NEW HAVEN, Conn., Nov. 14, 2017 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage
biopharmaceutical company with a portfolio of innovative,
late-stage product candidates targeting neurological diseases,
including rare disorders, today reported financial results for the
quarter ended September 30, 2017, and
provided a review of recent accomplishments and anticipated
upcoming milestones.
"We continue to execute rapidly on clinical programs across both
of our major technology platforms as we build a world-class
organization and make very efficient use of our funds," said
Vlad Coric, M.D., CEO of
Biohaven. "We are especially pleased that we are on track to
have both of our pivotal migraine trials fully enrolled by
year-end, with data readouts expected in the first quarter of
2018. Equally important, beyond migraine, we have made
strategic additions to our clinical programs in both common and
rare neurologic disorders and cancer during the fourth quarter,
from which we expect to receive additional topline results in
2018. Our goal in all our programs is to provide patients
with first-in-class and best-in-class therapies for severe
diseases."
Third Quarter and Recent Business Highlights
- Biohaven continues to make consistent and strong progress
across its oral, small molecule calcitonin gene related peptide
(CGRP) antagonist and glutamate modulation technology
platforms.
CGRP-Receptor Antagonist Platform – Recent Milestones and Next
Steps
- Enrollment nearing completion in two Pivotal Phase 3 trials
of rimegepant – Enrollment in the two Phase 3 pivotal trials to
evaluate the safety and efficacy of orally-dosed rimegepant, a
small-molecule, new chemical entity (NCE) for the acute treatment
of migraine, is expected to be completed before the end of the
year. The Company expects to report topline results from both
trials in the first quarter of 2018. The Company also commenced its
long-term safety study of rimegepant in migraine patients in
August 2017. Data from the long-term
safety study is expected to support a potential new drug
application (NDA) submission in 2019.
- Continued progress for BHV-3500 toward IND filing — The
filing of an investigational new drug application (IND) is now
planned for the first quarter of 2018 for BHV-3500, the Company's
third-generation CGRP-receptor antagonist. The planned IND filing
date was revised due to external manufacturing delays outside the
control of the Company.
Glutamate Modulation Platform – Recent Milestones and Next
Steps
- First patient dosed in pivotal bioequivalence study after
IND clearance for BHV-0223 in Amyotrophic Lateral Sclerosis
(ALS)—In October, the U.S. Food and Drug Administration (FDA)
cleared the Company to proceed with its clinical program of
BHV-0223 as a potential treatment for patients with ALS, and the
Company commenced dosing in the bioequivalence study. Based on
previous feedback from the FDA, the Section 505(b)(2) pathway is
acceptable and no additional efficacy or toxicology studies will be
required for the submission of a NDA in this indication.
- IND clearance received for trigriluzole in
Obsessive-Compulsive Disorder (OCD) — In October, the FDA
cleared the Company to proceed with a Phase 2/3 clinical trial of
trigriluzole for the treatment of OCD, and we anticipate enrolling
the first patient in the fourth quarter of 2017. Trigriluzole is a
novel third-generation prodrug glutamate modulator that has been
observed to have a favorable safety and tolerability profile in
studies completed to date. Exposure data from recent clinical
experience with trigriluzole has helped inform the dosing of
trigriluzole in the planned OCD Phase 2/3 trial.
- First patient treated with trigriluzole in Rutgers Cancer
Institute collaboration — As part of a clinical collaboration
with Drs. Ann Silk and James Goydos at the Rutgers Cancer Institute of
New Jersey, trigriluzole is being
evaluated for safety in a Phase 1 trial in combination with PD-1
blocking antibodies in patients with inoperable, advanced or
refractory cancers. The study began enrollment in October 2017 and the first patient has begun
treatment.
- Extension study of trigriluzole in patients with
Spinocerebellar Ataxia (SCA) — Following topline results of
trigriluzole in patients with SCA, Biohaven is continuing a
long-term (48-week) extension study and plans to have regulatory
interactions early in 2018 to discuss continued development in the
ataxias.
