BELLUS Health Reports Financial and Operating Results for the First Quarter Ended March 31, 2015

- Company also announces voting results from Annual Meeting of Shareholders -

LAVAL, QC, May 12, 2015 /CNW/ - BELLUS Health Inc. (TSX: BLU) (BELLUS Health or the Company), a drug development company focused on rare diseases, today reported its financial and operating results for the first quarter ended March 31, 2015.

Highlights

• Enrollment completed for the KIACTA™ Phase III Confirmatory Study in AA amyloidosis, with a total of 261 patients participating in the study;
• Approximately 75% of the required events to complete the KIACTA™ Phase III Confirmatory Study have occurred; the study is on track to conclude in 2016;
• Concluded the quarter with a cash position of $11.5 million, which should enable the Company to finance its operations beyond the end of the Phase III Confirmatory Study for KIACTA™.

"The KIACTA™ Phase III program completed its enrollment and continued to progress as planned in the first quarter," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "Enrollment completion for the KIACTA™ study represents a significant milestone in the largest clinical trial ever undertaken in AA amyloidosis. We also continued advancing our other rare disease programs towards greater value-creating events."

KIACTA™ for AA amyloidosis

During the first quarter of 2015, the KIACTA™ Phase III Confirmatory Study continued to progress. In January 2015, the study completed its enrollment with a total of 261 patients participating. The study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death.

The Phase III Confirmatory Study is an event-driven trial that will conclude when 120 patients have experienced an event linked to the deterioration of kidney function. To date, approximately 75% of the required events have occurred, and based on the current event rate, the KIACTA™ Phase III Confirmatory Study is expected to conclude in 2016.

KIACTA™ is partnered with global private equity firm Auven Therapeutics. Auven Therapeutics is conducting the KIACTA™ study and funding 100% of the development costs, including the Phase III Confirmatory Study and other related activities, which total costs are currently estimated to be in excess of US$60 million. Overall proceeds from potential future revenue of KIACTA™ will be shared between Auven Therapeutics and BELLUS Health based on a pre-agreed formula, and assuming that total divestiture transaction proceeds reach a pre-determined threshold, the parties will share aggregate proceeds equally.

The process to explore the sale of KIACTA™, which was initiated in May 2014 with the engagement of financial advisor Lazard by Auven Therapeutics, is on-going. This initiative provides increased flexibility to divest KIACTA™ at the most opportune time for stakeholders, whether that is prior to or following the conclusion of the KIACTA™ Phase III Confirmatory Study.

KIACTA™ for Sarcoidosis

BELLUS Health's partner, Auven Therapeutics, is currently developing a clinical study protocol to conduct a Phase II proof-of-concept trial to evaluate KIACTA™'s effectiveness in treating certain clinical manifestations of sarcoidosis. The Phase II trial is expected to begin in the second half of 2015.

All costs in relation to the development of KIACTA™ in sarcoidosis will be borne by Auven Therapeutics. Proceeds from potential future revenue of KIACTA™, including the rights to KIACTA™ for sarcoidosis, are subject to the proceeds sharing agreement between Auven Therapeutics and BELLUS Health.

Chronic sarcoidosis is a rare inflammatory condition that affects the lungs. There is no cure for sarcoidosis, and treatment options are limited and can have serious adverse effects.

Shigamab™ for sHUS

During 2014, in studies performed in collaboration with the Uniformed Services University of the United States Department of Defense, Shigamab™ was shown to reduce toxicity of Shiga toxin type 2 in a sHUS mouse model, even following delayed treatment, as measured by body weight loss, renal biomarkers and renal histopathology. These results support BELLUS Health's treatment approach of sHUS. Further pre-clinical studies are being conducted to evaluate Shigamab™ in the treatment of toxicity of Shiga toxin type 2.

Shigamab™ is a monoclonal antibody therapy being developed for the treatment of Hemolytic Uremic Syndrome caused by Shiga toxin-producing E. coli (sHUS), which principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children.

AL Amyloidosis Research Project

In February 2015, the agreement entered into by BELLUS Health with AmorChem Holdings Inc. in 2013 was terminated. This agreement focused on the development of drug candidates for the treatment of AL amyloidosis, a rare disease in which amyloid protein builds up and causes dysfunction in various parts of the body. As a result of the agreement termination, BELLUS Health regained exclusive rights to its AL amyloidosis program and related compounds.

Summary of Financial Results
All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

	Three months ended March 31, 2015	Three months ended March 31, 2014
	(in thousands of dollars, except per share data)
Revenues	786	475
Research and development expenses	(323)	(464)
General and administrative expenses	(719)	(890)
Net finance income	244	171
Deferred tax recovery	5	–
Net loss for the period	(7)	(708)
Net loss attributable to shareholders	(46)	(680)
Basic and diluted loss per share	–	(0.01)

The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three-month period ended March 31, 2015 will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.

