- Patient enrollment ongoing in the CALM Phase
3 program with topline data expected for CALM-1 in the second half
of 2024 -
- Ended year with US$337.1 million in cash,
cash equivalents and short-term investments; cash runway extends to
the second half of 2025 and through expected topline results of
both CALM-1 and CALM-2 trials -
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 year ended December 31,
2022.
“In 2022, we laid the groundwork to advance camlipixant, our
P2X3 receptor antagonist product candidate with best-in-class
potential, into late-stage development in RCC. This included
interacting with regulatory officials, solidifying the CALM Phase 3
trial designs and conducting validation work on the VitaloJAK cough
monitoring system – all of which allowed us to initiate CALM-1 and
CALM-2 in the fourth quarter,” commented Roberto Bellini, President
and Chief Executive Officer of BELLUS Health. “Looking ahead to
2023, we will remain focused on advancing our CALM Phase 3 clinical
program and building out our commercial strategy, while tracking
the upcoming key developments in the P2X3 receptor class.”
PROGRAM AND CORPORATE HIGHLIGHTS
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 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 24H 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.
- BELLUS Health conducted validation work on the VitaloJAK cough
monitoring system comparing compressed vs. non-compressed
recordings in a cohort of 45 SOOTHE Phase 2b trial participants.
The results showed a sensitivity of 98.7%, with no systematic error
observed. BELLUS Health submitted a validation protocol and
statistical analysis plan to the FDA in the fourth quarter of
2022.
- Topline results from CALM-1 are expected in the second half of
2024, and topline results from CALM-2 in 2025.
Completed large U.S. physician survey on the RCC market
landscape in 2022.
- Survey included 1,483 U.S. pulmonologists, allergists, ENTs,
gastroenterologists and primary care physicians and showed that
there are about 8.6 million RCC patients in the United States and
1.8 million RCC patients currently being seen by specialists.
Pursuing development of its P2X3 receptor pipeline.
- The Phase 1 clinical trial investigating the pharmacokinetics
of a once daily, extended-release formulation of camlipixant is
ongoing. The study is expected to be completed in the second
quarter of 2023.
Presented SOOTHE clinical data at the American Academy of
Allergy, Asthma & Immunology (“AAAAI”) Annual Meeting and the
CHEST Annual Meeting.
- Clinical data from the Phase 2b SOOTHE trial was presented at
the AAAAI Annual Meeting, held in San Antonio, Texas from February
24-27, 2023, and the CHEST Annual Meeting, held in Nashville,
Tennessee from October 16-19, 2022. The presentation materials are
available in the “Scientific Publications” section of BELLUS
Health's website here.
Presenting on camlipixant’s drug-drug interactions at the
American Society of Clinical Pharmacology & Therapeutics
(“ASCPT”) 2023 Annual Meeting, being held in Atlanta, GA.
- A poster presentation titled “In Vitro, In Silico, and Clinical
Investigations of BLU-5937 as Perpetrator of Drug-Drug
Interactions” will be presented at the upcoming ASCPT 2023 Annual
Meeting on Thursday, March 23, 2023 from 5:00 – 6:30 p.m. ET.
Following the conference, the poster will be available in the
“Scientific Publications” section of BELLUS Health's website
here.
Ended the year with cash, cash equivalents and short-term
investments totaling US$337.1 million.
FINANCIAL RESULTS
Cash Position: As of December 31, 2022, the Company had
available cash, cash equivalents and short-term investments
totaling US$337.1 million, compared to US$248.8 million as of
December 31, 2021. The net increase is primarily attributable to
the Company’s offering in July 2022, offset in part by funds used
to finance its operating activities, mainly the research and
development activities associated with its product candidate
camlipixant.
Net Loss: For the year ended December 31, 2022, net loss
amounted to US$76.1 million (US$0.66 per share), compared to
US$71.2 million (US$0.90 per share) for the previous year.
Research and Development Expenses: Research and
development expenses, net of research tax credits, amounted to
US$58.4 million for the year ended December 31, 2022, compared to
US$59.0 million for the previous year, a US$0.6 million or 1% year
over year decrease. The decrease is primarily attributable to a
decrease in external R&D spend as we have transitioned from our
Phase 2b SOOTHE clinical trial to the initiation of our CALM Phase
3 clinical program in 2022, offset in part by higher stock-based
compensation expense in relation 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$19.5 million for the
year ended December 31, 2022, compared to US$14.3 million for the
previous year, a US$5.2 million or 37% 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$1.9
million for the year ended December 31, 2022, compared to US$1.9
million for the previous year. In 2022, there was higher interest
income compared to the previous year due to the increased cash,
cash equivalents and short-term investments position following the
offerings in 2022 and 2021 and the increase in interest rates,
offset in part by an increase in foreign exchange loss resulting
from the conversion in U.S. dollars of the Company’s net monetary
assets denominated in Canadian dollars during the year (vs a
foreign exchange gain in 2021), due to the weakening of the
Canadian dollar versus the U.S. dollar in 2022.
SUMMARY OF FINANCIAL RESULTS
Unaudited
Year ended
December 31, 2022
Year ended
December 31, 2021
(in thousands of dollars, except
per share data)
Revenues
US$
16
US$
16
Research and development expenses, net
(58,403
)
(59,037
)
General and administrative expenses
(19,496
)
(14,263
)
Net finance income
1,863
1,861
Income tax (expense) recovery
(60
)
199
Net loss for the year
US$
(76,080
)
US$
(71,224
)
Basic and diluted loss per share
US$
(0.66
)
US$
(0.90
)
The Company’s full audited consolidated financial statements and
accompanying management’s discussion and analysis for the year
ended December 31, 2022 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 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 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 and 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: 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/20230321005909/en/
Ramzi Benamar Chief Financial Officer rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Strategic Communications
jdeutsch@soleburystrat.com
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