Arbutus Provides 2025 Corporate and Financial Update

Core Viewpoint - Arbutus Biopharma Corporation is advancing its mission to develop a functional cure for chronic hepatitis B virus (cHBV) infection, with plans to initiate a Phase 2b clinical trial in the first half of 2025 after demonstrating promising results in earlier trials [1][2]. Company Objectives and Clinical Trials - The company aims to initiate a Phase 2b clinical trial combining imdusiran, interferon, and nucleos(t)ide analogue therapy in the first half of 2025, following a meaningful functional cure rate observed in the IM-PROVE I Phase 2a clinical trial [2][5]. - In the IM-PROVE I trial, a functional cure rate of 50% was achieved in HBeAg-negative patients with baseline HBsAg levels less than 1000 IU/mL, and an overall functional cure rate of 25% [5][8]. - The company is also evaluating the addition of low-dose nivolumab in the IM-PROVE II Phase 2a trial, where 23% of patients achieved HBsAg loss by week 48 [5]. Financial Update - As of December 31, 2024, the company reported cash, cash equivalents, and investments totaling approximately $123 million [12]. - The expected net cash burn for 2025 is projected to be between$47 million and $50 million, a reduction from approximately$65 million in 2024 [12]. - The company believes its financial resources are sufficient to fund operations through the first quarter of 2028, including the Phase 2b clinical trial for imdusiran [12]. Intellectual Property and Litigation - Arbutus is actively defending its intellectual property in ongoing lawsuits against Moderna and Pfizer/BioNTech regarding its patented LNP technology [5][12]. - The claim construction hearing for the lawsuit against Pfizer/BioNTech took place on December 18, 2024, with a ruling expected in the first half of 2025 [12]. Product Pipeline - Imdusiran is an RNAi therapeutic designed to reduce HBV viral proteins and antigens, showing meaningful functional cure rates when combined with pegylated interferon and nucleos(t)ide analogue therapy [8][13]. - AB-101, an oral PD-L1 inhibitor, is currently in a Phase 1a/1b clinical trial, with data from the 10 mg cohort expected in the first half of 2025 [9][12]. Industry Context - Chronic hepatitis B virus infection affects over 250 million people globally and is a leading cause of liver cancer, representing a significant unmet medical need [10]. - Approximately 1.1 million people die annually from complications related to chronic HBV infection, despite the availability of effective vaccines and treatments [10].