Arbutus Releases Q2 2024 Financials and Corporate Update

Arbutus Biopharma Corporation has presented promising data at the EASL Congress for its chronic hepatitis B virus (cHBV) treatment candidate, imdusiran, from two Phase 2a clinical trials. These results are pushing the company to prioritize Phase 2b clinical development for imdusiran, while ceasing other HBV research efforts and reducing its workforce by 40%. This strategic shift is aimed at extending the company's cash runway into the fourth quarter of 2026.

Interim President and CEO Michael J. McElhaugh expressed enthusiasm about the data from the IM-PROVE I clinical trial, where 67% of patients with baseline HBsAg less than 1000 IU/mL achieved undetectable HBsAg after 48 weeks of imdusiran treatment combined with 24 weeks of IFN. These patients maintained undetectable HBsAg and HBV DNA after stopping all therapy, indicating a potential functional cure.

The IM-PROVE I trial showed that 33% of patients who received 48 weeks of imdusiran and 24 weeks of IFN achieved undetectable HBsAg at the end of treatment. All patients maintained undetectable HBsAg 24 weeks after treatment. Additionally, six patients achieved HBsAg loss with high anti-HBsAg antibody titers and stopped NA therapy, with two maintaining undetectable HBsAg and HBV DNA for 12 weeks after therapy.

The IM-PROVE II trial also presented end-of-treatment data, showing that imdusiran combined with VTP-300, an HBV antigen-specific immunotherapy, reached significant reductions in HBsAg levels compared to placebo. More patients maintained HBsAg thresholds of <100 IU/mL and <10 IU/mL with VTP-300 versus placebo. The combination was generally safe and well-tolerated. This trial includes an additional cohort set to receive imdusiran plus NA therapy followed by VTP-300 and low doses of nivolumab, with preliminary data expected in the second half of 2024.

Arbutus has discontinued its IM-PROVE III trial, which was set to combine imdusiran with durvalumab, an anti-PD-L1 monoclonal antibody, to focus resources on more promising areas.

In addition to imdusiran, Arbutus is advancing AB-101, an oral PD-L1 inhibitor designed to re-activate exhausted HBV-specific T-cells. A Phase 1a/1b trial is currently underway, showing that AB-101 is generally well-tolerated with dose-dependent receptor occupancy. Preliminary data from the multiple-ascending dose phase is expected later this year.

The company's decision to streamline operations includes a 40% workforce reduction, mainly impacting discovery and administrative functions. This restructuring will incur a one-time charge of $3.0 - $4.0 million in Q3 2024. These changes, along with ongoing cost management efforts, should sustain Arbutus' operations into late 2026.

Financially, Arbutus reported cash, cash equivalents, and investments totaling $148.5 million as of June 30, 2024, up from $132.3 million at the end of 2023. The company expects its 2024 cash burn to range from $63 million to $67 million. Revenues for Q2 2024 decreased to $1.7 million from $4.7 million in Q2 2023, largely due to reduced license revenue from Qilu Pharmaceutical and royalty revenue from Alnylam.

Research and development expenses fell to $15.6 million in Q2 2024 from $17.7 million in Q2 2023, primarily due to the end of the coronavirus and AB-161 programs, partially offset by increased clinical expenses for AB-101 and imdusiran trials. General and administrative expenses rose to $7.5 million from $6.0 million due to higher litigation costs.

Net loss for Q2 2024 was $19.8 million, or $0.11 per share, compared to $17.1 million, or $0.10 per share, in Q2 2023. As of June 30, 2024, Arbutus had 188.7 million common shares outstanding, with Roivant Sciences Ltd. owning approximately 21%.

Arbutus remains focused on advancing its key projects, imdusiran, and AB-101, to develop a functional cure for cHBV. The company continues to protect its intellectual property through ongoing litigation, seeking fair compensation for the use of its patented LNP technology by Moderna and Pfizer/BioNTech.