BELLUS Health Inc. (TSX: BLU) (BELLUS Health or the Company), a
clinical-stage biopharmaceutical company developing novel
therapeutics for the treatment of chronic cough and other
hypersensitization-related disorders, today provided an update on
BLU-5937, its lead drug candidate for refractory chronic cough, and
reported its financial and operating results for the first quarter
ended March 31, 2019. All currency figures reported in this press
release are in Canadian dollars, unless otherwise specified.
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the full release here:
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Key Updates:
- Two Abstracts Accepted for
Presentation: Two abstracts, including data from the clinical
Phase 1 study for BLU-5937, were accepted for presentation at the
American Thoracic Society Conference on May 21 and at the
American Cough Conference on June 7;
- CTA Accepted in the UK: The
United Kingdom Medicines and Healthcare products Regulatory Agency
(MHRA) accepted the Company’s Clinical Trial Authorisation (CTA)
application, clearing the start of its clinical Phase 2 study for
BLU-5937 in chronic cough patients in the United Kingdom;
- IND Accepted in the U.S.: In
April 2019, the Company announced that the U.S. Food and Drug
Administration (FDA) accepted its Investigational New Drug (IND)
application, clearing the start of its Phase 2 study in the United
States;
- Phase 2 Start on Track: The
clinical Phase 2 study for BLU-5937 in chronic cough patients is
scheduled to be initiated in mid-2019, with top-line results
anticipated in mid-2020;
- Cash Runway to 2021: The Company
concluded the quarter with cash, cash equivalents, and short-term
investments totalling $45.4 million, expected to provide enough
capital to fund its operations into Q1 2021.
“We are extremely pleased by the progress we’ve made in
advancing the development of BLU-5937 including getting both the
IND and CTA accepted, which clears the path for the initiation of
the Phase 2 study, a critical milestone for the Company,” said
Roberto Bellini, President and Chief Executive Officer
of BELLUS Health. “The clinical data from our successful Phase
1 study positions BLU-5937 as a potential best in class P2X3
antagonist for chronic cough, and we look forward to sharing more
data from that study at the American Thoracic Society Conference on
May 21 and the American Cough Conference on June 7.”
Abstracts Accepted for Presentation
Event: American Thoracic Society
ConferencePoster Presentation: BLU-5937 a Highly Selective
P2X3 Homotrimeric Receptor Antagonist with Improved Taste Safety
Profile in Healthy SubjectsPoster Board Number: P556Session Title:
C37 – Symptoms, Pleural Disease, Behavioral Science, and Other
TopicsDate: May 21, 2019Time: 11:15 am to 1:00 pm CTLocation:
Dallas, Texas
Event: American Cough
ConferenceOral Presentation: BLU-5937, a Highly Selective
P2X3 Homotrimeric Receptor Antagonist, Exhibits Excellent
Pharmacokinetic and Safety Profile Including Improved Taste Safety
Profile in Healthy SubjectsDate: June 7, 2019Time: 3:35 pm
ETLocation: Reston, Virginia
BLU-5937 for Chronic Cough
The Company’s lead drug candidate is BLU-5937, a
highly-selective P2X3 antagonist which has the potential to be a
best-in-class therapeutic for refractory chronic cough
patients.
Topline data from the Phase 1 study of orally administered
BLU-5937, reported in November 2018, demonstrated that it is safe
and well-tolerated, with a pharmacokinetic profile supporting
twice-daily dosing. At the anticipated therapeutic doses of 50mg –
100mg, BLU-5937 did not cause any loss of taste perception, and
only one subject out of 24 (4.2%) reported transient taste
alteration. No subject reported total loss of taste at any dose
levels.
The Company anticipates initiating a clinical Phase 2 study in
mid-2019. This will be a dose-escalation, crossover design study to
assess the efficacy, safety and tolerability of BLU-5937 at four
doses: 25, 50, 100 and 200mg BID. Approximately fifty patients with
refractory unexplained chronic cough are expected to be enrolled at
12 clinical sites in the United Kingdom and United States.
