock, including 750,000 shares sold
pursuant to the underwriters' full exercise of their option to
purchase additional shares, on July 5, 2017 that resulted in net
proceeds of approximately $41.5 million. These resources will
support the continued clinical development of MIN-101, MIN-202 and
MIN-117, as well as the initial clinical development of MIN-301 for
Parkinson's disease.
Second Quarter 2017
Financial Results
· Cash
Position: Cash, cash equivalents and marketable
securities as of June 30, 2017 were approximately $77.6 million,
compared to $83.0 million as of December 31, 2016.
· R&D
Expenses: Research and development (R&D) expenses
were $7.1 million in the second quarter of 2017, compared to $2.7
million in the second quarter of 2016, an increase in total expense
of $4.4 million. R&D expense in the three months ended
June 30, 2017 and 2016 included non-cash stock-based compensation
expenses of $0.5 million and $0.2 million, respectively. This
increase in R&D expenses primarily reflects higher development
expenses under the MIN-202 program for Phase 2 clinical trial
preparation, increased expenses for the MIN-101 program and an
increase in non-cash stock-based compensation expenses. These
amounts were partially offset by reduced costs related to our Phase
2a clinical trial of MIN-117 due to its completion in May 2016.
For the six months ended June 30, 2017, R&D
expenses were $14.8 million, compared to $8.1 million for the six
months ended June 30, 2016, an increase in total expense of $6.7
million. R&D expense in the six months ended June 30,
2017 and 2016 included non-cash stock-based compensation expenses
of $1.0 million and $0.5 million, respectively. This increase in
R&D expenses primarily reflects higher development expenses
under the MIN-202 program for Phase 2 clinical trial preparation,
increased expenses for the MIN-101 program and an increase in
non-cash stock-based compensation expenses. These amounts were
partially offset by reduced costs related to our Phase 2a clinical
trial of MIN-117 due to its completion in May 2016.
· G&A
Expenses: General and administrative (G&A)
expenses were $2.6 million in the second quarter of 2017, compared
to $2.3 million in the second quarter of 2016, an increase of
approximately $0.3 million. G&A expense in the three
months ended June 30, 2017 and 2016 included non-cash stock-based
compensation expenses of $0.7 million and $0.6 million,
respectively. This increase was primarily due to an increase
in professional fees during the three months ended June 30, 2016.
For the six months ended June 30, 2017, G&A
expenses were $5.5 million, compared to $4.6 million for the same
period in 2016, an increase of approximately $0.9 million. G&A
expense in the six months ended June 30, 2017 and 2016 included
non-cash stock-based compensation expenses of $1.5 million and $1.2
million, respectively. This increase was primarily due to an
increase in professional fees during the six months ended June 30,
2017.
· Net
Loss: Net loss was $9.8 million for the second
quarter of 2017, or a loss per share of $0.27 (basic and diluted),
as compared to a net loss of $5.2 million, or a loss per share of
$0.18 (basic and diluted) for the second quarter of 2016. Net
loss was $20.4 million for the first six months of 2017, or a loss
per share of $0.57 (basic and diluted), as compared to a net loss
of $13.2 million, or a loss per share of $0.47 (basic and diluted)
for the first six months of 2016.
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 53086270.
