- Reports Financial and Operating Results for
the Year Ended December 31, 2018
-
LAVAL, QC, Feb. 21, 2019 /CNW/ - BELLUS Health Inc. (TSX:
BLU) ("BELLUS Health" or the "Company"), a clinical-stage
biopharmaceutical company developing novel therapeutics for
conditions with high unmet medical need, today presented its 2018
achievements and corporate priorities for 2019. The Company also
reported its financial and operating results for the year ended
December 31, 2018. All currency
figures reported in this press release are in Canadian dollars,
unless otherwise specified.
"The positive Phase 1 data reinforces our position that our lead
drug candidate BLU-5937 has the potential to be a best-in-class
therapeutic for the treatment of chronic cough," said Roberto Bellini, President and CEO of BELLUS
Health. "The $35 million financing
completed in December also positions us for another year of
important milestones including the start of our Phase 2 study in
mid-2019."
2019 Corporate Plan
BELLUS Health priorities for 2019 will be focused on achieving
the following:
- Initiate a clinical Phase 2 study for BLU-5937 in chronic cough
patients in mid-2019, with top-line results anticipated in
mid-2020.
The clinical Phase 2 study will be a dose
escalation crossover design study to assess the efficacy, safety
and tolerability of BLU-5937 in chronic cough patients, in addition
to helping confirm the optimal dose regimen. A total of 50 patients
with refractory chronic cough are expected to be enrolled in
approximately 10 clinical sites located in the United Kingdom and Unites States.
- Pursue BLU-5937 enabling activities to prepare the program for
later stage clinical development.
- Present BLU-5937 Phase 1 data at medical conferences.
- Develop BLU-5937 program for potential expansion in other P2X3
indications.
2018 Highlights
- Announced positive top-line results from the clinical Phase
1 study for BLU-5937, the Company's lead drug candidate for
chronic cough.
BLU-5937 was shown to be safe and
well tolerated and did not cause any taste loss at the anticipated
therapeutic doses. This confirms the Company's expectation that at
the anticipated therapeutic doses there is no or very limited
effect on taste perception. The benign side effect profile, in
combination with the anti-tussive effect demonstrated in several
preclinical studies, further reinforces the Company's position that
BLU-5937 has the potential to be a best-in-class therapeutic for
chronic cough patients.
- Closed a $35 million equity
offering, led by OrbiMed
On December 18, 2018, the Company issued 36,842,105
common shares from treasury at a price of $0.95 per share for aggregate gross proceeds of
$35 million (the "Offering"). The
Offering was led by OrbiMed and also included New Leaf Venture
Partners, First Manhattan Co., Samsara BioCapital, Fonds de
solidarité FTQ, AppleTree Partners and Amzak Health.
- Secured patent protection for BLU-5937 in all major
pharmaceutical markets.
Patents were granted by the
European Patent Office and the Japan Patent Office in 2018, in
addition to patents granted in the United
States and China in 2017,
with claims covering the composition of matter of BLU-5937 until
2034. In addition, the Company further expanded BLU-5937's patent
protection to 2038 by securing a new U.S. patent claiming P2X3
selectivity as a means of minimizing taste effects.
- Appointed an international clinical advisory board ("CAB")
to provide strategic guidance and support to the BLU-5937
development program.
The CAB is comprised of highly-respected clinical leaders whose
work has influenced the treatment and management of chronic cough.
The Chair of the CAB is Dr. Jaclyn Smith, MB, ChB, FRCP, PhD,
Professor of Respiratory Medicine at the University of Manchester in the United Kingdom and an Honorary Consultant at
the University Hospital of South Manchester NHS Foundation
Trust.
- Concluded the year with cash, cash equivalents and
short-term investments totalling $48.9
million.
The liquidity position should enable the
Company to finance its operations for more than two years.
Summary of Financial Results
|
Year ended
December 31,
2018
|
Year ended
December 31,
2017
|
|
(in thousands of
dollars, except per share data)
|
Revenues
|
$
|
35
|
$
|
165
|
Research and
development expenses, net
|
|
(6,532)
|
|
(3,321)
|
General and
administrative expenses
|
|
(3,409)
|
|
(2,529)
|
Net finance
income
|
|
741
|
|
19
|
Change in fair value
of contingent consideration
receivable
|
|
81
|
|
—
|
Realized gain on sale
of investment in FB Health
|
|
—
|
|
1,909
|
Gain on sale of
subsidiary
|
|
—
|
|
1,944
|
Deferred tax
expense
|
|
—
|
|
(61)
|
Net loss for the
year
|
$
|
(9,084)
|
$
|
(1,874)
|
Basic and diluted
loss per share
|
$
|
(0.08)
|
$
|
(0.03)
|
- Research and development expenses, net of research tax credits,
amounted to $6,532,000 for the year
ended December 31, 2018, compared to
$3,321,000 for the previous year. The
increase is primarily attributable to higher expenses incurred in
relation to the development of BLU-5937, the Company's lead drug
candidate for chronic cough, including the clinical Phase 1 study
completed by the Company in 2018.
