Core Insights - Arbutus Biopharma Corporation is undergoing significant changes in leadership and operational strategy to enhance the development of its pipeline, particularly focusing on imdusiran for chronic hepatitis B virus (cHBV) treatment [2][3][24] - The company reported a substantial decrease in total revenue for 2024, amounting to $6.2 million, down from $18.1 million in 2023, primarily due to reduced collaboration efforts and license royalties [11][12] - A workforce reduction of 57% has been implemented, resulting in a streamlined team aimed at improving financial and operational efficiency [2][10][3] Financial Results - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $122.6 million, a decrease from $132.3 million in 2023 [8][18] - The net loss for the year ended December 31, 2024, was $69.9 million, or a loss of $0.38 per share, compared to a net loss of $72.8 million, or a loss of $0.44 per share, in 2023 [14][17] - Operating expenses decreased to $82.5 million in 2024 from $96.2 million in 2023, driven by reduced research and development costs [12][16] Clinical Development - Imdusiran (AB-729) has shown promising results in clinical trials, achieving a functional cure rate of 50% in specific patient groups during a Phase 2a trial [3][21] - The company is evaluating plans for a Phase 2b clinical trial of imdusiran, with a focus on accelerating the development timeline [3][4] - AB-101, an oral PD-L1 inhibitor, is currently in a Phase 1a/1b clinical trial, with data indicating it is well-tolerated and shows potential for treating cHBV [9][22] Legal and Corporate Updates - The company is actively involved in litigation to protect its intellectual property, including lawsuits against Moderna and Pfizer/BioNTech for patent infringement related to its lipid nanoparticle technology [3][4][6] - Tuan Nguyen has been appointed as the new Chief Financial Officer, bringing extensive experience in biopharma finance [2][10][24] - The company has terminated its at-the-market (ATM) offering program as part of its strategy to reduce cash burn and refocus operations [10][12]

Core Viewpoint - Genevant Sciences and Arbutus Biopharma have filed five international lawsuits against Moderna, seeking to enforce patents related to their lipid nanoparticle (LNP) technology, alleging infringement in 30 countries [1][2]. Group 1: Legal Actions - The lawsuits aim to obtain monetary relief and injunctions against Moderna's Spikevax and other products that allegedly utilize the same LNP technology [2]. - The enforcement actions cover multiple jurisdictions, including Austria, Belgium, France, Germany, Italy, Spain, and Turkey, among others [3]. - In addition to international lawsuits, there is an ongoing case in the U.S. District Court for the District of Delaware, with a jury trial scheduled for September 2025 [4]. Group 2: Technology Background - The LNP technology developed by Arbutus and Genevant is crucial for the effective delivery of mRNA to human cells, addressing significant technological challenges in mRNA medicine development [5]. - This technology involves microscopic particles made from four types of fat-like molecules, which protect mRNA and facilitate its delivery to target cells [5]. - Genevant has over 20 years of experience in LNP delivery technology, which has been licensed for various applications, including vaccines and gene editing [6]. Group 3: Company Profiles - Genevant Sciences is recognized for its robust LNP patent portfolio and has pioneered LNP delivery for over two decades, enabling a wide range of RNA-based applications [6]. - Arbutus Biopharma focuses on infectious diseases and is developing treatments for chronic hepatitis B, while also leveraging its partnership with Genevant to maximize the potential of LNP technology [8].

Core Viewpoint - Arbutus Biopharma Corporation has announced significant changes in its leadership, including the appointment of Lindsay Androski as the new CEO, aimed at enhancing the company's focus on its pipeline and LNP delivery technology [1][3]. Leadership Changes - Lindsay Androski has been appointed as the new CEO, replacing Michael J. McElhaugh, effective immediately [1]. - Four new directors have joined the board: Robert Alan Beardsley, Joseph Bishop, Matthew Gline, and Anuj Hasija, while all existing board members have stepped down [3]. - The board has been reduced to five members, with potential plans to expand in the future to include expertise in clinical development [3]. Strategic Focus - The company will temporarily pause participation in investor meetings and conferences to review development plans and strategic options for its hepatitis B programs [4]. - The leadership changes are expected to enable a renewed focus on advancing the company's pipeline and maximizing contributions to LNP delivery technology through Genevant [3]. Company Overview - Arbutus Biopharma Corporation is a clinical-stage biopharmaceutical company focused on infectious diseases, currently developing imdusiran (AB-729) for chronic hepatitis B [5]. - The company aims to leverage its ownership stake and license agreement with Genevant to enhance its LNP delivery technology [5].

