LAVAL, QC, Aug. 9, 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 second quarter ended June 30, 2016. All currency figures reported in
this press release are in Canadian dollars, unless otherwise
specified.
Highlights
- Announced top-line results from the KIACTA™ Phase 3
Confirmatory Study for the treatment of AA amyloidosis; KIACTA™ did
not meet the primary efficacy endpoint in slowing renal function
decline and continues to be evaluated in order to determine next
steps for the program;
- Subsequent to quarter end, completed an additional Shigamab™
pre-clinical study in a sHUS baboon model; Shigamab™ was shown to
rescue the animals against a lethal dose of toxin when administered
up to 48 hours post-intoxication;
- Subsequent to quarter end, highlighted other assets in its
pipeline 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;
- Completed simplification of the Company's capital structure by
issuing 6.4 million common shares upon scheduled conversion of
Pharmascience's interest in BHI Limited Partnership;
- Has reduced forecasted expenses, effectively decreasing its
projected monthly average burn rate from $300,000 to $225,000;
- Concluded the quarter with cash, cash equivalents and
short-term investments totaling $8.0 million.
"The negative top-line results for the KIACTA™ Phase 3 study in
AA amyloidosis results were not what we had been expecting" said
Roberto Bellini, President and Chief
Executive Officer of BELLUS Health. "While the KIACTA™ Phase 3 data
continues to be investigated, we would like to highlight that the
Company is financially secure and has a varied pipeline of projects
including Shigamab™ for Hemolytic Uremic Syndrome. We look forward
to providing further updates on all our projects throughout the
second half of the year."
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 which acquired the
rights to KIACTA™ from the Company in 2010, is currently proceeding
to additional analysis in order to determine the next steps for
KIACTA™.
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. All costs in
relation to the development of KIACTA™ in sarcoidosis will be borne
by Auven Therapeutics.
Shigamab™ for sHUS
A clinical Phase 2 study protocol is currently being designed
for the assessment of the efficacy of Shigamab™ in the treatment of
the Hemolytic Uremic Syndrome caused by Shiga toxin-producing E.
coli (sHUS). The Company intends to meet with regulatory
authorities in 2016 to present its clinical development plan for
Shigamab™.
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 2 and protect the animals against the
extra-renal complications associated with the Shiga toxin 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 dose of Shiga
toxin 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 mid-single digit
percentage royalty and revenue share. 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. This disease
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 for mid-single digit
percentage royalty and revenue share. 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 which demonstrated that
ALZ-801 had a substantially optimized pharmacokinetic profile and
favorable safety/tolerability in elderly subjects compared to oral
tramiprosate. ALZ-801 is an orally-available optimized prodrug of
tramiprosate, the active agent in ALZ-801, and clinical development
of ALZ-801 builds on the established safety and efficacy profile of
tramiprosate from two prior Phase 3 trials in more than 2,000 AD
patients. Alzheon is in preparation for a pivotal Phase 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. The Phase 3 study is expected to be
initiated in 2017.
Specialty Pharma Equity Stake
The Company has a 5.7% 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 June 30, 2016.
AL Amyloidosis Research Project
During the quarter, the Company took the decision to terminate
its research-stage project for AL amyloidosis.
Conversion of Pharmascience's interest in BHI Limited
Partnership
On June 2, 2016, BELLUS Health
issued 6,350,638 common shares from treasury upon the exercise of
Pharmascience's right to convert its 10.4% interest in BHI Limited
Partnership into common shares. The Company currently has 61.1
million common shares outstanding and 65.9 million common shares on
a fully diluted basis, including stock options granted under the
stock option plan.
Summary of Financial Results and Key Balance Sheet
Assets
Financial Results:
|
Three months ended
June 30,
2016
|
Three months ended
June 30,
2015
|
|
(in thousands of dollars, except per share
data)
|
Revenues
|
585
|
592
|
Research and development expenses,
net
|
(543)
|
(169)
|
General and administrative
expenses
|
(368)
|
(864)
|
Net finance
costs
|
(51)
|
–
|
Deferred tax
recovery
|
16
|
8
|
Net loss for the
period
|
(361)
|
(433)
|
Net loss attributable to
shareholders
|
(327)
|
(426)
|
Basic and diluted loss per
share
|
(0.01)
|
(0.01)
|
- Research and development expenses, net of research tax credits,
amounted to $543,000 for the
three-month period ended June 30,
2016, compared to $169,000 for
the corresponding period the previous year. The increase is
primarily attributable to higher expenses incurred in relation to
the development of Shigamab™. In addition, higher research tax
credits were recognized during the second quarter of 2015 in
relation to additional claims for prior years filed during that
quarter.
- General and administrative expenses amounted to $368,000 for the three-month period ended
June 30, 2016, compared to
$864,000 for the corresponding period
the previous year. The decrease is primarily attributable to the
income recorded in the second quarter of 2016 in relation to the
Company's deferred share unit plans due to the decrease in the
Company's stock price during that period.
Key Balance Sheet Assets:
|
As at June 30,
2016
|
|
(in thousands of
dollars)
|
Cash, cash equivalent and short-term
investments
|
7,950
|
Trade and other receivables, net of Trade and other
payables
|
551
|
Investment in FB
Health
|
957
|
- As at June 30, 2016, the Company
had available cash, cash equivalents and short-term investments
totalling $7,950,000, compared to
$9,702,000 as at December 31, 2015. During the quarter, the
Company has reduced forecasted expenses through the reduction of
non-core expenses and the termination of its AL amyloidosis
program, effectively decreasing its projected average monthly burn
rate from $300,000 to $225,000.
The Company's full unaudited consolidated financial statements
and accompanying management's discussion and analysis for the three
and six-month periods ended June 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 financial interests in some biotechnology
and pharmaceutical companies.
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.