AMGEN ANNOUNCES 2022 FOURTH QUARTER DIVIDEND

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BELLUS Well being Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Well being” or the “Firm”), a clinical-stage biopharmaceutical firm creating novel therapeutics for the remedy of refractory power cough (“RCC”) and different hypersensitivity indications, right this moment reported its monetary and working outcomes for the third quarter ended September 30, 2022.

PROGRAM AND CORPORATE HIGHLIGHTS

Initiated the CALM Section 3 scientific program (CALM-1 and CALM-2).

  • BELLUS Well being has accomplished a constructive Finish-Of-Section 2 assembly with the U.S. Meals and Drug Administration (“FDA”), and obtained scientific recommendation on the design of its CALM Section 3 scientific program from each the European Medicines Company (“EMA”) and the Medicines and Healthcare merchandise Regulatory Company (“MHRA”).
  • The CALM Section 3 scientific program has been initiated with affected person screening ongoing. The CALM program consists of two pivotal trials, CALM-1 and CALM-2, with the first endpoint of 24H cough frequency measured at 12- and 24-weeks, respectively, utilizing the VitaloJAK cough monitoring system. For added data on the CALM-1 and CALM-2 trials designs, click on right here .
  • BELLUS Well being carried out validation work on the VitaloJAK evaluating compressed vs. non-compressed recordings in a cohort of 45 SOOTHE Section 2b trial contributors. The outcomes confirmed a sensitivity of 98.7%, with no systemic error and no bias noticed. BELLUS Well being will submit a validation protocol and statistical evaluation plan to the FDA earlier than year-end.
  • Topline outcomes from CALM-1 are anticipated within the second half of 2024, with topline outcomes from CALM-2 anticipated in 2025.

Accomplished massive U.S. doctor survey on the RCC market panorama.

  • Survey included 1,483 U.S. pulmonologists, allergists, ENTs, gastroenterologists and first care physicians exhibiting that there are about 8.6 million RCC sufferers in the USA and 1.8 million RCC sufferers at present being seen by specialists.

Pursuing growth of its P2X3 pipeline.

  • The Section 1 scientific trial investigating the pharmacokinetics of a as soon as day by day, extended-release formulation of BLU-5937 has been initiated with enrollment ongoing. The examine is predicted to be accomplished within the first half of 2023.

Introduced on the CHEST Annual Assembly, the European Respiratory Society (“ERS”) Worldwide Congress 2022 and the Twelfth London Worldwide Cough Symposium (“LICS”).

  • Scientific information from the Section 2b SOOTHE trial was introduced on the CHEST Annual Assembly, held in Nashville, Tennessee from October 16-19, 2022, the ERS Worldwide Congress 2022, held in Barcelona, Spain from September 4-6, 2022, and the twelfth LICS, held from July 13-14, 2022. The presentation supplies can be found within the “Scientific Publications” part of BELLUS Well being’s web site right here .

Accomplished a US$176.0 million public providing of frequent shares in Canada and the USA.

  • In July 2022, the Firm accomplished a public providing of its frequent shares leading to gross proceeds of US$176.0 million (the “2022 Providing”), together with the total train of the choice to buy further shares. These proceeds prolonged the Firm’s money runway to the second half of 2025 and thru the topline outcomes of each CALM-1 and CALM-2.

Established At-the-Market (“ATM”) Facility.

  • The Firm entered into an settlement with Jefferies LLC pursuant to which the Firm might on occasion promote, by ATM distributions with Jefferies performing as gross sales agent, frequent shares with an mixture supply worth of as much as US$80.0 million, together with gross sales made immediately on The Nasdaq International Market (“Nasdaq”) or on another present buying and selling marketplace for the frequent shares in the USA. No frequent shares can be supplied or bought in Canada.
  • The Firm has filed a prospectus complement (the “Complement”) dated the date hereof and a brief type base shelf prospectus dated August 26, 2022 (the “Base Prospectus”) and in the USA pursuant to a registration assertion on Kind F-10, which was declared efficient by the U.S. Securities and Change Fee on August 26, 2022, in accordance with the Multijurisdictional Disclosure System established between Canada and the USA.
  • Copies of the Complement and accompanying Base Prospectus could also be obtained by contacting Jefferies LLC, Consideration: Fairness Syndicate Prospectus Division, 520 Madison Avenue, 2nd Flooring, New York, NY 10022, by phone at 877-821-7388 or by electronic mail at [email protected] . The Gross sales Settlement, the Complement and the accompanying Base Prospectus may also be discovered on SEDAR at www.sedar.com and on EDGAR at www.sec.gov .
  • BELLUS Well being’s frequent shares are dual-listed on Nasdaq and the Toronto Inventory Change (“TSX”) beneath the buying and selling image “BLU.” For the needs of the TSX approval, the Firm relied on the exemption set forth in Part 602.1 of the TSX Firm Guide, which offers that the TSX is not going to apply its requirements to sure transactions involving eligible interlisted issuers on a acknowledged change, reminiscent of Nasdaq. This information launch shall not represent a proposal to promote or the solicitation of a proposal to purchase, nor shall there be any sale of those securities in any province, state or jurisdiction during which such supply, solicitation or sale can be illegal previous to the registration or qualification beneath the securities legal guidelines of any such province, state or jurisdiction.

