Release Date: November 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Arbutus Biopharma Corp (ABUS, Financial) presented promising data from their phase two clinical trials, showing significant surface antigen loss in patients with chronic hepatitis B.
- The company has a strong financial position with approximately $131 million in cash, cash equivalents, and investments, providing a cash runway into the fourth quarter of 2026.
- ABUS's ongoing litigation with Moderna and Pfizer Biontech regarding LNP intellectual property is progressing, with trial dates set for 2025.
- The company's AB-101 oral small molecule PD-L1 checkpoint inhibitor showed favorable safety profiles and evidence of receptor occupancy in early trials.
- Arbutus Biopharma Corp (ABUS) is actively pursuing a functional cure for chronic hepatitis B, which could significantly reduce healthcare costs and improve patient outcomes.
Negative Points
- The data from ongoing phase two trials are under embargo, limiting the ability to provide updates at this time.
- The company's current treatments for chronic hepatitis B have a low functional cure rate, necessitating the development of new therapies.
- Arbutus Biopharma Corp (ABUS) reported a cash burn of $54.5 million in operations during the first half of 2024.
- The litigation process with Moderna and Pfizer Biontech is expected to be lengthy, with trial dates not set until late 2024 and 2025.
- The company's phase one trials for AB-101 are still in early stages, with preliminary data from hepatitis B patients expected only in the first half of next year.
Q & A Highlights
Q: What are your expectations for the functional cure data in the upcoming cohort A2 without inducer?
A: Michael McElhaugh, Interim President and CEO, explained that they have not presented any functional cure data related to inducer yet. The 20% functional cure rate is a baseline goal for the company, as current therapies achieve less than 10%. The aim is to reach a meaningful functional cure rate of 20% or more, which would be beneficial to patients. Karen Sims, Chief Medical Officer, clarified that all subjects in the improved one study received at least four doses of inducer before being randomized to different interferon-containing cohorts.
Q: How are you considering the denominator for functional cure in cohort A1?
A: Karen Sims, Chief Medical Officer, stated that they would consider the entire cohort of around 12 or 13 subjects for functional cure analysis. They have already presented surface antigen loss data, showing 33% loss in the entire cohort and 67% in those with baseline surface antigen less than 1,000. These results are above the 20% bar for functional cure.
Q: What are the expectations for the AB 101 trial results in the first half of next year?
A: Michael McElhaugh, Interim President and CEO, mentioned that they are still working through the details and cannot specify the exact data set to be presented. However, there will be HBV patient data included. They plan to find the right forum to present the multiple ascending dose data from healthy subjects.
Q: Can you provide any clarity on the timing for the phase 2B trial?
A: Michael McElhaugh, Interim President and CEO, stated that they are diligently working through the process and need to have internal discussions and talk to regulators. The goal is to advance inducer into a phase 2B trial as quickly as possible, but no specific timing can be provided at this point.
Q: What can be expected after the claim construction hearing in the lawsuit against Pfizer?
A: Michael McElhaugh, Interim President and CEO, explained that after the Markman hearing, they will await the court's schedule, which will provide insight into the trial date and subsequent proceedings. The outcome of the hearing will take a couple of months to be reported, and they are eagerly awaiting the results.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
