Life Science News

- Completed positive End-of-Phase 2 meeting with the Food and Drug Administration ("FDA") and received scientific advice from the European Medicines Agency ("EMA") to support design of its CALM Phase 3 program, which is expected to initiate in Q4 2022 -

- Ended second quarter 2022 with approximately US$384.6 million in pro-forma cash, cash equivalents and short-term investments, including net proceeds from the July 2022 financing; Cash runway extended to 2H 2025 and through the topline results of both CALM-1 and CALM-2 trials -

BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough ("RCC") and other cough hypersensitivity indications, today reported its financial and operating results for the second quarter ending June 30, 2022.

"BELLUS remains committed to bringing BLU-5937, our P2X3 antagonist product candidate, to patients burdened by RCC. This quarter, we have successfully identified a clear regulatory path to a potential approval for this candidate, bringing the Company one step closer to making this goal a reality," commented Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "Following the feedback from our End-of-Phase 2 meeting with the FDA and the scientific advice from the EMA we have solidified the trial design for our CALM Phase 3 program and are looking forward to initiating CALM-1 and CALM-2 later this year. With the proceeds from our recent financing, we have significantly improved our cash position, extending our runway to the second half of 2025, and now have sufficient resources to bring us through topline results of both CALM Phase 3 clinical trials."

PROGRAM AND CORPORATE HIGHLIGHTS

Completed positive End-of-Phase 2 meeting with the FDA and received scientific advice from the EMA to support the design of its CALM Phase 3 clinical program for BLU-5937 in RCC.

  • The CALM Phase 3 clinical program consists of two pivotal trials (CALM-1 and CALM-2), with primary efficacy endpoint of 24-hour cough frequency measured at 12- and 24-weeks, respectively. The Company has reached alignment with the FDA on the primary efficacy endpoint of 24H cough frequency reduction being assessed using the VitaloJAK cough monitoring system in a patient population enriched for baseline cough frequency.
  • Secondary efficacy endpoints include Cough Severity using Visual Analogue Scale (CS-VAS), the Leicester Cough Questionnaire (LCQ) and Chronic Cough Diary (CCD). The CALM Phase 3 trials will also enroll participants with baseline 24H cough frequency
  • The first patient is expected to be enrolled in both CALM-1 and CALM-2 in the fourth quarter of 2022. Topline results from CALM-1 are expected in the second half of 2024.
  • In addition, the Company has obtained scientific advice from the EMA and based on the feedback, it will not be making any modifications to the CALM Phase 3 program design. For additional information on the CALM-1 and CALM-2 trials designs, click here .

Completed a US$176.0 million public offering of common shares in Canada and the United States.

  • In July 2022, the Company completed an offering of its common shares resulting in gross proceeds of US$176.0 million and net proceeds of approximately US$164.5 million (the "2022 Offering"), including the full exercise of the over-allotment option.

Presented at the Twelfth London International Cough Symposium ("LICS") and the American Thoracic Society ("ATS") 2022 International Conference.

  • Clinical data from the Phase 2b SOOTHE trial was presented at both the 12 th LICS, held in London, England from July 13-14, 2022 and the ATS 2022 International Conference, held in San Francisco, California from May 13-18, 2022. The presentation materials are available in the "Scientific Publications" section of BELLUS Health's website.

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 fourth quarter of 2022.

Ended the second quarter of 2022 with cash, cash equivalents and short-term investments totaling US$220.1 million (approximately US$384.6 million proforma cash that includes the cash at the end of the second quarter and the net proceeds from the July 2022 Offering).

FINANCIAL RESULTS

Cash Position: As of June 30, 2022, the Company had available cash, cash equivalents and short-term investments totaling US$220.1 million (excluding proceeds from the July 2022 Offering), compared to US$248.8 million as of December 31, 2021. The net decrease is primarily attributable to funds used to finance the Company's operating activities, mainly the research and development activities associated with its product candidate BLU-5937.

Net Loss: For the quarter ended June 30, 2022, net loss amounted to US$18.8 million (US$0.18 per share), compared to US$17.8 million (US$0.23 per share) for the same period in 2021.

Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to US$12.5 million for the quarter ended June 30, 2022, compared to US$15.2 million for the same period in 2021, a US$2.7 million or 18% year over year decrease. The decrease in research and development expenses is primarily attributable to the decrease in external R&D spend as the Company is transitioning from its Phase 2b SOOTHE clinical trial and is in the planning stage of its Phase 3 clinical program. The decrease is partially offset by higher expenses due to the Company's increased workforce to support the next steps in its development plans for BLU-5937 as well as higher stock-based compensation expense in relation to its stock option plan.

General and Administrative ("G&A") Expenses: General and administrative expenses amounted to US$5.4 million for the quarter ended June 30, 2022, compared to US$2.8 million for the same period in 2021, a US$2.6 million or 92% year over year increase. The increase is mainly attributable to higher stock-based compensation expense in relation to the Company's deferred share unit plan and its stock option plan, as well as to higher external G&A expenses.

Net Finance (Costs) Income: Net finance costs amounted to US$0.9 million for the quarter ended June 30, 2022, compared to a net finance income of US$0.2 million for the same period in 2021. The increase in net finance costs during the current quarter is mainly attributable to a foreign exchange loss resulting from the conversion in US dollars of the Company's net monetary assets denominated in Canadian dollars during the period.

SUMMARY OF FINANCIAL RESULTS

Three months ended
June 30, 2022

Three months ended
June 30, 2021

(in thousands of dollars, except per share data)

Revenues

US$

4

US$

4

Research and development expenses, net

(12,460

)

(15,201

)

General and administrative expenses

(5,379

)

(2,805

)

Net finance (costs) income

(900

)

174

Income taxes

(41

)

Net loss for the period

US$

(18,776

)

US$

(17,828

)

Basic and diluted loss per share

US$

(0.18

)

US$

(0.23

)

The Company's full unaudited consolidated financial statements and accompanying management's discussion and analysis for the three and six-month periods ended June 30, 2022 will be available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar .

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 hypersensitivity plays an important role.

About BELLUS Health ( www.bellushealth.com )

BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of RCC and other cough hypersensitivity indications. The Company's product candidate, BLU-5937, has successfully completed a Phase 2b trial in RCC. BELLUS Health is preparing to initiate its CALM Phase 3 program in the fourth quarter of 2022.

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 United States suffering from RCC. RCC is associated with significant adverse physical, social, and psychological effects on health and quality of life. Currently, there is no specific therapy approved for RCC outside of Japan and Switzerland and treatment options are limited.

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 U.S. Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "estimates," "potential," "possible," "projects," "plans," and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health's control. Such statements include, but are not limited to, the potential of BLU-5937 to successfully treat RCC and other hypersensitization-related disorders and benefit such patients, BELLUS Health's expectations related to its preclinical studies and clinical trials, including the timing of initiation of and the design of the Phase 3 clinical trials of BLU-5937 in RCC, the timing and outcome of interactions with regulatory agencies, the potential activity and tolerability profile, selectivity, potency and other characteristics of BLU-5937, including as compared to other competitor candidates, especially where head-to-head studies have not been conducted and cross-trial comparisons may not be directly comparable due to differences in study protocols, conditions and patient populations, the commercial potential of BLU-5937, including with respect to patient population, pricing and labeling, BELLUS Health's financial position and sufficiency of cash resources to bring BELLUS Health through topline results of CALM-1 and CALM-2 clinical trials, and the potential applicability of BLU-5937 and BELLUS Health's P2X3 platform to treat other disorders. Risk factors that may affect BELLUS Health's future results include but are not limited to: the benefits and impact on label of its enrichment strategy, estimates and projections regarding the size and opportunity of the addressable RCC market for BLU-5937, the ability to expand and develop its project pipeline, the ability to obtain adequate financing, the ability of BELLUS Health to maintain its rights to intellectual property and obtain adequate protection of future products through such intellectual property, the impact of general economic conditions, general conditions in the pharmaceutical industry, the impact of the ongoing COVID-19 pandemic on BELLUS Health's operations, plans and prospects, including to the initiation and completion of clinical trials in a timely manner or at all, changes in the regulatory environment in the jurisdictions in which BELLUS Health does business, supply chain impacts, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted preclinical study and clinical trial milestones, reliance on third parties to conduct preclinical studies and clinical trials for BLU-5937 and that actual results may differ from topline results once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of BELLUS Health's product candidate's development process and its market size and commercial value are dependent upon a number of factors. Moreover, BELLUS Health's growth and future prospects are mainly dependent on the successful development, patient tolerability, regulatory approval, commercialization and market acceptance of its product candidate BLU-5937 and other products. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the 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 legislation or regulation. Please see BELLUS Health's public filings with the Canadian securities regulatory authorities, including, but not limited to, its Annual Information Form, and the United States Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 40-F, for further risk factors that might affect BELLUS Health and its business.

