Minerva Neurosciences Reports Second Quarter 2017 Financial Results and Business Updates
(Thomson Reuters ONE) -
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 (in thousands, except per
share amounts) 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
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Minerva Neurosciences, Inc. via GlobeNewswire
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