Arbutus Biopharma Corp Q1 FY2023 earnings call

• Arbutus was founded to develop a functional cure for chronic HBV and expanded focus to COVID-19.
• AB-729 is a key RNAi therapy for HBV, with Phase 1 data showing reduction in HBV DNA and surface antigen.
• Ongoing Phase 2a combination trials for AB-729 with interferon and Vaccitech's VTP-300; plan to add nivolumab to the VTP-300 combination.
• AB-161, a next-gen oral HBV-specific RNA destabilizer, dosed first healthy subject in March, with initial data expected in H2 2023.
• FDA placed AB-101 IND on clinical hold, delaying Phase 1 trial.
• Actively advancing COVID-19 strategy with AB-343 (Mpro inhibitor) and nsp12 program, planning Phase 1 trial for AB-343 in H2 2023.
• Reduced 2023 cash burn guidance due to AB-101 hold.
• Upcoming milestones include data from AB-729 combination trials, AB-161 Phase 1, and AB-343 Phase 1.
• Mention of ongoing litigation against Moderna, Pfizer, and BioNTech.

No specific product segment financial performance data with absolute revenue and contribution % provided in the transcript.

• Reduced 2023 cash burn guidance from $95M-$100M to $90M-$95M.
• Cash runway expected to fund operations into Q1 2025.
• Upcoming milestones: AB-729-202 data in H2 2023, AB-729-201 data in H1 2023, AB-161 Phase 1 data in H2 2023, AB-343 Phase 1 trial and nsp12 program in H2 2023.

• FDA placed AB-101 IND on clinical hold, delaying Phase 1 trial.
• Ongoing litigation efforts related to intellectual property, including suits against Moderna, Pfizer, and BioNTech.

Q: Regarding Phase 2a 729 study data readout, what to focus on?

A: Thomas Yip asked about focusing on surface antigen, with safety and tolerability also being important. Bill Collier and Karen Sims responded that surface antigen is the prime endpoint, with safety and tolerability also key.

Q: When to expect first patient in 729 study to reach off-treatment period?

A: Bill Collier said staggered start and finish of patients, with preliminary data expected in H1 2023.

Q: Details on AB-101 clinical hold?

A: Bill Collier stated they attended a telephone call with the FDA, are awaiting a letter from the FDA, and can't comment further until the letter is received.

Q: Concerns about nivolumab in Hep-B trials?

A: Bill Collier said it's still early, they're waiting for the FDA's full position after receiving the letter regarding AB-101.

Q: Strategy for AB-161 and combinations?

A: Karen Sims said Phase 1 data is needed before combinations, with guidance for H2 2023 single ascending dose data for AB-161.