- End-of-Phase 2 meeting with the
- Three late-breaking abstracts reviewing clinical data from the Phase 2b SOOTHE trial will be presented at the upcoming
- Ended first quarter 2022 with
“This quarter, we have focused our efforts on our clinical plans for BLU-5937, our highly selective, second generation P2X3 antagonist product candidate, for the treatment of RCC,” commented
PROGRAM AND CORPORATE HIGHLIGHTS
End-of-Phase 2 meeting with the FDA scheduled for June of 2022.
-
During the End-of-Phase 2 meeting with the FDA,
BELLUS Health intends to discuss its planned Phase 3 program, which the Company expects to initiate in the second half of 2022. The Company will also obtain scientific advice from theEuropean Medicines Agency (“EMA”) and the Medicines and Healthcare products Regulatory Agency (“MHRA”).
Presenting at the upcoming ATS 2022
-
Three late-breaking abstracts reviewing clinical data from the Phase 2b SOOTHE trial, including new responder analysis data, will be presented at the upcoming ATS 2022
International Conference , being held inSan Francisco, California fromMay 13-18, 2022 . The abstracts are currently available on the ATS website:- “Safety And Efficacy of BLU-5937 In the Treatment of Refractory Chronic Cough from the Phase 2b SOOTHE Trial” (view abstract);
- “Responders Analyses in Objective 24H Cough Frequency in SOOTHE, a Phase 2b Trial of a Selective P2X3 Antagonist in Refractory Chronic Cough” (view abstract);
- “Improvements in Cough Severity and Quality of Life in SOOTHE, a Phase 2b, Dose Finding Trial of BLU-5937 in Refractory Chronic Cough” (view abstract).
Pursuing development of its P2X3 pipeline.
-
BELLUS Health expects to initiate a Phase 1 clinical trial investigating a once-daily, extended-release formulation of BLU-5937 in the second half of 2022.
Ended the first quarter of 2022 with cash, cash equivalents and short-term investments totaling
FINANCIAL RESULTS
Cash Position: As of
Net Loss: For the quarter ended
Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to
General and Administrative (“G&A”) Expenses: General and administrative expenses amounted to
Net Finance Income: Net finance income amounted to
SUMMARY OF FINANCIAL RESULTS
|
Three months ended
|
Three months ended
|
||||
|
(in thousands of dollars, except per share data) |
|||||
Revenues |
US$ |
4 |
|
US$ |
4 |
|
Research and development expenses, net |
|
(11,254 |
) |
|
(12,448 |
) |
General and administrative expenses |
|
(4,050 |
) |
|
(3,470 |
) |
Net finance income |
|
973 |
|
|
163 |
|
Income taxes |
|
(25 |
) |
|
— |
|
Net loss for the year |
US$ |
(14,352 |
) |
US$ |
(15,751 |
) |
Basic and diluted loss per share |
US$ |
(0.13 |
) |
US$ |
(0.20 |
) |
The Company’s full unaudited consolidated financial statements and accompanying management’s discussion and analysis for the quarter ended
BELLUS Health Announces Election of Directors at Annual Meeting
At the Annual Meeting of Shareholders held by webcast today, the following director nominees listed in the Management Information Circular dated
The details of the election are as follows:
Director Nominee |
Outcome |
Votes For |
% For |
Votes
|
%
|
Dr. |
Elected |
74,115,825 |
99.02% |
732,126 |
0.98% |
|
Elected |
74,822,654 |
99.97% |
25,297 |
0.03% |
Dr. |
Elected |
73,859,442 |
98.68% |
988,509 |
1.32% |
|
Elected |
67,271,057 |
89.88% |
7,576,894 |
10.12% |
Dr. |
Elected |
73,701,642 |
98.47% |
1,146,282 |
1.53% |
|
Elected |
74,826,580 |
99.97% |
21,371 |
0.03% |
Dr. |
Elected |
74,668,597 |
99.76% |
179,353 |
0.24% |
|
Elected |
74,825,707 |
99.97% |
22,244 |
0.03% |
The results of the final votes regarding all matters subject to a vote during the Annual Meeting that took place today will be made available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.
Automatic Securities Disposition Plans
The Company also announced that
The ASDPs permit trades to be made in accordance with pre-arranged instructions. Up to 188,000 common shares of the Company may be sold under the ASDPs implemented by the Executives in the aggregate. The ASDPs are designed to allow for an orderly disposition of each of the Executives’ shares in the Company at prevailing market prices over the course of the 12 month-period during which the ASDPs will be in place. Sales of the common shares under the ASDPs will commence no earlier than
The ASDPs contain meaningful restrictions on the ability of the Executives to amend, suspend or terminate the ASDPs.
About BLU-5937
BLU-5937, a highly selective P2X3 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 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 cough hypersensitivity indications. The Company is evaluating potential opportunities to study BLU-5937 in additional cough indications where cough hypersensitivity plays an important role.
About
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 Company is exploring the potential use of BLU-5937 in other patient populations experiencing cough hypersensitivity as well as other P2X3-related hypersensitization conditions.
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
Source:
View source version on businesswire.com: https://www.businesswire.com/news/home/20220511006013/en/
Chief Financial Officer
rbenamar@bellushealth.com
Media:
Solebury Trout
jdeutsch@soleburytrout.com
Source: