- Announced agreement to be acquired by GSK for
US$14.75 per share of common stock in cash representing an
approximate total equity value of US$2.0 billion and a premium of
approximately 103%; transaction expected to close in Q3 2023 –
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the
“Company”), a clinical-stage biopharmaceutical company working to
better the lives of patients suffering from persistent cough,
starting with the development of camlipixant (BLU-5937) for the
treatment of refractory chronic cough (“RCC”), today reported its
financial and operating results for the quarter ended March 31,
2023.
“Our merger agreement with GSK underscores our corporate and
clinical achievements to date and marks the start of a new chapter
for our potentially best-in-class P2X3 receptor antagonist,
camlipixant,” commented Roberto Bellini, President and Chief
Executive Officer of BELLUS Health. “We are confident that GSK’s
resources and focused expertise in the development and
commercialization of respiratory therapies will help us to achieve
our mission of bettering the lives of patients suffering from
persistent cough. As we work to close this transaction with GSK, we
remain committed to advancing our CALM Phase 3 program and are on
track to report topline data from CALM-1 in the second half of 2024
and CALM-2 in 2025.”
PROGRAM AND CORPORATE HIGHLIGHTS
GSK to acquire BELLUS Health.
- On April 18, 2023, GSK plc (LSE/NYSE: GSK) and BELLUS Health
Inc. (TSX/NASDAQ: BLU) announced that they have entered into an
agreement under which GSK will acquire BELLUS Health for US$14.75
per share of common stock in cash representing an approximate total
equity value of US$2.0 billion. The per-share price represents a
premium of approximately 103% to BELLUS Health's closing stock
price on April 17, 2023 and a premium of approximately 101% to
BELLUS Health's volume-weighted average price (VWAP) over the prior
30 trading days. The transaction remains subject to shareholder and
regulatory approvals and is expected to close in the third quarter
of 2023 or earlier.
Actively advancing the CALM Phase 3 clinical program (CALM-1
and CALM-2 trials) for camlipixant (BLU-5937) in RCC, with patient
enrollment ongoing.
- The CALM Phase 3 clinical program was initiated by the Company
in the fourth quarter of 2022, with patient enrollment ongoing. The
CALM program consists of two pivotal trials, CALM-1 and CALM-2,
with the primary endpoint of 24-hour cough frequency measured at
12- and 24-weeks, respectively, using the VitaloJAK cough
monitoring system. For additional information on the CALM-1 and
CALM-2 trials designs, click here.
- Topline results from CALM-1 are expected in the second half of
2024, and topline results from CALM-2 are expected in 2025.
Pursuing development of its P2X3 receptor pipeline.
- BELLUS Health reported positive results from its Phase 1
clinical trial investigating the safety, tolerability, and
pharmacokinetic profile of a once-daily, Extended-Release (“ER”)
formulation of camlipixant. The ER formulation demonstrated
equivalent bioavailability to the twice-daily Immediate Release
(“IR”) formulation. In addition, the ER formulation was well
tolerated, with safety data observed to be consistent with previous
camlipixant trials and no taste-related adverse events
reported.
Presenting at the upcoming American Thoracic Society (“ATS”)
2023 International Conference, being held in Washington, DC from
May 19-24, 2023.
- The Company will be presenting an oral abstract entitled
“Response in Patient-reported Cough Severity in SOOTHE, a Phase 2b
Trial of Camlipixant in Refractory Chronic Cough” on Sunday, May
21, 2023 at 3:15-3:27 p.m. ET, and a poster presentation entitled
“Model-based Dose Selection for Phase 3 Trials of the Selective
P2X3 Antagonist Camlipixant in Refractory Chronic Cough” will be
presented on Monday, May 22, 2023 at 11:30-1:15 p.m. ET. Following
the ATS 2023 International Conference, the presentation materials
will be available in the “Scientific Publications” section of
BELLUS Health's website here.
- Additionally, conference participants are invited to attend two
BELLUS Health-sponsored Guru Bars on Tuesday, May 23, 2023. Booth
#1100 entitled “Refractory Chronic Cough: Is it All in Our Head?”
will be available at 1:00-1:20 p.m. ET and Booth #1200 entitled
“Understanding the Roadmap to Diagnosing Refractory Chronic Cough”
will be available at 1:30-1:50 p.m. ET.
Presented at the American Academy of Allergy, Asthma &
Immunology (“AAAAI”) Annual Meeting and at the American Society of
Clinical Pharmacology & Therapeutics (“ASCPT”) 2023 Annual
Meeting.
- The Company presented clinical data from the Phase 2b SOOTHE
trial at the AAAAI Annual Meeting, held in San Antonio, Texas from
February 24-27, 2023. The Company also presented results from phase
1 drug-drug interactions studies of camlipixant at the ASCPT 2023
Annual Meeting, held in Atlanta, Georgia from March 22-24, 2023.
The presentation materials are available in the “Scientific
Publications” section of BELLUS Health's website here.
FINANCIAL RESULTS
Cash Position: As of March 31, 2023, the Company had
available cash, cash equivalents and short-term investments
totaling US$313.0 million, compared to US$337.1 million as of
December 31, 2022. The net decrease for the three-month period
ended March 31, 2023 is primarily attributable to funds used to
finance the Company’s operating activities, mainly the research and
development activities associated with its product candidate
camlipixant (BLU-5937).
Net Loss: For the quarter ended March 31, 2023, net loss
amounted to US$25.1 million (US$0.20 per share), compared to
US$14.4 million (US$0.13 per share) for the same period in
2022.
