BELLUS Health (TSX:BLU)
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6 Months : From Jan 2019 to Jul 2019
- Reports Financial and Operating Results for the Year Ended December 31, 2018 -
LAVAL, QC, Feb. 21, 2019 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for conditions with high unmet medical need, today presented its 2018 achievements and corporate priorities for 2019. The Company also reported its financial and operating results for the year ended December 31, 2018. All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.
"The positive Phase 1 data reinforces our position that our lead drug candidate BLU-5937 has the potential to be a best-in-class therapeutic for the treatment of chronic cough," said Roberto Bellini, President and CEO of BELLUS Health. "The $35 million financing completed in December also positions us for another year of important milestones including the start of our Phase 2 study in mid-2019."
2019 Corporate Plan
BELLUS Health priorities for 2019 will be focused on achieving the following:
- Initiate a clinical Phase 2 study for BLU-5937 in chronic cough patients in mid-2019, with top-line results anticipated in mid-2020.
The clinical Phase 2 study will be a dose escalation crossover design study to assess the efficacy, safety and tolerability of BLU-5937 in chronic cough patients, in addition to helping confirm the optimal dose regimen. A total of 50 patients with refractory chronic cough are expected to be enrolled in approximately 10 clinical sites located in the United Kingdom and Unites States.
- Pursue BLU-5937 enabling activities to prepare the program for later stage clinical development.
- Present BLU-5937 Phase 1 data at medical conferences.
- Develop BLU-5937 program for potential expansion in other P2X3 indications.
- Announced positive top-line results from the clinical Phase 1 study for BLU-5937, the Company's lead drug candidate for chronic cough.
BLU-5937 was shown to be safe and well tolerated and did not cause any taste loss at the anticipated therapeutic doses. This confirms the Company's expectation that at the anticipated therapeutic doses there is no or very limited effect on taste perception. The benign side effect profile, in combination with the anti-tussive effect demonstrated in several preclinical studies, further reinforces the Company's position that BLU-5937 has the potential to be a best-in-class therapeutic for chronic cough patients.
- Closed a $35 million equity offering, led by OrbiMed
On December 18, 2018, the Company issued 36,842,105 common shares from treasury at a price of $0.95 per share for aggregate gross proceeds of $35 million (the "Offering"). The Offering was led by OrbiMed and also included New Leaf Venture Partners, First Manhattan Co., Samsara BioCapital, Fonds de solidarité FTQ, AppleTree Partners and Amzak Health.
- Secured patent protection for BLU-5937 in all major pharmaceutical markets.
Patents were granted by the European Patent Office and the Japan Patent Office in 2018, in addition to patents granted in the United States and China in 2017, with claims covering the composition of matter of BLU-5937 until 2034. In addition, the Company further expanded BLU-5937's patent protection to 2038 by securing a new U.S. patent claiming P2X3 selectivity as a means of minimizing taste effects.
- Appointed an international clinical advisory board ("CAB") to provide strategic guidance and support to the BLU-5937 development program.
The CAB is comprised of highly-respected clinical leaders whose work has influenced the treatment and management of chronic cough. The Chair of the CAB is Dr. Jaclyn Smith, MB, ChB, FRCP, PhD, Professor of Respiratory Medicine at the University of Manchester in the United Kingdom and an Honorary Consultant at the University Hospital of South Manchester NHS Foundation Trust.
- Concluded the year with cash, cash equivalents and short-term investments totalling $48.9 million.
The liquidity position should enable the Company to finance its operations for more than two years.
Summary of Financial Results
December 31, 2018
December 31, 2017
(in thousands of dollars, except per share data)
Research and development expenses, net
General and administrative expenses
Net finance income
Change in fair value of contingent consideration
Realized gain on sale of investment in FB Health
Gain on sale of subsidiary
Deferred tax expense
Net loss for the year
Basic and diluted loss per share
- Research and development expenses, net of research tax credits, amounted to $6,532,000 for the year ended December 31, 2018, compared to $3,321,000 for the previous year. The increase is primarily attributable to higher expenses incurred in relation to the development of BLU-5937, the Company's lead drug candidate for chronic cough, including the clinical Phase 1 study completed by the Company in 2018.
- General and administrative expenses amounted to $3,409,000 for the year ended December 31, 2018, compared to $2,529,000 for the previous year. The increase is mainly due to higher stock-based compensation expense in relation to the Company's stock option plan and deferred share unit plans.
- Net finance income amounted to $741,000 for the year ended December 31, 2018, compared to $19,000 for the previous year. The increase is primarily attributable to higher interest income due to the Company's increased cash, cash equivalents and short-term investments position following the equity offering in December 2017 as well as to the foreign exchange gain that arose from the translation of the Company's net monetary assets denominated in US dollars.
- Realized gain on sale of 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 S.p.A.
- Gain on sale of subsidiary amounted to $1,944,000 for the year ended December 31, 2017 and is related to the sale of the Company's wholly-owned subsidiary Thallion Pharmaceuticals Inc.
As at December 31, 2018, the Company had available cash, cash equivalents and short-term investments totalling $48,906,000, compared to $23,888,000 as at December 31, 2017.
The Company's full audited consolidated financial statements and accompanying management's discussion and analysis for the year ended December 31, 2018 will be available shortly on SEDAR at www.sedar.com.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for conditions with high unmet medical need. The Company's lead drug candidate is BLU-5937 being developed for the treatment of chronic cough. BLU-5937, a highly 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 Bluestar BioAdvisors (formerly known as 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.
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.