LAVAL, QC, Nov. 10, 2016 /CNW/ - BELLUS Health Inc.
(TSX: BLU) (BELLUS Health or the Company), a drug development
company focused on rare diseases, today reported its financial and
operating results for the third quarter ended September 30, 2016. All currency figures reported
in this press release are in Canadian dollars, unless otherwise
specified.
Highlights
- Completed an additional Shigamab™ pre-clinical study in a sHUS
baboon model; Shigamab™ was shown to rescue the animals against a
lethal dose of Shiga toxin type 2 when administered up to 48 hours
post-intoxication;
- Highlighted partnered assets, including AMO-01 for Fragile X
Syndrome, ALZ-801 for APOE4 homozygous Alzheimer's disease and an
equity stake in an Italian specialty pharma company;
- Ongoing evaluation of the KIACTA™ program in AA amyloidosis and
sarcoidosis by BELLUS Health partner, Auven Therapeutics, in order
to determine next steps;
- Concluded the quarter with cash, cash equivalents and
short-term investments totaling $7.2 million; forecasted average monthly
burn rate reduced from $300,000 to
$225,000.
"We are expecting to receive our partner's decision for the
Kiacta program in AA amyloidosis and sarcoidosis before the end of
the year," said Roberto Bellini, President and Chief Executive
Officer of BELLUS Health. " In the meantime, we continue to
focus on the rest of our pipeline, particularly Shigamab where we
spent the third quarter advancing necessary pre-clinical work for
the Shigamab program and are now evaluating clinical options for
future development."
KIACTA™ for AA Amyloidosis
On June 20, 2016, the Company
announced top-line results from the Phase 3 study of KIACTA™ for
the treatment of AA amyloidosis, an orphan indication resulting in
renal dysfunction that often leads to dialysis and death. In the
study, KIACTA™ did not meet the primary efficacy endpoint in
slowing renal function decline. KIACTA™ was shown to be safe and
well tolerated over treatment periods of greater than 4 years.
Auven Therapeutics, BELLUS Health's partner who acquired the
rights to KIACTA™ from the Company in 2010, continues to evaluate
the clinical data for determining the next steps for KIACTA™. A
decision is expected to be made by year-end.
KIACTA™ for Sarcoidosis
BELLUS Health's partner, Auven Therapeutics, is currently
developing a clinical Phase 2/3 study protocol to evaluate the
safety and efficacy of KIACTA™ for the treatment of patients
suffering from chronic pulmonary sarcoidosis. In conjunction with
the review of KIACTA™ for AA amyloidosis, the sarcoidosis program
is also currently under review by Auven Therapeutics. A decision is
expected to be made by year-end.
Shigamab™ for sHUS
A clinical Phase 2 study protocol has been designed for the
assessment of the efficacy of Shigamab™ in the treatment of sHUS, a
rare disease which principally affects the kidneys and often leads
to acute dialysis, and in certain cases, chronic kidney disease and
death, primarily in children.
In parallel with the preparation of the clinical Phase 2 study,
BELLUS Health has recently completed an additional pre-clinical
study in a sHUS baboon model, which recapitulates a pathophysiology
similar to that in sHUS patients. The objective of this study was
to assess the effect of Shigamab™ on the progression of sHUS. In
this study, Shigamab™ was shown to rescue the animals against a
lethal dose of toxin when administered up to 48 hours
post-intoxication. Shigamab™ was also found to inhibit the kidney
injury caused by Shiga toxin type 2 and protect the animals against
the extra-renal complications associated with the Shiga toxin type
2 intoxication. These results are consistent with the protective
effects of Shigamab™ previously seen in the mice that received
lethal doses of Shiga toxin E. coli or lethal doses of Shiga
toxin type 2.
Shigamab™ is a monoclonal antibody therapy being developed for
the treatment of sHUS, a rare disease which principally affects the
kidneys and often leads to acute dialysis, and in certain cases
chronic kidney disease and death, primarily in children.
AMO-01 for Fragile X Syndrome
In 2014, BELLUS Health entered into a development and license
agreement with AMO Pharma Limited (AMO Pharma) for the worldwide
rights to AMO-01 (formerly TLN-4601) for the treatment of
neurologic and psychiatric disorders in return for royalties on
sales and revenue sharing. TLN-4601 was acquired by BELLUS Health
as part of the Thallion Pharmaceutical Inc. acquisition in
August 2013.
