Arbutus Biopharma(US:ABUS)2025-08-06 11:32Financial Performance - Total revenue for the three months ended June 30, 2025, was $10,739,000, a significant increase of $9,013,000 (520%) compared to $1,726,000 in the same period of 2024[152]. - Revenue from Qilu Pharmaceutical Co., Ltd. accounted for 90% of total revenue in Q2 2025, up from 30% in Q2 2024[153]. - Operating expenses decreased to $9,251,000 for the three months ended June 30, 2025, down from $23,309,000 in the same period of 2024, representing a reduction of 60%[155]. - Research and development expenses decreased by $10.1 million (65%) for the three months ended June 30, 2025, compared to the same period in 2024, primarily due to a workforce reduction[157]. - Net cash used in operating activities for the six months ended June 30, 2025, was $29,140,000, a decrease of $4,659,000 (14%) from $33,799,000 in the same period of 2024[167]. - Net cash provided by investing activities was $26,960,000 for the six months ended June 30, 2025, compared to $21,523,000 in the same period of 2024, an increase of $5,437,000 (25.3%)[168]. - As of June 30, 2025, the company had cash, cash equivalents, and investments in marketable securities totaling $98,100,000, with no outstanding debt[170]. - The company recorded a net loss of $22,003,000 for the six months ended June 30, 2025, compared to a net loss of $37,671,000 in the same period of 2024[166]. Restructuring and Cost Management - Arbutus Biopharma 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[98]. - The restructuring charge incurred in Q1 2025 amounted to $12.4 million, primarily related to workforce reduction and exiting the corporate headquarters[161]. - The company expects to significantly reduce its net cash burn in 2025 compared to 2024 due to organizational changes and ongoing cost management efforts[175]. Clinical Trials and Development - In the IM-PROVE I clinical trial, a functional cure rate of 50% (3 out of 6 patients) was achieved in HBeAg negative patients with baseline HBsAg levels less than 1000 IU/mL[107]. - In the IM-PROVE II clinical trial, 25% (2 out of 8 patients) achieved functional cure when treated with imdusiran, VTP-300, NA therapy, and low dose nivolumab[109]. - A total of eight patients with chronic hepatitis B (cHBV) have been functionally cured following treatment with imdusiran in combination with ongoing nucleos(t)ide analogue therapy[106]. - The company is focused on developing a functional cure for cHBV infection, with imdusiran as a potential cornerstone in combination therapy[104]. - Over 250 patients with cHBV infection have been dosed with imdusiran in Phase 1 and Phase 2a clinical trials, showing meaningful reductions in HBsAg and HBV DNA[108]. - The newly formed Scientific Advisory Board (SAB) will advise on the strategic evaluation of the cHBV pipeline[99]. - The company is developing an RNAi therapeutic, imdusiran, aimed at reducing HBsAg and HBV antigen expression in patients with chronic HBV infection[113]. - In the IM-PROVE I Phase 2a trial, 50% (3/6) of patients with baseline HBsAg <1000 IU/mL achieved a functional cure after treatment with imdusiran and IFN[119]. - The IM-PROVE II trial showed a 25% (2/8) functional cure rate in patients receiving imdusiran, VTP-300, ongoing NA therapy, and low dose nivolumab[119]. - The IM-PROVE I trial demonstrated that imdusiran was generally safe and well-tolerated, with no serious adverse events related to the treatment[117]. - In the IM-PROVE II trial, the addition of low dose nivolumab increased HBsAg loss rates to 23% (3/13) by week 48[122]. - AB-101, an oral PD-L1 inhibitor, is designed to enhance HBV-specific T-cell function while minimizing systemic safety issues[125]. - The Phase 1a/1b trial of AB-101 showed high receptor occupancy, with 100% receptor occupancy observed in the 40mg cohort[127]. Legal Matters and Patent Issues - Arbutus is involved in ongoing patent infringement lawsuits against Moderna and Pfizer/BioNTech regarding the use of its lipid nanoparticle delivery technology[97]. - The company and Genevant filed a lawsuit against Moderna for patent infringement related to its COVID-19 vaccine, with a jury trial scheduled for March 2026[141]. - Five international lawsuits have been filed against Moderna in 30 countries to enforce patents protecting lipid nanoparticle technology[142]. - A lawsuit against Pfizer and BioNTech for patent infringement related to COVID-19 mRNA-LNP vaccines was filed on April 4, 2023, with ongoing fact discovery[145]. - The company is involved in ongoing patent opposition proceedings with Moderna and Merck regarding its European patent EP 2279254, with oral proceedings scheduled for January 2026[146]. - Moderna filed a revocation action on EPO patent EP 4 241 767, with the company preparing its response[147]. Strategic Partnerships and Agreements - The Qilu License Agreement included a one-time upfront cash payment of $40 million and potential milestone payments up to $245 million[130]. - The company recognized all previously deferred revenue in Q2 2025 after mutually terminating the Qilu License Agreement, regaining global rights for imdusiran[133]. - In December 2021, the company entered into a technology transfer and exclusive licensing agreement with Qilu, receiving a one-time upfront cash payment of $40 million and an equity investment of $15 million[174]. - The agreement includes potential milestone payments of up to $245 million, net of withholding taxes, based on the achievement of specific development and commercialization milestones[174]. - Qilu will pay double-digit royalties in the low twenties percent based on annual net sales of imdusiran in Greater China and Taiwan[174]. - The company is exploring pipeline opportunities through potential strategic alliances to enhance its product offerings[112]. Royalty Interests - Alnylam Pharmaceuticals has a tiered royalty entitlement on global net sales of ONPATTRO, ranging from 1.00% to 2.33%, with the highest tier applicable to annual net sales above $500 million[134]. - The royalty interest sold to OMERS for $20 million will revert to the company after OMERS collects $30 million in royalties, with $25.9 million earned by OMERS as of June 30, 2025[134]. - The company retains a second royalty interest from Acuitas, ranging from 0.75% to 1.125% on global net sales of ONPATTRO, with 0.75% applicable to sales greater than $500 million[135]. - The company is entitled to receive 20% of certain revenues from Genevant's sublicensed products, or tiered low single-digit royalties on net sales[137]. - The royalty entitlement from ONPATTRO has the potential to provide an active royalty stream if it reverts to the company after OMERS collects $30 million in royalties[173]. Future Funding and Financial Strategy - Future funding needs may vary based on factors such as patent enforcement costs, revenue from collaborative partnerships, and the development of new product candidates[175]. - The company may seek funding from various sources, including public or private equity, debt financing, and collaborative arrangements with pharmaceutical companies[176]. - If adequate funding is not available, the company may need to delay or reduce development programs or relinquish rights to product candidates[177]. - The company does not have any off-balance sheet arrangements that materially affect its financial condition or operations[178].