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 December 2021
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 December 13, 2021, 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. 333-251329), 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: December 13, 2021||By:||/s/ Ramzi Benamar|
Name: Ramzi Benamar
Title: Chief Financial Officer
Form 6-K Exhibit Index
|99.1||News Release dated December 13, 2021. BELLUS Health Announces the Launch of a Public Offering of Common Shares in Canada and the United States.|
|99.2||Material Change Report dated December 13, 2021|
|BELLUS Health Inc.|
|275 Armand-Frappier Blvd.|
|Laval, Quebec, Canada|
BELLUS Health Announces the Launch of a Public Offering of Common Shares in Canada and the United States
LAVAL, Quebec, December 13, 2021 – 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 short form base shelf prospectus dated December 23, 2020 (the “Base Prospectus”) in connection with a proposed public offering of its common shares of US$175 million (the “Offering”). The Supplement was filed with each of the securities regulatory authorities in the provinces of Canada. The Supplement and accompanying 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 research and development activities, general and administrative expenses, 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 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 Nasdaq.
Jefferies, Evercore ISI and RBC Capital Markets are acting as joint book-running managers.
The Supplement and the accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and the accompanying Base Prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from the Company, by telephone at 450-680-4500 or by email at firstname.lastname@example.org or you may request them from: 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 email@example.com; 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 firstname.lastname@example.org; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at email@example.com. Prospective investors should read the Supplement and accompanying 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 and territories 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|
December 13, 2021
|Item 3||News Release|
A news release was issued on December 13, 2021, and disseminated by Business Wire, in Canada and in the United States
|Item 4||Summary of Material Change|
BELLUS Health announces positive topline results from its Phase 2b SOOTHE Trial of BLU-5937 for the treatment of refractory chronic cough
|Item 5||Full Description of Material Change|
5.1 Full Description of Material Change
The SOOTHE trial, which enrolled 249 participants with a baseline awake cough frequency of ≥ 25 per hour, demonstrated a clinically meaningful and statistically significant placebo-adjusted reduction in 24-hour cough frequency of 34% at the 50 mg and 200 mg BID dose levels of BLU-5937 (p ≤ 0.005) at day 28. The 12.5 mg BID dose demonstrated a statistical trend with 21% reduction in placebo-adjusted 24-hour cough frequency (p=0.098) with a dose response observed between the 12.5 mg and 50 mg BID doses.
SOOTHE Primary Efficacy Endpoint
|Dose||Placebo-adjusted change in 24-hour cough frequency at day 28||p-value|
|12.5 mg BID||-21.1%||p=0.098|
|50 mg BID||-34.4%||p=0.003|
|200 mg BID||-34.2%||p=0.005|
Safety and Tolerability Results:
BLU-5937’s safety and tolerability data were consistent with previous trials, including the Phase 2a RELIEF trial. BLU-5937 was well-tolerated with low impact on taste perception. Taste-related side effects were infrequent at all dose levels with taste alteration observed in 4.8%, 6.5% and 4.8% of participants at 12.5 mg BID, 50 mg BID and 200 mg BID, respectively. No participant reported complete or partial taste loss and there were no discontinuations due to taste-related adverse events.
The treatment emergent adverse event profile was comparable to placebo. There were no treatment emergent serious adverse events reported in the trial.
The Company intends to request an End of Phase 2 meeting with the FDA that is expected to take place in 2Q 2022 to discuss the Phase 3 program which is expected to start in 2H 2022.
Update on P2X3 Pipeline
Summary of Topline Results: Phase 2a Proof-of-Concept BLUEPRINT Trial in Chronic Pruritus
In the Phase 2a proof-of-concept BLUEPRINT trial in patients with chronic pruritus associated with atopic dermatitis (“AD”), BLU-5937 (200 mg BID) did not achieve statistical significance for the primary endpoint of placebo-adjusted reduction in weekly mean Worst Itch-Numeric Rating Scale (“WI-NRS”). BLU-5937 was well tolerated and the treatment emergent adverse event profile was comparable to placebo. The Company does not intend to further pursue development of BLU-5937 in pruritic conditions.
The success of the Phase 2b SOOTHE trial further validates the role of P2X3 in cough hypersensitivity. The Company intends to evaluate potential opportunities to study BLU-5937 in additional cough indications where cough hypersensitivity plays an important role.
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|
December 13, 2021