- Proceeds Received from Equity Sale Extend
Cash Runway to 2019 -
LAVAL, QC, Aug. 9, 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 second quarter ended
June 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
potent, highly selective, orally bioavailable small molecule
antagonist of the P2X3 receptor, a clinically validated target for
chronic cough;
- 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;
- 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, cash held in
trust and short-term investments totaling $8.0 million, which the Company believes should
be sufficient to finance its operations to the first quarter of
2019.
"The strategic divestitures of Thallion and our interest in FB
Health have generated $4.1 million to
date, and could provide up to an additional $1.1 million within the next 12 months," said
Roberto Bellini, President and CEO
of BELLUS Health. "These funds extend our runway into 2019 and are
allowing us to expedite the development of BLU-5937, as we plan to
submit an investigational new drug (IND) application in 2018 and
initiate a phase 1 clinical study in the second half of that
year."
Q2 2017 Highlights
BLU-5937
On April 24, 2017, the Company
announced that the U.S. Patent and Trademark Office issued U.S.
Patent No. 9,598,409, which grants claims covering the composition
of matter of BELLUS' lead drug candidate, BLU-5937, and related
imidazopyridine compounds, in addition to pharmaceutical
compositions comprising BLU-5937 and uses thereof. The patent has
an expiration date of 2034, excluding any potential patent term
extension. Patent applications with similarly broad claims are
currently pending in Europe,
Japan, China and other industrialized nations.
The Company is currently performing preclinical studies on
BLU-5937 to complete its submission package for an IND application
expected in 2018. The Company plans to initiate a phase 1
clinical study in the second half of 2018.
Sale of equity interest in FB Health
On June 30 2017, the Company sold
its equity interest in FB Health for a potential total
consideration of $2,536,000,
consisting of upfront cash payments of $1,769,000 and a contingent revenue-based
milestone payment of up to $767,000
(€518,000), which will be determined one year from the closing of
the transaction.
The proceeds from this transaction, along with the proceeds from
the sale of Thallion, will support the development of the Company's
lead drug candidate for the treatment of chronic cough, BLU-5937,
while extending the Company's cash runway to the first quarter of
2019.
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 month
ended
June 30,
2017
|
Three month
ended
June 30,
2016
|
|
(in thousands of
dollars, except per share data)
|
Revenues
|
$
|
41
|
$
|
585
|
Research and
development expenses, net
|
|
(1,084)
|
|
(543)
|
General and
administrative expenses
|
|
(541)
|
|
(368)
|
Net finance income
(costs)
|
|
3
|
|
(51)
|
Realized gain on sale
of available-for-sale financial asset
|
|
1,644
|
|
—
|
Deferred tax
recovery
|
|
204
|
|
16
|
Net income (loss) for
the period
|
|
267
|
|
(361)
|
Net income (loss)
attributable to shareholders
|
|
267
|
|
(327)
|
Basic diluted income
(loss) per share
|
$
|
Nil
|
$
|
(0.01)
|
- Revenues amounted to $41,000 for
the three-month period ended June 30,
2017, compared to $585,000 for
the corresponding period the previous year. Revenues for 2016
included those related to Auven Therapeutics' development of
KIACTA™ in AA Amyloidosis, which was completed in 2016.
- Research and development expenses, net of research tax credits,
amounted to $1,084,000 for the
three-month period ended June 30,
2017, compared to $543,000 for
the corresponding period the previous year. The increase is
primarily 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. Expenses incurred in 2016 were
related to the development of Shigamab™, which was sold to Taro in
March 2017 as part of the sale of the
Company's wholly-owned subsidiary Thallion.
- General and administrative expenses amounted to $541,000 for the three-month period ended
June 30, 2017, compared to
$368,000 for the corresponding period
the previous year. The increase is primarily attributable to income
recorded in 2016 in relation to the Company's deferred share unit
plans, due to the decrease in the Company's stock price during that
period.
- Net finance income amounted to $3,000 for the three-month period ended
June 30, 2017, compared to net
finance costs of $51,000 for the
corresponding period the previous year. The increase in net finance
income is primarily attributable to lower foreign exchange loss in
2017 that arose from the translation of the Company's net monetary
assets denominated in US dollars.
- As a result of the Company's sale of its investment in FB
Health in June 2017, the realized
gain on sale of available-for-sale financial assets amounted to
$1,644,000 for the three-month period
ended June 30, 2017.
As at June 30, 2017, the Company had available cash, cash
equivalents, cash held in trust and short-term investments
totalling $7,986,000, compared to
$6,834,000 as at
December 31, 2016. The cash held in trust was released
and transferred to cash and cash equivalents on July 3, 2017. The Company believes its cash
position should be sufficient to finance its operations to the
first quarter of 2019.
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,
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 BLU-5937 for chronic cough
and several other partnered clinical-stage drug development
programs. BLU-5937 is a promising best-in-class drug candidate that
has the potential to help chronic cough patients who do not respond
to current therapies. It is estimated that more than 2.7 million
patients suffer from refractory chronic cough, in the United States alone.
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.