Multiple abstracts accepted featuring imdusiran clinical data – highlighting progress toward a potential functional cure for chronic hepatitis B virus AB-101 clinical data abstract recognized as a Poster of Distinction WARMINSTER, Pa., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that three abstracts featuring imdusiran data and one abstract featuring AB-1 ...

Company Performance - Aquestive Therapeutics (AQST) has returned approximately 12.6% year-to-date, outperforming the Medical sector, which has returned an average of -4.9% [4] - The Zacks Consensus Estimate for AQST's full-year earnings has increased by 0.5% over the past 90 days, indicating improving analyst sentiment [3] Industry Ranking - Aquestive Therapeutics is part of the Medical - Drugs industry, which consists of 153 companies and currently ranks 84 in the Zacks Industry Rank [5] - The average return for the Medical - Drugs industry so far this year is 8.3%, suggesting that AQST is performing better than its industry peers [5] Sector Overview - The Medical sector includes 978 individual stocks and is currently ranked 8 in the Zacks Sector Rank, which evaluates 16 different sector groups [2] - Arbutus Biopharma (ABUS), another stock in the Medical sector, has returned 3.1% year-to-date and has a Zacks Rank of 2 (Buy) [4][5]

Arbutus shares have added about 4.3% since the beginning of the year versus the S&P 500's gain of 7.1%. What's Next for Arbutus? While Arbutus has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? Arbutus Biopharma (ABUS) came out with quarterly earnings of $0.01 per share, beating the Zacks Consensus Estimate of a loss of $0.02 per share. This compares to a loss of $0.11 per share a year ago. These figures are adjusted for non-recurring i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q For the quarterly period ended June 30, 2025 (Exact Name of Registrant as Specified in Its Charter) British Columbia, Canada 98-0597776 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) 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 ☒ ...

EXHIBIT 99.1 Arbutus Reports Second Quarter 2025 Financial Results and Provides Corporate Update Q2 total revenue of $10.7M includes previously-deferred revenue following reacquisition of Greater China rights to imdusiran Dr. Roger Sawhney joins the Arbutus Board of Directors following resignation of Anuj Hasija Dr. Harry Janssen joins the Arbutus Scientific Advisory Board Strong financial position with cash, cash equivalents and marketable securities of $98.1M WARMINSTER, Pa., Aug. 06, 2025 (GLOBE NEWSWIRE ...

Core Insights - Arbutus Biopharma Corporation reported a strong second quarter in 2025, with total revenue of $10.7 million, significantly up from $1.7 million in the same period in 2024, primarily due to the recognition of previously-deferred revenue following the conclusion of its partnership with Qilu Pharmaceutical [8][11] - The company has strengthened its leadership team by appointing Dr. Roger Sawhney to the Board of Directors and Dr. Harry Janssen to the Scientific Advisory Board, enhancing its expertise in chronic hepatitis B virus (cHBV) programs [2][6] - Arbutus maintains a solid financial position with cash, cash equivalents, and marketable securities totaling $98.1 million as of June 30, 2025, although this is a decrease from $122.6 million at the end of 2024 [7][15] Financial Performance - Total revenue for Q2 2025 was $10.7 million, a $9.0 million increase compared to Q2 2024, attributed to the conclusion of the partnership with Qilu and the recognition of deferred revenue [8][11] - Research and development expenses decreased to $5.5 million in Q2 2025 from $15.6 million in Q2 2024, reflecting cost-saving measures implemented by the company [9] - General and administrative expenses also saw a reduction, falling to $3.3 million in Q2 2025 from $7.5 million in Q2 2024, due to cost-cutting efforts [10] Corporate Developments - The company concluded its strategic partnership with Qilu Pharmaceutical for the development and commercialization of imdusiran in Greater China, regaining global rights for the compound [5][6] - Dr. Harry Janssen's appointment to the Scientific Advisory Board is expected to enhance the company's clinical development efforts in cHBV [2][6] - Anuj Hasija resigned from the Board of Directors to focus on a new role at Vertex Pharmaceuticals, and Dr. Roger Sawhney has been appointed to fill the vacancy [2][6] Legal and Intellectual Property - Arbutus is actively involved in litigation to protect its intellectual property related to its patented LNP technology, with ongoing lawsuits against Moderna and Pfizer/BioNTech [5] - The summary judgment phase of the litigation against Moderna began in July 2025, with a jury trial scheduled for March 2026 [5]