Summary of Financial Results
Three months ended
March 31, 2019
Three months ended
March 31, 2018
(in thousands of dollars, except per
share data) Revenues $ 9 $ 9
Research and development expenses, net
(3,229) (1,245) General and administrative
expenses (1,403)
(704) Net finance (costs) income (168)
97 Net loss for the period
(4,791) (1,843) Basic and
diluted loss per share $ (0.03)
$ (0.02)
- Research and development expenses, net
of research tax credits, amounted to $3,229,000 for the three-month
period ending March 31, 2019, compared to $1,245,000 for the
corresponding period the previous year. The increase is primarily
attributable to higher expenses incurred in relation to the
development of BLU-5937.
- General and administrative expenses
amounted to $1,403,000 for the three-month period ended March 31,
2019, compared to $704,000 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.
- Net finance costs amounted to $168,000
for the three-month period ended March 31, 2019, compared to net
finance income of $97,000 for the corresponding period the previous
year. The increase in net finance costs is primarily attributable
to a foreign exchange loss that arose from the translation of the
Company’s net monetary assets denominated in US dollars.
As at March 31, 2019, the Company had available cash, cash
equivalents and short-term investments totalling $45,442,000,
compared to $48,906,000 as at December 31, 2018.
The Company’s full unaudited condensed consolidated interim
financial statements and accompanying management’s discussion and
analysis for the three-month period ended March 31, 2019 will be
available shortly on SEDAR at www.sedar.com.
BELLUS Health Announces Election of Directors at Annual and
Special Meeting
At the Annual and Special Meeting of Shareholders held in Laval,
Quebec, each director nominee listed in the Management Information
Circular dated March 13, 2019 was elected as a Director of the
Company.
The details of the election are as follows:
Director
Nominee Outcome
Votes For % For
VotesWithheld
%Withheld
Dr. Francesco Bellini, O.C. Elected
91,760,403 99.42% 531,254
0.58% Roberto Bellini Elected
92,165,217 99.86% 126,440
0.14% Dr. Youssef L. Bennani Elected
92,225,148 99.93% 66,509
0.07% Franklin M. Berger Elected
90,613,767 98.18%
1,677,890 1.82% Dr. Clarissa Desjardins
Elected 92,252,093 99.96%
38,564 0.04% Chau Q. Khuong
Elected 92,216,129 99.92%
75,528 0.08% Pierre Larochelle
Elected 91,813,995 99.48%
477,662 0.52% Joseph Rus
Elected 92,164,483 99.86%
127,174 0.14%
The results of the final votes regarding all matters subject to
a vote during the Annual and Special Meeting that took place today
will be made available on SEDAR’s website (www.sedar.com).
About BLU-5937
BLU-5937, a highly selective P2X3 antagonist - (>1500 fold)
for human P2X3 receptors versus P2X2/3 receptors - has the
potential to be a best-in-class therapeutic for refractory chronic
cough patients.
The P2X3 receptor in the cough reflex pathway is a rational
target for treating refractory chronic cough, and it has been
validated in multiple clinical studies. With a modestly-selective
P2X3 antagonist therapy for chronic cough, an adverse effect on
taste perception is a well-known and widely-documented tolerability
issue. The Company believes that a highly selective P2X3 antagonist
can reduce coughing in patients with refractory chronic cough,
while maintaining taste function, by not inhibiting P2X2/3
receptors.
In addition to chronic cough, BLU-5937 may potentially have
clinical benefit in other afferent hypersensitization-related
disorders, such as visceral pain, hypertension, and migraine, among
others. BELLUS Health is exploring how P2X3 activation can
contribute to irritation and pain, and that inhibition of P2X3
receptors may be able to help treat these afferent
hypersensitization-related disorders.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for the treatment of chronic cough
and other hypersensitization-related disorders. The Company's lead
drug candidate, BLU-5937, is being developed for the treatment of
chronic cough.
Chronic cough is a cough lasting more than eight weeks and is
associated with significant adverse physical, social and
psychosocial effects on health and quality of life. It is estimated
that approximately 26 million adults in the United States suffer
from chronic cough with more than 2.6 million having unexplained or
refractory chronic cough lasting for more than a year. There are
limited treatment options for refractory chronic cough, including
no currently approved therapeutics.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190508005921/en/
Investors:BELLUS HealthFrançois
DesjardinsVice-President,
Finance450-680-4525fdesjardins@bellushealth.comSolebury TroutChad
Rubin646-378-2947crubin@soleburytrout.comMedia:Solebury TroutBrad
Miles646-513-3125bmiles@soleburytrout.com
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