Arbutus Biopharma Sets Sights on Advancing HBV Cure in 2025

Arbutus Biopharma

WARMINSTER, PA — Arbutus Biopharma Corporation (NASDAQ: ABUS) has unveiled its strategic objectives for 2025 alongside an encouraging financial update, emphasizing progress in its efforts to develop a functional cure for chronic hepatitis B (cHBV).

“We enter 2025 with solid financial footing and strong momentum in achieving our mission of developing a functional cure for cHBV,” said Michael J. McElhaugh, Interim President and Chief Executive Officer. “The data we reported late last year from our IM-PROVE I Phase 2a clinical trial showed a meaningful functional cure rate and immune activation in cHBV patients treated with our RNAi therapeutic, imdusiran, interferon and nucleos(t)ide analogue (NA) therapy.”

Clinical Programs Advance

Following positive Phase 2a results, Arbutus is gearing up to launch a Phase 2b clinical trial of imdusiran in the first half of 2025. The trial will focus on combining imdusiran with interferon and NA therapy in approximately 170 HBeAg-negative cHBV patients, pending regulatory approval. The Phase 2a study demonstrated a functional cure rate of 50% in certain patients, affirming the potential of this treatment to differentiate itself from other RNAi therapeutics.

Additionally, the IM-PROVE II Phase 2a trial showed that integrating low-dose nivolumab into imdusiran and Barinthus Biotherapeutics’ VTP-300 regimen heightened HBsAg loss rates. Data from this study and the ongoing AB-101 trial, focused on the company’s oral PD-L1 inhibitor, are expected in the first half of 2025.

Litigation to Protect Intellectual Property

Arbutus is also actively pursuing lawsuits against Moderna and Pfizer/BioNTech to secure compensation for their alleged use of the company’s lipid nanoparticle (LNP) technology in COVID-19 vaccines. A ruling on claim construction in the lawsuit against Pfizer/BioNTech is anticipated in the first half of 2025, with the Moderna trial scheduled for September 2025.

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Financial Strength and Outlook

Arbutus closed 2024 with approximately $123 million in cash, cash equivalents, and investments, and anticipates significantly reducing its net cash burn to between $47 million and $50 million in 2025 from $65 million in 2024. The company expects its capital to support operations, including funding the imdusiran Phase 2b trial, through the first quarter of 2028.

With its robust clinical pipeline and determined defense of its intellectual property, Arbutus is poised to make significant strides this year in its mission to address the global burden of cHBV.

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