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

LAVAL, QC, May 12, 2016 /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, 2016.

Highlights

• Completion of the KIACTA™ Phase 3 Confirmatory Study for the treatment of AA amyloidosis in January 2016; top-line results expected in Q2 2016;
• Issued 7.3 million common shares on January 1, 2016 to settle convertible notes, as scheduled, further simplifying the Company's capital structure;
• Concluded the quarter with cash, cash equivalents and short-term investments totaling $9.0 million.

"With the KIACTA™ Phase 3 top-line results expected before the end of June, it is an important period for the Company and its shareholders, as well as for AA amyloidosis patients who are waiting for a much needed treatment," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health.

KIACTA™ for AA amyloidosis

On January 21, 2016, BELLUS Health and Auven Therapeutics announced the completion of the KIACTA™ Phase 3 Confirmatory Study for the treatment of AA amyloidosis. The Phase 3 study completed enrollment in January 2015 with a total of 261 patients participating in the study. In January 2016, the event-driven study met its completion target of 120 patient events linked to the deterioration of kidney function. Top-line results are expected in the second quarter of 2016.

The Phase 3 study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis. KIACTA™'s safety and efficacy were demonstrated in a previous Phase 2/3 study. The Phase 3 Confirmatory Study is the last key step before applications for regulatory approval for KIACTA™ can be filed.

No major safety concerns have been raised by the Data Safety Monitoring Board, which independently assessed the safety of KIACTA™ throughout the study and most recently met in July 2015.

BELLUS Health is partnered with global private equity firm Auven Therapeutics for the development of KIACTA™. Auven Therapeutics, which acquired the rights to KIACTA™ from the Company in 2010, is conducting the KIACTA™ study and funding 100% of the development costs of KIACTA™, including the Phase 3 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.

Auven Therapeutics has engaged Lazard as a financial advisor for the sale of KIACTA™.

KIACTA™ for Sarcoidosis

BELLUS Health's partner, Auven Therapeutics, is currently developing a clinical Phase 2/3 study protocol to evaluate the safety and efficacy of KIACTA™ for the treatment of patients suffering from chronic pulmonary sarcoidosis. An investigational new drug application (IND) for this clinical Phase 2/3 study is expected to be filed with the U.S. Food and Drug Administration in 2016.

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

A clinical Phase 2/3 study protocol is currently being designed for the assessment of the efficacy of Shigamab™ in the treatment of the Hemolytic Uremic Syndrome caused by Shiga toxin-producing E. coli (sHUS). The Company intends to meet with regulatory authorities in 2016 to present its clinical development plan for Shigamab™.

In parallel with the preparation of the clinical Phase 2/3 study, BELLUS Health is also performing an additional pre-clinical study in a sHUS baboon model to help establish the optimal effective dose and treatment window for Shigamab™ in sHUS patients. 

Shigamab™ is a monoclonal antibody therapy being developed for the treatment of sHUS, a rare disease which principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children.

Settlement of Convertible Notes

As scheduled, on January 1, 2016, BELLUS Health issued 7,286,828 common shares from treasury in settlement of convertible notes. The convertible notes' notional amount was approximately $10.9 million and terms of the conversion were determined as part of BELLUS Health's capital reorganization in 2012. The settlement further simplified the Company's capital structure.

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

The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three-month period ended March 31, 2016 will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.

• Revenues amounted to $591,000 for the three-month period ended March 31, 2016, compared to $786,000 for the corresponding period the previous year. The decrease is primarily attributable to lower revenues recognized for accounting purposes in 2016 in relation to the VIVIMIND™ license agreement with FB Health S.p.A.
• General and administrative expenses amounted to $988,000 for the three-month period ended March 31, 2016, compared to $719,000 for the corresponding period the previous year. The increase is primarily attributable to higher expenses recognized in 2016 in relation to the Company's deferred share unit plans due to the increase in the Company's stock price during the first quarter of 2016.
• Net finance costs amounted to $88,000 for the three-month period ended March 31, 2016, compared to net finance income of $244,000 for the corresponding period the previous year. The decrease is primarily attributable to an increase in the foreign exchange loss that arose from the translation of the Company's net monetary assets denominated in US dollars, due to the depreciation of the US dollar versus the Canadian dollar in the first quarter of 2016.

As at March 31, 2016, the Company had available cash, cash equivalents and short-term investments totalling $8,951,000, compared to $9,702,000 as at December 31, 2015.

BELLUS Health Announces Election of Directors at Annual Meeting

Each director nominee listed in the Management Information Circular dated March 15, 2016 was elected as Director of the Company during the Annual Meeting of Shareholders held today in Laval, Quebec.

The details of the election are as follows:

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 website (www.sedar.com).

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.

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a drug development company focused on rare diseases. Its pipeline of rare disease projects includes KIACTA™ for AA amyloidosis, KIACTA™ for sarcoidosis, clinical-stage Shigamab™ for sHUS and a research-stage project for AL amyloidosis. The lead program KIACTA™ has completed a Phase 3 Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death, and top-line results are expected in Q2 2016. BELLUS Health is partnered with global private equity firm Auven Therapeutics for the development of KIACTA™.

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 the 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, dependence on Auven Therapeutics for the completion of the KIACTA™ Phase 3 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™ Phase 3 Confirmatory Study and the sharing of proceeds between Auven Therapeutics and BELLUS Health Inc. from potential future revenue of KIACTA™ are 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. The Company 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.