Arbutus Biopharma(ABUS)2024-11-06 19:52Financial Data and Key Metrics - The company ended Q3 2024 with approximately 132 million as of December 31, 2023 [19] - Net proceeds from the issuance of common shares under the at-the-market offering program were approximately 54.5 million of cash used in operations [19] - The company expects its 2024 cash burn to range between 67 million, with sufficient cash runway to fund operations into Q4 2026 [20] Business Line Data and Key Metrics - The IM-PROVE I clinical trial showed that 33% of patients in Cohort A1 achieved sustained surface antigen loss at 24 weeks post-treatment, with 67% of patients with baseline surface antigen <1,000 IU/mL maintaining surface antigen loss [9][10] - In the IM-PROVE II trial, 95% of patients achieved surface antigen levels <100 IU/mL prior to dosing with VTP-300 or placebo, with more patients maintaining thresholds <100 or <10 IU/mL versus placebo [12] - AB-101, the oral small molecule PD-L1 checkpoint inhibitor, demonstrated dose-dependent receptor occupancy in Phase Ia/Ib trials, with 7 out of 8 subjects in the 25-milligram cohort showing >70% receptor occupancy [16] Market Data and Key Metrics - Chronic HBV affects over 250 million people globally, with current treatments offering a functional cure rate of less than 10% [6][25] - The company is focused on developing a functional cure for HBV, aiming for a 20% functional cure rate, which would significantly reduce the risk of liver cirrhosis and hepatocellular carcinoma [7][25] Company Strategy and Industry Competition - The company is advancing imdusiran into a Phase IIb clinical trial as a cornerstone in a potential HBV functional cure treatment regimen, combining it with immune modulators like interferon and VTP-300 [13] - AB-101 is being developed to enhance HBV-specific immune responses in combination with imdusiran, with preliminary data from HBV patients expected in the first half of 2025 [14][17] - The company is involved in litigation with Moderna and Pfizer/BioNTech regarding LNP intellectual property, with trial dates set for September 2025 and December 2024, respectively [18] Management Commentary on Operating Environment and Future Outlook - The company remains committed to transforming the HBV treatment landscape and providing hope to millions of patients worldwide [49] - Management is optimistic about the upcoming data presentations at AASLD, including updates from the IM-PROVE I trial and preliminary data from the nivolumab arm of the IM-PROVE II trial [21] Other Important Information - The company has achieved all of its second-half milestones, including reporting multiple ascending dose data from healthy subjects in the AB-101-001 trial [21] Q&A Session Summary Question: Functional Cure Data Expectations - The company has not presented functional cure data for imdusiran yet but aims for a 20% functional cure rate as a meaningful benchmark [24][25] - All subjects in the IM-PROVE I study received at least 4 doses of imdusiran, with Cohort A1 continuing imdusiran during interferon treatment, while Cohort A2 received only interferon after the initial 4 doses [26] Question: Denominator for Functional Cure Calculation - The denominator for functional cure in Cohort A1 is 12 patients, with 33% achieving surface antigen loss [29] - Patients with baseline surface antigen <1,000 IU/mL showed a 67% surface antigen loss rate, aligning with industry trends [30] Question: AB-101 Data and Study Design - Preliminary data from AB-101 in HBV patients is expected in the first half of 2025, with biomarker collection ongoing to assess receptor occupancy and immune response [39][40] - The company plans to combine AB-101 with imdusiran as quickly as possible, following monotherapy evaluation [42] Question: IM-PROVE II Data at AASLD - The AASLD presentation will focus on Group C of the IM-PROVE II study, which includes low-dose nivolumab [43] Question: Litigation Update - The claim construction hearing for the Pfizer/BioNTech lawsuit is scheduled for December 18, 2024, with a trial date for the Moderna case set for September 24, 2025 [18][45] Question: Cash Runway and ATM Program - The company's cash runway into Q4 2026 does not include any expected proceeds from the ATM program [48]