- General and administrative expenses amounted to $3,409,000 for the year ended December 31, 2018, compared to $2,529,000 for the previous year. The increase is
mainly due to higher stock-based compensation expense in relation
to the Company's stock option plan and deferred share unit
plans.
- Net finance income amounted to $741,000 for the year ended December 31, 2018, compared to $19,000 for the previous year. The increase is
primarily attributable to higher interest income due to the
Company's increased cash, cash equivalents and short-term
investments position following the equity offering in December 2017 as well as to the foreign exchange
gain that arose from the translation of the Company's net monetary
assets denominated in US dollars.
- Realized gain on sale of investment in FB Health amounted to
$1,909,000 for the year ended
December 31, 2017 and is related to
the sale of the Company's equity interest in FB Health S.p.A.
- Gain on sale of subsidiary amounted to $1,944,000 for the year ended December 31, 2017 and is related to the sale of
the Company's wholly-owned subsidiary Thallion Pharmaceuticals
Inc.
As at December 31, 2018, the
Company had available cash, cash equivalents and short-term
investments totalling $48,906,000,
compared to $23,888,000 as at
December 31, 2017.
The Company's full audited consolidated financial statements and
accompanying management's discussion and analysis for the year
ended December 31, 2018 will be
available shortly on SEDAR at www.sedar.com.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for conditions with high unmet
medical need. The Company's lead drug candidate is BLU-5937 being
developed for the treatment of chronic cough. BLU-5937, a highly
selective P2X3 antagonist, has the potential to be a best-in-class
therapeutic for chronic cough patients who do not respond to
current therapies.
Chronic cough is a cough that lasts more than eight weeks and is
associated with significant adverse social, psychosocial and
physical effects on quality of life. A recent commercial assessment
performed by Bluestar BioAdvisors (formerly known as Torreya
Insights) on behalf of the Company concluded that, in the United States alone, more than
26 million adults have chronic cough and more than 2.6 million
of these patients suffer from refractory chronic cough lasting for
more than a year.
Forward-Looking Statements
Certain statements contained in this news release, other than
statements of fact that are independently verifiable at the date
hereof, may constitute "forward-looking statements"
within the meaning of Canadian securities legislation and
regulations. Such statements, based as they are on the current
expectations of management, inherently involve numerous important
risks, uncertainties and assumptions, known and unknown, many of
which are beyond BELLUS Health Inc.'s control. Such risks factors
include but are not limited to: the ability to expand and develop
its project pipeline, the ability to obtain financing, the impact
of general economic conditions, general conditions in the
pharmaceutical industry, changes in the regulatory environment in
the jurisdictions in which BELLUS Health Inc. does business, stock
market volatility, fluctuations in costs, changes to the
competitive environment due to consolidation, achievement of
forecasted burn rate, potential payments/outcomes in relation to
indemnity agreements and contingent value rights, achievement of
forecasted pre-clinical and clinical trial milestones and that
actual results may vary once the final and quality-controlled
verification of data and analyses has been completed. In addition,
the length of BELLUS Health Inc.'s drug candidates' development
process, their market size and commercial value, as well as the
sharing of proceeds between BELLUS Health Inc. and its potential
partners from potential future revenues, if any, are dependent upon
a number of factors. Consequently, actual future results and events
may differ materially from the anticipated results and events
expressed in the forward-looking statements. BELLUS Health Inc.
believes that expectations represented by forward-looking
statements are reasonable, yet there can be no assurance that such
expectations will prove to be correct. The reader should not place
undue reliance, if any, on any forward-looking statements included
in this news release. These forward-looking statements speak only
as of the date made, and BELLUS Health Inc. is under no obligation
and disavows any intention to update publicly or revise such
statements as a result of any new information, future event,
circumstances or otherwise, unless required by applicable
legislation or regulation. Please see BELLUS Health Inc.'s public
filings with the Canadian securities regulatory authorities,
including the Annual Information Form, for further risk factors
that might affect BELLUS Health Inc. and its business.
SOURCE BELLUS Health Inc.