AMO Pharma is a private company focused on the treatment of
central nervous system and neuromuscular diseases. AMO Pharma is
preparing for a Phase 2 study on patients with Fragile X Syndrome,
a deadly disease with no current approved therapies. The condition
affects approximately 180,000 patients in the United States.
ALZ-801 for APOE4 Homozygous Alzheimer's Disease
In 2013, worldwide rights to ALZ-801 (formerly BLU8499) were
licensed to Alzheon Inc. (Alzheon) in return royalties on sales and
revenue sharing. BLU8499 was initially developed by BELLUS Health
for the treatment of Alzheimer's disease (AD). Alzheon is a private
company focused on AD and other neurodegenerative disorders.
In July 2016, Alzheon announced
that it had completed Phase 1b studies with ALZ-801. Alzheon is in
preparation for a pivotal Phase 2/3 program focusing on treatment
of Alzheimer's patients who are homozygous for apolipoprotein E
(APOE4), the most important genetic risk factor for late-onset
AD.
Specialty Pharma Equity Stake
The Company has a 5.72% equity interest in FB Health S.p.A (FB
Health), an Italy-based specialty
pharma focused on neurology and psychiatry. FB Health is a growing
and profitable company which distributes over ten nutraceutical and
pharmaceutical products in Italy
with annual sales in excess of 8 million euros. The investment
in FB Health is presented at fair value in BELLUS Health's
financial statements and amounted to $957,000 as of September
30, 2016.
Other
The Company continues to explore opportunities in order to
expand its pipeline, including through acquisitions and/or
in-licensing.
Summary of Financial Results and Key Balance Sheet
Assets
Financial Results:
|
Three months
ended
September 30, 2016
|
Three months
ended
September 30, 2015
|
|
(in thousands of
dollars, except per share data)
|
|
$
|
$
|
Revenues
|
358
|
593
|
Research and
development expenses, net
|
(330)
|
(340)
|
General and
administrative expenses
|
(664)
|
(622)
|
Net finance
income
|
24
|
174
|
Deferred tax
recovery
|
—
|
17
|
Net loss for the
period
|
(612)
|
(178)
|
Net loss attributable
to shareholders
|
(612)
|
(191)
|
Basic and diluted
loss per share
|
(0.01)
|
Nil
|
- Revenues amounted to $358,000 for
the three-month period ended September 30,
2016, compared to $593,000 for
the corresponding period the previous year. The decrease is
primarily attributable to lower revenues recognized for accounting
purposes from the service agreement entered into with Auven
Therapeutics for the development of KIACTA™. Following the
announcement of the results from the Phase 3 Confirmatory Study of
KIACTA™ on June 20, 2016, the
Company's expected support and assistance to Auven Therapeutics
after that date was decreased.
- Net finance income amounted to $24,000 for the three-month period ended
September 30, 2016, compared to
$174,000 for the corresponding period
the previous year. The decrease is primarily attributable to lower
foreign exchange gain that arose from the translation of the
Company's net monetary assets denominated in US dollars, due to the
depreciation of the US dollar vs the Canadian dollar during the
period.
Key Balance Sheet Assets:
|
As at September 30,
2016
|
|
(in thousands of
dollars)
|
Cash, cash equivalent
and short-term investments
|
$ 7,210
|
Investment in FB
Health
|
$
957
|
- As at September 30, 2016, the
Company had available cash, cash equivalents and short-term
investments totalling $7,210,000,
compared to $9,702,000 as at
December 31, 2015. In the second
quarter of 2016, the forecasted average monthly burn rate was
decreased from $300,000 to
$225,000 through the reduction of
non-core expenses and the termination of the AL amyloidosis
program.
The Company's full unaudited consolidated financial statements
and accompanying management's discussion and analysis for the three
and nine-month periods ended September 30,
2016 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 drug development company focused on rare
diseases. Its pipeline of rare disease projects includes KIACTA™
for AA amyloidosis, KIACTA™ for sarcoidosis and clinical-stage
Shigamab™ for sHUS. BELLUS Health is partnered with global private
equity firm Auven Therapeutics for the development of KIACTA™.
BELLUS Health also has economic interests in several other
partnered drug development projects.
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 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, dependence
on Auven Therapeutics for the development of KIACTA™ 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 the KIACTA™ development process and the sharing of
proceeds between Auven Therapeutics and BELLUS Health Inc. from
potential future revenue of KIACTA™ are dependent upon a number of
factors, including the quantum of proceeds. 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.