- Initiated the Phase 2b SOOTHE clinical trial
in refractory chronic cough; topline results expected Q4 2021 with
an interim analysis expected in mid-2021 -
- Initiated the Phase 2 BLUEPRINT clinical
trial in chronic pruritus associated with atopic dermatitis;
topline results expected Q4 2021 -
- Ended year with US$98.3 million in cash, cash
equivalents and short-term investments; current cash position
expected to be sufficient to fund operating plan until end of 2022
-
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the
“Company”), a clinical-stage biopharmaceutical company developing
novel therapeutics for the treatment of chronic cough and other
hypersensitization-related disorders, today reported its financial
and operating results for the year ending December 31, 2020.
“Over the past 12 months, we have made significant progress with
our corporate strategy, financial position, and clinical
development of BLU-5937 – laying the groundwork for what we
anticipate will be a transformative year ahead,” commented Roberto
Bellini, President and Chief Executive Officer of BELLUS Health.
“Building off the proof-of-concept RELIEF Phase 2 data announced
last summer, we have advanced BLU-5937 into our recently initiated
Phase 2b SOOTHE trial in refractory chronic cough, with topline
results anticipated to read out in the fourth quarter of this year.
We believe BLU-5937 has the potential to treat a wide range of
hypersensitization-related conditions and have begun to explore
this potential through the initiation of our Phase 2 BLUEPRINT
trial in chronic pruritus associated with atopic dermatitis, with
topline data expected in the fourth quarter of 2021.”
PROGRAM AND CORPORATE HIGHLIGHTS
Initiated the Phase 2b SOOTHE clinical trial of BLU-5937 in
patients with refractory chronic cough (“RCC”) in December
2020.
- Topline results from the SOOTHE trial are expected in Q4
2021.
- An interim analysis using a predefined efficacy and probability
threshold is expected to be performed in mid-2021, once 50% of
participants have completed the study.
- Phase 2b SOOTHE trial population enriched for participants with
cough frequency above 25 coughs/h at baseline.
Initiated the Phase 2 BLUEPRINT clinical trial of BLU-5937 in
patients with chronic pruritus associated with atopic dermatitis
(“AD”) in December 2020.
- Topline results from the BLUEPRINT trial are expected in Q4
2021.
Announced topline results from the Phase 2 RELIEF clinical
trial of BLU-5937 in patients with RCC in July 2020.
- The RELIEF trial achieved proof-of-concept in reducing cough
frequency in RCC patients, including statistically significant and
clinically meaningful reductions in two pre-specified sub-group
analyses of participants with baseline awake cough frequency of ≥20
coughs/hour (80% of trial participants) and ≥32 coughs/hour (50% of
trial participants).
- Numerical differences in favor of BLU-5937 were also observed
in the whole study (intention-to-treat) population; however the
trial did not meet its primary endpoint in this population.
- BLU-5937 was well tolerated and showed an adverse event profile
comparable to placebo. The taste disturbance adverse events were
limited to 10% or less, confirming the hypothesis that BLU-5937 has
a favorable adverse event profile compared to the first generation
P2X3 antagonist. Additionally, no complete loss of taste was
observed at any dose, no severe taste adverse event was reported
and no dropouts due to taste disturbance occurred.
Completed a US$40.3 million offering in October
2020.
- In October 2020, BELLUS Health completed an offering of its
common shares, resulting in gross proceeds to the Company of
US$40.3 million.
Acquired complete ownership of the intellectual property
rights to BLU-5937 and related P2X3 antagonists.
- In March 2020, the Company acquired all remaining BLU-5937 and
related P2X3 antagonists intellectual property rights from adMare
BioInnovations’ NEOMED Institute. BELLUS Health now owns 100% of
the rights to BLU-5937 and related P2X3 antagonists, with no future
payments due.
Appointed Ramzi Benamar as Chief Financial Officer.
- In December 2020, the Company appointed Ramzi Benamar to the
role of Chief Financial Officer. Mr. Benamar brings to the Company
extensive experience in corporate strategy, finance and
operations.
FINANCIAL RESULTS
Cash Position: As of December 31, 2020, the Company had
available cash, cash equivalents and short-term investments
totaling US$98.3 million, compared to US$90.0 million at December
31, 2019. The increase is primarily attributable to US$37.6 million
in net proceeds from the October 2020 offering, offset by funds
used to finance its operating activities, mainly research and
development activities associated with its product candidate
BLU-5937. Current cash, cash equivalents and short-term investments
are projected to be sufficient to fund the Company’s operating plan
until the end of 2022.
