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Arbutus Biopharma(ABUS) - 2025 Q1 - Quarterly Report
2025-05-14 21:21
For the quarterly period ended March 31, 2025 OR 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 ☐ 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 or O ...
Arbutus Biopharma (ABUS) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-14 13:45
Arbutus Biopharma (ABUS) came out with a quarterly loss of $0.13 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to loss of $0.10 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -44.44%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.08 per share when it actually produced a loss of $0.07, delivering a surprise of 12.50%.Over the last four quarters, the ...
Arbutus Biopharma(ABUS) - 2025 Q1 - Quarterly Results
2025-05-14 11:31
EXHIBIT 99.1 Arbutus Reports First Quarter 2025 Financial Results and Provides Corporate Update Imdusiran combination therapy has functionally cured 8 patients with chronic hepatitis B (cHBV) to date, including 2 patients who received no interferon AB-101, oral small-molecule PD-L1 inhibitor, shown generally safe and well-tolerated with evidence of high receptor occupancy in Phase 1a/1b Andrew J. Sung joins Arbutus as General Counsel, bringing more than $28 billion in life sciences deal experience Strong fi ...
Arbutus Reports First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2025-05-14 11:30
Imdusiran combination therapy has functionally cured 8 patients with chronic hepatitis B (cHBV) to date, including 2 patients who received no interferon AB-101, oral small-molecule PD-L1 inhibitor, shown generally safe and well-tolerated with evidence of high receptor occupancy in Phase 1a/1b Andrew J. Sung joins Arbutus as General Counsel, bringing more than $28 billion in life sciences deal experience Strong financial position with cash, cash equivalents and marketable securities of $113M WARMINSTER, Pa., ...
Arbutus Presents Clinical Trial Data from its Two HBV Assets, Imdusiran and AB-101, at the European Association for the Study of the Liver (EASL) Congress 2025
GlobeNewswire News Room· 2025-05-07 06:01
Core Insights - Arbutus Biopharma Corporation presented promising data on imdusiran and AB-101 at the EASL Congress 2025, indicating potential for functional cure in chronic hepatitis B patients [1][5] Group 1: Imdusiran and Clinical Trials - Imdusiran, when combined with VTP-300 and low-dose nivolumab, has shown to achieve functional cure in chronic hepatitis B (cHBV) patients [1] - In the Phase 2a clinical trial (IM-PROVE II), patients receiving imdusiran (60mg every 8 weeks) demonstrated significant reductions in HBsAg levels, with 25% of patients in the group receiving nivolumab achieving functional cure [2][7] - A total of 8 patients across all Phase 2a trials have been reported to achieve functional cure, with 7 of these having baseline HBsAg levels below 1000 IU/mL [3] Group 2: AB-101 and Safety Profile - AB-101, an oral PD-L1 inhibitor, has been shown to be generally safe and well-tolerated in a Phase 1a/1b clinical trial, with no liver dysfunction reported in cHBV patients [1][4] - Data from the first cohort of cHBV patients indicated that daily dosing of 10mg of AB-101 for 28 days was well tolerated, with no immune-related adverse events reported [4][10] Group 3: Background on Hepatitis B and Arbutus - Chronic hepatitis B infection represents a significant unmet medical need, affecting over 250 million people globally, with approximately 1.1 million deaths annually from related complications [11] - Arbutus Biopharma is focused on developing innovative therapies for infectious diseases, particularly chronic HBV infection, and is also involved in legal actions to protect its intellectual property [12]
Arbutus to Present Imdusiran and AB-101 Data at EASL Congress 2025
Newsfilter· 2025-04-23 06:01
