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
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 |
|
|
|
|
|
|
|
|
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Minerva Neurosciences (NASDAQ:NERV)
Historical Stock Chart
From Apr 2023 to Apr 2024