Arbutus Biopharma Corp (ABUS) has announced encouraging data from its Phase 2 clinical trials, revealing significant surface antigen loss in patients with chronic hepatitis B. These findings, coupled with a robust financial position, signal potential advancements in the pursuit of a functional cure for this widespread liver disease. The company's Q3 2024 earnings call highlighted these developments, alongside updates on its ongoing litigation and early-stage trials of its PD-L1 inhibitor, AB-101.
Hepatitis B Clinical Trial Updates
Arbutus Biopharma is focused on developing a functional cure for chronic hepatitis B, a condition affecting millions globally. Current treatments have limited success, with functional cure rates below 10%. The company's goal is to achieve a meaningful functional cure rate of 20% or higher.
Data from the ongoing Phase 2 trials are currently under embargo, limiting the details that can be shared. However, Karen Sims, Chief Medical Officer, noted that in one cohort, 33% of subjects experienced surface antigen loss, with 67% loss observed in those with baseline surface antigen levels below 1,000. These results surpass the company's 20% benchmark for functional cure.
Michael McElhaugh, Interim President and CEO, clarified that the presented data does not yet include results related to an inducer. All subjects in the improved one study received at least four doses of inducer before randomization into different interferon-containing cohorts.
AB-101 Clinical Trial Updates
AB-101, Arbutus's oral small molecule PD-L1 checkpoint inhibitor, has shown a favorable safety profile and evidence of receptor occupancy in early trials. Preliminary data from hepatitis B patients are expected in the first half of next year. The company plans to present multiple ascending dose data from healthy subjects in an appropriate forum.
Financial Stability
Arbutus Biopharma reported a strong financial position, with approximately $131 million in cash, cash equivalents, and investments as of the end of Q3 2024. The company anticipates a cash burn ranging from $63 million to $67 million for the full year 2024. This financial runway is expected to fund operations into Q4 2026.
In the first half of 2024, the company received approximately $44 million in net proceeds from common shares and used $54.5 million in operations.
Litigation Update
Arbutus Biopharma is engaged in ongoing litigation with Moderna and Pfizer BioNTech concerning LNP (lipid nanoparticle) intellectual property. Trial dates are set for 2025. Following the claim construction hearing (Markman hearing), the company awaits the court's schedule, which will provide insight into the trial date and subsequent proceedings. The outcome of the hearing is expected to be reported in a couple of months.
Future Directions
Arbutus is actively working to advance its inducer into a Phase 2B trial as quickly as possible, though specific timing cannot be provided at this point. Internal discussions and consultations with regulators are underway to facilitate this advancement.