Research and Development Expenses: Research and
development expenses, net of research tax credits, amounted to
US$22.3 million for the quarter ended March 31, 2023, compared to
US$11.3 million for the same period in 2022, a US$11.0 million or
98% year over year increase. The increase is primarily attributable
to higher external R&D spend incurred for the development of
camlipixant, mainly for activities in relation to the Company’s
CALM Phase 3 clinical program, which was initiated in the fourth
quarter of 2022. The increase is also due to higher stock-based
compensation expense in relation to the Company’s stock option plan
and higher workforce expenses due to an increase in headcount to
support the development of camlipixant.
General and Administrative (“G&A”) Expenses: General
and administrative expenses amounted to US$5.4 million for the
quarter ended March 31, 2023, compared to US$4.1 million for the
same period in 2022, a US$1.3 million or 33% year over year
increase. The increase is mainly attributable to higher external
G&A expenses, as well as to higher stock-based compensation
expense in relation to the Company’s stock option plan.
Net Finance Income: Net finance income amounted to US$2.7
million for the quarter ended March 31, 2023, compared to US$1.0
million for the same period in 2022. The increase in net finance
income is mainly attributable to higher interest income due to the
increased cash, cash equivalents and short-term investments
position following the July 2022 Offering and the increase in
interest rates, offset in part by a lower foreign exchange gain in
the current period resulting from the conversion in U.S. dollars of
the Company’s net monetary assets denominated in Canadian
dollars.
SUMMARY OF FINANCIAL RESULTS
Unaudited
Quarter ended March 31, 2023
Quarter ended March 31, 2022
(in thousands of dollars, except
per share data)
Revenues
US$
3
US$
4
Research and development expenses, net
(22,335
)
(11,254
)
General and administrative expenses
(5,392
)
(4,050
)
Net finance income
2,683
973
Income tax expense
(19
)
(25
)
Net loss for the period
US$
(25,060
)
US$
(14,352
)
Basic and diluted loss per share
US$
(0.20
)
US$
(0.13
)
The Company’s full unaudited consolidated interim financial
statements and accompanying management’s discussion and analysis
for the quarter ended March 31, 2023 will be available shortly on
SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.
About Camlipixant (BLU-5937)
Camlipixant, a highly selective P2X3 receptor 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 successfully evaluated in multiple clinical
trials with different P2X3 antagonists. The Company believes that
camlipixant’s high selectivity as a P2X3 receptor antagonist and
the results of its Phase 2b SOOTHE trial position it as a potential
best in class P2X3 receptor antagonist to significantly improve the
quality of life of patients suffering from RCC.
In addition to RCC, the mechanism of action of camlipixant may
also have broad therapeutic applicability across other cough
hypersensitivity indications. The Company is evaluating potential
opportunities to study camlipixant in additional indications where
cough hypersensitivity plays an important role.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
working to better the lives of patients suffering from persistent
cough, starting with the development of camlipixant (BLU-5937) for
the treatment of refractory chronic cough (RCC). Camlipixant, the
Company’s lead asset, is an investigational P2X3 receptor
antagonist for the treatment of refractory chronic cough (RCC),
which is currently being evaluated in the CALM Phase 3 clinical
program. With no approved treatments in the U.S., camlipixant has
the potential to be a breakthrough in the RCC treatment
landscape.
Chronic cough is defined as a cough lasting longer than eight
weeks. When the cause of chronic cough cannot be identified or the
cough persists despite treatment of any associated condition, the
condition is referred to as RCC. RCC is a frequent, yet often
under-recognized, medical condition that has significant physical,
social, and psychological consequences on one’s quality of life.
There are currently no approved treatments for this condition in
the United States, European Union or the United Kingdom.
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 closing of the acquisition of BELLUS
Health by GSK, the timeline thereof and the realization of the
anticipated benefits from the transaction, the potential of
camlipixant (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 completion of its Phase 3 clinical
trials of camlipixant in RCC and the expected timing of topline
results from CALM-1 and CALM-2 Phase 3 clinical trials, the timing
and outcome of interactions with regulatory agencies, the ability
of BELLUS Health to validate its use of the VitaloJAK cough
monitoring system to the satisfaction of relevant regulatory
agencies, the potential activity and tolerability profile,
selectivity, potency and other characteristics of camlipixant,
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 camlipixant, including with respect to patient
population, pricing and labeling and potential treatment
alternatives, BELLUS Health’s financial position and sufficiency of
cash resources to bring through topline results of CALM-1 and
CALM-2 clinical trials, timely or at all, and the potential
applicability of camlipixant, BELLUS Health’s P2X3 receptor
platform to treat other disorders. Risk factors that may affect
BELLUS Health’s future results include but are not limited to:
risks associated with the closing of the acquisition of BELLUS
Health by GSK on the expected timeline, including as regards
regulatory and shareholder approvals, the intended benefits,
acceptability to regulatory agencies and impact of its enrichment
strategy, continuing feedback and discussions with the FDA and
other regulatory authorities regarding the design of the CALM Phase
3 program, estimates and projections regarding the size and
opportunity of the addressable RCC market for camlipixant, 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
camlipixant, that final data from studies and clinical trials may
differ from reported data from preliminary studies or clinical
trials 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 camlipixant 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/20230512005376/en/
Ramzi Benamar Chief Financial Officer
rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Strategic Communications
jdeutsch@soleburystrat.com
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