BLU BELLUS Health Inc

LAVAL, QC, Nov. 10, 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 third quarter ended September 30, 2016. All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

Highlights

• Completed an additional Shigamab™ pre-clinical study in a sHUS baboon model; Shigamab™ was shown to rescue the animals against a lethal dose of Shiga toxin type 2 when administered up to 48 hours post-intoxication;
• Highlighted partnered assets, including AMO-01 for Fragile X Syndrome, ALZ-801 for APOE4 homozygous Alzheimer's disease and an equity stake in an Italian specialty pharma company;
• Ongoing evaluation of the KIACTA™ program in AA amyloidosis and sarcoidosis by BELLUS Health partner, Auven Therapeutics, in order to determine next steps;
• Concluded the quarter with cash, cash equivalents and short-term investments totaling $7.2 million; forecasted average monthly burn rate reduced from $300,000 to $225,000.

"We are expecting to receive our partner's decision for the Kiacta program in AA amyloidosis and sarcoidosis before the end of the year," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. " In the meantime, we continue to focus on the rest of our pipeline, particularly Shigamab where we spent the third quarter advancing necessary pre-clinical work for the Shigamab program and are now evaluating clinical options for future development."

KIACTA™ for AA Amyloidosis

On June 20, 2016, the Company announced top-line results from the Phase 3 study of KIACTA™ for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death. In the study, KIACTA™ did not meet the primary efficacy endpoint in slowing renal function decline. KIACTA™ was shown to be safe and well tolerated over treatment periods of greater than 4 years.

Auven Therapeutics, BELLUS Health's partner who acquired the rights to KIACTA™ from the Company in 2010, continues to evaluate the clinical data for determining the next steps for KIACTA™. A decision is expected to be made by year-end.

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. In conjunction with the review of KIACTA™ for AA amyloidosis, the sarcoidosis program is also currently under review by Auven Therapeutics. A decision is expected to be made by year-end.

Shigamab™ for sHUS

A clinical Phase 2 study protocol has been designed for the assessment of the efficacy of Shigamab™ in 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.

In parallel with the preparation of the clinical Phase 2 study, BELLUS Health has recently completed an additional pre-clinical study in a sHUS baboon model, which recapitulates a pathophysiology similar to that in sHUS patients. The objective of this study was to assess the effect of Shigamab™ on the progression of sHUS. In this study, Shigamab™ was shown to rescue the animals against a lethal dose of toxin when administered up to 48 hours post-intoxication. Shigamab™ was also found to inhibit the kidney injury caused by Shiga toxin type 2 and protect the animals against the extra-renal complications associated with the Shiga toxin type 2 intoxication. These results are consistent with the protective effects of Shigamab™ previously seen in the mice that received lethal doses of Shiga toxin E. coli or lethal doses of Shiga toxin type 2.

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.

AMO-01 for Fragile X Syndrome

In 2014, BELLUS Health entered into a development and license agreement with AMO Pharma Limited (AMO Pharma) for the worldwide rights to AMO-01 (formerly TLN-4601) for the treatment of neurologic and psychiatric disorders in return for royalties on sales and revenue sharing. TLN-4601 was acquired by BELLUS Health as part of the Thallion Pharmaceutical Inc. acquisition in August 2013.

AMO Pharma is a private company focused on the treatment of central nervous system and neuromuscular diseases. AMO Pharma is preparing for a Phase 2 study on patients with Fragile X Syndrome, a deadly disease with no current approved therapies. The condition affects approximately 180,000 patients in the United States.

ALZ-801 for APOE4 Homozygous Alzheimer's Disease

In 2013, worldwide rights to ALZ-801 (formerly BLU8499) were licensed to Alzheon Inc. (Alzheon) in return royalties on sales and revenue sharing. BLU8499 was initially developed by BELLUS Health for the treatment of Alzheimer's disease (AD). Alzheon is a private company focused on AD and other neurodegenerative disorders.

In July 2016, Alzheon announced that it had completed Phase 1b studies with ALZ-801. Alzheon is in preparation for a pivotal Phase 2/3 program focusing on treatment of Alzheimer's patients who are homozygous for apolipoprotein E (APOE4), the most important genetic risk factor for late-onset AD.

Specialty Pharma Equity Stake

The Company has a 5.72% equity interest in FB Health S.p.A (FB Health), an Italy-based specialty pharma focused on neurology and psychiatry. FB Health is a growing and profitable company which distributes over ten nutraceutical and pharmaceutical products in Italy with annual sales in excess of 8 million euros. The investment in FB Health is presented at fair value in BELLUS Health's financial statements and amounted to $957,000 as of September 30, 2016.

Other

The Company continues to explore opportunities in order to expand its pipeline, including through acquisitions and/or in-licensing.

Summary of Financial Results and Key Balance Sheet Assets

Financial Results:

• Revenues amounted to $358,000 for the three-month period ended September 30, 2016, compared to $593,000 for the corresponding period the previous year. The decrease is primarily attributable to lower revenues recognized for accounting purposes from the service agreement entered into with Auven Therapeutics for the development of KIACTA™. Following the announcement of the results from the Phase 3 Confirmatory Study of KIACTA™ on June 20, 2016, the Company's expected support and assistance to Auven Therapeutics after that date was decreased.
• Net finance income amounted to $24,000 for the three-month period ended September 30, 2016, compared to $174,000 for the corresponding period the previous year. The decrease is primarily attributable to lower foreign exchange gain that arose from the translation of the Company's net monetary assets denominated in US dollars, due to the depreciation of the US dollar vs the Canadian dollar during the period.

Key Balance Sheet Assets:

• As at September 30, 2016, the Company had available cash, cash equivalents and short-term investments totalling $7,210,000, compared to $9,702,000 as at December 31, 2015. In the second quarter of 2016, the forecasted average monthly burn rate was decreased from $300,000 to $225,000 through the reduction of non-core expenses and the termination of the AL amyloidosis program.

The Company's full unaudited consolidated financial statements and accompanying management's discussion and analysis for the three and nine-month periods ended September 30, 2016 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 drug development company focused on rare diseases. Its pipeline of rare disease projects includes KIACTA™ for AA amyloidosis, KIACTA™ for sarcoidosis and clinical-stage Shigamab™ for sHUS. BELLUS Health is partnered with global private equity firm Auven Therapeutics for the development of KIACTA™. BELLUS Health also has economic interests in several other partnered drug development projects.

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 pre-clinical and clinical trial milestones, dependence on Auven Therapeutics for the development of KIACTA™ 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™ development process 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.