Arbutus Biopharma(US:ABUS)2025-11-13 12:31Financial Performance - Total revenue for the three months ended September 30, 2025, was $529,000, a decrease of $810,000 (60.5%) compared to $1,339,000 in the same period of 2024[157]. - Total revenue for the nine months ended September 30, 2025, increased by $8.4 million (182.3%) to $13,032,000, primarily due to recognizing $9.6 million of previously deferred revenue from a partnership with Qilu[159]. - Operating expenses for the three months ended September 30, 2025, were $9,188,000, a decrease of $13,591,000 (59.7%) compared to $22,779,000 in the same period of 2024[160]. - Research and development expenses decreased by $8.5 million (59.7%) for the three months ended September 30, 2025, compared to the same period in 2024, due to a workforce reduction and cessation of discovery efforts[162]. - General and administrative expenses decreased by $1.5 million (33.0%) for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to lower employee compensation and litigation-related legal fees[164]. - The net loss for the three months ended September 30, 2025, was $7,742,000, compared to a net loss of $19,717,000 in the same period of 2024[157]. - For the nine months ended September 30, 2025, the net loss was $29.7 million, a decrease of $27.6 million compared to a net loss of $57.4 million for the same period in 2024[171]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $35.0 million, down from $54.5 million in 2024, reflecting a decrease of $19.6 million[172]. - Net cash provided by investing activities was $16.9 million for the nine months ended September 30, 2025, compared to $9.5 million in 2024, primarily due to maturities of investments in marketable securities[173]. - As of September 30, 2025, the company had cash, cash equivalents, and investments in marketable securities totaling $93.7 million, with no outstanding debt[175]. - Net cash provided by financing activities was $4.1 million for the nine months ended September 30, 2025, significantly lower than $50.6 million in 2024, which included $44.1 million from common share sales[174]. Restructuring and Cost Management - Arbutus Biopharma Corporation reported a one-time restructuring charge of $12.4 million in Q1 2025 due to workforce reductions and organizational changes[98]. - The company aims to significantly reduce its net cash burn in 2025 compared to 2024 through ongoing cost management efforts[98]. - The company incurred a one-time restructuring charge of $12.4 million in Q1 2025, related to a 57% workforce reduction and exiting its corporate headquarters[166]. - As of September 30, 2025, there was $0.5 million of accrued restructuring costs for severance payments and $0.3 million for lease-related operating expenses[167]. - The company expects to significantly reduce net cash burn in 2025 compared to 2024 due to organizational changes and ongoing cost management efforts[180]. Clinical Development and Trials - Over 250 patients with chronic hepatitis B (cHBV) infection have been dosed with imdusiran in Phase 1 and Phase 2a clinical trials, showing meaningful reductions in HBsAg, HBV DNA, and HBV RNA[106]. - 46% (48 out of 105) of all Phase 2a patients achieved functional cure or remained off nucleos(t)ide analog (NA) therapy after treatment with imdusiran[106]. - The company is currently developing AB-101, a proprietary oral PD-L1 inhibitor, which is in a Phase 1a/1b clinical trial[106]. - The company has streamlined its organization to focus on advancing the clinical development of imdusiran and AB-101, ceasing all discovery efforts and in-house scientific research[98]. - The newly formed Scientific Advisory Board (SAB) will advise on the strategic evaluation of the cHBV pipeline[99]. - The company’s strategy emphasizes maximizing opportunities for its cHBV development programs and its in-house developed lipid nanoparticle technology[101]. - In the IM-PROVE I trial, 50% (3/6) of patients with baseline HBsAg <1000 IU/mL achieved a functional cure, with an overall rate of 25% (3/12)[108]. - In the IM-PROVE II trial, 25% (2/8) of patients with low dose nivolumab and baseline HBsAg <1000 IU/mL achieved functional cure[122]. - Across all cohorts in the IM-PROVE II trial, 52% (32/62) of patients either achieved functional cure or remained off NA therapy for at least 48 weeks after treatment with imdusiran[123]. - In the IM-PROVE I trial, 37% (16/43) of patients either achieved functional cure or remained off NA therapy for at least 48 weeks after treatment with imdusiran[117]. - Imdusiran treatment was generally safe and well-tolerated, with no serious adverse events reported in the IM-PROVE I and II trials[118][123]. - The IM-PROVE I trial demonstrated that patients who achieved functional cure experienced HBsAg seroclearance associated with immune activation markers[116]. - The IM-PROVE II trial included a cohort with low dose nivolumab, which showed increased rates of HBsAg seroclearance[120]. - Imdusiran is designed to reduce HBV DNA, HBV RNA, and HBsAg, potentially allowing cHBV patients to become treatment-free[112]. - AB-101 clinical trial demonstrated 100% receptor occupancy in all five evaluable subjects at the 40mg dose level in Part 1[130]. - In Part 2, 100% receptor occupancy was achieved by six out of eight subjects at the 40mg daily dose over seven days[130]. - Part 3 of the trial showed that a single 10mg dose of AB-101 for 28 days in cHBV patients was well tolerated, with PD-L1 receptor occupancy similar to healthy subjects[131]. Legal Matters - The ongoing lawsuits against Moderna and Pfizer/BioNTech for patent infringement involve the use of Arbutus's lipid nanoparticle technology in their COVID-19 vaccines[97]. - A trial date for the Moderna lawsuit in the U.S. has been set for March 2026, with public oral hearings for related cases scheduled for May 2026[97]. - A lawsuit against Moderna for patent infringement related to lipid nanoparticle technology was filed, with a jury trial scheduled for March 2026[144]. - Five international lawsuits against Moderna were filed in March 2025, targeting alleged infringing activities in 30 countries[145]. - The company is currently preparing responses to multiple revocation actions against its patents filed by Moderna and Merck[150]. Strategic Partnerships - Qilu Pharmaceutical paid a one-time upfront cash payment of $40 million and agreed to pay up to $245 million upon achieving certain milestones related to imdusiran[133]. - Qilu is responsible for all costs related to the development and commercialization of imdusiran in Greater China and Taiwan[134]. - The strategic partnership with Qilu was mutually concluded in June 2025, allowing the company to regain global rights for imdusiran[136]. - The company is exploring strategic alliances to accelerate the development of its pipeline programs[111]. - The company has a royalty entitlement on ONPATTRO, with an aggregate of $26.3 million recorded as non-cash royalty revenue since the inception of the royalty sale through September 30, 2025[178]. - In June 2025, the company concluded its strategic partnership with Qilu, regaining global rights for imdusiran, which had previously been licensed for development in Greater China and Taiwan[179]. - The company may seek funding from various sources, including public or private equity or debt financing, to maintain and advance its business[181]. - The company does not have any off-balance sheet arrangements that could materially affect its financial condition or results of operations[183].