☐ Form 20-F
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☒ Form 40-F
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BELLUS Health Inc.
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Date: November 14, 2022
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By:
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/s/ Ramzi Benamar
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Name: Ramzi Benamar
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Title: Chief Financial Officer
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Exhibit
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Document Description
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BELLUS Health Inc.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
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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”).
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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.
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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.
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Topline results from CALM-1 are expected in the second half of 2024, with topline results from CALM-2 expected in 2025.
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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.
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BELLUS Health Inc.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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BELLUS Health Inc.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
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Three months ended
September 30, 2022
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Three months ended
September 30, 2021
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(in
thousands of dollars, except per share data) |
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Revenues
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US$
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4
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US$
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4
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Research and development expenses, net
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(17,241
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(19,054
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General and administrative expenses
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(5,838
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(3,821
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Net finance income
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(1,656
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(10
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Income taxes
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25
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—
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Net loss for the year
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US$
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(24,706
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US$
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(22,881
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Basic and diluted loss per share
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US$
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(0.20
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US$
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(0.29
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) |
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BELLUS Health Inc.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
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BELLUS Health Inc.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
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