Source: BELLUS Health Inc.

Ramzi Benamar
Chief Financial Officer
rbenamar@bellushealth.com

Media:
Julia Deutsch
Solebury Trout
jdeutsch@soleburytrout.com

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  • XEN 63 is a minimally invasive, micro-incisional glaucoma surgery designed to lower IOP 2
  • XEN 63 Gel Implant provides innovative treatment option for Canadians impacted by glaucoma

 ABBVie (NYSE: ABBV) announced today the availability of the XEN ® 63 Gel Implant, a surgical implant designed to lower high eye pressure in open angle glaucoma sufferers, where previous medical treatment options have failed. 1 The XEN 63 Gel Implant is an additional option for surgeons, clinically proven to reduce intraocular pressure (IOP) in patients with primary open angle glaucoma. 3

AbbVie Logo (CNW Group/AbbVie Canada)

"I see the impact of glaucoma on patients' quality of life every day in my practice. Glaucoma typically damages the peripheral vision first, so it often goes unnoticed by patients as the disease worsens. That's why glaucoma is known as the silent thief of sight," said Dr. David Yan , Ophthalmologist-in-Chief, Mount Sinai Hospital, University of Toronto and Glaucoma Service Director, Kensington Eye Institute. "XEN 63 Gel Implant offers patients a new surgical option to reduce intraocular pressure when medical therapy cannot adequately control the disease and renewed hope to prevent optic nerve damage."

XEN 63 is a gel implant consisting of a small 6mm long tube, delivered via a micro-incisional glaucoma surgery. 1 , 2 It creates a new fluid outflow channel using a similar principle to conventional trabeculectomy, but allows fluid to bypass the impaired trabecular meshwork, the drainage system that becomes impaired in glaucoma. 2 ,4

"Glaucoma affects more than 728,000 Canadians. It is one of the leading causes of preventable blindness. Anyone can develop glaucoma but there are several different factors that can increase your risk of developing the disease," said Doug Earle , President and CEO of Fighting Blindness Canada. "It's both exciting and important to see new, innovative treatment options being approved that could have a positive impact on Canadians living with primary open angle glaucoma."

"As a leader in Eye Care in Canada , we are committed to help preserve and protect people's vision through innovating and addressing the greatest unmet needs in glaucoma," says Tracey Ramsay , Vice President and General Manager, AbbVie Canada. "Today, we're pleased to launch the XEN 63 Gel Implant and offer a minimally invasive solution for uncontrolled primary open angle glaucoma."

The glaucoma treatment spectrum extends from pharmacotherapy involving topical medications (eye drops) as the first-line therapy to traditional, invasive filtration surgeries, such as trabeculectomy and aqueous shunt implantation. 5,6,7 Common challenges associated with pharmacotherapy include ineffective use (e.g., incorrect dose timing or administration), 8 ,9 local or systemic side effects (e.g., irritation) or toxicity, 10,11 and considerable lifetime costs. 12 Filtration surgical options are typically used in advanced glaucoma cases or when targeting a very low intraocular pressure as a treatment outcome. 13 These invasive surgeries may be considered for medically refractory cases, or when there are such issues as intolerable side effects or from ineffective use of medications. 14

About Glaucoma

Glaucoma affects more than 728,000 Canadians and takes the form of several related disease types, the most common being open angle glaucoma. 15 Glaucoma is characterized by a build-up of aqueous humour fluid and increased intraocular pressure (IOP) that damages the optic nerve. 15 There is no cure for glaucoma, but early detection and treatment can help prevent damage to the optic nerve, and as a result, save vision. 15