• Revenues amounted to $786,000 for the three-month period ended March 31, 2015, compared to $475,000 for the corresponding period the previous year. The increase is primarily attributable to sales-based royalty revenue received in 2015 in relation to the VIVIMIND™ license agreement with FB Health. The increase is also attributable to higher revenue recognized for accounting purposes in 2015 in relation to the service agreement with Auven Therapeutics for KIACTA™.
• Research and development expenses amounted to $323,000 for the three-month period ended March 31, 2015, compared to $464,000 for the corresponding period the previous year. The decrease is primarily attributable to lower expenses incurred in relation to the development of Shigamab™ during the first quarter of 2015.
• General and administrative expenses amounted to $719,000 for the three-month period ended March 31, 2015, compared to $890,000 for the corresponding period the previous year. The decrease is primarily attributable to lower expenses recognized in 2015 in relation to the Company's deferred share unit plans as well as the stock option plan.
• Net finance income amounted to $244,000 for the three-month period ended March 31, 2015, compared to $171,000 for the corresponding period the previous year. The increase is primarily attributable to an increase in the foreign exchange gain that arose from the translation of the Company's net monetary assets denominated in U.S. dollars, due to the appreciation of the U.S. dollar versus the Canadian dollar during the first quarter of 2015.

As at March 31, 2015, the Company had available cash, cash equivalents and short-term investments totalling $11,537,000, compared to $12,307,000 as at December 31, 2014. Based on management's estimate, the current cash position should enable the Company to finance its operations beyond the end of the KIACTA™ Phase III Confirmatory Study, expected in 2016.

BELLUS Health Announces Election of Directors at Annual Meeting

Each director nominee listed in the Management Information Circular dated March 17, 2015 was elected as Director of the Company during the Annual Meeting of the Holders of Common Shares held today in Laval, Quebec.

The details of the election are as follows:

Director Nominee	Outcome	Votes For	% For	Votes Withheld	% Withheld
Dr. Francesco Bellini, O.C.	Elected	34,150,336	99.98%	7,199	0.02%
Roberto Bellini	Elected	34,150,286	99.98%	7,249	0.02%
Franklin M. Berger	Elected	34,155,805	99.99%	1,730	0.01%
Charles Cavell	Elected	34,155,784	99.99%	1,751	0.01%
Hélène F. Fortin	Elected	34,145,703	99.97%	11,832	0.03%
Pierre Larochelle	Elected	34,152,144	99.98%	5,391	0.02%
Murielle Lortie	Elected	34,140,092	99.95%	17,443	0.05%
Joseph Rus	Elected	34,150,182	99.98%	7,353	0.02%
Dr. Martin Tolar	Elected	34,150,157	99.98%	7,378	0.02%

The results of the final votes regarding all matters subject to a vote during the Annual Meeting that took place today will be made available on SEDAR's site (www.sedar.com).

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a drug development company focused on rare diseases. It has a pipeline of rare disease projects including KIACTA™ in Phase III for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage Shigamab^TM for sHUS and a research-stage project for AL amyloidosis. The lead program KIACTA™ is currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics.

About AA Amyloidosis

AA amyloidosis is a deadly condition that progresses from chronic inflammatory diseases such as rheumatoid arthritis. The disease causes a protein called amyloid A to accumulate in major organs, particularly the kidneys, which leads to organ dysfunction, failure, and eventually death.

There is currently no available treatment for AA amyloidosis. A recent commercial assessment study conducted by Navigant Consulting on behalf of Auven Therapeutics and BELLUS Health identified between 10,000 and 15,000 KIACTA™ eligible patients with AA amyloidosis in the United States and Europe.

KIACTA™ has been granted Orphan Drug designation or its equivalent for the treatment of AA amyloidosis in the United States, Europe and Japan, which provide for market exclusivity for a period of seven to ten years once the drug is approved, as well as a reduction in application and review fees.

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 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 clinical trial milestones, dependence on Auven Therapeutics for the completion of the KIACTA™ Phase III Confirmatory Study 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 the KIACTA^TM Phase III Confirmatory Study is dependent upon many factors, including patient drop-out rate and occurrence of clinical endpoint events, and the sharing of proceeds between Auven Therapeutics and BELLUS Health Inc. from potential future revenue of KIACTA™ is dependent upon a number of factors, including the quantum of proceeds. 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.

Adam Peeler, TMX Equicom, 416-815-0700 ext. 225, [email protected]