August 09, 2017

BELLUS Health Reports Financial and Operating Results for the Second Quarter Ended June 30, 2017

- Proceeds Received from Equity Sale Extend Cash Runway to 2019 -

LAVAL, QC, Aug. 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 second quarter ended June 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 potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for chronic cough;

  • 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;

  • 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, cash held in trust and short-term investments totaling $8.0 million, which the Company believes should be sufficient to finance its operations to the first quarter of 2019.

"The strategic divestitures of Thallion and our interest in FB Health have generated $4.1 million to date, and could provide up to an additional $1.1 million within the next 12 months," said Roberto Bellini, President and CEO of BELLUS Health. "These funds extend our runway into 2019 and are allowing us to expedite the development of BLU-5937, as we plan to submit an investigational new drug (IND) application in 2018 and initiate a phase 1 clinical study in the second half of that year."

Q2 2017 Highlights

BLU-5937

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.

The Company is currently performing preclinical studies on BLU-5937 to complete its submission package for an IND application expected in 2018. The Company plans to initiate a phase 1 clinical study in the second half of 2018.

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 upfront cash payments 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.

The proceeds from this transaction, along with the proceeds from the sale of Thallion, will support the development of the Company's lead drug candidate for the treatment of chronic cough, BLU-5937, while extending the Company's cash runway to the first quarter of 2019.

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 month ended

June 30, 2017

Three month ended

June 30, 2016


(in thousands of dollars, except per share data)

Revenues

$

41

$

585

Research and development expenses, net


(1,084)


(543)

General and administrative expenses


(541)


(368)

Net finance income (costs)


3


(51)

Realized gain on sale of available-for-sale financial asset


1,644


Deferred tax recovery


204


16

Net income (loss) for the period


267


(361)

Net income (loss) attributable to shareholders


267


(327)

Basic diluted income (loss) per share

$

Nil

$

(0.01)

 

  • Revenues amounted to $41,000 for the three-month period ended June 30, 2017, compared to $585,000 for the corresponding period the previous year. Revenues for 2016 included those related to Auven Therapeutics' development of KIACTA™ in AA Amyloidosis, which was completed in 2016.

  • Research and development expenses, net of research tax credits, amounted to $1,084,000 for the three-month period ended June 30, 2017, compared to $543,000 for the corresponding period the previous year. The increase is primarily 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. Expenses incurred in 2016 were related to the development of Shigamab™, which was sold to Taro in March 2017 as part of the sale of the Company's wholly-owned subsidiary Thallion.

  • General and administrative expenses amounted to $541,000 for the three-month period ended June 30, 2017, compared to $368,000 for the corresponding period the previous year. The increase is primarily attributable to income recorded in 2016 in relation to the Company's deferred share unit plans, due to the decrease in the Company's stock price during that period.

  • Net finance income amounted to $3,000 for the three-month period ended June 30, 2017, compared to net finance costs of $51,000 for the corresponding period the previous year. The increase in net finance income is primarily attributable to lower foreign exchange loss in 2017 that arose from the translation of the Company's net monetary assets denominated in US dollars.

  • As a result of the Company's sale of its investment in FB Health in June 2017, the realized gain on sale of available-for-sale financial assets amounted to $1,644,000 for the three-month period ended June 30, 2017.

As at June 30, 2017, the Company had available cash, cash equivalents, cash held in trust and short-term investments totalling $7,986,000, compared to $6,834,000 as at December 31, 2016. The cash held in trust was released and transferred to cash and cash equivalents on July 3, 2017. The Company believes its cash position should be sufficient to finance its operations to the first quarter of 2019.

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, 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 BLU-5937 for chronic cough and several other partnered clinical-stage drug development programs. BLU-5937 is a promising best-in-class drug candidate that has the potential to help chronic cough patients who do not respond to current therapies. It is estimated that more than 2.7 million patients suffer from refractory chronic cough, in the United States alone.

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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