Core Insights - Arbutus Biopharma Corporation has reacquired the rights to its lead compound, imdusiran, from Qilu Pharmaceutical, concluding their strategic partnership for the development and commercialization of imdusiran in Greater China [1][2] - The decision to terminate the partnership was influenced by Qilu's pipeline reprioritization and Arbutus' focus on advancing its pipeline efficiently [2] - Imdusiran has shown promising results, achieving functional cure in eight patients during Phase 2a trials [2][3] Company Overview - Arbutus Biopharma is a clinical-stage biopharmaceutical company focused on infectious diseases, particularly chronic hepatitis B virus (cHBV) [7] - The company is also developing an oral PD-1 inhibitor (AB-101) for cHBV treatment and is involved in legal actions to protect its intellectual property related to its patented LNP technology [7] Product Details - Imdusiran is designed to reduce all HBV viral proteins and antigens, which is essential for reawakening the immune system to control the virus [5] - The treatment has been reported to be generally safe and well-tolerated, with significant reductions in hepatitis B surface antigen (HBsAg) and HBV DNA [5] Scientific Advisory Board - Arbutus has established a new Scientific Advisory Board consisting of experts in chronic hepatitis B treatment to guide its strategic evaluation of the cHBV pipeline [2]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20(UNAUDITED)) For the three months ended March 31, 2025, Arbutus Biopharma reported a net loss of $24.5 million, an increase from the $17.9 million net loss in the same period of 2024, primarily driven by a $12.4 million restructuring charge Condensed Consolidated Balance Sheets As of March 31, 2025, total assets were $117.0 million, a decrease from $131.7 million at December 31, 2024, mainly due to reduced marketable securities and property and equipment, while total liabilities increased to $37.9 million from $34.3 million, and total stockholders' equity decreased to $79.2 million from $97.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $37,076 | $36,330 | | Investments in marketable securities, current | $75,631 | $86,293 | | Total current assets | $116,808 | $127,316 | | **Total assets** | **$117,010** | **$131,707** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $19,431 | $15,618 | | **Total liabilities** | **$37,853** | **$34,341** | | **Total stockholders' equity** | **$79,157** | **$97,366** | Condensed Consolidated Statements of Operations and Comprehensive Loss For the first quarter of 2025, the company reported a net loss of $24.5 million, or ($0.13) per share, compared to a net loss of $17.9 million, or ($0.10) per share, for the same period in 2024, primarily due to a one-time restructuring charge of $12.4 million, partially offset by a $6.4 million decrease in R&D expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total Revenue | $1,764 | $1,532 | | Research and development | $8,959 | $15,403 | | General and administrative | $5,832 | $5,312 | | Restructuring | $12,373 | $0 | | Total operating expenses | $27,463 | $20,895 | | Loss from operations | ($25,699) | ($19,363) | | **Net loss** | **($24,526)** | **($17,875)** | | **Loss per share (basic and diluted)** | **($0.13)** | **($0.10)** | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities for the first quarter of 2025 was $13.4 million, a decrease from $19.3 million in the prior-year period, reflecting cost-saving measures, while net cash provided by investing activities was $11.3 million, mainly from net dispositions of marketable securities, and net cash from financing activities was $2.8 million, primarily from stock option exercises Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,391) | ($19,295) | | Net cash provided by investing activities | $11,349 | $11,694 | | Net cash provided by financing activities | $2,784 | $24,430 | | **Increase in cash and cash equivalents** | **$746** | **$16,816** | | **Cash and cash equivalents, end of period** | **$37,076** | **$43,101** | Notes to Condensed Consolidated Financial Statements The notes detail the company's business focus on infectious diseases, particularly cHBV with imdusiran and AB-101, and its ongoing patent litigation against Moderna and Pfizer/BioNTech, along with key accounting policies, revenue recognition, fair value measurements, and details of the March 2025 restructuring, with the company believing its cash resources of $112.7 million are sufficient for at least the next 12 months - The company is a clinical-stage biopharmaceutical firm focused on developing treatments for chronic hepatitis B (cHBV), specifically imdusiran (AB-729) and AB-101[22](index=22&type=chunk) - Arbutus is engaged in ongoing patent infringement lawsuits against Moderna and Pfizer/BioNTech concerning its lipid nanoparticle (LNP) delivery technology used in their COVID-19 vaccines. A trial date against Moderna in the U.S. is set for September 29, 2025[23](index=23&type=chunk) - In March 2025, the company implemented a significant restructuring, reducing its workforce by **57% to 19 employees**, exiting its corporate headquarters, and discontinuing in-house research, resulting in a one-time charge of **$12.4 million**[49](index=49&type=chunk)[81](index=81&type=chunk) - The company believes its cash, cash equivalents, and marketable securities of **$112.7 million** as of March 31, 2025, are sufficient to fund operations for at least the next 12 months[24](index=24&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's strategic focus on its cHBV pipeline (imdusiran and AB-101) and the monetization of its LNP technology through patent litigation, with a major restructuring in Q1 2025, including a 57% workforce reduction, expected to significantly lower the net cash burn, while net loss for Q1 2025 increased to $24.5 million due to restructuring costs, though R&D spending decreased, and the company ended the quarter with $112.7 million in cash and investments, deemed sufficient for at least the next year Overview and Strategy Arbutus is a clinical-stage biopharma company focused on developing a functional cure for chronic hepatitis B (cHBV) with its candidates imdusiran and AB-101, with a key part of its strategy involving defending and monetizing its lipid nanoparticle (LNP) delivery technology through patent infringement lawsuits against Moderna and Pfizer/BioNTech, and following significant restructuring, the company aims to reduce its cash burn while advancing its clinical programs - The company's strategy focuses on maximizing opportunities for its cHBV development programs and its LNP delivery technology[96](index=96&type=chunk) - Arbutus has filed patent infringement lawsuits against Moderna and Pfizer/BioNTech for unlicensed use of its LNP technology in their COVID-19 vaccines. The U.S. trial against Moderna is scheduled for September 29, 2025[94](index=94&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - The company's cHBV strategy aims to develop a functional cure using imdusiran as a cornerstone therapy in combination with other agents to suppress HBsAg and boost immune response[99](index=99&type=chunk) - Recent restructuring actions, including a **57% workforce reduction** in Q1 2025, are expected to significantly reduce net cash burn in 2025 compared to 2024[95](index=95&type=chunk) Our Product Candidates The company's pipeline features two main cHBV candidates: imdusiran (AB-729), an RNAi therapeutic, and AB-101, an oral PD-L1 inhibitor, with imdusiran showing meaningful HBsAg reduction and leading to functional cures in eight patients in combination therapies, and AB-101 demonstrating good tolerability and high receptor occupancy in its Phase 1a/1b trial - Imdusiran (RNAi therapeutic) has achieved functional cure in **8 cHBV patients** to date in combination therapies[103](index=103&type=chunk) - The IM-PROVE I trial (imdusiran + IFN) showed a **50% (3/6) functional cure rate** in patients with baseline HBsAg <1000 IU/mL[104](index=104&type=chunk)[115](index=115&type=chunk) - The IM-PROVE II trial (imdusiran + VTP-300 + nivolumab) showed a **25% (2/8) functional cure rate** in patients with baseline HBsAg <1000 IU/mL[104](index=104&type=chunk) - AB-101 (oral PD-L1 inhibitor) is in a Phase 1a/1b trial and has shown to be well-tolerated with evidence of high receptor occupancy in healthy subjects and cHBV patients[103](index=103&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk) Other Collaborations, Royalty Entitlements and Intellectual Property Litigation Arbutus has a licensing agreement with Qilu for imdusiran in Greater China, which included a $40 million upfront payment and potential for $245 million in milestones plus royalties, and receives two royalty streams on Alnylam's ONPATTRO sales, one of which was partially sold to OMERS and is close to reverting back to Arbutus, while its LNP platform was licensed to Genevant, entitling Arbutus to sublicensing revenues and a share of litigation proceeds, with detailed updates on the patent infringement lawsuits against Moderna and Pfizer/BioNTech in the U.S. and internationally - Collaboration with Qilu for imdusiran in Greater China includes up to **$245 million in milestones** and double-digit royalties[123](index=123&type=chunk) - The company has two royalty entitlements on Alnylam's ONPATTRO. A portion sold to OMERS for **$20 million** is expected to revert to Arbutus after OMERS receives **$30 million in royalties** (**$25.3 million** earned as of March 31, 2025)[126](index=126&type=chunk) - Arbutus and Genevant filed five international lawsuits against Moderna in March 2025, targeting infringing activities in **30 countries** and seeking monetary relief and injunctions[135](index=135&type=chunk) - In the U.S. lawsuit against Pfizer/BioNTech, the claim construction hearing occurred in December 2024, with a court ruling and trial schedule expected in 2025[137](index=137&type=chunk) Results of Operations For Q1 2025, total revenue increased to $1.8 million from $1.5 million in Q1 2024, driven by higher revenue from the Qilu collaboration, while total operating expenses rose to $27.5 million from $20.9 million, primarily due to a $12.4 million restructuring charge, partially offset by a $6.4 million decrease in R&D expenses, and general and administrative expenses saw a slight increase of $0.5 million due to higher legal fees Revenue Comparison (in thousands) | Revenue Source | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Royalties from sales of ONPATTRO | $504 | $695 | | Qilu Pharmaceutical Co., Ltd. | $812 | $244 | | Non-cash royalty revenue (ONPATTRO) | $448 | $593 | | **Total revenue** | **$1,764** | **$1,532** | Operating Expenses Comparison (in thousands) | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $8,959 | $15,403 | | General and administrative | $5,832 | $5,312 | | Restructuring | $12,373 | $0 | | **Total operating expenses** | **$27,463** | **$20,895** | - R&D expenses decreased by **$6.4 million** YoY due to ceasing discovery efforts, discontinuing the IM-PROVE III trial, and workforce reductions[151](index=151&type=chunk) - A one-time restructuring charge of **$12.4 million** was incurred in Q1 2025, related to workforce reduction, facility exit, and asset impairments[155](index=155&type=chunk) Liquidity and Capital Resources As of March 31, 2025, the company had $112.7 million in cash, cash equivalents, and marketable securities with no outstanding debt, with net cash used in operations decreasing to $13.4 million in Q1 2025 from $19.3 million in Q1 2024, reflecting cost-saving initiatives, and the company terminated its Open Market Sale Agreement in March 2025, having raised no funds through it in Q1 2025, compared to $21.8 million in Q1 2024, while management believes current cash is sufficient to fund operations for at least the next year but notes that substantial additional funds will be required for future development - The company had cash, cash equivalents, and investments of **$112.7 million** as of March 31, 2025, with no debt[164](index=164&type=chunk) - Net cash used in operating activities decreased by **$5.9 million** YoY, from **$19.3 million** in Q1 2024 to **$13.4 million** in Q1 2025[161](index=161&type=chunk) - The Open Market Sale Agreement with Jefferies was terminated on March 26, 2025. No shares were sold under this agreement in Q1 2025[165](index=165&type=chunk)[166](index=166&type=chunk) - Future