LAVAL, Quebec–(BUSINESS WIRE)–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.
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 Conference
Poster
Presentation: BLU-5937 a Highly Selective P2X3 Homotrimeric Receptor
Antagonist with Improved Taste Safety Profile in Healthy Subjects
Poster
Board Number: P556
Session Title: C37 – Symptoms, Pleural Disease,
Behavioral Science, and Other Topics
Date: May 21, 2019
Time:
11:15 am to 1:00 pm CT
Location: Dallas, Texas
Event: American Cough Conference
Oral
Presentation: BLU-5937, a Highly Selective P2X3 Homotrimeric Receptor
Antagonist, Exhibits Excellent Pharmacokinetic and Safety Profile
Including Improved Taste Safety Profile in Healthy Subjects
Date:
June 7, 2019
Time: 3:35 pm ET
Location: 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 |
Votes |
% |
|||||||||||
| 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.
Contacts
Investors:
BELLUS Health
François
Desjardins
Vice-President, Finance
450-680-4525
fdesjardins@bellushealth.com
Solebury
Trout
Chad Rubin
646-378-2947
crubin@soleburytrout.com
Media:
Solebury
Trout
Brad Miles
646-513-3125
bmiles@soleburytrout.com