BELLUS Health Reports Financial and Operating Results for the First Quarter Ended March 31, 2017

- Company focused operations on BLU-5937 for chronic cough -

- Company announces voting results from Annual and Special Meeting;
Shareholders approved reduction of number of directors and nomination of Dr. Youssef L. Bennani -

LAVAL, QC, May 9, 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 first quarter ended March 31, 2017. All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

Recent highlights

  • Entered into a license agreement for the exclusive worldwide rights to develop and commercialize BLU-5937 (formerly NEO5937), a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for chronic cough;

  • Announced on April 24, 2017, that the U.S. Patent and Trademark Office issued a patent which grants claims covering the composition of matter of the Company's lead drug candidate, BLU-5937;

  • 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;

  • Shareholders approved the reduction of the number of directors and the nomination of Dr. Youssef L. Bennani to the Board of Directors;

  • Concluded the quarter with cash, cash equivalents and short-term investments totaling $7.0 million, which the Company believes is sufficient to finance its operations to the end of 2018.

"During the first quarter, BELLUS Health focused its core business plan around the development of BLU-5937, a potentially best-in-class drug candidate for the treatment of chronic cough," said Roberto Bellini, President and CEO of BELLUS Health. "Our strategic divestiture of Thallion will also largely support our development program for BLU-5937, with the upfront payment from the transaction extending our cash runway to the end of 2018."

BLU-5937 for chronic cough

On February 28, 2017, BELLUS Health announced that it had obtained from the NEOMED Institute (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 is a promising best-in-class drug candidate that has the potential to help millions of chronic cough patients who do not respond to current therapies.

Under the terms of the agreement, the Company paid an upfront fee of $3.2 million, consisting of $1.7 million in cash and $1.5 million with the issuance of 5,802,177 BELLUS Health's common shares. NEOMED will be entitled to receive a royalty on net sales-based revenues. In lieu of milestone payments, a certain portion of all other revenues received by BELLUS Health from BLU-5937 will be shared with NEOMED in accordance with a pre-established schedule whereby the shared revenue portion decreases as the program progresses in development.

On April 24, 2017, the Company announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,598,409, which grants claims covering the composition of matter of BELLUS' lead drug candidate, BLU-5937, and related imidazopyridine compounds, in addition to pharmaceutical compositions comprising BLU-5937 and uses thereof. The patent has an expiration date of 2034, excluding any potential patent term extension. Patent applications with similarly broad claims are currently pending in Europe, Japan, China and other industrialized nations.

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. It is estimated that, in the United States alone, more than 2.7 million patients suffer from chronic cough that is not controlled by currently available medications.

Sale of Thallion

On March 16, 2017, the Company entered into a share purchase agreement with Taro for the sale of the Company's wholly-owned subsidiary Thallion, including all the rights to the drug candidate ShigamabTM. Taro acquired all issued and outstanding shares of Thallion for 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 to occur within 24 months of the closing of the transaction. In addition, BELLUS Health will receive a portion of certain post-approval revenues related to the ShigamabTM program.

KIACTA™ for Sarcoidosis

In 2010, BELLUS Health entered into a sale and license agreement with global private equity firm Auven Therapeutics for the worldwide rights to KIACTATM in exchange for an upfront fee and revenue sharing.

Auven Therapeutics is currently evaluating whether to further pursue the development of KIACTA™ for the treatment of patients suffering from active pulmonary sarcoidosis. Auven Therapeutics has developed a clinical Phase 2/3 study protocol to evaluate the safety and efficacy of KIACTA™ in pulmonary sarcoidosis. The U.S. Food and Drug Administration has cleared the investigational new drug application (IND) for this clinical Phase 2/3 study.

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 revenue sharing and royalties on sales.

AMO Pharma is a private company focused on the treatment of central nervous system and neuromuscular diseases. AMO Pharma is expected to initiate a Phase 2 study to evaluate the efficacy of AMO-01 in patients suffering from Fragile X Syndrome in 2017.

