Mr. Roberto Bellini reports
BELLUS HEALTH REPORTS YEAR 2022 FINANCIAL RESULTS AND BUSINESS HIGHLIGHTS
Bellus Health Inc. has released its financial and operating results for the year ended Dec. 31, 2022.
"In 2022, we laid the groundwork to advance camlipixant, our P2X3 receptor antagonist product candidate with best-in-class potential, into late-stage development in [refractory chronic cough]. This included interacting with regulatory officials, solidifying the Calm phase 3 trial designs and conducting validation work on the VitaloJAK cough monitoring system -- all of which allowed us to initiate Calm-1 and Calm-2 in the fourth quarter," commented Roberto Bellini, president and chief executive officer of Bellus. "Looking ahead to 2023, we will remain focused on advancing our Calm phase 3 clinical program and building out our commercial strategy while tracking the upcoming key developments in the P2X3 receptor class."
Program and corporate highlights
Actively advancing the Calm phase 3 clinical program (Calm-1 and Calm-2 trials) for camlipixant (BLU-5937) in RCC, with patient enrolment continuing:
The Calm phase 3 clinical program was initiated in the fourth quarter of 2022, with patient enrolment continuing. The Calm program consists of two pivotal trials, Calm-1 and Calm-2, with the primary end point of 24-hour cough frequency measured at 12 and 24 weeks, respectively, using the VitaloJAK cough monitoring system.
Bellus conducted validation work on the VitaloJAK cough monitoring system comparing compressed versus non-compressed recordings in a cohort of 45 Soothe phase 2b trial participants. The results showed a sensitivity of 98.7 per cent, with no systematic error observed. Bellus submitted a validation protocol and statistical analysis plan to the Food and Drug Administration in the fourth quarter of 2022.
Top-line results from Calm-1 are expected in the second half of 2024 and top-line results from Calm-2 in 2025.
Completed large U.S. physician survey on the RCC market landscape in 2022:
- Survey included 1,483 U.S. pulmonologists, allergists, ENTs, gastroenterologists and primary care physicians, and showed that there are about 8.6-million RCC patients in the United States and 1.8-million RCC patients currently being seen by specialists.
Pursuing development of its P2X3 receptor pipeline:
- The phase 1 clinical trial investigating the pharmacokinetics of a once-daily, extended-release formulation of camlipixant is continuing. The study is expected to be completed in the second quarter of 2023.
Presented Soothe clinical data at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting and the Chest annual meeting:
Clinical data from the phase 2b Soothe trial were presented at the AAAAI annual meeting, held in San Antonio, Tex., from Feb. 24 to Feb. 27, 2023, and the Chest annual meeting, held in Nashville, Tenn., from Oct. 16 to Oct. 19, 2022. The presentation materials are available in the scientific publications section of Bellus's website.
Presenting on camlipixant's drug-to-drug interactions at the American Society of Clinical Pharmacology & Therapeutics (ASCPT) 2023 annual meeting, being held in Atlanta, Ga.:
A poster presentation titled "In Vitro, In Silico, and Clinical Investigations of BLU-5937 as Perpetrator of Drug-Drug Interactions" will be presented at the coming ASCPT 2023 annual meeting on Thursday, March 23, 2023, from 5 to 6:30 p.m. ET. Following the conference, the poster will be available in the scientific publications section of Bellus's website.
Ended the year with cash, cash equivalents and short-term investments totalling $337.1-million (U.S.).
Cash position: As of Dec. 31, 2022, the company had available cash, cash equivalents and short-term investments totalling $337.1-million (U.S.), compared with $248.8-million (U.S.) as of Dec. 31, 2021. The net increase is primarily attributable to the company's offering in July, 2022, offset in part by funds used to finance its operating activities, mainly the research and development activities associated with its product candidate camlipixant.
Net loss: For the year ended Dec. 31, 2022, net loss amounted to $76.1-million (U.S.) (66 U.S. cents per share), compared with $71.2-million (U.S.) (90 U.S. cents per share) for the previous year.
Research and development expenses: Research and development expenses, net of research tax credits, amounted to $58.4-million (U.S.) for the year ended Dec. 31, 2022, compared with $59.0-million (U.S.) for the previous year, a $600,000 (U.S.) or 1-per-cent year-over-year decrease. The decrease is primarily attributable to a decrease in external R&D spend as it has transitioned from its phase 2b Soothe clinical trial to the initiation of its Calm phase 3 clinical program in 2022, offset in part by higher stock-based compensation expense in relation to the company's stock option plan and higher work force expenses due to an increase in head count to support the development of camlipixant.
General and administrative (G&A) expenses: General and administrative expenses amounted to $19.5-million (U.S.) for the year ended Dec. 31, 2022, compared with $14.3-million (U.S.) for the previous year, a $5.2-million (U.S.) or 37-per-cent year-over-year increase. The increase is mainly attributable to higher external G&A expenses, as well as to higher stock-based compensation expense in relation to the company's stock option plan.
Net finance income: Net finance income amounted to $1.9-million (U.S.) for the year ended Dec. 31, 2022, compared with $1.9-million (U.S.) for the previous year. In 2022, there was higher interest income compared with the previous year due to the increased cash, cash equivalents and short-term investments position following the offerings in 2022 and 2021 and the increase in interest rates, offset in part by an increase in foreign exchange loss resulting from the conversion in U.S. dollars of the company's net monetary assets denominated in Canadian dollars during the year (versus a foreign exchange gain in 2021) due to the weakening of the Canadian dollar versus the U.S. dollar in 2022.
The company's full audited consolidated financial statements and accompanying management's discussion and analysis for the year ended Dec. 31, 2022, will be available shortly on SEDAR and on EDGAR.
About camlipixant (BLU-5937)
Camlipixant, a highly selective P2X3 receptor antagonist, is in development for RCC and other cough hypersensitivity indications.
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 camlipixant's high selectivity as a P2X3 receptor antagonist and the results of its phase 2b Soothe trial position it as a potential best-in-class P2X3 receptor antagonist to significantly improve the quality of life of patients suffering from RCC.
In addition to RCC, the mechanism of action of camlipixant may also have broad therapeutic applicability across other cough hypersensitivity indications. The company is evaluating potential opportunities to study camlipixant in additional indications where cough hypersensitivity plays an important role.
About Bellus Health Inc.
Bellus is a clinical-stage biopharmaceutical company working to better the lives of patients suffering from persistent cough, starting with the development of camlipixant (BLU-5937) for the treatment of refractory chronic cough (RCC). Camlipixant, the company's lead asset, is an investigational P2X3 receptor antagonist for the treatment of RCC, which is currently being evaluated in the Calm phase 3 clinical program. With no approved treatments in the United States, camlipixant has the potential to be a breakthrough in the RCC treatment landscape.
Chronic cough is defined as a cough lasting longer than eight weeks. When the cause of chronic cough cannot be identified or the cough persists despite treatment of any associated condition, the condition is referred to as RCC. RCC is a frequent, yet often underrecognized, medical condition that has significant physical, social and psychological consequences on one's quality of life. There are currently no approved treatments for this condition in the United States, European Union or the United Kingdom.
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