funding needs are substantial and depend on litigation costs, clinical development progress, and potential partnership revenue[169](index=169&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company has indicated that this information is not required to be provided as it qualifies as a smaller reporting company - As a smaller reporting company, Arbutus is not required to provide disclosures about market risk[173](index=173&type=chunk) [Controls and Procedures](index=36&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the principal executive and financial officers, evaluated the company's disclosure controls and procedures as of March 31, 2025, and concluded that these controls were effective at a reasonable assurance level, with no material changes in internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at the reasonable assurance level[174](index=174&type=chunk) - No changes in internal control over financial reporting occurred during the first quarter of 2025 that have materially affected, or are reasonably likely to materially affect, these controls[175](index=175&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) This section details the company's significant ongoing patent litigation, with Arbutus and its partner Genevant suing Moderna and Pfizer/BioNTech in the U.S. for infringing on LNP technology patents with their COVID-19 vaccines, and the U.S. trial against Moderna set for September 2025, while five new international lawsuits were filed against Moderna across 30 countries in March 2025, and the company is also involved in European patent opposition proceedings with Moderna and Merck - U.S. lawsuit against Moderna: Trial is scheduled for September 29, 2025. The court's claim construction ruling in April 2024 was largely favorable to Arbutus's positions[177](index=177&type=chunk) - International lawsuits against Moderna: In March 2025, Arbutus and Genevant filed five lawsuits in Canada, Japan, Switzerland, and the Unified Patent Court, targeting Moderna's COVID-19 and RSV vaccines in **30 countries**[178](index=178&type=chunk) - U.S. lawsuit against Pfizer/BioNTech: A claim construction hearing was held in December 2024, with a ruling and trial schedule expected in 2025. Fact discovery is ongoing[180](index=180&type=chunk) - European Patent Oppositions: The company is engaged in ongoing opposition and appeal proceedings with Moderna and Merck regarding European patents EP 2279254 and EP 4 241 767[181](index=181&type=chunk)[182](index=182&type=chunk) [Risk Factors](index=39&type=page&id=ITEM%201A.%20RISK%20FACTORS) The company reports that there have been no material changes to its risk factors from those disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - No material changes in risk factors were reported since the last Annual Report on Form 10-K[184](index=184&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The company reported no unregistered sales of equity securities during the period - None[185](index=185&type=chunk) [Other Information](index=39&type=section&id=ITEM%205.%20OTHER%20INFORMATION) During the first quarter of 2025, the company's Chief Financial Officer, Tuan Nguyen, entered into a Rule 10b5-1 trading arrangement, which provides for the automatic sale of common shares upon the vesting of restricted stock units (RSUs) to cover applicable tax withholding obligations - On March 28, 2025, CFO Tuan Nguyen entered into a Rule 10b5-1 trading plan to automatically sell shares to cover tax obligations upon the vesting of RSUs[188](index=188&type=chunk) [Exhibits](index=40&type=section&id=ITEM%206.%20EXHIBITS) This section provides an index of the exhibits filed with the Form 10-Q, including employment and separation agreements, certifications by the CEO and CFO, and the XBRL data files - The Exhibit Index lists various legal documents and certifications filed with the report, including new executive employment agreements and separation agreements[190](index=190&type=chunk)

