- Initiated CALM Phase 3 program with topline
data expected for CALM-1 and CALM-2 in the second half of 2024 and
2025, respectively -
- Ended third quarter 2022 with US$364.4
million in cash, cash equivalents and short-term investments; Cash
runway extended 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 developing
novel therapeutics for the treatment of refractory chronic cough
(“RCC”) and other hypersensitivity indications, today reported its
financial and operating results for the third quarter ended
September 30, 2022.
“We are pleased to announce the initiation of our CALM Phase 3
program, which we expect to be the final clinical step in
potentially bringing BLU-5937, our P2X3 antagonist product
candidate, to patients burdened by RCC, if approved. To add, this
quarter, we have also made key advancements to ensure successful
execution of these pivotal trials, including communicating with
regulatory officials, conducting validation work on the VitaloJAK –
as well as strengthening our cash position,” commented Roberto
Bellini, President and Chief Executive Officer of BELLUS Health.
“With no approved treatments in the United States, RCC remains a
high unmet need and we are encouraged by BLU-5937’s potential to be
an innovative and best-in-class product in the treatment landscape,
if approved. We look forward to advancing the CALM program and
expect to share topline data from CALM-1 in the second half of
2024.”
PROGRAM AND CORPORATE HIGHLIGHTS
Initiated the CALM Phase 3 clinical program (CALM-1 and
CALM-2).
- BELLUS Health has completed a positive End-Of-Phase 2 meeting
with the U.S. Food and Drug Administration (“FDA”), and received
scientific advice on the design of its CALM Phase 3 clinical
program from both the European Medicines Agency (“EMA”) and the
Medicines and Healthcare products Regulatory Agency (“MHRA”).
- The CALM Phase 3 clinical program has been initiated with
patient screening 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
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 systemic error and no bias observed.
BELLUS Health will submit a validation protocol and statistical
analysis plan to the FDA before year-end.
- Topline results from CALM-1 are expected in the second half of
2024, with topline results from CALM-2 expected in 2025.
Completed large U.S. physician survey on the RCC market
landscape.
- Survey included 1,483 U.S. pulmonologists, allergists, ENTs,
gastroenterologists and primary care physicians showing 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 pipeline.
- The Phase 1 clinical trial investigating the pharmacokinetics
of a once daily, extended-release formulation of BLU-5937 has been
initiated with enrollment ongoing. The study is expected to be
completed in the first half of 2023.
Presented at the CHEST Annual Meeting, the European
Respiratory Society (“ERS”) International Congress 2022 and the
Twelfth London International Cough Symposium (“LICS”).
- Clinical data from the Phase 2b SOOTHE trial was presented at
the CHEST Annual Meeting, held in Nashville, Tennessee from October
16-19, 2022, the ERS International Congress 2022, held in
Barcelona, Spain from September 4-6, 2022, and the 12th LICS, held
from July 13-14, 2022. The presentation materials are available in
the “Scientific Publications” section of BELLUS Health's website
here.
Completed a US$176.0 million public offering of common shares
in Canada and the United States.
- In July 2022, the Company completed a public offering of its
common shares resulting in gross proceeds of US$176.0 million (the
“2022 Offering”), including the full exercise of the option to
purchase additional shares. These proceeds extended the Company’s
cash runway to the second half of 2025 and through the topline
results of both CALM-1 and CALM-2.
Established At-the-Market (“ATM”) Facility.
- The Company entered into an agreement with Jefferies LLC
pursuant to which the Company may from time to time sell, through
ATM distributions with Jefferies acting as sales agent, common
shares with an aggregate offer price of up to US$80.0 million,
including sales made directly on The Nasdaq Global Market
(“Nasdaq”) or on any other existing trading market for the common
shares in the United States. No common shares will be offered or
sold in Canada.
- The Company has filed a prospectus supplement (the
“Supplement”) dated the date hereof and a short form base shelf
prospectus dated August 26, 2022 (the “Base Prospectus”) and in the
United States pursuant to a registration statement on Form F-10,
which was declared effective by the U.S. Securities and Exchange
Commission on August 26, 2022, in accordance with the
Multijurisdictional Disclosure System established between Canada
and the United States.
