LAVAL, QC, Nov. 8, 2017
/CNW/ - BELLUS Health Inc. (TSX: BLU) (BELLUS Health or the
Company), a biopharmaceutical development company advancing novel
therapeutics for conditions with high unmet medical need, today
reported its financial and operating results for the third quarter
ended September 30, 2017. All currency figures reported
in this press release are in Canadian dollars, unless otherwise
specified.
2017 Highlights
- Entered into a license agreement for the exclusive worldwide
rights to develop and commercialize BLU-5937 (formerly NEO5937), a
selective antagonist of the P2X3 receptor, a clinically validated
target for chronic cough, that has the potential to be a
best-in-class therapeutic for chronic cough patients who do not
respond to current therapies;
- Announced that in the guinea pig cough model, BLU-5937 has
shown comparable efficacy to the current leading P2X3 antagonist,
Merck & Co's Gefapixant;
- Announced that in the rat taste model, BLU-5937 did not inhibit
taste; however, consistent with clinical trial data previously
presented by Merck & Co, Gefapixant led to significant taste
disturbance;
- Hosted a Key Opinion Leader event on chronic cough with Dr.
Jacky Smith. For the archived
version of the webcast and presentation:
https://event.webcasts.com/starthere.jsp?ei=1159556&tp_key=4a0ae58b66;
- Announced that the U.S. Patent and Trademark Office issued a
patent that grants claims covering the composition of matter of the
Company's lead drug candidate, BLU-5937, until 2034;
- Sold the Company's wholly-owned subsidiary, Thallion
Pharmaceuticals Inc. (Thallion), to Taro Pharmaceuticals Inc.
(Taro) for total consideration of $2.7
million, including an upfront payment of $2.3 million;
- Sold the Company's equity interest in FB Health S.p.A. (FB
Health) for a potential total consideration of approximately
$2.5 million, of which $1.8 million was received in the second
quarter;
- Concluded the quarter with cash, cash equivalents and
short-term investments totaling $6.3
million, which should be sufficient to finance the Company's
operations to the first quarter of 2019.
"The data presented in two preclinical models during our Key
Opinion Leader event demonstrated the differentiated profile of
BLU-5937 and highlighted its potential to drive comparable
anti-cough effect to the leading P2X3 antagonist, but with a
substantially improved side effect profile" said Roberto Bellini, President and CEO of BELLUS
Health. "During the quarter we made significant strides towards
moving BLU-5937 into human clinical studies and continue to expect
filing a Clinical Trial Application, to support starting a Phase 1
study, in the second quarter of 2018."
Q3 2017 Highlights
BLU-5937
On September 18, 2017, the Company
announced that BLU-5937 showed a significant reduction in cough and
no taste disturbance in two separate preclinical models. In the
guinea pig cough model, BLU-5937 showed comparable efficacy to the
current leading P2X3 antagonist, Merck & Co's Gefapixant (also
named AF-219 or MK-7264). In the rat taste model, BLU-5937 did not
inhibit taste; however, consistent with clinical trial data
previously presented by Merck & Co, Gefapixant led to
significant taste disturbance.
The Company is currently performing preclinical studies on
BLU-5937 to complete its package for submission of a Clinical Trial
Application (CTA), expected in the second quarter of 2018. The
Company plans to initiate a Phase 1 clinical study in the
third quarter of 2018.
Other development programs
Information on the Company's other development programs –
KIACTA™ for Sarcoidosis, AMO-01 for Fragile X Syndrome and ALZ-801
for APOE4 Homozygous Alzheimer's Disease – can be found on the
Company's website at www.bellushealth.com.
Summary of Financial Results
|
|
|
|
Three months
ended
September 30,
2017
|
Three months
ended
September 30,
2016
|
|
(in thousands of
dollars, except per share data)
|
Revenues
|
$
|
93
|
$
|
358
|
Research and
development expenses, net
|
|
(1,194)
|
|
(330)
|
General and
administrative expenses
|
|
(571)
|
|
(664)
|
Net finance (costs)
income
|
|
(8)
|
|
24
|
Net loss for the
period
|
|
(1,680)
|
|
(612)
|
Basic and diluted
loss per share
|
$
|
(0.03)
|
$
|
(0.01)
|
- Revenues amounted to $93,000 for
the three-month period ended September 30,
2017, compared to $358,000 for
the corresponding period the previous year. Revenues for 2016
included those related to the agreements with Auven
Therapeutics.
- Research and development expenses, net of research tax credits,
amounted to $1,194,000 for the
three-month period ended September 30,
2017, compared to $330,000 for
the corresponding period the previous year. The increase is
attributable to expenses incurred in relation to the development of
BLU-5937, the Company's lead drug candidate for chronic cough, for
which an exclusive worldwide license to develop and commercialize
was entered into in February
2017.
- General and administrative expenses amounted to $571,000 for the three-month period ended
September 30, 2017, compared to
$664,000 for the corresponding period
the previous year. The decrease is primarily attributable to
temporary cost reduction measures implemented by the Company in
2016 after the announcement of the KIACTA™ Phase 3 results in
June 2016.
As at September 30, 2017, the Company had available cash,
cash equivalents and short-term investments totalling $6,296,000, compared to $6,834,000 as at December 31, 2016. The
Company expects its cash position to be sufficient to finance its
operations to the first quarter of 2019.
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, 2017 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 biopharmaceutical development company
advancing 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 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 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. The Company 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.