BELLUS Health Reports Year 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 year ending December 31, 2020.

“Over the past 12 months, we have made significant progress with our corporate strategy, financial position, and clinical development of BLU-5937 – laying the groundwork for what we anticipate will be a transformative year ahead,” commented Roberto Bellini, President and Chief Executive Officer of BELLUS Health. “Building off the proof-of-concept RELIEF Phase 2 data announced last summer, we have advanced BLU-5937 into our recently initiated Phase 2b SOOTHE trial in refractory chronic cough, with topline results anticipated to read out in the fourth quarter of this year. We believe BLU-5937 has the potential to treat a wide range of hypersensitization-related conditions and have begun to explore this potential through the initiation of our Phase 2 BLUEPRINT trial in chronic pruritus associated with atopic dermatitis, with topline data expected in the fourth quarter of 2021.”

PROGRAM AND CORPORATE HIGHLIGHTS

Initiated the Phase 2b SOOTHE clinical trial of BLU-5937 in patients with refractory chronic cough (“RCC”) in December 2020.

• Topline results from the SOOTHE trial are expected in Q4 2021.
• An interim analysis using a predefined efficacy and probability threshold is expected to be performed in mid-2021, once 50% of participants have completed the study.
• Phase 2b SOOTHE trial population enriched for participants with cough frequency above 25 coughs/h at baseline.

Initiated the Phase 2 BLUEPRINT clinical trial of BLU-5937 in patients with chronic pruritus associated with atopic dermatitis (“AD”) in December 2020.

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

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

• The RELIEF trial achieved proof-of-concept in reducing cough frequency in RCC patients, including statistically significant and clinically meaningful reductions in two pre-specified sub-group analyses of participants with baseline awake cough frequency of ≥20 coughs/hour (80% of trial participants) and ≥32 coughs/hour (50% of trial participants).
• Numerical differences in favor of BLU-5937 were also observed in the whole study (intention-to-treat) population; however the trial did not meet its primary endpoint in this population.
• BLU-5937 was well tolerated and showed an adverse event profile comparable to placebo. The taste disturbance adverse events were limited to 10% or less, confirming the hypothesis that BLU-5937 has a favorable adverse event profile compared to the first generation P2X3 antagonist. Additionally, no complete loss of taste was observed at any dose, no severe taste adverse event was reported and no dropouts due to taste disturbance occurred.

Completed a US$40.3 million offering in October 2020.

• In October 2020, BELLUS Health completed an offering of its common shares, resulting in gross proceeds to the Company of US$40.3 million.

Acquired complete ownership of the intellectual property rights to BLU-5937 and related P2X3 antagonists.

• In March 2020, the Company acquired all remaining BLU-5937 and related P2X3 antagonists intellectual property rights from adMare BioInnovations’ NEOMED Institute. BELLUS Health now owns 100% of the rights to BLU-5937 and related P2X3 antagonists, with no future payments due.

Appointed Ramzi Benamar as Chief Financial Officer.

• In December 2020, the Company appointed Ramzi Benamar to the role of Chief Financial Officer. Mr. Benamar brings to the Company extensive experience in corporate strategy, finance and operations.

FINANCIAL RESULTS

Cash Position: As of December 31, 2020, the Company had available cash, cash equivalents and short-term investments totaling US$98.3 million, compared to US$90.0 million at December 31, 2019. The increase is primarily attributable to US$37.6 million in net proceeds from the October 2020 offering, offset by funds used to finance its operating activities, mainly research and development activities associated with 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 year ended December 31, 2020, net loss amounted to US$31.8 million (US$0.54 per share), compared to US$26.0 million (US$0.55 per share) for the same period in 2019.

Research and Development Expenses: Research and development expenses, net of research tax credits, amounted to US$23.2 million for the y