About XEN 63

XEN is a gel implant consisting of a small 6mm long tube, delivered via a micro-incisional glaucoma surgery, which is intended to reduce intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. 1 The XEN filtration procedure creates a new fluid outflow channel using a similar principle to trabeculectomy, but allows fluid to bypass the impaired trabecular meshwork. 2,3 XEN is inserted via an ab-interno approach 1 (from within the anterior chamber) and allows aqueous humor to flow out from the anterior chamber into the subconjunctival space, minimizing tissue disruption seen with trabeculectomy or traditional glaucoma drainage implants. 1,3, 16 XEN 63 consists of a small tube that is 6mm long. 1 The inner diameter of XEN63 is 63µm and the external diameter is 170µm. 1 XEN63 has an outflow resistance of 2-3mmHg. 6 XEN63 was developed to increase the aqueous humor flow rate with the intention of potentially providing lower IOPs.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca . Follow @abbviecanada on Twitter and Instagram , or find us on LinkedIn.

1

AbbVie Canada. Add XEN 63 Gel Implant Health Canada directions for use.

2

European Glaucoma Society Terminology and Guidelines for Glaucoma, 5th Edition. (2021). British Journal of Ophthalmology , 105(Suppl 1), pp.1–169. doi:10.1136/bjophthalmol-2021-egsguidelines

3

Lavin-Dapena C, Cordero-Ros R, D'Anna O, Mogollón I. XEN 63 gel stent device in glaucoma surgery: A 5-years follow-up prospective study. Eur J Ophthalmol. 2021 Jul;31(4):1829-1835. doi: 10.1177/1120672120952033. Epub 2020 Aug 18. PMID: 32811168. https://pubmed.ncbi.nlm.nih.gov/32811168/

4

De Gregorio A, et al. Clin Ophthalmol. 2018;12:773-782. doi:10.2147/OPTH.S146919.

5

Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE, US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67.

6

Malvankar-Mehta MS, Iordanous Y, Chen YN, Wang WW, Patel SS, Costella J, et al. iStent with phacoemulsification versus phacoemulsification alone for patients with glaucoma and cataract: A meta-analysis. PLoS One [Internet]. 2015 [cited 2018 Jan 2];10(7):e0131770. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4492499/

7

Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104.

8

Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, et al. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9.

9

Terminology and guidelines for glaucoma [Internet]. 4th ed. Savona (ITA): European Glaucoma Society; 2014 Jun. [cited 2017 Aug 8]. Available: http://www.icoph.org/dynamic/attachments/resources/egs_guidelines_4_english.pdf

10

Everitt DE, Avorn J. Systemic effects of medications used to treat glaucoma. Ann Intern Med. 1990 Jan 15;112(2):120-5.

11

Sambhara D, Aref AA. Glaucoma management: relative value and place in therapy of available drug treatments. Ther Adv Chronic Dis [Internet]. 2014 Jan [cited 2017 Dec 22];5(1):30-43. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3871276

12

Iordanous Y, Kent JS, Hutnik CM, Malvankar-Mehta MS. Projected cost comparison of Trabectome, iStent, and endoscopic cyclophotocoagulation versus glaucoma medication in the Ontario Health Insurance Plan. J Glaucoma. 2014 Feb;23(2):e112-e118.

13

Perez-Torregrosa VT, Olate-Perez A, Cerda-Ibanez M, Gargallo-Benedicto A, Osorio-Alayo V, Barreiro-Rego A, et al. Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Arch Soc Esp Oftalmol. 2016 Sep;91(9):415-21.

14

Michael Raj, Charlotte Wells, Caitlyn Ford. Minimally Invasive Glaucoma Surgery: Implementation Considerations. Ottawa: CADTH; 2018. (Environmental scan; no. 76). https://www.cadth.ca/minimally-invasive-glaucoma-surgery-implementation-considerations-0

15

Fighting Blindness. Glaucoma. Available at: https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/

16

Lewis RA. J Cataract Refract Surg. 2014;40(8):1301–6. doi: 10.1016/j.jcrs.2014.01.032.

SOURCE AbbVie Canada

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