SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of July 2022
Commission File Number: 001-39034
BELLUS HEALTH INC.
(Name of registrant)
275 Armand-Frappier Blvd.
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
|¨ Form 20-F||x Form 40-F|
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
INCORPORATION BY REFERENCE
On July 13, 2022, the Registrant filed with the Canadian Securities Regulatory Authorities on the System for Electronic Data Analysis and Retrieval (SEDAR) a material change report, a copy of which is attached hereto as Exhibit 99.2, and which is incorporated by reference to the Company’s Registration Statement on Form F-10 (File No. 333-261632), as amended and supplemented.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|BELLUS Health Inc.|
|Date: July 13, 2022||By:||/s/ Ramzi Benamar|
Title: Chief Financial Officer
Form 6-K Exhibit Index
|99.1||News Release dated July 13, 2022. BELLUS Health Announces the Launch of a Public Offering of Common Shares in Canada and the United States.|
|99.2||Material Change Report dated July 13, 2022.|
BELLUS Health Inc.
275 Armand--Frappier Blvd.
BELLUS Health Announces the Launch of a Public Offering of Common Shares in Canada and the United States
LAVAL, Quebec, July 13, 2022 – BELLUS Health Inc. (“BELLUS Health” or the “Company”) (TSX and Nasdaq: BLU), announced today the filing of a preliminary prospectus supplement (the “Supplement”) to its amended and restated short form base shelf prospectus dated December 14, 2021, amending and restating the short form base shelf prospectus dated December 23, 2020 (the “A&R Base Prospectus”) in connection with a proposed public offering of its common shares (the “Offering”). The Supplement was filed with each of the securities regulatory authorities in the provinces of Canada. The Supplement and accompanying A&R Base Prospectus were also filed with the U.S. Securities and Exchange Commission (the “SEC”) as part of a registration statement on Form F-10, as it may be amended from time to time, in accordance with the Multijurisdictional Disclosure System established between Canada and the United States. The Company intends to use the net proceeds of the Offering primarily to fund BLU-5937 research and development activities, working capital needs and other general corporate purposes, as set out in the Supplement.
The Company also expects to grant to the underwriters a 30---day option to purchase up to an additional 15% of the number of common shares offered in the Offering. The Offering is expected to be priced in the context of the market, with the final terms of the Offering to be determined at the time of pricing. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. The closing of the Offering will be subject to customary closing conditions including approval from the Toronto Stock Exchange (the “TSX”). For the purposes of the TSX approval, the Company intends to rely 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 the Nasdaq Global Market (“Nasdaq”).
Jefferies, Evercore ISI and RBC Capital Markets are acting as joint book---running managers.
The Supplement and the accompanying A&R Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying A&R Base Prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying A&R Base Prospectus may also be obtained from the Company, by telephone at 450---680---4500 or by email at email@example.com or you may request them from, in the United States, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877--821--7388 or by email at firstname.lastname@example.org, or Evercore Group L.L.C., Attention: Equity Capital Markets , 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at 888-474-0200 or by email at email@example.com, or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at 877-822-4089 or by email at firstname.lastname@example.org or, in Canada, Jefferies Securities, Inc., Attention: General Counsel, 161 Bay Street, Suite 2600, Toronto, ON M5J 2S1 by email at email@example.com, or RBC Dominion Securities Inc., Attention: Distribution Centre, 180 Wellington Street West, 8th Floor, Toronto, ON M5J 0C2, by telephone at 1-416-842-5349 or by email at Distribution.RBCDS@rbccm.com. Prospective investors should read the Supplement and accompanying A&R Base Prospectus and the other documents the Company has filed before making an investment decision.
No regulatory authority has either approved or disapproved the contents of this news release. 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.
About BELLUS Health
BELLUS Health Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough (“RCC”) and other hypersensitization-related disorders. The Company's product candidate, BLU-5937, is being developed for the treatment of adults with RCC.
Cautionary Note Regarding 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. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown. In this news release, such forward-looking statements include, but are not limited to, statements regarding the Offering, the granting of the option to purchase additional shares and the anticipated use of proceeds from the Offering. Completion of the Offering is subject to numerous factors, many of which are beyond BELLUS Heath’s control, including but not limited to, market conditions, the failure of the parties to satisfy certain closing conditions and other important factors disclosed previously and from time to time in BELLUS Health’s filings with the securities regulatory authorities in each of the provinces of Canada and the SEC. Actual future events may differ from the anticipated events expressed in such 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 securities laws.
FOR MORE INFORMATION, PLEASE CONTACT:
Chief Financial Officer
SOURCE: BELLUS Health Inc.
MATERIAL CHANGE REPORT
|Item||1 Name and Address of Company|
BELLUS Health Inc. (“BELLUS Health” or the “Company”)
275 Blvd. Armand-Frappier
|Item||2 Date of Material Change|
July 12, 2022
|Item||3 News Release|
A news release was issued on July 12, 2022, and disseminated by Business Wire, in Canada and in the United States.
|Item||4 Summary of Material Change|
BELLUS Health announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) and its CALM Phase 3 program for BLU-5937 in refractory chronic cough.
|Item||5 Full Description of Material Change|
5.1 Full Description of Material Change
On July 12, 2022, BELLUS Health announced a positive End-of-Phase 2 (“EOP2”) meeting with the FDA and the details of the CALM Phase 3 program for BLU-5937, a highly selective, second generation P2X3 antagonist product candidate, for the treatment of refractory chronic cough (“RCC”).
Based on the FDA's feedback, the CALM Phase 3 program is composed of two pivotal trials, CALM-1 and CALM-2, each evaluating the efficacy, safety and tolerability of BLU-5937 in approximately 675 adults with RCC. CALM-1 and CALM-2 will be placebo-controlled, parallel-arm trials randomized 1:1:1 with expected treatment arms of 25 mg BID, 50 mg BID and placebo. The primary endpoint of 24H cough frequency will be measured at 12-weeks for CALM-1 and 24-weeks for CALM-2. The Company has reached alignment with the FDA that the CALM Phase 3 program’s primary endpoint, similar to the successful SOOTHE Phase 2b trial, can be assessed using the VitaloJAK cough monitoring system in a patient population enriched for baseline 24H cough frequency of ≥20 coughs/hour (equivalent to awake cough frequency of ≥25 coughs/hour used in SOOTHE Phase 2b trial). Key secondary efficacy endpoints include Cough Severity using Visual Analogue Scale, the Leicester Cough Questionnaire and Chronic Cough Diary. The CALM Phase 3 trials will also enroll participants with baseline 24H cough frequency <20 coughs/hour. A key secondary efficacy endpoint will assess reduction in cough frequency in a broader population including the enriched population and additional participants with baseline 24H cough frequency below 20 coughs/hour. CALM-1 will have a 40-week randomized extension period and an additional 24-week open label extension. CALM-2 will have a 28-week open label extension. The trials are planned to run in parallel, and the Phase 3 CALM program is expected to enroll its first patient in the fourth quarter of 2022. Topline data from CALM-1 are expected in the second half of 2024.
The Company also terminated, on July 13, 2022, its Open Market Sale Agreement with Jefferies LLC.
5.2 Disclosure for Restructuring Transactions
|Item||6 Reliance on subsection 7.1(2) of National Instrument 51-102|
This report is not being filed on a confidential basis.
|Item||7 Omitted Information|
|Item||8 Executive Officer|
For further information, please contact Ramzi Benamar, Chief Financial Officer (450) 680-4500.
|Item||9 Date of Report|
July 13, 2022