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 products to treat CNS
diseases. Minerva's proprietary compounds include: MIN-101,
in clinical development for schizophrenia; MIN-202 (JNJ-42847922),
in 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 improved formulation of MIN-101 to be
used in the planned Phase 3 trial of MIN-101; the approval by the
European Commission of the amendment to our co-development
agreement with Janssen and the related stock repurchase agreement;
our ability to negotiate and execute the definitive agreements
described above; the timing and results of future clinical
milestones with MIN-202 in insomnia and major depressive disorder,
including the timing and scope of future clinical trials and
results of clinical trials with this compound; the timing and
outcomes of future interactions with U.S. and foreign regulatory
bodies; our agreements with Janssen related to MIN-202; our ability
to successfully develop and commercialize MIN-101, MIN-202, MIN-117
and MIN-301; 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, the
inherent uncertainty in approval by the European Commission of the
amendment to our co-development agreement with Janssen and the
related stock repurchase agreement; whether MIN-101, MIN-202,
MIN-117 and MIN-301 will advance further in the clinical trials
process and whether and when, if at all, it will receive final
approval from the U.S. Food and Drug Administration or equivalent
foreign regulatory agencies and for which indications; whether the
results of future clinical trials of MIN-101, MIN-202, MIN-117 and
MIN-301, if any, will be consistent with the results of past
clinical trials; whether MIN-101, MIN-202, MIN-117 and MIN-301 will
be successfully marketed if approved; whether any of our
therapeutic product discovery and development efforts will be
successful; our ability to achieve the results contemplated by our
co-development agreements; 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 June 30, 2017, filed with the Securities and
Exchange Commission on August 3, 2017. 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, |
|
|
2017 |
|
|
2016 |
|
|
|
(in thousands) |
|
ASSETS |
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
50,191 |
|
$ |
82,981 |
|
|
Marketable securities |
|
27,381 |
|
|
- |
|
|
Restricted cash |
|
80 |
|
|
80 |
|
|
Prepaid expenses and other
current assets |
|
423 |
|
|
803 |
|
|
Total current assets |
|
78,075 |
|
|
83,864 |
|
|
Equipment, net |
|
3 |
|
|
10 |
|
|
In-process research and
development |
|
34,200 |
|
|
34,200 |
|
|
Goodwill |
|
14,869 |
|
|
14,869 |
|
|
Deferred public offering
costs |
|
233 |
|
|
- |
|
|
Total Assets |
$ |
127,380 |
|
$ |
132,943 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
Current Liabilities: |
|
|
|
Notes payable - current
portion |
$ |
5,067 |
|
$ |
4,854 |
|
|
Accounts payable |
|
1,432 |
|
|
1,467 |
|
|
Accrued expenses and other
current liabilities |
|
1,443 |
|
|
816 |
|
|
Accrued collaborative
expenses |
|
6,646 |
|
|
2,548 |
|
|
Total current liabilities |
|
14,588 |
|
|
9,685 |
|
|
Long-Term Liabilities: |
|
|
|
Notes payable -
noncurrent |
|
1,326 |
|
|
3,841 |
|
|
Deferred taxes |
|
13,434 |
|
|
13,434 |
|
|
Total liabilities |
|
29,348 |
|
|
26,960 |
|
|
Stockholders' Equity: |
|
|
|
Common stock |
|
4 |
|
|
4 |
|
|
Additional paid-in
capital |
|
251,311 |
|
|
238,837 |
|
|
Accumulated deficit |
|
(153,283 |
) |
|
(132,858 |
) |
|
Total stockholders'
equity |
|
98,032 |
|
|
105,983 |
|
|
Total Liabilities and
Stockholders' Equity |
$ |
127,380 |
|
$ |
132,943 |
|
|
|
|
|
|
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) |
|
|
|
2017 |
|
|
2016 |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
Revenues |
|
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
7,144 |
|
|
2,714 |
|
|
|
14,758 |
|
|
8,089 |
|
General and
administrative |
|
|
2,601 |
|
|
2,250 |
|
|
|
5,472 |
|
|
4,632 |
|
Total operating expenses |
|
|
9,745 |
|
|
4,964 |
|
|
|
20,230 |
|
|
12,721 |
|
|
|
|
|
|
|
|
Foreign exchange losses |
|
|
(20 |
) |
|
(16 |
) |
|
|
(37 |
) |
|
(25 |
) |
Investment income |
|
|
156 |
|
|
35 |
|
|
|
214 |
|
|
67 |
|
Interest expense |
|
|
(170 |
) |
|
(268 |
) |
|
|
(372 |
) |
|
(539 |
) |
Net loss |
|
$ |
(9,779 |
) |
$ |
(5,213 |
) |
|
$ |
(20,425 |
) |
$ |
(13,218 |
) |
Loss per share: |
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.27 |
) |
$ |
(0.18 |
) |
|
$ |
(0.57 |
) |
$ |
(0.47 |
) |
Weighted average shares: |
|
|
|
|
|
|
Basic and diluted |
|
|
36,720 |
|
|
29,122 |
|
|
|
36,048 |
|
|
28,163 |
|
|
|
|
|
|
|
|