- Reports Financial and Operating Results for
the Third Quarter Ended September 30,
2018 -
LAVAL, QC, Nov. 14, 2018 /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 updated the top-line
phase 1 results timeline to November
2018 for its lead drug candidate BLU-5937 for chronic cough.
The Company also reported its financial and operating results for
the third quarter ended September 30,
2018. All currency figures reported in this press release
are in Canadian dollars, unless otherwise specified.
Recent Highlights
- Expects by the end of November
2018 top-line results of the clinical Phase 1 study for
BLU-5937, the Company's lead drug candidate for chronic cough; the
study was initiated in July 2018 and
all subjects have completed dosing;
- Was granted a new U.S. patent claiming P2X3 selectivity as a
means of minimizing taste effects for BLU-5937; the patent extends
BLU-5937's patent protection to 2038;
- Appointed an international clinical advisory board to provide
strategic guidance and support to the BLU-5937 development program
as the Company prepares for a clinical study Phase 2, expected to
be initiated in 2019;
- Concluded the quarter with cash, cash equivalents and
short-term investments totalling $18.1
million.
"With the BLU-5937 Phase 1 top-line results expected by the end
of November, we are fast-approaching a key milestone for the
Company," said Roberto Bellini,
President and CEO of BELLUS Health. "Based on the pre-clinical data
generated to date, we believe that BLU-5937 could be a
best-in-class P2X3 antagonist for chronic cough and look forward to
the Phase 1 data to support the continued advancement of the
program."
BLU-5937 for Chronic Cough
The Company expects top-line results of the clinical Phase 1
study for BLU-5937 by the end of November
2018. The study was initiated in July
2018. The clinical Phase 1 study is a randomized,
double-blind, placebo-controlled study of orally administered
BLU-5937 in 90 healthy adult subjects. The clinical Phase 1
study results will help define BLU-5937's expected product profile,
including the safety, tolerability (including taste perception) and
dosing regimen for the Phase 2 study. The study is divided in two
parts: a single-ascending dose ("SAD") study, which was conducted
in 60 healthy subjects, and a multiple-ascending dose ("MAD")
study, which was conducted in 30 healthy subjects. All subjects in
both cohorts have completed dosing.
On October 31, 2018, BELLUS Health
announced that the U.S. Patent and Trademark Office had issued a
patent granting claims for the use of BLU-5937 for the treatment of
chronic cough without affecting taste response. More generally, the
patent claims the use of imidazopyridine compounds that are
selective for the P2X3 receptor as a means of minimizing taste
perturbation in patients treated for chronic cough. In addition to
BLU-5937, the patent claims the use of related selective
imidazopyridine compounds and pharmaceutical compositions
comprising BLU-5937. This patent has an expiration date of 2038,
excluding any potential patent term extension.
On September 25, 2018, the Company
announced the appointment of an international clinical advisory
board (the "CAB"), which will provide strategic guidance and
support to the BLU-5937 development program as the Company prepares
for a clinical Phase 2 study. 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.
Summary of Financial Results
|
|
|
|
Three months
ended
September 30,
2018
|
Three months
ended
September 30,
2017
|
|
(in thousands of
dollars, except per share data)
|
Revenues
|
$
|
9
|
$
|
93
|
Research and
development expenses, net
|
|
(2,138)
|
|
(1,194)
|
General and
administrative expenses
|
|
(888)
|
|
(571)
|
Net finance income
(costs)
|
|
60
|
|
(8)
|
Change in fair value
of contingent consideration
|
|
|
|
|
receivable
|
|
(90)
|
|
—
|
Net loss for the
period
|
$
|
(3,047)
|
$
|
(1,680)
|
Basic and diluted
loss per share
|
$
|
(0.03)
|
$
|
(0.03)
|
- Research and development expenses, net of research tax credits,
amounted to $2,138,000 for the
three-month period ended September 30,
2018, compared to $1,194,000
for the corresponding period the previous year. The increase is
primarily attributable to higher expenses incurred in relation to
the development of BLU-5937, for which the Company initiated a
clinical Phase 1 study in July
2018.
- General and administrative expenses amounted to $888,000 for the three-month period ended
September 30, 2018, compared to
$571,000 for the corresponding period
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.
As at September 30, 2018, the
Company had available cash, cash equivalents and short-term
investments totalling $18,095,000,
compared to $23,888,000 as at
December 31, 2017.
The Company's full unaudited condensed consolidated interim
financial statements and accompanying management's discussion and
analysis for the three and nine-month periods ended September 30, 2018 will be available shortly on
SEDAR at www.sedar.com and on the Company's website at
www.bellushealth.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. Its pipeline of projects includes the Company's lead
drug candidate BLU-5937 for chronic cough and several other
partnered clinical-stage drug development programs. 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 commercial assessment
performed by 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.