BELLUS Health Reports Second Quarter 2020 Financial Results and Business Highlights

BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today reported its financial and operating results for the second quarter ended June 30, 2020.

PROGRAM AND CORPORATE HIGHLIGHTS

Announced topline results from the Phase 2 RELIEF clinical trial of BLU-5937 in patients with refractory chronic cough in July 2020.

• While the primary endpoint of placebo-adjusted reduction in awake cough frequency was not achieved, a numerical difference in favor of BLU-5937 was observed at all doses.
• A pre-specified analysis of high cough frequency (≥median) patients achieved highly statistically significant (p<0.0015) and clinically meaningful reductions (28-32%) in placebo-adjusted awake cough frequency at all doses.
• Results showed that BLU-5937 was well tolerated, with taste disturbance events reported by fewer than 10% of patients receiving BLU-5937 and an overall safety profile similar to placebo.
• Additional data from the Phase 2 RELIEF clinical trial of BLU-5937 in patients with refractory chronic cough will be presented at upcoming respiratory conferences.

Expects to initiate an adaptive Phase 2b trial of BLU-5937 enriched for higher cough count patients in the fourth quarter of 2020.

• The Company expects to provide the Phase 2b trial design in the third quarter of 2020 and plans to have a meeting with the U.S. Food and Drug Administration (“FDA”) prior to trial initiation in the fourth quarter of 2020.

“Our Phase 2 RELIEF trial, including the reduction in cough frequency observed in patients with higher cough counts in addition to the low taste effect, support advancing the study of BLU-5937,” said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. “We look forward to initiating our Phase 2b trial enriched for higher cough count patients by year end following regulatory feedback from the FDA in the fourth quarter of this year.”

FINANCIAL RESULTS

Cash Position: As of June 30, 2020, the Company had available cash, cash equivalents and short-term investments totaling US$74.0 million, compared to US$90.0 million at December 31, 2019.

Net Loss: For the second quarter ended June 30, 2020, net loss amounted to US$8,422,000 (US$0.14 per share), compared to US$5,909,000 (US$0.13 per share) for the same period in 2019.