Arbutus Q1 2024 Financial Results and Corporate Update

Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company specializing in virology to combat chronic hepatitis B virus (cHBV) infection, has released its financial results for the first quarter of 2024 and provided an update on its corporate activities.

Michael J. McElhaugh, the Interim President and CEO of Arbutus Biopharma, highlighted the company's advances in its HBV pipeline during the first quarter. He emphasized the potential of imdusiran as a cornerstone therapeutic for cHBV and the role of immune modulators in achieving a functional cure. Arbutus has initiated its third Phase 2a trial combining imdusiran with an immune modulator. End-of-treatment data from two ongoing Phase 2a combination trials with imdusiran will be presented at the EASL Congress in June 2024.

Clinical Development Highlights

Imdusiran (AB-729, RNAi Therapeutic)

AB-729-201 Trial:
This Phase 2a trial evaluates the safety, tolerability, and antiviral activity of combining imdusiran with nucleos(t)ide analogue (NA) therapy and pegylated interferon alfa-2a (IFN). Preliminary data indicate that adding IFN to imdusiran was generally well-tolerated and resulted in HBsAg declines in some patients. End-of-treatment data will be shared at the EASL Congress.

AB-729-202 Trial:
This trial assesses the safety and immunogenicity of imdusiran combined with NA therapy and VTP-300, an HBV antigen-specific immunotherapy from Barinthus Bio. Preliminary data showed a notable reduction in HBsAg levels. An additional cohort will be included to receive imdusiran plus NA therapy followed by VTP-300 and up to two doses of nivolumab. Preliminary data from this cohort are expected in the latter half of 2024.

AB-729-203 Trial:
This Phase 2a trial evaluates imdusiran with NA therapy and intermittent low doses of durvalumab, an anti-PD-L1 monoclonal antibody. The trial aims to enroll 30 patients, all receiving 60mg of imdusiran every 8 weeks for 48 weeks with durvalumab administered at specific times. Post-treatment, patients will be assessed for NA discontinuation and monitored for 24 to 48 weeks.

AB-101 (Oral PD-L1 Inhibitor)

AB-101-001 Trial:
This Phase 1a/1b double-blind, randomized, placebo-controlled trial investigates the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-101. Preliminary data from the single-dose portion revealed that AB-101 was generally well-tolerated, showing dose-dependent receptor occupancy. Part 2 of the trial, evaluating multiple-ascending doses, is in progress, with preliminary data expected later this year.

Corporate Updates

Michael J. Sofia, PhD, co-founder and Chief Scientific Officer, announced his retirement at the end of 2024.

Financial Results

As of March 31, 2024, Arbutus had cash, cash equivalents, and investments totaling $137.9 million, an increase from $132.3 million at the end of 2023. The company used $19.3 million in operating activities during the first quarter but offset this with $21.8 million in net proceeds from its "at-the-market" (ATM) offering program. Additional net proceeds of $22.4 million were received in April 2024. The company expects its cash runway to extend through the second quarter of 2026.

Total revenue for the first quarter of 2024 was $1.5 million, a decrease from $6.7 million in the same period of 2023, primarily due to reduced license revenue and lower sales of ONPATTRO. Research and development expenses decreased to $15.4 million from $18.3 million, mainly due to the discontinuation of certain programs, while general and administrative expenses were slightly lower at $5.3 million.

The net loss for the first quarter was $17.9 million, slightly higher than the $16.3 million loss in the first quarter of 2023. 

Arbutus also reported significant progress in its litigation efforts, with a claim construction ruling in its patent infringement lawsuit against Moderna. A trial date is set for April 21, 2025.

Conclusion

Arbutus Biopharma continues to advance its clinical programs and maintain a strong financial position, aiming to achieve meaningful clinical data and progress into later-stage trials. The company remains committed to developing therapeutics for chronic hepatitis B and protecting its intellectual property.

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