- Orphan Designation received as progress continues for
BHV-5000 toward Phase 1 trial — Following the Orphan
Designation received from the FDA in July, the Company continues to
optimize its formulation to support a Phase 1 pharmacokinetic trial
for BHV-5000, a low trapping NMDA receptor antagonist in-licensed
from AstraZeneca AB and then advance BHV-5000 into clinical trials
in Rett syndrome, as well as other neuropsychiatric
indications. Biohaven is on track to submit an IND by the end
of 2017.
Kleo Investment
Kleo Pharmaceuticals, Inc. (Kleo) is a privately held,
preclinical-stage company founded at Yale
University that is developing small molecule immunotherapies
that emulate biologics to fight cancers and infectious diseases.
Biohaven currently owns approximately 43% of the outstanding stock
of Kleo.
- On October 5, 2017, the Company
purchased 1,375,000 shares of common stock, $0.0001 par value of Kleo in satisfaction of the
third of a series of four purchase commitments pursuant to the
Securities Purchase Agreement between Kleo and the Company, dated
as of August 29, 2016. The
total consideration paid by the Company to Kleo for these shares
was $1.4 million.
- In addition, on October 5, 2017,
the Company entered into two separate subscription agreements with
Kleo in order to maintain the Company's relative ownership interest
in Kleo. Pursuant to the First Subscription Agreement, the
Company purchased 1,397,904 shares of Kleo's common stock at a
purchase price of $1.0993 per share,
for total consideration of $1.5
million. Pursuant to the Second Subscription
Agreement, the Company purchased an additional 651,639 shares of
Kleo's common stock at a purchase price of $1.0993 per share, for total consideration of
$0.7 million.
Portage Announcement Regarding Biohaven Shares
In early November, Portage Biotech Inc., a Biohaven shareholder,
announced that it intends to distribute a substantial part of its
Biohaven holdings as a dividend to Portage shareholders in
2018. In its announcement, Portage explained that the
distribution was being effected so that Portage could avoid being
characterized as an investment company under U.S. law. Thus,
rather than selling its Biohaven shares on the open market, Portage
is distributing its Biohaven shares to its shareholders so that
each shareholder has the option to continue to hold or sell the
Biohaven stock it receives in the distribution. Of particular note,
the majority of the recipients of Portage's Biohaven stock would in
fact be existing Biohaven shareholders and/or directors (including
Drs. Declan Doogan and Greg Bailey) who own over 50% of the outstanding
shares of Portage. In its announcement, Portage Chairman
Greg Bailey stated, "I have great
confidence in the team at Biohaven and look forward to read-outs of
their various clinical programs in 2018."
Dr. Coric added, "We thank Portage for its early support of
Biohaven and understand its need to distribute its Biohaven stock
next year in 2018," said Dr. Coric. "We welcome the existing
and new holders of Biohaven shares that we may acquire as a result
of the 2018 Portage distribution, and we will continue to drive our
development programs toward commercialization to create value for
all of our shareholders."
Key talent added to leadership team
As previously announced, Biohaven recently added two executives
to its management team to broaden and strengthen the Company's
capabilities in key areas.
- Clifford Bechtold joined
Biohaven as Chief Operating Officer in October. Mr. Bechtold
was most recently Development Team Leader for Genetically Defined
Diseases at Bristol-Myers Squibb (BMS), where he led a team that
developed innovative strategies and executed on two novel programs
in neuromuscular and neurodegenerative diseases. In
addition to these disease areas, he has had in-depth experience in
advancing a number of programs from discovery to launch in diverse
disease areas including virology, oncology, immunology,
cardiovascular and neuroscience. Mr. Bechtold will focus
on further optimizing Biohaven's organizational and operational
efficiency to support the growth of Biohaven's diverse portfolio of
therapeutic candidates across multiple neurological
disorders.
- Scott Phillips joined Biohaven
as Senior Vice President of Finance in October. Mr.
Phillips was most recently employed by Alexion Pharmaceuticals
where he served as Chief Accounting Officer and then SVP of Global
Business Finance. Mr. Phillips was responsible for expanding
the accounting organization and internal control structure of
Alexion from a pre-commercial business to a global accounting
organization supporting over 50 countries. In these roles,
his responsibilities included overseeing Alexion's global
accounting, SEC reporting, Sarbanes-Oxley 404 compliance, tax
functions, shared services and financial planning and
analysis. Mr. Phillips will focus on overseeing accounting,
SEC Reporting, regulatory compliance (Sarbanes-Oxley/404), as well
as developing new accounting policies and procedures for Biohaven
as the Company continues to expand.
