- Announced positive topline results from the
Phase 2b SOOTHE clinical trial in refractory chronic cough (“RCC”),
positioning BLU-5937 as a potentially best-in-class P2X3 antagonist
-
- Plans to request an End-of-Phase 2 meeting
with the Food and Drug Administration (“FDA”) in the second quarter
and initiate the Phase 3 program in the second half of 2022 -
- Ended year with US$248.8 million in cash,
cash equivalents and short-term investments -
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the
“Company”), a clinical-stage biopharmaceutical company developing
novel therapeutics for the treatment of refractory chronic cough
and other cough hypersensitivity indications, today reported its
financial and operating results for the year ending December 31,
2021.
“2021 was a momentous year for BELLUS Health, underscored by
positive topline results from the Phase 2b SOOTHE trial and
developments within the P2X3 class that positioned BLU-5937 as a
differentiated product candidate with the potential to be
best-in-class,” commented Roberto Bellini, President and Chief
Executive Officer of BELLUS Health. “Our optimized Phase 2b design
showcased the true promise of our highly selective, second
generation P2X3 antagonist in RCC, demonstrating its ability to
significantly decrease cough frequency with a favorable
tolerability profile. We look forward to another productive year
ahead, as we plan to take the necessary steps – including
conducting an End-of-Phase 2 meeting with the FDA – to initiate our
Phase 3 program in RCC this year.”
PROGRAM AND CORPORATE HIGHLIGHTS
Announced positive topline results from the Phase 2b SOOTHE
clinical trial of BLU-5937 in patients with RCC.
- In December 2021, BELLUS Health announced that the 50 mg and
200 mg twice-daily (“BID”) doses of BLU-5937 in its Phase 2b SOOTHE
clinical trial for the treatment of RCC each achieved statistical
significance on the primary endpoint, with 34% placebo-adjusted
reduction in 24-hour cough frequency observed at day 28. BLU-5937
was generally well-tolerated. Additionally, a dose response was
observed between 12.5 mg and 50 mg BID doses.
- The Company intends to request an End-of-Phase 2 meeting with
the FDA to discuss its planned Phase 3 program. The meeting is
expected to take place in the second quarter of 2022, with plans to
initiate the Phase 3 program in the second half of 2022. The
Company also intends to obtain scientific advice from the European
Medicines Agency.
Completed a $224 million offering in December 2021.
- In December 2021, the Company completed an offering of its
common shares (the “2021 Offering”) resulting in gross proceeds,
including from the underwriters’ partial exercise of their
over-allotment option, of $224 million.
Announced an update on its P2X3 pipeline.
- The Company believes the success of its Phase 2b SOOTHE
clinical trial further validates the role of P2X3 in cough
hypersensitivity. BELLUS Health intends to evaluate potential
opportunities to study BLU-5937 in additional cough indications
where hypersensitivity plays an important role.
- The Company plans to initiate a Phase 1 clinical trial
investigating a once-daily (“QD”), extended release formulation of
BLU-5937 in the second half of 2022.
- In December 2021, BELLUS Health announced that the Phase 2a
BLUEPRINT clinical trial evaluating BLU-5937 in chronic pruritus
did not meet the primary endpoint. The Company does not intend to
pursue development of BLU-5937 in pruritic conditions.
Hosted a virtual Analyst Event to discuss the chronic cough
landscape and its selective P2X3 antagonist BLU-5937.
- On November 15, 2021, the Company hosted an Analyst Event to
discuss topics including the RCC landscape, clinical development
updates for BLU-5937, RCC market dynamics and P2X3 antagonist
platform potential. The event was hosted virtually, and a replay of
the event is available on the Events & Presentations page of
the Company’s website.
Ended the year with cash, cash equivalents and short-term
investments totaling US$248.8 million.
FINANCIAL RESULTS
Cash Position: As of December 31, 2021, the Company had
available cash, cash equivalents and short-term investments
totaling US$248.8 million, compared to US$98.3 million as of
December 31, 2020. The net increase is primarily attributable to
funds received from the 2021 Offering, offset by funds used to
finance its operating activities, mainly the research and
development activities associated with its product candidate
BLU-5937.
Net Loss: For the year ended December 31, 2021, net loss
amounted to US$71.2 million (US$0.90 per share), compared to
US$31.8 million (US$0.54 per share) for the previous year. The
increase in net loss is primarily attributable to higher research
and development expenses in relation to the development of
BLU-5937, the Company’s product candidate for the treatment of
RCC.
Research and Development Expenses: Research and
development expenses, net of research tax credits, amounted to
US$59.0 million for the year ended December 31, 2021, compared to
US$23.2 million for the previous year, a US$35.8 million or 154%
year over year increase to support the development of BLU-5937. The
increase is primarily attributable to higher expenses incurred for
the development of BLU-5937.
General and Administrative (“G&A”) Expenses: General
and administrative expenses amounted to US$14.3 million for the
year ended December 31, 2021, compared to US$9.7 million for the
previous year, a US$4.6 million or 47% year over year increase. The
increase is mainly attributable to higher stock-based compensation
expenses related to the Company’s stock option and deferred share
unit plans.
Net Finance Income: Net finance income amounted to US$1.9
million for the year ended December 31, 2021, compared to US$1.2
million for the previous year. The increase in net finance income
is mainly attributable to a higher foreign exchange gain, offset in
part by lower interest income.
