BLU BELLUS Health Inc.

6
+0.02  (+0%)
Previous Close 5.98
Open 5.86
52 Week Low 2.01
52 Week High 6.34
Market Cap $470,024,166
Shares 78,337,361
Float 78,337,361
Enterprise Value $344,026,381
Volume 529,630
Av. Daily Volume 2,247,054
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Upcoming Catalysts

Drug Stage Catalyst Date
BLU-5937 (SOOTHE)
Chronic cough
Phase 2b
Phase 2b
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BLU-5937 (BLUEPRINT)
Chronic pruritus associated with atopic dermatitis
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
BLU-5937 (RELIEF)
Chronic cough
Phase 2a
Phase 2a
Phase 2a trial did not meet primary endpoint July 6 2020.

Latest News

  1. Interim analysis met the threshold for a high probability of clinical efficacy

    Data from interim analysis support accelerated planning for the Phase 3 program

    SOOTHE Phase 2b trial is on track to deliver topline results in Q4 2021

    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 and other hypersensitization-related disorders, today announced positive findings from a preplanned administrative interim analysis of the ongoing Phase 2b SOOTHE trial of BLU-5937, the Company's highly selective P2X3 antagonist, in patients with refractory chronic cough ("RCC").

    An independent statistical team reported…

    Interim analysis met the threshold for a high probability of clinical efficacy

    Data from interim analysis support accelerated planning for the Phase 3 program

    SOOTHE Phase 2b trial is on track to deliver topline results in Q4 2021

    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 and other hypersensitization-related disorders, today announced positive findings from a preplanned administrative interim analysis of the ongoing Phase 2b SOOTHE trial of BLU-5937, the Company's highly selective P2X3 antagonist, in patients with refractory chronic cough ("RCC").

    An independent statistical team reported that the predefined stringent probability threshold for clinical efficacy was met for at least one dose of BLU-5937. The following observations of the interim data were made regarding key aspects of the BLU-5937 product profile:

    - At least one dose of BLU-5937 met the stringent predefined probability threshold for a clinically meaningful reduction in placebo-adjusted 24-hour cough frequency;

    - Limited taste-related adverse events were observed, consistent with previous BLU-5937 trials;

    - No serious adverse events were reported.

    "We believe the encouraging SOOTHE Phase 2b trial interim analysis will enable us to accelerate the planning for our Phase 3 program while awaiting SOOTHE final results," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "With trial enrollment progressing as planned, we anticipate announcing topline data in the fourth quarter of 2021."

    About SOOTHE

    The SOOTHE trial is a multicenter, randomized, double-blind, four-week, parallel arm, placebo-controlled Phase 2b trial evaluating three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID) in 300 participants with refractory chronic cough. 240 participants with a baseline awake cough frequency of ≥25 awake coughs per hour are expected to be randomized across four arms (1:1:1:1) evaluating the three active doses of BLU-5937 and placebo in the main study. Treatment arms will be stratified to balance the number of participants with baseline awake cough frequency ≥45 coughs per hour across trial arms. The primary efficacy endpoint will be the placebo-adjusted change in the 24-hour cough frequency from baseline to day 28 collected with a cough recorder. An exploratory group of an additional 60 participants with a baseline awake cough frequency of ≥10 and <25 coughs per hour are expected to be randomized across 2 arms (1:1) evaluating one active dose (200 mg BID) and placebo to further investigate the effect of BLU-5937 in patients with lower cough frequency. More information about the trial is available at www.clinicaltrials.gov: NCT04678206.

    About the Interim Analysis

    An independent statistical team conducted the preplanned interim analysis once half of the total participants in the main trial completed their treatment period. The interim analysis was performed for administrative purposes and has no impact on the design or future conduct of the SOOTHE trial. Trial participants will continue to be enrolled and followed to trial completion.

    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 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 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 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 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, the ability of the interim analysis to predict the final results of the SOOTHE trial, 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.

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  2. 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 announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will present a corporate overview of the Company at the H.C. Wainwright Global Investment Conference.

    Presentation Details:

    Event: H.C. Wainwright 23rd Annual Global Investment Conference
    Date/Time: Monday, September 13th, 2021 at 7:00 a.m. ET

    A webcast of the presentation may be accessed on the Events & Presentations page under the Investors & Media section of BELLUS Health's website at www.bellushealth.com

    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 announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will present a corporate overview of the Company at the H.C. Wainwright Global Investment Conference.

