- Announced positive findings from the Phase 2b
SOOTHE trial administrative interim analysis, with at least one
dose of BLU-5937 meeting the threshold for a high probability of
clinical efficacy -
- Phase 2b SOOTHE and Phase 2a BLUEPRINT trials
are fully enrolled, with topline results expected in December 2021
-
- Ended third quarter 2021 with US$58.4M cash
and cash runway extending to 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 refractory chronic cough
(“RCC”) and other hypersensitization-related disorders, today
reported its financial and operating results for the third quarter
ending September 30, 2021.
“We are pleased with the substantial progress we have made
advancing our two ongoing Phase 2 trials this quarter, as the
clinical milestones achieved for each of these trials represent
important steps forward in our development strategy for our
selective P2X3 antagonist, BLU-5937,” commented Roberto Bellini,
President and Chief Executive Officer of BELLUS Health. “Both
SOOTHE and BLUEPRINT trials completed participant enrollment in
September, which should enable us to announce topline results from
both trials in December 2021. Importantly, we reported positive
interim findings from the SOOTHE trial in refractory chronic cough
and, while we wait for topline results, we have initiated our
planning efforts for the Phase 3 program. We’re looking forward to
an eventful fourth quarter, with our virtual Analyst Event taking
place on November 15th, in addition to the expected topline data
from our two randomized, placebo-controlled Phase 2 trials.”
PROGRAM AND CORPORATE HIGHLIGHTS
Ongoing Phase 2b SOOTHE clinical trial of BLU-5937 in
patients with RCC.
- In September 2021, the Company announced positive findings from
a preplanned administrative interim analysis of the SOOTHE trial. A
predefined stringent probability threshold for clinical efficacy
was met for at least one and up to all three doses of BLU-5937
tested. Limited taste-related adverse events were observed,
consistent with previous BLU-5937 trials, and no serious adverse
events were reported.
- As of September 2021, the Company completed participant
enrollment in the SOOTHE trial with a total of 310 participants
with RCC enrolled, including 249 participants in the main trial and
61 in the exploratory group.
- Topline results are expected in December 2021.
- The positive findings from the SOOTHE trial interim analysis
enabled the Company to accelerate the planning for its Phase 3
program while awaiting the SOOTHE trial’s final results.
Ongoing Phase 2a BLUEPRINT clinical trial of BLU-5937 in
patients with chronic pruritus associated with atopic dermatitis
(“AD”).
- As of September 2021, the Company completed participant
enrollment in the BLUEPRINT trial, with a total of 142 participants
with moderate to severe chronic pruritus associated with mild to
moderate AD enrolled.
- Topline results are expected in December 2021.
Presented additional RELIEF data at the European Respiratory
Society International Congress 2021 (“ERS”)
- Additional data from the Phase 2a RELIEF trial was presented in
an oral presentation at ERS, which was held September 5-8, 2021.
The presentation reviewed the observed improvements seen in cough
severity and quality of life over a 16-day treatment period that
favored BLU-5937.
Hosting a virtual Analyst Event to discuss the chronic cough
landscape and the Company’s selective P2X3 antagonist
BLU-5937.
- On November 15, 2021, the Company is planning to host 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 will be hosted
virtually, and a replay of the event will be available on the
Events & Presentations page of the Company’s website.
Ended the third quarter of 2021 with cash, cash equivalents
and short-term investments totaling US$58.4 million.
- Current cash position is expected to be sufficient to fund the
Company’s operating plan until the end of 2022.
FINANCIAL RESULTS
Cash Position: As of September 30, 2021, the Company had
available cash, cash equivalents and short-term investments
totaling US$58.4 million, compared to US$98.3 million as of
December 31, 2020. The net decrease is primarily attributable to
funds used to finance the Company’s operating activities, mainly
the research and development activities associated with its product
candidate BLU-5937.
Net Loss: For the quarter ended September 30, 2021, net
loss amounted to US$22.9 million (US$0.29 per share), compared to
US$5.7 million (US$0.09 per share) for the same period in 2020.
Research and Development Expenses: Research and
development expenses, net of research tax credits, amounted to
US$19.1 million for the quarter ended September 30, 2021, compared
to US$5.8 million for the same period in 2020, an increase of
US$13.3 million or 229% year over year. The increase is primarily
attributable to higher expenses incurred for the development of
BLU-5937, mainly activities in relation to the Phase 2b SOOTHE
trial in RCC, as well as activities in relation to the Phase 2a
BLUEPRINT trial in chronic pruritus associated with AD, preclinical
and clinical development activities to support the Company’s RCC
program and CMC activities.
General and Administrative (“G&A”) Expenses: General
and administrative expenses amounted to US$3.8 million for the
quarter ended September 30, 2021, compared to US$0.5 million for
the same period in 2020, an increase of US$3.3 million or 738% year
over year. The increase is mainly attributable to a higher
stock-based compensation expense related to the Company’s deferred
share unit plan, due to an increase in the stock price compared to
the previous year.
Net Finance (Costs) Income: Net finance costs amounted to
US$0.0 million for the quarter ended September 30, 2021, compared
to a net finance income of US$0.5 million for the same period in
2020. The increase in net finance costs is mainly attributable to a
foreign exchange loss that arose from the translation of the
Company’s net monetary assets denominated in Canadian dollars
during the period, compared to a foreign exchange gain in the
corresponding period the previous year, as well as to lower
interest income due to lower interest rates on short term
investments.
SUMMARY OF FINANCIAL RESULTS
Three months ended
September 30, 2021
Three months ended
September 30, 2020
(in thousands of dollars, except
per share data)
Revenues
US$
4
US$
3
Research and development expenses, net
(19,054)
(5,796)
General and administrative expenses
(3,821)
(456)
Net finance (costs) income
(10)
540
Net loss for the period
US$
(22,881)
US$
(5,709)
Basic and diluted loss per share
US$
(0.29)
US$
(0.09)
The Company’s full unaudited condensed consolidated interim
financial statements and accompanying management’s discussion and
analysis for the three and nine-month periods ended September 30,
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, 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 cough
frequency in patients with RCC, while limiting taste disturbance
adverse events.
In addition to RCC and chronic pruritus, 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 how the P2X3 pathway may contribute to
irritation and pain in a variety of afferent
hypersensitization-related disorders and whether inhibition of P2X3
receptors can help treat these 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
hypersensitization-related disorders. The Company's product
candidate, BLU-5937, is being developed for the treatment of adults
with RCC and chronic pruritus associated with AD.
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.
Chronic pruritus associated with AD is an irritating sensation
that leads to scratching and persists for longer than 6 weeks in AD
patients. It is estimated that up to 10% of adults in the United
States suffer from AD – almost all report symptoms of pruritus with
over 50% of patients attributing chronic pruritus as their most
burdensome symptom. Despite currently available treatments
targeting AD, there continues to be a lack of options specifically
targeting the burden of pruritus in patients with AD.
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, chronic pruritus associated with AD and other
hypersensitization-related disorders, BELLUS Health’s expectations
related to its preclinical studies and clinical trials, including
the design, timing and results of its Phase 2b clinical trial of
BLU-5937 in RCC and its Phase 2a 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 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, 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, the
ability of the Company’s interim analysis of the Phase 2b SOOTHE
trial to predict the final results of the trial and the
interpretability thereof, 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.
Source: BELLUS Health Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211110006251/en/
Ramzi Benamar Chief Financial Officer
rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Trout
jdeutsch@soleburytrout.com
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