Third Quarter and Nine Months ended September 30, 2017 Financial Results
Cash Position: Cash as of September 30, 2017 was $175.8 million. Cash as of December 31, 2016, prior to the Company's initial
public offering, was $23.6
million.
R&D Expenses: Research and development (R&D)
expenses for the three and nine months ended September 30, 2017 were $35.0 million and $66.8
million, respectively, compared to $27.0 million and $35.1
million for the same periods in 2016. The increases
primarily reflect continued investment in Biohaven's clinical
development strategy, formulation and product supply for product
candidates, and planned growth of its development operations
organization. Included in R&D expenses for the three and
nine months ended September 30, 2017
is a $5.0 million payment to BMS for
achievement of a development milestone. In addition, R&D
expenses includes increased non-cash share-based compensation
driven largely by increased headcount. For the three
and nine months ended September 30,
2017, these expenses aggregated $4.2
million and $6.4 million,
respectively, compared to $0.3
million and $1.0 million,
respectively, in 2016.
G&A Expenses: General and administrative
(G&A) expenses for the three and nine months ended September 30, 2017 were $4.6 million and $12.5
million, respectively, compared to $0.9 million and $2.7
million for the same periods in 2016. The increases over
prior year primarily reflect personnel related costs, professional
fees supporting ongoing business operations, insurance, as well as
conference and facility costs. Personnel related cost
increases were primarily driven by non-cash share-based
compensation, which, for the three and nine months ended
September 30, 2017 aggregated
$2.1 million and $4.4 million, respectively, compared to
$0.4 million and $1.1 million, respectively, in 2016.
Net Loss: The Company reported a net loss
attributable to common shareholders for the three and nine months
ended September 30, 2017 of
$42.9 million and $112.1 million respectively, or $1.19 and $4.47 per
share, respectively, compared to $28.2
million and $38.0 million,
respectively, or $2.16 and
$3.05 per share, respectively, for
the same period in 2016. Net loss for the nine months ended
September 2017 includes $30.9 million in non-cash charges comprised of
$10.8 million in share-based
compensation and $18.1 million of
changes in fair value of liabilities from various credit and
license agreements, which were primarily settled in the second
quarter upon completion of our initial public offering.
About Biohaven
Biohaven is a clinical-stage
biopharmaceutical company with a portfolio of innovative,
late-stage product candidates targeting neurological diseases,
including rare disorders. Biohaven has combined internal
development and research with intellectual property licensed from
companies and institutions including Bristol-Myers Squibb Company,
AstraZeneca AB, Yale University,
Catalent, ALS Biopharma LLC and Massachusetts General
Hospital. Currently, Biohaven's lead development programs
include multiple compounds across its CGRP receptor antagonist and
glutamate modulation platforms. More information about
Biohaven is available at www.biohavenpharma.com.
Forward-Looking Statements
This news release includes
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements involve substantial risks and uncertainties, including
statements that are based on the current expectations and
assumptions of the Company's management. All statements, other than
statements of historical facts, included in this press release
regarding the Company's business and product candidate plans and
objectives are forward-looking statements. Forward-looking
statements include those related to: the expected timing,
commencement and outcomes of the Company's planned and ongoing
clinical trials, the timing of planned interactions with the FDA,
the timing and outcome of expected regulatory filings and the
timing and consequences of the proposed distribution of Biohaven
stock by Portage. The use of certain words, including "believe",
"may", "expects" and "will" and similar expressions, are intended
to identify forward-looking statements. The Company may not
actually achieve the plans and objectives disclosed in the
forward-looking statements and you should not place undue reliance
on the Company's forward-looking statements. Various important
factors could cause actual results or events to differ materially
from those that may be expressed or implied by our forward-looking
statements. Additional important factors to be considered in
connection with forward-looking statements are described in the
"Risk Factors" section of the Company's Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission on
November 14, 2017. The
forward-looking statements are made as of this date and the Company
does not undertake any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
For further information, contact Dr. Vlad Coric, the Chief
Executive
Officer
at Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.