Core Insights - Arbutus Biopharma Corporation announced the acceptance of five abstracts for presentation at the EASL Congress 2025, including one late-breaker, highlighting the company's ongoing research in hepatitis B treatments [2][9]. Group 1: Abstract Presentations - Five abstracts will be presented in the Viral Hepatitis B and D session on May 8, 2025, showcasing new therapies and strategies [3]. - The late-breaker abstract will focus on the antiviral efficacy and safety of imdusiran followed by VTP-300 in chronic hepatitis B subjects [9]. Group 2: Key Findings from Abstracts - Abstract 1768 discusses the factors associated with functional cure in chronic hepatitis B subjects, indicating that baseline HBsAg levels are significant [4]. - Abstract 2043 reveals that rapid HBV RNA decline during treatment with imdusiran and interferon is linked to HBsAg seroclearance [6]. - Abstract 1990 presents the pharmacokinetics and pharmacodynamics of AB-101, showing it to be safe and well-tolerated with dose-responsive increases in PD-L1 receptor occupancy [7]. - Abstract 1978 indicates that AB-101 is well-tolerated in both healthy and chronic hepatitis B subjects, with ongoing dosing studies [8]. Group 3: Product Information - Imdusiran is an RNAi therapeutic designed to reduce HBV viral proteins, showing promising results in Phase 2a trials for achieving functional cure rates [10]. - AB-101 is an oral PD-L1 inhibitor currently in Phase 1a/1b trials, aimed at reactivating exhausted HBV-specific T-cells [11]. Group 4: Industry Context - Chronic hepatitis B infection affects over 250 million people globally, representing a significant unmet medical need, with approximately 1.1 million deaths annually from related complications [12].
All You Need to Know About Arbutus (ABUS) Rating Upgrade to Buy
ZACKS· 2025-03-31 17:00
Core Viewpoint - Arbutus Biopharma (ABUS) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with near-term stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, thus affecting stock prices [4]. Recent Earnings Estimate Revisions - For the fiscal year ending December 2025, Arbutus is expected to earn -$0.29 per share, representing a 23.7% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Arbutus has increased by 13.7%, indicating a positive trend in earnings outlook [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimates into five groups, with Zacks Rank 1 (Strong Buy) to Zacks Rank 5 (Strong Sell), and has shown a strong track record of performance [7][9]. - Only the top 20% of Zacks-covered stocks receive a 'Strong Buy' or 'Buy' rating, indicating superior earnings estimate revisions, positioning Arbutus favorably for potential market-beating returns [10].
Arbutus Biopharma (ABUS) Reports Q4 Loss, Tops Revenue Estimates
ZACKS· 2025-03-27 13:45
Company Performance - Arbutus Biopharma reported a quarterly loss of $0.07 per share, better than the Zacks Consensus Estimate of a loss of $0.08, and an improvement from a loss of $0.12 per share a year ago, indicating an earnings surprise of 12.50% [1] - The company posted revenues of $1.57 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 17.46%, although this is a decline from year-ago revenues of $2.15 million [2] - Over the last four quarters, Arbutus has surpassed consensus EPS estimates just once and topped consensus revenue estimates two times [2] Future Outlook - The sustainability of Arbutus's stock price movement will depend on management's commentary during the earnings call and the earnings outlook for the coming quarters [3][4] - The current consensus EPS estimate for the next quarter is -$0.09 on revenues of $1.36 million, and for the current fiscal year, it is -$0.34 on revenues of $5.64 million [7] - The estimate revisions trend for Arbutus is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Arbutus belongs, is currently in the top 28% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [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]
Arbutus Biopharma(ABUS) - 2024 Q4 - Annual Report
2025-03-27 11:31
Organizational Changes - Arbutus Biopharma streamlined its organization, reducing workforce by 40% in 2024 and an additional 57% in early 2025, resulting in a total of 19 employees remaining[315] - The company expects a one-time restructuring charge of approximately $11 million to $13 million in Q1 2025 due to organizational changes[315] - A one-time restructuring charge of approximately $3.7 million was incurred in Q3 2024 due to workforce reduction and discontinuation of certain clinical trials[360] - The company expects to significantly reduce net cash burn in 2025 compared to 2024 due to organizational changes and ongoing cost management efforts[371] Financial Performance - Total revenue for the year ended December 31, 2024, was $6.171 million, a decrease of $12.0 million compared to $18.141 million