LAVAL, QC, Aug. 9, 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 second quarter ended June 30, 2016. All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

Highlights

• Announced top-line results from the KIACTA™ Phase 3 Confirmatory Study for the treatment of AA amyloidosis; KIACTA™ did not meet the primary efficacy endpoint in slowing renal function decline and continues to be evaluated in order to determine next steps for the program;
  
  
• Subsequent to quarter end, completed an additional Shigamab™ pre-clinical study in a sHUS baboon model; Shigamab™ was shown to rescue the animals against a lethal dose of toxin when administered up to 48 hours post-intoxication;
  
  
• Subsequent to quarter end, highlighted other assets in its pipeline 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;
  
  
• Completed simplification of the Company's capital structure by issuing 6.4 million common shares upon scheduled conversion of Pharmascience's interest in BHI Limited Partnership;
  
  
• Has reduced forecasted expenses, effectively decreasing its projected monthly average burn rate from $300,000 to $225,000;
  
  
• Concluded the quarter with cash, cash equivalents and short-term investments totaling $8.0 million.

"The negative top-line results for the KIACTA™ Phase 3 study in AA amyloidosis results were not what we had been expecting" said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "While the KIACTA™ Phase 3 data continues to be investigated, we would like to highlight that the Company is financially secure and has a varied pipeline of projects including Shigamab™ for Hemolytic Uremic Syndrome. We look forward to providing further updates on all our projects throughout the second half of the year."

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 which acquired the rights to KIACTA™ from the Company in 2010, is currently proceeding to additional analysis in order to determine the next steps for 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. In conjunction with the review of KIACTA™ for AA amyloidosis, the Sarcoidosis program is also currently under review by Auven Therapeutics. All costs in relation to the development of KIACTA™ in sarcoidosis will be borne by Auven Therapeutics.

Shigamab™ for sHUS

A clinical Phase 2 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 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 2 and protect the animals against the extra-renal complications associated with the Shiga toxin 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 dose of Shiga toxin 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 mid-single digit percentage royalty and revenue share. 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. This disease 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 for mid-single digit percentage royalty and revenue share. 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 which demonstrated that ALZ-801 had a substantially optimized pharmacokinetic profile and favorable safety/tolerability in elderly subjects compared to oral tramiprosate. ALZ-801 is an orally-available optimized prodrug of tramiprosate, the active agent in ALZ-801, and clinical development of ALZ-801 builds on the established safety and efficacy profile of tramiprosate from two prior Phase 3 trials in more than 2,000 AD patients. Alzheon is in preparation for a pivotal Phase 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. The Phase 3 study is expected to be initiated in 2017.

Specialty Pharma Equity Stake

The Company has a 5.7% 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 June 30, 2016.

AL Amyloidosis Research Project

During the quarter, the Company took the decision to terminate its research-stage project for AL amyloidosis.

Conversion of Pharmascience's interest in BHI Limited Partnership

On June 2, 2016, BELLUS Health issued 6,350,638 common shares from treasury upon the exercise of Pharmascience's right to convert its 10.4% interest in BHI Limited Partnership into common shares. The Company currently has 61.1 million common shares outstanding and 65.9 million common shares on a fully diluted basis, including stock options granted under the stock option plan.

Summary of Financial Results and Key Balance Sheet Assets

Financial Results:

• Research and development expenses, net of research tax credits, amounted to $543,000 for the three-month period ended June 30, 2016, compared to $169,000 for the corresponding period the previous year. The increase is primarily attributable to higher expenses incurred in relation to the development of Shigamab™. In addition, higher research tax credits were recognized during the second quarter of 2015 in relation to additional claims for prior years filed during that quarter.
  
  
• General and administrative expenses amounted to $368,000 for the three-month period ended June 30, 2016, compared to $864,000 for the corresponding period the previous year. The decrease is primarily attributable to the income recorded in the second quarter of 2016 in relation to the Company's deferred share unit plans due to the decrease in the Company's stock price during that period.

Key Balance Sheet Assets:

• As at June 30, 2016, the Company had available cash, cash equivalents and short-term investments totalling $7,950,000, compared to $9,702,000 as at December 31, 2015. During the quarter, the Company has reduced forecasted expenses through the reduction of non-core expenses and the termination of its AL amyloidosis program, effectively decreasing its projected average monthly burn rate from $300,000 to $225,000.

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, 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 financial interests in some biotechnology and pharmaceutical companies.

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.