Company Performance - Arbutus Biopharma reported a quarterly loss of $0.13 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.09, and compared to a loss of $0.10 per share a year ago, indicating an earnings surprise of -44.44% [1] - The company posted revenues of $1.76 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 10.25%, and showing an increase from year-ago revenues of $1.53 million [2] - Over the last four quarters, Arbutus has surpassed consensus EPS estimates just once, but has topped consensus revenue estimates three times [2] Stock Outlook - The immediate price movement of Arbutus shares will depend on management's commentary during the earnings call, as the stock has lost about 2.5% since the beginning of the year, while the S&P 500 has gained 0.1% [3] - The current consensus EPS estimate for the coming quarter is -$0.02 on $1.6 million in revenues, and -$0.20 on $7.35 million in revenues for the current fiscal year [7] - The estimate revisions trend for Arbutus is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Arbutus belongs, is currently in the top 30% of over 250 Zacks industries, indicating a favorable outlook for stocks within this sector [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

[Corporate Update and Financial Highlights](index=1&type=section&id=Corporate%20Update%20and%20Financial%20Highlights) [Overview](index=1&type=section&id=Overview) Arbutus Biopharma reported positive clinical trial results for its chronic hepatitis B (cHBV) and oral PD-L1 inhibitor programs in the first quarter of 2025, achieving functional cures in eight cHBV patients and demonstrating safety for AB-101, while maintaining a strong financial position with **$113 million** in cash and marketable securities - Imdusiran combination therapy has resulted in a functional cure for **8 patients** with chronic hepatitis B (cHBV), including two patients who did not receive interferon[1](index=1&type=chunk)[2](index=2&type=chunk) - The oral small-molecule PD-L1 inhibitor, AB-101, was shown to be generally **safe and well-tolerated** in its Phase 1a/1b trial, with evidence of **high receptor occupancy**[1](index=1&type=chunk)[3](index=3&type=chunk) - Andrew J. Sung joined Arbutus as General Counsel, bringing significant life sciences deal experience, including over **$28 billion** in transactions[1](index=1&type=chunk)[4](index=4&type=chunk) - The company reported a strong financial position with cash, cash equivalents, and marketable securities of **$113 million** as of the end of Q1 2025[1](index=1&type=chunk) [Clinical Development Update](index=1&type=section&id=Clinical%20Development%20Update) [Imdusiran (AB-729)](index=1&type=section&id=Imdusiran%20%28AB-729%29) Arbutus has reported a total of eight functionally cured chronic hepatitis B (cHBV) patients following treatment with imdusiran in combination with other therapies, with baseline HBsAg levels identified as a key marker for functional cure, and two of the eight cured patients not receiving interferon - A total of **eight cHBV patients** have achieved **functional cure** after treatment with imdusiran and ongoing NA therapy, combined with either IFN or nivolumab plus an immunotherapeutic[6](index=6&type=chunk) - Data from the IM-PROVE I trial presented at EASL 2025 indicated that **HBsAg level at baseline** was the only common marker associated with **functional cure** among the six patients studied[6](index=6&type=chunk) - Data from the IM-PROVE II trial showed that **25% (2 of 8)** of patients with baseline HBsAg **<1000 IU/mL** achieved **functional cure** when low-dose nivolumab was added to the treatment regimen[6](index=6&type=chunk) - **Seven of the eight patients** who achieved functional cure had baseline HBsAg levels below **1000 IU/mL**, a significant portion of the cHBV population[6](index=6&type=chunk) [AB-101 (oral PD-L1 inhibitor)](index=1&type=section&id=AB-101%20%28oral%20PD-L1%20inhibitor%29) The Phase 1a/1b clinical trial for AB-101, an oral PD-L1 inhibitor, demonstrated that the drug is well-tolerated and achieves high, dose-dependent receptor occupancy in both healthy subjects and cHBV patients, with no serious adverse events or evidence of liver dysfunction observed - In the Phase 1a/1b trial, **11 of 13** evaluable healthy subjects receiving the **40mg dose** of AB-101 achieved **100% receptor occupancy**[3](index=3&type=chunk)[11](index=11&type=chunk) - Across all cohorts presented, there have been **no serious adverse events** (SAEs) or early discontinuations due to AB-101, and **no evidence of liver dysfunction**[3](index=3&type=chunk)[11](index=11&type=chunk) - Part 