Arbutus Announces Q3 2024 Financial Results and Corporate Update

Arbutus Biopharma Corporation, a clinical-stage company focusing on therapies for chronic hepatitis B virus (cHBV) infection, has released its financial results for the third quarter of 2024 and provided a corporate update. Highlighting significant strides in the development of imdusiran, the company aims to offer hope to millions suffering from cHBV worldwide. Interim President and CEO, Michael J. McElhaugh, emphasized the promising data from their IM-PROVE I Phase 2a clinical trial, which showed a trend towards a functional cure in patients treated with imdusiran and interferon. Further follow-up data from this trial, as well as data from the IM-PROVE II Phase 2a trial involving nivolumab, will be presented at the upcoming AASLD meeting. With continued positive data and a cash runway extending into the fourth quarter of 2026, Arbutus is poised to advance imdusiran into a Phase 2b clinical trial.

Arbutus' proprietary oral PD-L1 checkpoint inhibitor, AB-101, has also shown promising progress. The Phase 1a/1b clinical trial of AB-101 in healthy subjects indicated it was generally safe and well-tolerated, with evidence of dose-dependent receptor occupancy. The trial is now in Part 3, dosing cHBV patients, with further updates expected as the trial progresses.

The IM-PROVE I Phase 2a clinical trial presented end-of-treatment data evaluating the combination of imdusiran, nucleos(t)ide analogue (NA) therapy, and pegylated interferon alfa-2a in cHBV patients. The results showed that 33.3% of patients receiving 48 weeks of imdusiran combined with 24 weeks of IFN and NA therapy achieved HBsAg loss, which was maintained in all these patients 24 weeks post-treatment. Additionally, HBsAg loss was sustained in 67% of patients with baseline HBsAg levels under 1000 IU/mL. Six patients seroconverted with HBsAg loss, with data showing sustained HBsAg and HBV DNA loss in those who stopped all therapy.

The IM-PROVE II Phase 2a trial's end-of-treatment data, which evaluated imdusiran, NA therapy, and VTP-300 immunotherapy, indicated that the combination was safe and well-tolerated. Statistical significance in HBsAg levels was observed between the VTP-300 arm and placebo at 24-weeks post-end of treatment. The trial also includes a cohort receiving imdusiran and NA therapy followed by VTP-300 and nivolumab, with preliminary end-of-treatment data to be presented at the upcoming AASLD meeting.

The AB-101 Phase 1a/1b clinical trial includes multiple ascending doses in healthy subjects, showing it was well-tolerated with dose-dependent receptor occupancy. Arbutus has commenced repeat dosing in cHBV patients and anticipates reporting preliminary data in the first half of next year.

Financially, as of September 30, 2024, Arbutus reported cash, cash equivalents, and investments totaling $130.8 million, compared to $132.3 million at the end of 2023. During the first nine months of 2024, the company used $54.5 million in operating activities, offset by $44.1 million from common shares issuance and $6.1 million from stock options exercise. The company did not issue any shares under its ATM program in Q3 2024. Arbutus forecasts a cash burn of $63 million to $67 million in 2024, with sufficient funds to operate into Q4 2026.

Revenue for Q3 2024 was $1.3 million, a decrease from $4.7 million in Q3 2023, primarily due to reduced license revenue from Qilu Pharmaceutical and lower royalty revenue from Alnylam. Research and development expenses decreased to $14.3 million from $20.2 million in Q3 2023, primarily due to the discontinuation of coronavirus and AB-161 programs. General and administrative expenses also dropped to $4.5 million from $5.8 million, attributed to decreased employee compensation and non-cash stock-based expenses. Additionally, a $3.6 million restructuring charge was incurred in Q3 2024.

Net loss for Q3 2024 was $19.7 million, slightly lower than the $20.1 million loss in Q3 2023. The company had approximately 189.4 million common shares issued and outstanding as of September 30, 2024, with Roivant Sciences Ltd. holding about 21% of the common shares.

Arbutus continues to focus on advancing the clinical development of imdusiran and AB-101, anticipating further progress and updates in the coming quarters.