Corporate Update and Financial Highlights 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 interferon12 - 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 occupancy13 - Andrew J. Sung joined Arbutus as General Counsel, bringing significant life sciences deal experience, including over $28 billion in transactions14 - The company reported a strong financial position with cash, cash equivalents, and marketable securities of $113 million as of the end of Q1 20251 Clinical Development Update Imdusiran (AB-729) 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 immunotherapeutic6 - 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 studied6 - 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 regimen6 - Seven of the eight patients who achieved functional cure had baseline HBsAg levels below 1000 IU/mL, a significant portion of the cHBV population6 AB-101 (oral PD-L1 inhibitor) 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 occupancy311 - Across all cohorts presented, there have been no serious adverse events (SAEs) or early discontinuations due to AB-101, and no evidence of liver dysfunction311 - 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 volunteers11 Corporate and Legal Updates Corporate Updates 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 litigation8 - Mr. Sung's experience includes over $24 billion in M&A deals and licensing/collaboration agreements exceeding $4 billion in potential payments8 LNP Litigation 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 vaccines11 - The jury trial in the U.S. litigation against Moderna is scheduled for September 29, 202511 - A court ruling on the claim construction in the lawsuit against Pfizer/BioNTech is expected in 202511 - In March 2025, Arbutus and Genevant filed five international lawsuits against Moderna to enforce patents across 30 countries11 Financial Results Financial Position 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 activities9 Financial Performance 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 workforce13 - Restructuring costs of $12.4 million included cash severance, non-cash stock compensation expenses, and charges related to exiting the corporate headquarters15 Unaudited Condensed Consolidated Financial Statements Statements of Loss 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 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 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 About Imdusiran and AB-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 system23 - AB-101 is an oral PD-L1 inhibitor candidate designed for controlled checkpoint blockade while minimizing systemic safety issues24 About HBV 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 infection25 - Chronic HBV infection leads to a higher risk of death from cirrhosis and liver cancer, causing approximately 1.1 million deaths annually25 Forward-Looking Statements Risk Factors and Disclaimers 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 litigation27 - Known risk factors include clinical trial costs and timelines, regulatory approvals, litigation uncertainties, market conditions, and the sufficiency of cash resources28 - 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 websites29
Arbutus Biopharma(ABUS) - 2025 Q1 - Quarterly Results