    Presentation Details:

    Event: H.C. Wainwright 23rd Annual Global Investment Conference

    Date/Time: Monday, September 13th, 2021 at 7:00 a.m. ET

    A webcast of the presentation may be accessed on the Events & Presentations page under the Investors & Media section of BELLUS Health's website at www.bellushealth.com. Following the event, an archived webcast will be available on the Company's website.

    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 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.

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  3. 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 announced that an abstract covering additional data from the RELIEF Phase 2a trial has been accepted for oral presentation at the upcoming European Respiratory Society ("ERS") International Congress 2021, being held September 5-8, 2021.

    "Refractory chronic cough can be a debilitating condition that impacts a patient's everyday life. With limited therapy options available, there is a significant need for new treatments that reduce cough, improve a patient's quality of life and are well tolerated…

    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 announced that an abstract covering additional data from the RELIEF Phase 2a trial has been accepted for oral presentation at the upcoming European Respiratory Society ("ERS") International Congress 2021, being held September 5-8, 2021.

    "Refractory chronic cough can be a debilitating condition that impacts a patient's everyday life. With limited therapy options available, there is a significant need for new treatments that reduce cough, improve a patient's quality of life and are well tolerated. P2X3 antagonists, an emerging new class of therapy for refractory chronic cough, have shown promise in addressing the burden of this condition on patients," commented Catherine Bonuccelli, M.D., Chief Medical Officer of BELLUS Health. "In our Phase 2a RELIEF trial, we observed improvements in cough severity and quality of life over a 16-day treatment period that favored our P2X3 antagonist, BLU-5937. These positive trends suggest that over a longer period of time, BLU-5937 may show greater treatment benefit. We are encouraged by these results and based on the design of our ongoing Phase 2b SOOTHE trial, we are confident that we can demonstrate improvements in cough severity and quality of life."

    Oral Presentation Details:

    Title:
    Improvements in cough severity and cough-related quality of life in a phase 2 trial with the P2X3 antagonist BLU-5937 in refractory chronic cough

    Session: Clinical trials in airway diseases: novel treatments and new evidence

    Format: Pre-recorded presentation and live QA

    Date: Sunday, September 5, 2021

    Time: 8:45 a.m. EDT/2:45 p.m. CET

    For more information and to access the pre-recorded presentation, please visit the ERS congress platform. Following the conference, the presentation materials will be available in the "Scientific Publications" section of BELLUS Health's website at www.bellushealth.com.

    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 coughing in patients with RCC, while limiting taste disturbance adverse events.

    In addition to RCC and chronic pruritus, the mechanism 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 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 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 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 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 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.

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  4. - The Phase 2b SOOTHE and Phase 2a BLUEPRINT clinical trials are on track, with topline results expected in Q4 2021 -

    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 and other hypersensitization-related disorders, today reported its financial and operating results for the second quarter ending June 30, 2021.

    "Our focus remains on the completion of our two ongoing Phase 2 clinical trials – SOOTHE and BLUEPRINT – evaluating our selective P2X3 antagonist BLU-5937, in refractory chronic cough and chronic pruritus associated with atopic dermatitis, respectively. Both clinical trials are advancing on…

    - The Phase 2b SOOTHE and Phase 2a BLUEPRINT clinical trials are on track, with topline results expected in Q4 2021 -

    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 and other hypersensitization-related disorders, today reported its financial and operating results for the second quarter ending June 30, 2021.

    "Our focus remains on the completion of our two ongoing Phase 2 clinical trials – SOOTHE and BLUEPRINT – evaluating our selective P2X3 antagonist BLU-5937, in refractory chronic cough and chronic pruritus associated with atopic dermatitis, respectively. Both clinical trials are advancing on track, with topline results expected in the fourth quarter of 2021," commented Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We expect the second half of this year to be an exciting time for BELLUS, as we believe the upcoming milestones will be key to advancing the development of BLU-5937."

    PROGRAM AND CORPORATE HIGHLIGHTS

    Ongoing Phase 2b SOOTHE clinical trial of BLU-5937 in patients with refractory chronic cough ("RCC").