Net Loss: For the year ended December 31, 2020, net loss
amounted to US$31.8 million (US$0.54 per share), compared to
US$26.0 million (US$0.55 per share) for the same period in
2019.
Research and Development Expenses: Research and
development expenses, net of research tax credits, amounted to
US$23.2 million for the year ended December 31, 2020, compared to
US$19.2 million for the same period in 2019, a US$4.0 million or
21% year on year increase to support the development of BLU-5937.
The increase is primarily attributable to the Company’s increased
workforce in 2020 as well as to higher stock-based compensation
expense in relation to BELLUS Health’s stock option plan.
General and Administrative Expenses: General and
administrative expenses amounted to US$9.7 million for the year
ended December 31, 2020, compared to US$6.6 million for the same
period in 2019, a US$3.1 million or 48% year on year increase. The
increase is mainly due to costs related to the Company’s public
listing on the NASDAQ, which occurred in September 2019, as well as
to higher stock-based compensation expense in relation to the
Company’s stock option plan.
Net Finance Income (Costs): Net finance income amounted
to US$1.2 million for the year ended December 31, 2020, compared to
net finance costs of US$0.3 million for the same period in 2019.
The increase in net finance income is mainly attributable to a
foreign exchange gain that arose from the translation of the
Company’s net monetary assets denominated in Canadian dollars
during the year. In 2019, prior to the change in functional
currency effective January 1, 2020, the Company incurred a foreign
exchange loss from the translation of its net monetary assets
denominated in US dollars during the year.
SUMMARY OF FINANCIAL RESULTS
Year ended December 31, 2020
Year ended December 31, 2019
(in thousands of dollars, except
per share data)
Revenues
US$
15
US$
27
Research and development expenses, net
(23,222
)
(19,178
)
General and administrative expenses
(9,735
)
(6,580
)
Net finance income (loss)
1,185
(277
)
Net loss for the year
US$
(31,757
)
US$
(26,008
)
Basic and diluted loss per share
US$
(0.54
)
US$
(0.55
)
The Company’s full audited consolidated financial statements and
accompanying management’s discussion and analysis for the year
ended December 31, 2020 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 - (>1500 fold) -
is in development for chronic cough, chronic pruritus and other
hypersensitization-related disorders.
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 coughing in
patients with RCC while limiting taste disturbance adverse
events.
In addition to chronic cough and chronic pruritus, BLU-5937 may
also have broad applicability across other afferent
hypersensitization-related disorders, enabling the Company to
consider developing a pipeline of therapies using its P2X3
platform. BELLUS Health is exploring how P2X3 activation can
contribute to irritation and pain, and whether inhibition of P2X3
receptors can help treat these afferent hypersensitization-related
disorders.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for the treatment of chronic cough
and other hypersensitization-related disorders. The Company's
product candidate, BLU-5937, is being developed for the treatment
of chronic cough and chronic pruritus.
Chronic cough, the lead indication for BLU-5937, is a cough
lasting more than eight weeks and is associated with significant
adverse physical, social and psychosocial effects on health and
quality of life. It is estimated that approximately 26 million
adults in the United States suffer from chronic cough, of which
approximately 9 million patients are identified as having RCC.
There is no specific therapy approved for RCC and current treatment
options are limited.
Chronic pruritus, the second indication for BLU-5937, is
commonly known as chronic itch and is an irritating sensation that
leads to scratching and persists for longer than six weeks, which
can be debilitating and can significantly impact quality of life.
It is a hallmark of many inflammatory skin diseases, including AD.
It is estimated that AD afflicts approximately 5% of adults in the
United States. Despite currently available treatments targeting AD,
there continues to be a lack of options targeting the burden of
pruritus in AD patients.
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 chronic cough, chronic pruritus and other
hypersensitization-related disorders, BELLUS Health’s expectations
related to its preclinical studies and clinical trials, including
the design and timing of its Phase 2b clinical trial of BLU-5937 in
RCC and its Phase 2 clinical trial of BLU-5937 in chronic pruritus
associated with AD, including 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, the commercial potential of BLU-5937,
including with respect to patient population, pricing and labeling,
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 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, 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 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 vary 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210225006121/en/
Danny Matthews Director, Investor Relations and Communications
danny@bellushealth.com
Media: Julia Deutsch Solebury Trout
jdeutsch@soleburytrout.com
BELLUS Health (TSX:BLU)
Historical Stock Chart
From Mar 2024 to Apr 2024
BELLUS Health (TSX:BLU)
Historical Stock Chart
From Apr 2023 to Apr 2024