BLU BELLUS Health Inc

LAVAL, QC, Feb. 21, 2018 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company"), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, today reported its financial and operating results for the year ended December 31, 2017. All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

2017 Highlights

• Entered into a license agreement with the NEOMED Institute ("NEOMED") for the exclusive worldwide rights to develop and commercialize BLU-5937 - a selective antagonist of the P2X3 receptor, a clinically validated target for chronic cough - that has the potential to be a best-in-class therapeutic for chronic cough patients who do not respond to current therapies;
  
  
• Closed a $20 million equity offering subscribed to in majority by institutional healthcare investors and which also included the participation by members of the senior management team and board of directors of the Company;
  
  
• Announced that in a guinea pig cough model, BLU-5937 has shown comparable efficacy to the current leading P2X3 antagonist in development, Merck & Co's Gefapixant;
  
  
• Announced that in a rat taste model, BLU-5937 did not inhibit taste, while, consistent with clinical trial data previously presented by Merck & Co, Gefapixant led to significant taste disturbance;
  
  
• Hosted a Key Opinion Leader ("KOL") event on chronic cough with Dr. Jacky Smith. The archived version of the webcast and presentation are available on the Company's website at www.bellushealth.com;
  
  
• Announced that the U.S. Patent and Trademark Office issued a patent that grants claims covering the composition of matter of the Company's lead drug candidate, BLU-5937, until 2034. The Company was granted a patent for similarly broad claims in China in July 2017;
  
  
• Sold its wholly-owned subsidiary, Thallion Pharmaceuticals Inc. ("Thallion"), to Taro Pharmaceuticals Inc. ("Taro") for total consideration of $2.7 million;
  
  
• Sold its equity interest in FB Health S.p.A. ("FB Health") for a potential total consideration of approximately $2.5 million;
  
  
• Concluded the quarter with cash, cash equivalents and short-term investments totaling $23.9 million.

"2017 has been a very productive year for BELLUS Health, beginning with the in-licensing of our new lead program BLU-5937, that has the potential to be a best-in-class treatment for chronic cough, and closing the year with a $20 million financing, a testament to the potential of the program," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "The funds obtained through the financing will support the momentum of BLU-5937's development into clinical testing. We expect starting a Phase 1 study in Q3 2018, with top line data expected by year-end."

Equity Offering

On December 12, 2017, the Company closed an equity offering, issuing a total of 52,631,580 common shares at a price of $0.38 per share for aggregate gross proceeds of $20 million (the "Offering"). The Offering was subscribed to in majority by institutional healthcare investors and also included the participation by members of the senior management team and board of directors of the Company.

In addition, 1,806,735 broker warrants exercisable for common shares were issued to the agents of the Offering. Each broker warrant entitles the agents to buy one common share at a price of $0.38 per share for a period of 18 months from the closing of the Offering.

BLU-5937 for Chronic Cough

On February 28, 2017, the Company announced that it had obtained from NEOMED an exclusive worldwide license to develop and commercialize BLU-5937, a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for chronic cough. BLU-5937 has the potential to be a best-in-class therapeutic for chronic cough patients who do not respond to current therapies.

On September 18, 2017, the Company announced that BLU-5937 showed a significant reduction in cough and no taste disturbance in two separate preclinical models. In a guinea pig cough model, BLU-5937 showed comparable efficacy to the current leading P2X3 antagonist in development, Merck & Co's Gefapixant (also named AF-219 or MK-7264). In a rat taste model, BLU-5937 did not inhibit taste, while, consistent with clinical trial data previously presented by Merck & Co, Gefapixant led to significant taste disturbance.

On April 24, 2017, the Company announced that the U.S. Patent and Trademark Office issued a patent which grants claims covering the composition of matter of BLU-5937, with an expiration date of 2034. The Company was granted a patent for similarly broad claims in China on July 10, 2017. Similar patent applications are currently pending in Europe, Japan and other industrialized nations.

The Company is currently performing preclinical studies on BLU-5937 to complete its package for submission of a Clinical Trial Application ("CTA"), expected in the second quarter of 2018. The Company plans to initiate a Phase 1 clinical study in the third quarter of 2018.

Sale of Thallion

On March 16, 2017, the Company sold its wholly-owned subsidiary Thallion to Taro, including all the rights to the drug candidate Shigamab^TM. Taro acquired all issued and outstanding shares of Thallion for a total consideration of $2.7 million, consisting of a cash payment of $2.3 million on closing and a deferred payment of $0.4 million upon the completion of a pre-established milestone event, which payment was received in January 2018. In addition, BELLUS Health will receive a portion of certain potential future post-approval revenues related to the Shigamab^TM program.

Sale of Equity Interest in FB Health

On June 30, 2017, the Company sold its equity interest in FB Health for a potential total consideration of $2,536,000, consisting of an upfront cash payment of $1,769,000 and a contingent revenue-based milestone payment of up to $767,000 (€518,000), which will be determined one year from the closing of the transaction.

Other Development Programs

Information on the Company's other partnered development programs – KIACTA™ for Sarcoidosis, AMO-01 for Fragile X Syndrome and ALZ-801 for APOE4 Homozygous Alzheimer's Disease – can be found on the Company's website at www.bellushealth.com.

Summary of Financial Results

• Revenues amounted to $165,000 for the year ended December 31, 2017, compared to $1,893,000 for the previous year. Revenues for 2016 included those related to agreements with a partner for the now terminated development of a drug candidate.
  
  
• Research and development expenses, net of research tax credits, amounted to $3,321,000 for the year ended December 31, 2017, compared to $1,366,000 for the previous year. The increase is attributable to expenses incurred in relation to the development of BLU-5937, the Company's lead drug candidate for chronic cough, for which an exclusive worldwide license to develop and commercialize was entered into in February 2017.
  
  
• Realized gain on sale of available-for-sale investment in FB Health amounted to $1,909,000 for the year ended December 31, 2017 and is related to the sale of the Company's equity interest in FB Health in June 2017.
  
  
• Gain on sale of subsidiary amounted to $1,944,000 for the year ended December 31, 2017 and is related to the sale of Thallion in March 2017.

As at December 31, 2017, the Company had available cash, cash equivalents and short-term investments totalling $23,888,000, compared to $6,834,000 as at December 31, 2016.

The Company's full audited consolidated financial statements and accompanying management's discussion and analysis for the year ended December 31, 2017 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 biopharmaceutical development company advancing 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 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 recent 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.