ALZ-801 for APOE4 Homozygous Alzheimer's Disease

ALZ-801 for the treatment of Alzheimer's disease (AD), initially developed by BELLUS Health, was licensed to Alzheon Inc. (Alzheon) in 2013 in return for revenue sharing and royalties on sales.

Alzheon, a private company focused on AD and other neurodegenerative disorders, has completed two Phase 1b clinical studies with ALZ-801 and is currently in preparation for further late-stage clinical studies.

Summary of Financial Results





Three months ended

March 31, 2017

Three months ended

March 31, 2016


(in thousands of dollars, except per share data)

Revenues

$

9

$

591

Research and development expenses, net


(251)


(286)

General and administrative expenses


(566)


(988)

Net finance income (costs)


8


(88)

Gain on subsidiary disposal


1,944


Deferred tax recovery



12

Net income (loss) for the period


1,144


(759)

Net income (loss) attributable to shareholders


1,144


(724)

Basic diluted income (loss) per share

$

0.02

$

(0.01)

 

  • Revenues amounted to $9,000 for the three-month period ended March 31, 2017, compared to $591,000 for the corresponding period the previous year. Revenues for 2016 included revenues from Auven Therapeutics in relation to the development of KIACTA™ in AA Amyloidosis, which was completed in 2016.

  • General and administrative expenses amounted to $566,000 for the three-month period ended March 31, 2017, compared to $988,000 for the corresponding period the previous year. The decrease is primarily attributable to cost reduction measures implemented by the Company after the announcement of the KIACTATM Phase 3 results in June 2016 as well as to lower expenses recorded in relation to the Company's deferred share unit plans.

  • Net finance income amounted to $8,000 for the three-month period ended March 31, 2017, compared to net finance costs of $88,000 for the corresponding period the previous year. The increase in net finance income is primarily attributable to lower foreign exchange loss that arose from the translation of the Company's net monetary assets denominated in US dollars.

  • Gain on subsidiary disposal amounted to $1,944,000 for the three-month period ended March 31, 2017 and is in relation to the sale of Thallion.

As at March 31, 2017, the Company had available cash, cash equivalents and short-term investments totalling $7,019,000, compared to $6,834,000 as at December 31, 2016. The Company believes its cash position should be sufficient to finance its operations to the end of 2018.

BELLUS Health Announces Election of Directors at Annual and Special Meeting

At the Annual and Special Meeting of Shareholders held today in Laval, Quebec, shareholders approved the reduction of the number of directors from nine to seven. Each director nominee listed in the Management Information Circular dated March 15, 2017, was elected as a Director of the Company, including a new director, Dr. Youssef L. Bennani, Vice-President, Research and Development of Vertex Pharmaceuticals Canada Inc.

"We would like to thank Ms. Hélène F. Fortin, Ms. Murielle Lortie and Mr. Charles Cavell for their contribution and thoughtful advice over the years," said Dr. Francesco Bellini, Chairman of the Board of BELLUS Health. "At the same time, we welcome Dr. Youssef L. Bennani whose valuable scientific experience and expertise will support the development of BLU-5937, our new lead compound for the treatment of chronic cough."

The details of the election are as follows:

Director Nominee

Outcome

Votes For

% For

Votes
Withheld

%
Withheld

Dr. Francesco Bellini, O.C.

Elected

38,150,298

99.70%

115,828

0.30%

Roberto Bellini

Elected

38,183,589

99.78%

82,537

0.22%

Dr. Youssef L. Bennani

Elected

38,178,176

99.77%

87,950

0.23%

Franklin Berger

Elected

38,147,433

99.69%

118,693

0.31%

Pierre Larochelle

Elected

38,174,998

99.76%

91,128

0.24%

Joseph Rus

Elected

38,181,312

99.78%

84,814

0.22%

Dr. Martin Tolar

Elected

38,148,170

99.69%

117,956

0.31%

 

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 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 BLU-5937 for chronic cough and several other partnered clinical-stage drug development programs.

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.

For further information: François Desjardins, Vice-President, Finance, 450-680-4525, fdesjardins@bellushealth.com

RELATED LINKS
www.bellushealth.com

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890