3 of the clinical trial, which is ongoing, showed that **10mg of AB-101 daily** for 28 days was **well tolerated** in patients with cHBV, with **similar receptor occupancy** to that in healthy volunteers[11](index=11&type=chunk) [Corporate and Legal Updates](index=2&type=section&id=Corporate%20and%20Legal%20Updates) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) In April 2025, Arbutus appointed Andrew J. Sung as its new General Counsel, bringing over **20 years** of legal experience in the life sciences sector, including managing M&A deals worth over **$24 billion** and licensing agreements exceeding **$4 billion** in potential payments - Andrew J. Sung was hired as **General Counsel** in April, bringing over **20 years** of legal experience in corporate matters, IP, and litigation[8](index=8&type=chunk) - Mr. Sung's experience includes over **$24 billion** in M&A deals and licensing/collaboration agreements exceeding **$4 billion** in potential payments[8](index=8&type=chunk) [LNP Litigation](index=2&type=section&id=LNP%20Litigation) Arbutus and Genevant Sciences are actively pursuing patent litigation against Moderna and Pfizer/BioNTech for the use of their LNP technology in COVID-19 vaccines, with a jury trial against Moderna scheduled for September 2025 and a claim construction ruling in the Pfizer/BioNTech case expected in 2025 - The company is seeking **fair compensation** from Moderna and Pfizer/BioNTech for the use of its **patented LNP technology** in their COVID-19 vaccines[11](index=11&type=chunk) - The jury trial in the U.S. litigation against Moderna is scheduled for **September 29, 2025**[11](index=11&type=chunk) - A court ruling on the claim construction in the lawsuit against Pfizer/BioNTech is **expected in 2025**[11](index=11&type=chunk) - In March 2025, Arbutus and Genevant filed **five international lawsuits** against Moderna to enforce patents across **30 countries**[11](index=11&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Financial Position](index=2&type=section&id=Financial%20Position) As of March 31, 2025, Arbutus held **$112.7 million** in cash, cash equivalents, and investments, a decrease from **$122.6 million** at the end of 2024, with **$13.4 million** used in operating activities during the quarter Financial Position | Financial Position | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and investments | $112.7 million | $122.6 million | - During Q1 2025, the company used **$13.4 million** in cash for operating activities[9](index=9&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) For Q1 2025, Arbutus reported total revenue of **$1.8 million**, up from **$1.5 million** in Q1 2024, with a net loss of **$24.5 million** ($0.13 per share) largely due to **$12.4 million** in restructuring costs, while R&D expenses decreased significantly to **$9.0 million** from **$15.4 million** Financial Performance | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | $1.8 million | $1.5 million | | R&D Expenses | $9.0 million | $15.4 million | | G&A Expenses | $5.8 million | $5.3 million | | Restructuring Costs | $12.4 million | $0 | | Net Loss | $24.5 million | $17.9 million | | Net Loss per Share | $0.13 | $0.10 | - The **$6.4 million** decrease in R&D expenses was primarily due to cost savings from the August 2024 decision to streamline the organization, which included ceasing discovery efforts and reducing the workforce[13](index=13&type=chunk) - Restructuring costs of **$12.4 million** included cash severance, non-cash stock compensation expenses, and charges related to exiting the corporate headquarters[15](index=15&type=chunk) [Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Statements of Loss](index=3&type=section&id=Statements%20of%20Loss) For the three months ended March 31, 2025, Arbutus reported total revenues of **$1.8 million** and total operating expenses of **$27.5 million**, including **$12.4 million** in restructuring costs, resulting in a loss from operations of **$25.7 million** and a net loss of **$24.5 million**, or **$0.13** per share Statements of Loss (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Total revenue** | **$1,764** | **$1,532** | | Research and development | $8,959 | $15,403 | | General and administrative | $5,832 | $5,312 | | Restructuring costs | $12,373 | $— | | **Total operating expenses** | **$27,463** | **$20,895** | | **Loss from operations** | **$(25,699)** | **$(19,363)** | | Total other income | $1,173 | $1,488 | | **Net loss** | **$(24,526)** | **$(17,875)** | | **Net loss per common share** | **$(0.13)** | **$(0.10)** | [Balance Sheets](index=4&type=section&id=Balance%20Sheets) As of March 31, 2025, the company's balance sheet showed total assets of **$117.0 million**, down from **$131.7 million** at year-end 2024, with total liabilities at **$37.9 million** and total stockholders' equity at **$79.2 million** Balance Sheets (in thousands) | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash, cash equivalents and marketable securities** | **$112,707** | **$122,623** | | **Total current assets** | **$116,808** | **$127,316** | | **Total assets** | **$117,010** | **$131,707** | | Total current liabilities | $19,431 | $15,618 | | **Total liabilities** | **$37,853** | **$34,341** | | **Total stockholders' equity** | **$79,157** | **$97,366** | | **Total liabilities and stockholders' equity** | **$117,010** | **$131,707** | [Statements of Cash Flows](index=4&type=section&id=Statements%20of%20Cash%20Flows) For the first quarter of 2025, net cash used in operating activities was **$13.4 million**, with **$11.3 million** provided by investing activities and **$2.8 million** from financing activities, ending the period with **$112.7 million** in cash, cash equivalents, and marketable securities Statements of Cash Flows (in thousands) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,391) | $(19,295) | | Net cash provided by investing activities | $11,349 | $11,694 | | Net cash provided by financing activities | $2,784 | $24,430 | | **Cash, cash equivalents and marketable securities, end of period** | **$112,707** | **$137,917** | [Company and Product Overview](index=5&type=section&id=Company%20and%20Product%20Overview) [About Imdusiran and AB-101](index=5&type=section&id=About%20Imdusiran%20and%20AB-101) Arbutus is developing two key candidates for chronic HBV infection: Imdusiran (AB-729), an **RNAi therapeutic** designed to reduce all HBV viral proteins and antigens, and AB-101, an **oral PD-L1 inhibitor** for controlled checkpoint blockade with minimized systemic safety issues - Imdusiran (AB-729) is an **RNAi therapeutic** designed to **reduce all HBV viral proteins and antigens**, including HBsAg, to reawaken the patient's immune system[23](index=23&type=chunk) - AB-101 is an **oral PD-L1 inhibitor** candidate designed for **controlled checkpoint blockade** while minimizing systemic safety issues[24](index=24&type=chunk) [About HBV](index=5&type=section&id=About%20HBV) Hepatitis B is a potentially fatal liver infection caused by the hepatitis B virus (HBV), leading to chronic infection and increasing the risk of death from cirrhosis and liver cancer, with over **250 million people** worldwide suffering from chronic HBV - The World Health Organization estimates **over 250 million people** worldwide have chronic HBV infection[25](index=25&type=chunk) - Chronic HBV infection leads to a higher risk of death from cirrhosis and liver cancer, causing approximately **1.1 million deaths annually**[25](index=25&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) [Risk Factors and Disclaimers](index=5&type=section&id=Risk%20Factors%20and%20Disclaimers) This press release contains forward-looking statements concerning Arbutus's product candidates and patent litigation, which are subject to numerous assumptions and risks including clinical trial timelines, regulatory approvals, litigation uncertainties, and economic conditions, with a more complete discussion of risks available in the company's public filings - Forward-looking statements include the potential for imdusiran to be a **functional cure for HBV** and plans regarding **ongoing patent litigation**[27](index=27&type=chunk) - Known risk factors include **clinical trial costs and timelines**, **regulatory approvals**, **litigation uncertainties**, **market conditions**, and the **sufficiency of cash resources**[28](index=28&type=chunk) - A more complete discussion of risks is available in the company's **Annual Report on Form 10-K** and **Quarterly Reports on Form 10-Q**, available on SEDAR and SEC websites[29](index=29&type=chunk)