Core Viewpoint - Arbutus Biopharma Corporation is advancing its mission to develop a functional cure for chronic hepatitis B virus (cHBV) infection, with plans to initiate a Phase 2b clinical trial in the first half of 2025 after demonstrating promising results in earlier trials [1][2]. Company Objectives and Clinical Trials - The company aims to initiate a Phase 2b clinical trial combining imdusiran, interferon, and nucleos(t)ide analogue therapy in the first half of 2025, following a meaningful functional cure rate observed in the IM-PROVE I Phase 2a clinical trial [2][5]. - In the IM-PROVE I trial, a functional cure rate of 50% was achieved in HBeAg-negative patients with baseline HBsAg levels less than 1000 IU/mL, and an overall functional cure rate of 25% [5][8]. - The company is also evaluating the addition of low-dose nivolumab in the IM-PROVE II Phase 2a trial, where 23% of patients achieved HBsAg loss by week 48 [5]. Financial Update - As of December 31, 2024, the company reported cash, cash equivalents, and investments totaling approximately $123 million [12]. - The expected net cash burn for 2025 is projected to be between $47 million and $50 million, a reduction from approximately $65 million in 2024 [12]. - The company believes its financial resources are sufficient to fund operations through the first quarter of 2028, including the Phase 2b clinical trial for imdusiran [12]. Intellectual Property and Litigation - Arbutus is actively defending its intellectual property in ongoing lawsuits against Moderna and Pfizer/BioNTech regarding its patented LNP technology [5][12]. - The claim construction hearing for the lawsuit against Pfizer/BioNTech took place on December 18, 2024, with a ruling expected in the first half of 2025 [12]. Product Pipeline - Imdusiran is an RNAi therapeutic designed to reduce HBV viral proteins and antigens, showing meaningful functional cure rates when combined with pegylated interferon and nucleos(t)ide analogue therapy [8][13]. - AB-101, an oral PD-L1 inhibitor, is currently in a Phase 1a/1b clinical trial, with data from the 10 mg cohort expected in the first half of 2025 [9][12]. Industry Context - Chronic hepatitis B virus infection affects over 250 million people globally and is a leading cause of liver cancer, representing a significant unmet medical need [10]. - Approximately 1.1 million people die annually from complications related to chronic HBV infection, despite the availability of effective vaccines and treatments [10].

Group 1 - Arbutus Biopharma reported positive data from its phase 2a IM-PROVE I trial, utilizing its drug Imdusiran (AB-729) in combination with short courses of pegylated interferon alfa-2a to treat Hepatitis B patients [2] - The combination regimen showed promising results, indicating potential for further development in Hepatitis B treatment [2] Group 2 - The Biotech Analysis Central service offers in-depth analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2] - The service is available for $49 per month, with a discounted yearly plan at $399, providing investors with resources to make informed decisions [1]

WARMINSTER, Pa., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today announced that the Company will participate in the virtual H.C Wainwright @ Home fireside chat series taking place on Tuesday, December 3, 2024 at 11:00 am ET. To access the live webcast of the fireside ...

50% of patients who had baseline HBsAg levels less than 1000 IU/mL achieved functional cure in Cohort A1 of the IM-PROVE I Phase 2a clinical trial Overall, in Cohort A1, 25% of patients achieved functional cure Data to be presented in late-breaker poster session at AASLD – The Liver Meeting® on Monday, November 18, 2024 WARMINSTER, Pa., Nov. 15, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its exten ...

WARMINSTER, Pa., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today announced that the Company will present at and host one-on-one meetings at the following upcoming investor conference: Jefferies London Healthcare Conference: Fireside Chat on November 21, 2024 at 12:00 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 001-34949 ARBUTUS BIOPHARMA CORPORATION (Exact Name of Registrant as Specified in Its Charter) British Columbia, Canada 98-0597776 (State ...

Financial Data and Key Metrics - The company ended Q3 2024 with approximately $131 million in cash, cash equivalents, and marketable securities, compared to $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 $44 million in the first half of 2024, offset by $54.5 million of cash used in operations [19] - The company expects its 2024 cash burn to range between $63 million and $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]