Arbutus Biopharma(ABUS) - 2024 Q4 - Annual Results

Chronic HBV Treatment - Approximately 250 million people are affected by chronic HBV, with current treatment options limited to lifelong suppressive therapy, indicating a significant unmet medical need for a finite curative regimen[5] - The combination therapy strategy aims to develop a finite, curative treatment for chronic HBV by utilizing antivirals and immunomodulators[6] - Phase 2a clinical trial data for imdusiran shows a 50% functional cure rate in patients with baseline HBsAg <1000 IU/mL when combined with a short course of interferon[25] - The Phase 2a trial (IM-PROVE I) demonstrated that 25% of all patients achieved a functional cure, with no serious adverse events related to imdusiran or interferon[25] - Imdusiran demonstrated a 50% functional cure rate in patients with HBsAg <1000 IU/mL when combined with a short course of IFN[28] - Imdusiran resulted in HBsAg declines of approximately 1.5-2.0 log10 across various dosing regimens[28] - Data from Phase 2a trials suggest that imdusiran combined with interferon is generally safe and well-tolerated[49] Clinical Trials - The company is initiating a placebo-controlled Phase 2b clinical trial with 170 HBeAg-negative cHBV patients in the first half of 2025[24] - The company plans to initiate a Phase 2b clinical trial for imdusiran combined with IFN in 2025[47] - The ongoing IM-PROVE II trial is evaluating imdusiran in combination with Barinthus Bio's immunotherapeutic, VTP-300, and low dose nivolumab[26] - The company expects to present preliminary data from Cohort 3A of the AB-101 trial in the first half of 2025[47] - Preliminary data from the AB-101 Phase 1a/1b trial indicates that all evaluable subjects in the 25mg cohort showed receptor occupancy between 50-100%[42] Financial Position - The company has a strong financial position with a cash runway through Q1 2028, fully funding the Phase 2b clinical trial[5] - As of December 31, 2024, the company reported a cash balance of $123M, with a projected cash runway through Q1 2028[49] - The anticipated costs to complete the Phase 2b clinical trial are estimated to be between$30 million and $40 million[24] - The company anticipates a cash burn of$47-50M in 2025 as it advances its clinical trials and litigation efforts[49] Legal Matters - The company is seeking damages from patent litigation against Moderna and Pfizer/BioNTech related to COVID-19 vaccine sales[5] - The ongoing litigation with Pfizer and Moderna could result in royalties of 20% to Arbutus from related damages[44] - The strategic collaboration with Qilu Pharmaceutical includes a $40M upfront payment and potential commercialization payments up to$245M[30] Future Presentations - The company plans to present additional data at AASLD 2024, subject to regulatory approval[23]