SUMMARY OF FINANCIAL RESULTS
Year ended
December 31, 2021
Year ended
December 31, 2020
(in thousands of dollars, except
per share data)
Revenues
US$
16
US$
15
Research and development expenses, net
(59,037
)
(23,222
)
General and administrative expenses
(14,263
)
(9,735
)
Net finance income
1,861
1,185
Income taxes
199
—
Net loss for the year
US$
(71,224
)
US$
(31,757
)
Basic and diluted loss per share
US$
(0.90
)
US$
(0.54
)
The Company’s full audited consolidated financial statements and
accompanying management’s discussion and analysis for the year
ended December 31, 2021 will be available shortly on SEDAR at
www.sedar.com and on EDGAR at www.sec.gov/edgar.
About BLU-5937
BLU-5937, a highly selective P2X3 antagonist, is in development
for RCC and other cough hypersensitivity indications.
The P2X3 receptor, which is implicated in cough reflex
hypersensitization, is a rational target for treating chronic
cough, and it has been evaluated in multiple clinical trials with
different P2X3 antagonists. The Company believes that its highly
selective P2X3 antagonist has the potential to reduce cough
frequency in patients with RCC and improve quality of life while
limiting taste disturbance adverse events.
In addition to RCC, the mechanism of action of BLU-5937 may also
have broad therapeutic applicability across other afferent
hypersensitization-related disorders, enabling the Company to
consider BLU-5937 as a potential treatment for development in a
number of other indications. Consequently, BELLUS Health is
exploring the potential use of BLU-5937 in other patient
populations experiencing cough hypersensitivity as well as other
P2X3-related hypersensitization conditions.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for the treatment of RCC and other
cough hypersensitivity indications. The Company's product
candidate, BLU-5937, has successfully completed a Phase 2b trial in
RCC and is planning a Phase 3 program that is expected to begin in
the second half of 2022.
RCC is a cough lasting more than 8 weeks despite appropriate
treatment for underlying condition(s). It is estimated that there
are approximately 9 million patients in the United States suffering
from RCC. RCC is associated with significant adverse physical,
social, and psychosocial effects on health and quality of life.
Currently, there is no specific therapy approved for RCC and
treatment options are limited.
The Company is exploring the potential use of BLU-5937 in other
patient populations experiencing cough hypersensitivity as well as
other P2X3-related hypersensitization conditions.
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, the
U.S. Private Securities Litigation Reform Act of 1995, as amended,
and other applicable securities laws. Forward-looking statements
are frequently, but not always, identified by words such as
“expects,” “anticipates,” “believes,” “intends,” “estimates,”
“potential,” “possible,” “projects,” “plans,” and similar
expressions. 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's control. Such statements include,
but are not limited to, the potential of BLU-5937 to successfully
treat RCC and other hypersensitization-related disorders and
benefit such patients, BELLUS Health’s expectations related to its
preclinical studies and clinical trials, including the timing of
initiation of its Phase 3 clinical trial of BLU-5937 in RCC, the
timing and outcome of interactions with regulatory agencies, the
potential activity and tolerability profile, selectivity, potency
and other characteristics of BLU-5937, including as compared to
other competitor candidates, especially where head-to-head studies
have not been conducted and cross-trial comparisons may not be
directly comparable due to differences in study protocols,
conditions and patient populations, the commercial potential of
BLU-5937, including with respect to patient population, pricing and
labeling, BELLUS Health’s intention to discontinue development of
BLU-5937 in pruritic conditions, BELLUS Health’s financial
position, and the potential applicability of BLU-5937 and BELLUS
Health’s P2X3 platform to treat other disorders. Risk factors that
may affect BELLUS Health’s future results include but are not
limited to: the benefits and impact on label of its enrichment
strategy, estimates and projections regarding the size and
opportunity of the addressable RCC market for BLU-5937, the ability
to expand and develop its project pipeline, the ability to obtain
adequate financing, the ability of BELLUS Health to maintain its
rights to intellectual property and obtain adequate protection of
future products through such intellectual property, the impact of
general economic conditions, general conditions in the
pharmaceutical industry, the impact of the ongoing COVID-19
pandemic on BELLUS Health’s operations, plans and prospects,
including to the initiation and completion of clinical trials in a
timely manner or at all, changes in the regulatory environment in
the jurisdictions in which BELLUS Health does business, supply
chain impacts, stock market volatility, fluctuations in costs,
changes to the competitive environment due to consolidation,
achievement of forecasted burn rate, achievement of forecasted
preclinical study and clinical trial milestones, reliance on third
parties to conduct preclinical studies and clinical trials for
BLU-5937 and that actual results may differ from topline results
once the final and quality-controlled verification of data and
analyses has been completed. In addition, the length of BELLUS
Health’s product candidate’s development process and its market
size and commercial value are dependent upon a number of factors.
Moreover, BELLUS Health’s growth and future prospects are mainly
dependent on the successful development, patient tolerability,
regulatory approval, commercialization and market acceptance of its
product candidate BLU-5937 and other products. Consequently, actual
future results and events may differ materially from the
anticipated results and events expressed in the forward-looking
statements. BELLUS Health 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 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's public filings with the Canadian securities regulatory
authorities, including, but not limited to, its Annual Information
Form, and the United States Securities and Exchange Commission,
including, but not limited to, its Annual Report on Form 40-F, for
further risk factors that might affect BELLUS Health and its
business.
Source: BELLUS Health Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220223006178/en/
Ramzi Benamar Chief Financial Officer rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Trout
jdeutsch@soleburytrout.com
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