- Copies of the Supplement and accompanying Base Prospectus may
be obtained by contacting Jefferies LLC, Attention: Equity
Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New
York, NY 10022, by telephone at 877-821-7388 or by email at
prospectus_department@jefferies.com. The Sales Agreement, the
Supplement and the accompanying Base Prospectus can also be found
on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
- BELLUS Health’s common shares are dual-listed on Nasdaq and the
Toronto Stock Exchange (“TSX”) under the trading symbol “BLU.” For
the purposes of the TSX approval, the Company relied on the
exemption set forth in Section 602.1 of the TSX Company Manual,
which provides that the TSX will not apply its standards to certain
transactions involving eligible interlisted issuers on a recognized
exchange, such as Nasdaq. This news release shall not constitute an
offer to sell or the solicitation of an offer to buy, nor shall
there be any sale of these securities in any province, state or
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to the registration or qualification under the
securities laws of any such province, state or jurisdiction.
Ended the third quarter of 2022 with cash, cash equivalents
and short-term investments totaling US$364.4 million.
FINANCIAL RESULTS
Cash Position: As of September 30, 2022, the Company had
available cash, cash equivalents and short-term investments
totaling US$364.4 million, compared to US$248.8 million as of
December 31, 2021. The net increase is primarily attributable to
funds obtained through the 2022 Offering, offset in part 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 quarter ended September 30, 2022, net
loss amounted to US$24.7 million (US$0.20 per share), compared to
US$22.9 million (US$0.29 per share) for the same period in
2021.
Research and Development Expenses: Research and
development expenses, net of research tax credits, amounted to
US$17.2 million for the quarter ended September 30, 2022, compared
to US$19.1 million for the same period in 2021, a US$1.8 million or
10% quarter over quarter decrease. The decrease in research and
development expenses is primarily attributable to a decrease in
external R&D spend as the Company has transitioned from its
Phase 2b SOOTHE clinical trial to the initiation of its CALM Phase
3 clinical program. The decrease is partially offset by higher
expenses due to the Company’s increased workforce to support the
CALM Phase 3 program as well as higher stock-based compensation
expense in relation to the Company’s stock option plan.
General and Administrative (“G&A”) Expenses: General
and administrative expenses amounted to US$5.8 million for the
quarter ended September 30, 2022, compared to US$3.8 million for
the same period in 2021, a US$2.0 million or 53% quarter over
quarter 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 Costs: Net finance costs amounted to US$1.7
million for the quarter ended September 30, 2022, compared to
US$0.0 million for the same period in 2021. The increase in net
finance costs during the current quarter is mainly attributable to
an increase in foreign exchange loss resulting from the conversion
in U.S. dollars of the Company’s net monetary assets denominated in
Canadian dollars during the period, due to the weakening of the
Canadian dollar versus the U.S. dollar during the period. The
increase is partially offset by higher interest income due to the
increased cash, cash equivalents and short-term investments
position following the 2022 and 2021 Offerings and the increase in
interest rates.
SUMMARY OF FINANCIAL RESULTS
Three months ended
September 30, 2022
Three months ended
September 30, 2021
(in thousands of dollars, except
per share data)
Revenues
US$
4
US$
4
Research and development expenses, net
(17,241
)
(19,054
)
General and administrative expenses
(5,838
)
(3,821
)
Net finance income
(1,656
)
(10
)
Income taxes
25
—
Net loss for the year
US$
(24,706
)
US$
(22,881
)
Basic and diluted loss per share
US$
(0.20
)
US$
(0.29
)
The Company’s full unaudited consolidated financial statements
and accompanying management’s discussion and analysis for the
three- and nine-month periods ended September 30, 2022 will be
available 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 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 neuronal
hypersensitivity indications. The Company is evaluating potential
opportunities to study BLU-5937 in additional indications where
hypersensitivity plays an important role.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for the treatment of RCC and other
hypersensitivity indications. The Company has successfully
completed a Phase 2b trial in RCC and has initiated the CALM Phase
3 clinical program (CALM-1 and CALM-2).
Chronic cough is a cough lasting longer than eight weeks. When
the cause of chronic cough cannot be identified or the cough
persists despite treatment of all identified associated causes, the
condition is referred to as RCC. 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 psychological effects on health and quality of life.
Currently, there is no specific therapy approved for RCC outside of
Japan and Switzerland and treatment options are limited.
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 completion
of its Phase 3 clinical trials of BLU-5937 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 to the satisfaction of relevant 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 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 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, 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 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/20221114005958/en/
Ramzi Benamar Chief Financial Officer
rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Strategic Communications
jdeutsch@soleburystrat.com
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