BELLUS Health Reports First Quarter 2021 Financial Results and Business Highlights

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BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough and other hypersensitization-related disorders, today reported its financial and operating results for the first quarter ending March 31, 2021.

“During the first quarter, we continued to build on the progress we made last year, with a key focus on advancing the clinical development of our P2X3 antagonist, BLU-5937, in two distinct indications,” commented Roberto Bellini, President and Chief Executive Officer of BELLUS Health. “Both our Phase 2b SOOTHE trial in refractory chronic cough and our Phase 2a BLUEPRINT trial in chronic pruritus associated with atopic dermatitis are progressing well. We look forward to clinical, regulatory and corporate updates across the entire P2X3 antagonist class during this catalyst-rich year ahead, including expected topline results from both our Phase 2 trials in the fourth quarter.”

PROGRAM AND CORPORATE HIGHLIGHTS

Ongoing Phase 2b SOOTHE clinical trial of BLU-5937 in patients with refractory chronic cough (“RCC”).

  • Topline results from the SOOTHE trial are expected in the fourth quarter of 2021.
  • An administrative interim analysis is expected to be performed in the third quarter of 2021.

Ongoing Phase 2a BLUEPRINT clinical trial of BLU-5937 in patients with chronic pruritus associated with atopic dermatitis (“AD”).

  • Topline results from the BLUEPRINT trial are expected in Q4 2021.

Appointed William Mezzanotte, MD, MPH to Board of Directors.

  • In March 2021, the Company appointed William Mezzanotte, MD, MPH to its Board of Directors. Dr. Mezzanotte brings decades of vast development and commercial experience to the Board, including the development and approval of 30 products across multiple therapeutic areas.

FINANCIAL RESULTS

Cash Position: As of March 31, 2021, the Company had available cash, cash equivalents and short-term investments totaling US$81.9 million, compared to US$98.3 million on December 31, 2020. The decrease is primarily attributable to funds used to finance its operating activities, mainly the development of its product candidate BLU-5937. Current cash, cash equivalents and short-term investments are projected to be sufficient to fund the Company’s operating plan until the end of 2022.

Net Loss: For the quarter ended March 31, 2021, net loss amounted to US$15.8 million (US$0.20 per share), compared to US$10.1 million (US$0.18 per share) for the same period in 2020.

Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to US$12.4 million for the quarter ended March 31, 2021, compared to US$6.5 million for the same period in 2020, an increase of US$5.9 million or 91% year over year. The increase is primarily attributable to higher expenses incurred for the development of BLU-5937, mainly activities in relation to the Phase 2b SOOTHE trial in RCC and the Phase 2a BLUEPRINT trial in chronic pruritus associated with AD, which were initiated in December 2020 and for which topline results are expected in the fourth quarter of 2021.

General and Administrative Expenses: General and administrative expenses amounted to US$3.5 million for the quarter ended March 31, 2021, compared to US$2.8 million for the same period in 2020, an increase of US$0.7 million or 26% year over year. The increase is mainly due to higher stock-based compensation expense in relation to the Company’s stock option plan.

Net Finance Income (Costs): Net finance income amounted to US$0.2 million for the quarter ended March 31, 2021, compared to net finance costs of US$0.9 million for the same period in 2020. Net finance costs for the corresponding period the previous year included a foreign exchange loss of US$1.2 million that arose from the translation of the Company’s net monetary assets denominated in Canadian dollars during the period. Excluding this, the increase in finance income is partially offset by lower interest income in 2021 due to decreased cash, cash equivalents and short-term investments position.

SUMMARY OF FINANCIAL RESULTS

 

Three months ended
March 31, 2021

Three months ended
March 31, 2020

 

(in thousands of dollars, except per share data)

Revenues

US$

4

US$

4

Research and development expenses, net

 

(12,448)

 

(6,510)

General and administrative expenses

 

(3,470)

 

(2,762)

Net finance income (costs)

 

163

 

(864)

Net loss for the period

US$

(15,751)

US$

(10,132)

Basic and diluted loss per share

US$

(0.20)

US$

(0.18)

The Company’s full unaudited condensed consolidated interim financial statements and accompanying management’s discussion and analysis for the three-month period ended March 31, 2021 will be available shortly on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

BELLUS Health Announces Election of Directors at Annual Meeting

At the Annual Meeting of Shareholders held by webcast today, the following director nominees listed in the Management Information Circular dated March 23, 2021 were elected as Directors of the Company.

The details of the election are as follows:

Director Nominee

Outcome

 

 

Votes For

 

 

% For

 

 

Votes
Withheld

 

 

%
Withheld

Dr. Francesco Bellini, O.C.

Elected

 

 

47 991 755

 

 

99.96%

 

 

20 519

 

 

0.04%

Roberto Bellini

Elected

 

 

47 987 509

 

 

99.95%

 

 

24 765

 

 

0.05%

Dr. Youssef L. Bennani

Elected

 

 

47 975 565

 

 

99.92%

 

 

36 709

 

 

0.08%

Franklin M. Berger

Elected

 

 

38 786 592

 

 

80.78%

 

 

9 225 682

 

 

19.22%

Dr. Clarissa Desjardins

Elected

 

 

47 990 988

 

 

99.96%

 

 

21 285

 

 

0.04%

Pierre Larochelle

Elected

 

 

47 987 417

 

 

99.95%

 

 

24 857

 

 

0.05%

Dr. William Mezzanotte

Elected

 

 

47 989 421

 

 

99.95%

 

 

22 853

 

 

0.05%

Joseph Rus

Elected

 

 

47 983 232

 

 

99.94%

 

 

29 042

 

 

0.06%

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 at www.sedar.com and on EDGAR at www.sec.gov/edgar.

About BLU-5937

BLU-5937, a highly selective P2X3 antagonist - is in development for RCC, chronic pruritus and other hypersensitization-related disorders.

The P2X3 receptor, which is implicated in cough reflex hypersensitization, is a rational target for treating chronic cough, and it has been evaluated in multiple clinical trials with different P2X3 antagonists. The Company believes that its highly selective P2X3 antagonist has the potential to reduce coughing in patients with RCC, while limiting taste disturbance adverse events.

In addition to RCC and chronic pruritus, the mechanism of BLU-5937 may also have broad therapeutic applicability across other afferent hypersensitization-related disorders, enabling the Company to consider BLU-5937 as a potential treatment for a number of other indications. Consequently, BELLUS Health is exploring how the P2X3 pathway may contribute to irritation and pain in a variety of afferent hypersensitization-related disorders and whether inhibition of P2X3 receptors can help treat these conditions.

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a clinical-stage biopharmaceutical company develop