Ended the third quarter of 2022 with money, money equivalents and short-term investments totaling US$364.4 million.

FINANCIAL RESULTS

Money Place: As of September 30, 2022, the Firm had obtainable money, money equivalents and short-term investments totaling US$364.4 million, in comparison with US$248.8 million as of December 31, 2021. The web enhance is primarily attributable to funds obtained by the 2022 Providing, offset partially by funds used to finance its working actions, primarily the analysis and growth actions related to its product candidate BLU-5937.

Web Loss: For the quarter ended September 30, 2022, web loss amounted to US$24.7 million (US$0.20 per share), in comparison with US$22.9 million (US$0.29 per share) for a similar interval in 2021.

Analysis and Improvement Bills: Analysis and growth bills, web of analysis tax credit, amounted to US$17.2 million for the quarter ended September 30, 2022, in comparison with US$19.1 million for a similar interval in 2021, a US$1.8 million or 10% quarter over quarter lower. The lower in analysis and growth bills is primarily attributable to a lower in exterior R&D spend because the Firm has transitioned from its Section 2b SOOTHE scientific trial to the initiation of its CALM Section 3 scientific program. The lower is partially offset by greater bills as a result of Firm’s elevated workforce to assist the CALM Section 3 program in addition to greater stock-based compensation expense in relation to the Firm’s inventory possibility plan.

Common and Administrative (“G&A”) Bills: Common and administrative bills amounted to US$5.8 million for the quarter ended September 30, 2022, in comparison with US$3.8 million for a similar interval in 2021, a US$2.0 million or 53% quarter over quarter enhance. The rise is especially attributable to greater exterior G&A bills, in addition to to greater stock-based compensation expense in relation to the Firm’s inventory possibility plan.

Web Finance Prices: Web finance prices amounted to US$1.7 million for the quarter ended September 30, 2022, in comparison with US$0.0 million for a similar interval in 2021. The rise in web finance prices in the course of the present quarter is especially attributable to a rise in overseas change loss ensuing from the conversion in U.S. {dollars} of the Firm’s web financial property denominated in Canadian {dollars} in the course of the interval, as a result of weakening of the Canadian greenback versus the U.S. greenback in the course of the interval. The rise is partially offset by greater curiosity revenue as a result of elevated money, money equivalents and short-term investments place following the 2022 and 2021 Choices and the rise in rates of interest.

SUMMARY OF FINANCIAL RESULTS

Three months ended

September 30, 2022

Three months ended

September 30, 2021

(in 1000’s of {dollars}, besides per share information)

Revenues

US$

4

US$

4

Analysis and growth bills, web

(17,241

)

(19,054

)

Common and administrative bills

(5,838

)

(3,821

)

Web finance revenue

(1,656

)

(10

)

Earnings taxes

25

Web loss for the 12 months

US$

(24,706

)

US$

(22,881

)

Primary and diluted loss per share

US$

(0.20

)

US$

(0.29

)

The Firm’s full unaudited consolidated monetary statements and accompanying administration’s dialogue and evaluation for the three- and nine-month intervals ended September 30, 2022 can be obtainable on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar .

About BLU-5937

BLU-5937, a extremely selective P2X3 antagonist, is in growth for RCC and different hypersensitivity indications.

The P2X3 receptor, which is implicated in cough reflex hypersensitization, is a rational goal for treating power cough, and it has been evaluated in a number of scientific trials with completely different P2X3 antagonists. The Firm believes that its extremely selective P2X3 antagonist has the potential to scale back cough frequency in sufferers with RCC and enhance high quality of life whereas limiting style disturbance hostile occasions.

Along with RCC, the mechanism of motion of BLU-5937 may have broad therapeutic applicability throughout different neuronal hypersensitivity indications. The Firm is evaluating potential alternatives to review BLU-5937 in further indications the place hypersensitivity performs an vital function.

About BELLUS Well being ( www.bellushealth.com )

BELLUS Well being is a clinical-stage biopharmaceutical firm creating novel therapeutics for the remedy of RCC and different hypersensitivity indications. The Firm has efficiently accomplished a Section 2b trial in RCC and has initiated the CALM Section 3 scientific program (CALM-1 and CALM-2).

