November 08, 2017

BELLUS Health Reports Financial and Operating Results for the Third Quarter Ended September 30, 2017

LAVAL, QC, Nov. 8, 2017 /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 third quarter ended September 30, 2017. All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

2017 Highlights

  • Entered into a license agreement for the exclusive worldwide rights to develop and commercialize BLU-5937 (formerly NEO5937), 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;

  • Announced that in the guinea pig cough model, BLU-5937 has shown comparable efficacy to the current leading P2X3 antagonist, Merck & Co's Gefapixant;

  • Announced that in the rat taste model, BLU-5937 did not inhibit taste; however, consistent with clinical trial data previously presented by Merck & Co, Gefapixant led to significant taste disturbance;

  • Hosted a Key Opinion Leader event on chronic cough with Dr. Jacky Smith. For the archived version of the webcast and presentation: https://event.webcasts.com/starthere.jsp?ei=1159556&tp_key=4a0ae58b66;

  • 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;

  • Sold the Company's wholly-owned subsidiary, Thallion Pharmaceuticals Inc. (Thallion), to Taro Pharmaceuticals Inc. (Taro) for total consideration of $2.7 million, including an upfront payment of $2.3 million;

  • Sold the Company's equity interest in FB Health S.p.A. (FB Health) for a potential total consideration of approximately $2.5 million, of which $1.8 million was received in the second quarter;

  • Concluded the quarter with cash, cash equivalents and short-term investments totaling $6.3 million, which should be sufficient to finance the Company's operations to the first quarter of 2019.

"The data presented in two preclinical models during our Key Opinion Leader event demonstrated the differentiated profile of BLU-5937 and highlighted its potential to drive comparable anti-cough effect to the leading P2X3 antagonist, but with a substantially improved side effect profile" said Roberto Bellini, President and CEO of BELLUS Health. "During the quarter we made significant strides towards moving BLU-5937 into human clinical studies and continue to expect filing a Clinical Trial Application, to support starting a Phase 1 study, in the second quarter of 2018."

Q3 2017 Highlights

BLU-5937

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 the guinea pig cough model, BLU-5937 showed comparable efficacy to the current leading P2X3 antagonist, Merck & Co's Gefapixant (also named AF-219 or MK-7264). In the rat taste model, BLU-5937 did not inhibit taste; however, consistent with clinical trial data previously presented by Merck & Co, Gefapixant led to significant taste disturbance.

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.

Other development programs

Information on the Company's other 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





Three months ended

September 30, 2017

Three months ended

September 30, 2016


(in thousands of dollars, except per share data)

Revenues

$

93

$

358

Research and development expenses, net


(1,194)


(330)

General and administrative expenses


(571)


(664)

Net finance (costs) income


(8)


24

Net loss for the period


(1,680)


(612)

Basic and diluted loss per share

$

(0.03)

$

(0.01)

 

  • Revenues amounted to $93,000 for the three-month period ended September 30, 2017, compared to $358,000 for the corresponding period the previous year. Revenues for 2016 included those related to the agreements with Auven Therapeutics.

  • Research and development expenses, net of research tax credits, amounted to $1,194,000 for the three-month period ended September 30, 2017, compared to $330,000 for the corresponding period 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.

  • General and administrative expenses amounted to $571,000 for the three-month period ended September 30, 2017, compared to $664,000 for the corresponding period the previous year. The decrease is primarily attributable to temporary cost reduction measures implemented by the Company in 2016 after the announcement of the KIACTA™ Phase 3 results in June 2016.

 

As at September 30, 2017, the Company had available cash, cash equivalents and short-term investments totalling $6,296,000, compared to $6,834,000 as at December 31, 2016. The Company expects its cash position to be sufficient to finance its operations to the first quarter of 2019.

The Company's full unaudited condensed consolidated interim financial statements and accompanying management's discussion and analysis for the three and nine-month periods ended September 30, 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. 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.

François Desjardins, Vice-President, Finance, 450-680-4525, fdesjardins@bellushealth.com

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