November 14, 2018

BELLUS Health Updates BLU-5937 Top-Line Phase 1 Results Timeline to November 2018

- Reports Financial and Operating Results for the Third Quarter Ended September 30, 2018 -

LAVAL, QC, Nov. 14, 2018 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for conditions with high unmet medical need, today updated the top-line phase 1 results timeline to November 2018 for its lead drug candidate BLU-5937 for chronic cough. The Company also reported its financial and operating results for the third quarter ended September 30, 2018. All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

Recent Highlights

  • Expects by the end of November 2018 top-line results of the clinical Phase 1 study for BLU-5937, the Company's lead drug candidate for chronic cough; the study was initiated in July 2018 and all subjects have completed dosing;

  • Was granted a new U.S. patent claiming P2X3 selectivity as a means of minimizing taste effects for BLU-5937; the patent extends BLU-5937's patent protection to 2038;

  • Appointed an international clinical advisory board to provide strategic guidance and support to the BLU-5937 development program as the Company prepares for a clinical study Phase 2, expected to be initiated in 2019;

  • Concluded the quarter with cash, cash equivalents and short-term investments totalling $18.1 million.

"With the BLU-5937 Phase 1 top-line results expected by the end of November, we are fast-approaching a key milestone for the Company," said Roberto Bellini, President and CEO of BELLUS Health. "Based on the pre-clinical data generated to date, we believe that BLU-5937 could be a best-in-class P2X3 antagonist for chronic cough and look forward to the Phase 1 data to support the continued advancement of the program."

BLU-5937 for Chronic Cough

The Company expects top-line results of the clinical Phase 1 study for BLU-5937 by the end of November 2018. The study was initiated in July 2018. The clinical Phase 1 study is a randomized, double-blind, placebo-controlled study of orally administered BLU-5937 in 90 healthy adult subjects. The clinical Phase 1 study results will help define BLU-5937's expected product profile, including the safety, tolerability (including taste perception) and dosing regimen for the Phase 2 study. The study is divided in two parts: a single-ascending dose ("SAD") study, which was conducted in 60 healthy subjects, and a multiple-ascending dose ("MAD") study, which was conducted in 30 healthy subjects. All subjects in both cohorts have completed dosing.

On October 31, 2018, BELLUS Health announced that the U.S. Patent and Trademark Office had issued a patent granting claims for the use of BLU-5937 for the treatment of chronic cough without affecting taste response. More generally, the patent claims the use of imidazopyridine compounds that are selective for the P2X3 receptor as a means of minimizing taste perturbation in patients treated for chronic cough. In addition to BLU-5937, the patent claims the use of related selective imidazopyridine compounds and pharmaceutical compositions comprising BLU-5937. This patent has an expiration date of 2038, excluding any potential patent term extension.

On September 25, 2018, the Company announced the appointment of an international clinical advisory board (the "CAB"), which will provide strategic guidance and support to the BLU-5937 development program as the Company prepares for a clinical Phase 2 study. The CAB is comprised of highly-respected clinical leaders whose work has influenced the treatment and management of chronic cough. The Chair of the CAB is Dr. Jaclyn Smith, MB, ChB, FRCP, PhD, Professor of Respiratory Medicine at the University of Manchester in the United Kingdom and an Honorary Consultant at the University Hospital of South Manchester NHS Foundation Trust.

Summary of Financial Results





Three months ended

September 30, 2018

Three months ended

September 30, 2017


(in thousands of dollars, except per share data)

Revenues

$

9

$

93

Research and development expenses, net


(2,138)


(1,194)

General and administrative expenses


(888)


(571)

Net finance income (costs)


60


(8)

Change in fair value of contingent consideration receivable


(90)


Net loss for the period

$

(3,047)

$

(1,680)

Basic and diluted loss per share

$

(0.03)

$

(0.03)

 

  • Research and development expenses, net of research tax credits, amounted to $2,138,000 for the three-month period ended September 30, 2018, compared to $1,194,000 for the corresponding period the previous year. The increase is primarily attributable to higher expenses incurred in relation to the development of BLU-5937, for which the Company initiated a clinical Phase 1 study in July 2018.

  • General and administrative expenses amounted to $888,000 for the three-month period ended September 30, 2018, compared to $571,000 for the corresponding period the previous year. The increase is mainly due to higher stock-based compensation expense in relation to the Company's stock option plan and deferred share unit plans.

As at September 30, 2018, the Company had available cash, cash equivalents and short-term investments totalling $18,095,000, compared to $23,888,000 as at December 31, 2017.

The Company's full unaudited condensed consolidated interim financial statements and accompanying management's discussion and analysis for the three and nine-month periods ended September 30, 2018 will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for conditions with high unmet medical need. Its pipeline of projects includes the Company's lead drug candidate BLU-5937 for chronic cough and several other partnered clinical-stage drug development programs. BLU-5937, a highly selective P2X3 antagonist, has the potential to be a best-in-class therapeutic for chronic cough patients who do not respond to current therapies.

Chronic cough is a cough that lasts more than eight weeks and is associated with significant adverse social, psychosocial and physical effects on quality of life. A commercial assessment performed by Torreya Insights on behalf of the Company concluded that, in the United States alone, more than 26 million adults have chronic cough and more than 2.6 million of these patients suffer from refractory chronic cough lasting for more than a year.

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. 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 Inc.'s control. Such risks factors include but are not limited to: the ability to expand and develop its project pipeline, the ability to obtain financing, the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity agreements and contingent value rights, achievement of forecasted pre-clinical and clinical trial milestones and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of BELLUS Health Inc.'s drug candidates' development process, their market size and commercial value, as well as the sharing of proceeds between BELLUS Health Inc. and its potential partners from potential future revenues, if any, are dependent upon a number of factors. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. BELLUS Health Inc. 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 Inc. 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 Inc.'s public filings with the Canadian securities regulatory authorities, including the Annual Information Form, for further risk factors that might affect BELLUS Health Inc. and its business.

SOURCE BELLUS Health Inc.

François Desjardins, Vice President, Finance, 450-680-4525, fdesjardins@bellushealth.com

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