    • As of August 2021, the SOOTHE trial has achieved approximately 80% of its enrollment target of 300 patients.
    • A pre-specified, blinded Sample Size Re-Estimation ("SSRE") analysis has been conducted, and no changes have been made to the SOOTHE trial size.
    • We expect topline results in the fourth quarter of 2021.
    • We expect to conduct an administrative interim analysis in September 2021.

    Ongoing Phase 2a BLUEPRINT clinical trial of BLU-5937 in patients with chronic pruritus associated with atopic dermatitis ("AD").

    • As of August 2021, the BLUEPRINT trial has achieved approximately 90% of its enrollment target of 128 patients.
    • A pre-specified, blinded SSRE analysis has been conducted, and no changes have been made to the BLUEPRINT trial size.
    • We expect topline results in the fourth quarter of 2021.

    Presented clinical data at the American Thoracic Society 2021 International Conference ("ATS").

    • Three abstracts on BLU-5937 – including a mini symposium presentation – were presented at ATS, which was held on May 14-19, 2021.

    Presenting at the upcoming European Respiratory Society International Congress 2021 ("ERS").

    • An abstract on BLU-5937 has been accepted for oral presentation at ERS, which is being held September 5-8, 2021. The pre-recorded presentation will be available on the ERS congress platform on August 23, 2021, with a live QA session on Sunday, September 5, 2021 at 8:45 a.m. EDT.

    Ended the second quarter of 2021 with cash, cash equivalents and short-term investments totaling US$72.3 million.

    • We expect current cash position to be sufficient to fund our operating plan until the end of 2022. 

    FINANCIAL RESULTS

    Cash Position: As of June 30, 2021, the Company had available cash, cash equivalents and short-term investments totaling US$72.3 million, compared to US$98.3 million on 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 June 30, 2021, net loss amounted to US$17.8 million (US$0.23 per share), compared to US$8.4 million (US$0.14 per share) for the same period in 2020.

    Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to US$15.2 million for the quarter ended June 30, 2021, compared to US$5.9 million for the same period in 2020, an increase of US$9.3 million or 158% 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 and the Phase 2a BLUEPRINT trial in chronic pruritus associated with AD.

    General and Administrative ("G&A") Expenses: General and administrative expenses amounted to US$2.8 million for the quarter ended June 30, 2021, compared to US$3.4 million for the same period in 2020, a decrease of US$0.6 million or 18% year over year. The decrease is mainly due to lower external G&A expenses.

    Net Finance Income: Net finance income amounted to US$0.2 million for the quarter ended June 30, 2021, compared to US$0.9 million for the same period in 2020.

    SUMMARY OF FINANCIAL RESULTS

     

    Three months ended

    June 30, 2021

    Three months ended

    June 30, 2020

     

    (in thousands of dollars, except per share data)

    Revenues

    US$

    4

     

    US$

    6

     

    Research and development expenses, net

     

    (15,201

    )

     

    (5,899

    )

    General and administrative expenses

     

    (2,805

    )

     

    (3,439

    )

    Net finance income

     

    174

     

     

    912

     

    Net loss for the period

    US$

    (17,828

    )

    US$

    (8,422

    )

    Basic and diluted loss per share

    US$

    (0.23

    )

    US$

    (0.14

    )

    The Company's full unaudited condensed consolidated interim financial statements and accompanying management's discussion and analysis for the three and six-month periods ended June 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 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 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 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 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 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 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.

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  5. 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 announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will be participating in a fireside chat at the Jefferies Virtual Healthcare Conference.

    Presentation Details:

    Event: Jefferies Virtual Healthcare Conference

    Date/Time: Tuesday, June 1, 2021 at 10:30 a.m. ET

    A live webcast of fireside chat may be accessed on the Events & Presentations page under the Investors & Media section of BELLUS Health's website at www.bellushealth.com. Following the event, an…

    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 announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will be participating in a fireside chat at the Jefferies Virtual Healthcare Conference.

    Presentation Details:

    Event: Jefferies Virtual Healthcare Conference

    Date/Time: Tuesday, June 1, 2021 at 10:30 a.m. ET

    A live webcast of fireside chat may be accessed on the Events & Presentations page under the Investors & Media section of BELLUS Health's website at www.bellushealth.com. Following the event, an archived webcast will be available on the Company's website.

    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 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 current 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 targeting the burden of pruritus in patients with AD.

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