Arbutus Biopharma Corporation Q4 FY2023 earnings call

Michael McElhaugh discussed strategic choices in 2023, including focusing on HBV and extending cash runway into Q1 2026, and his role as Interim CEO. He plans to advance HBV assets like imdusiran and AB-101, with a goal of a 20% functional cure rate for HBV. Karen Sims provided updates on clinical trials: three ongoing trials (two Phase 2a for imdusiran, one Phase 1a/1b for AB-101) with data expected in 2024, and plan to initiate a third Phase 2a trial with imdusiran and durvalumab. David Hastings discussed financials: ended 2023 with ~$132M cash, net proceeds from share offering, and expects cash burn to reduce in 2024 with cash runway into Q1 2026.

Anticipate data from Phase 2a trials with imdusiran and preliminary data from AB-101's Phase 1a/1b trial in 2024. Plan to initiate a third Phase 2a trial with imdusiran and durvalumab in H1 2024. Expect cash burn in 2024 to range $63M-$67M, with cash runway to Q1 2026.

Intellectual property litigation with Moderna and Pfizer-BioNTech, including ongoing claim construction hearing and trial set for April 21, 2025, with uncertainties in outcomes.

Q: Can you frame what to expect at the upcoming claim construction order and a good outcome for the patent litigation?

A: David Hastings said they look forward to the judge's ruling within 60 days of February 8th and expect a schedule for summary judgment in late summer.

Q: Thoughts on PD-L1 antibody study designs, comparing PD-1 vs PD-L1 and selection of nivo for 202 and durva for study 203?

A: Mike Sofia discussed PD-L1 being upregulated in hepatocytes and suitability for small molecule targeting; Karen Sims explained rationale for nivo in 202 trial based on prior VTP-300 studies and durvalumab in 203 trial for informing combination study with AB-101.

Q: When might Arbutus re-engage with the FDA on AB-101 and plans following Phase 1a/1b?

A: Karen Sims said they'll re-engage when they have sufficient data, have progressed the study into multiple dosing in healthy subjects, and intend to share preliminary data from healthy subjects in H1 2024, with a seamless transition to chronic hepatitis B patients.

Q: What's needed to move forward with VTP-300 approach and its role in combos?

A: Michael McElhaugh said it will depend on data from the study, including nivo data, and they'll evaluate as data comes forward.

Q: Details on 203 Phase 2a study design and combination study with imdusiran and AB-101?

A: Karen Sims said they'll share more specific details on 203 trial once enrolled, and typically start with Phase 2a studies to derisk compounds before larger trials.