Continual cough is a cough lasting longer than eight weeks. When the reason for power cough can’t be recognized or the cough persists regardless of remedy of all recognized related causes, the situation is known as RCC. It’s estimated that there are roughly 9 million sufferers in the USA affected by RCC. RCC is related to vital hostile bodily, social, and psychological results on well being and high quality of life. Presently, there is no such thing as a particular remedy accepted for RCC exterior of Japan and Switzerland and remedy choices are restricted.

Ahead-Wanting Statements

Sure statements contained on this information launch, apart from statements of truth which are independently verifiable on the date hereof, might represent “forward-looking statements” inside the which means of Canadian securities laws and laws, the U.S. Personal Securities Litigation Reform Act of 1995, as amended, and different relevant securities legal guidelines. Ahead-looking statements are ceaselessly, however not at all times, recognized by phrases reminiscent of “expects,” “anticipates,” “believes,” “intends,” “estimates,” “potential,” “doable,” “initiatives,” “plans,” and related expressions. Such statements, based mostly as they’re on the present expectations of administration, inherently contain quite a few vital dangers, uncertainties and assumptions, identified and unknown, lots of that are past BELLUS Well being’s management. Such statements embrace, however are usually not restricted to, the potential of BLU-5937 to efficiently deal with RCC and different hypersensitization-related problems and profit such sufferers, BELLUS Well being’s expectations associated to its preclinical research and scientific trials, together with the completion of its Section 3 scientific trials of BLU-5937 in RCC and the anticipated timing of topline outcomes from CALM-1 and CALM-2 Section 3 scientific trials, the timing and end result of interactions with regulatory businesses, the power of BELLUS Well being to validate its use of the VitaloJAK to the satisfaction of related regulatory businesses, the potential exercise and tolerability profile, selectivity, efficiency and different traits of BLU-5937, together with as in comparison with different competitor candidates, particularly the place head-to-head research haven’t been carried out and cross-trial comparisons will not be immediately comparable attributable to variations in examine protocols, circumstances and affected person populations, the business potential of BLU-5937, together with with respect to affected person inhabitants, pricing and labeling and potential remedy options, BELLUS Well being’s monetary place and sufficiency of money assets to deliver by topline outcomes of CALM-1 and CALM-2 scientific trials, well timed or in any respect, and the potential applicability of BLU-5937 and BELLUS Well being’s P2X3 platform to deal with different problems. Danger elements that will have an effect on BELLUS Well being’s future outcomes embrace however are usually not restricted to: the advantages and impression on label of its enrichment technique, estimates and projections concerning the dimensions and alternative of the addressable RCC marketplace for BLU-5937, the power to develop and develop its challenge pipeline, the power to acquire ample financing, the power of BELLUS Well being to take care of its rights to mental property and procure ample safety of future merchandise by such mental property, the impression of normal financial circumstances, normal circumstances within the pharmaceutical trade, the impression of the continuing COVID-19 pandemic on BELLUS Well being’s operations, plans and prospects, together with to the initiation and completion of scientific trials in a well timed method or in any respect, adjustments within the regulatory setting within the jurisdictions during which BELLUS Well being does enterprise, provide chain impacts, inventory market volatility, fluctuations in prices, adjustments to the aggressive setting attributable to consolidation, achievement of forecasted burn fee, achievement of forecasted preclinical examine and scientific trial milestones, reliance on third events to conduct preclinical research and scientific trials for BLU-5937, that closing information from research and scientific trials might differ from reported information from preliminary research or scientific trials and that precise outcomes might differ from topline outcomes as soon as the ultimate and quality-controlled verification of information and analyses has been accomplished. As well as, the size of BELLUS Well being’s product candidate’s growth course of and its market dimension and business worth are dependent upon a variety of elements. Furthermore, BELLUS Well being’s progress and future prospects are primarily depending on the profitable growth, affected person tolerability, regulatory approval, commercialization and market acceptance of its product candidate BLU-5937 and different merchandise. Consequently, precise future outcomes and occasions might differ materially from the anticipated outcomes and occasions expressed within the forward-looking statements. BELLUS Well being believes that expectations represented by forward-looking statements are cheap, but there could be no assurance that such expectations will show to be right. The reader mustn’t place undue reliance, if any, on any forward-looking statements included on this information launch. These forward-looking statements communicate solely as of the date made, and BELLUS Well being is beneath no obligation and disavows any intention to replace publicly or revise such statements on account of any new data, future occasion, circumstances or in any other case, until required by relevant laws or regulation. Please see BELLUS Well being’s public filings with the Canadian securities regulatory authorities, together with, however not restricted to, its Annual Data Kind, and the USA Securities and Change Fee, together with, however not restricted to, its Annual Report on Kind 40-F, for additional threat elements which may have an effect on BELLUS Well being and its enterprise.

Ramzi Benamar
Chief Monetary Officer
[email protected]

Media:
Julia Deutsch
Solebury Strategic Communications
[email protected]



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