in 2023[348] - Net loss for 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[348] - Revenue from royalties on sales of Onpattro decreased to $2.562 million in 2024, representing 41% of total revenue, down from $3.608 million or 20% in 2023[349] - Operating expenses for 2024 totaled $82.490 million, down from $96.244 million in 2023[348] - Other income increased to $6.399 million in 2024, up from $5.254 million in 2023, driven by a rise in interest income[361] - The company incurred a net loss of $69.9 million in 2024, compared to a net loss of $72.8 million in 2023[375] Research and Development - Over 250 patients with chronic hepatitis B (cHBV) have been dosed with imdusiran, achieving a functional cure rate of 50% in HBeAg-negative patients with baseline HBsAg levels less than 1000 IU/mL[323] - AB-101, an oral PD-L1 inhibitor, is currently in a Phase 1a/1b clinical trial, with evidence of dose-dependent receptor occupancy and generally well-tolerated results[324] - Research and development expenses decreased by $19.7 million to $54.037 million in 2024, primarily due to the discontinuation of certain programs and a 40% workforce reduction[354][360] Revenue Generation and Agreements - Revenue generation primarily comes from collaboration and license agreements, which may include upfront payments, milestone payments, and royalties[338] - Arbutus has a technology transfer and license agreement with Qilu Pharmaceutical, which includes a one-time upfront cash payment of $40 million and potential milestone payments up to $245 million[326] - Qilu is responsible for all costs related to developing and commercializing imdusiran in Greater China and Taiwan, with royalties payable in the low twenties percent based on annual net sales[326] - The company has obligations to make potential future payments of up to $102.5 million related to the acquisition of Enantigen Therapeutics, contingent on achieving certain commercial milestones[335] - Arbutus owns approximately 16% of Genevant Sciences Ltd., with rights to receive a specified percentage of revenue from sublicensed products[330] Cash Flow and Investments - As of December 31, 2024, the company had total cash, cash equivalents, and investments of $122.6 million, with no outstanding debt[365] - Net cash used in operating activities decreased by $21.1 million in 2024 compared to 2023, primarily due to reduced research and development expenses[375] - Net cash provided by investing activities decreased by $27.8 million in 2024 compared to 2023, mainly due to the timing of acquisitions and maturities of investments[376] - Net cash provided by financing activities increased by $21.3 million in 2024 compared to 2023, driven by a $14.2 million increase in proceeds from sales of common shares[376] - Cash and cash equivalents at the end of the period increased to $36.3 million in 2024 from $26.3 million in 2023[375] Legal Matters - The company is involved in multiple patent infringement lawsuits, which may require substantial resources and could impact financial results[20]
Arbutus Biopharma(ABUS) - 2024 Q4 - Annual Results
2025-03-27 11:31
Chronic HBV Treatment - Approximately 250 million people are affected by chronic HBV, with current treatment options limited to lifelong suppressive therapy, indicating a significant unmet medical need for a finite curative regimen[5] - The combination therapy strategy aims to develop a finite, curative treatment for chronic HBV by utilizing antivirals and immunomodulators[6] - Phase 2a clinical trial data for imdusiran shows a 50% functional cure rate in patients with baseline HBsAg <1000 IU/mL when combined with a short course of interferon[25] - The Phase 2a trial (IM-PROVE I) demonstrated that 25% of all patients achieved a functional cure, with no serious adverse events related to imdusiran or interferon[25] - Imdusiran demonstrated a 50% functional cure rate in patients with HBsAg <1000 IU/mL when combined with a short course of IFN[28] - Imdusiran resulted in HBsAg declines of approximately 1.5-2.0 log10 across various dosing regimens[28] - Data from Phase 2a trials suggest that imdusiran combined with interferon is generally safe and well-tolerated[49] Clinical Trials - The company is initiating a placebo-controlled Phase 2b clinical trial with 170 HBeAg-negative cHBV patients in the first half of 2025[24] - The company plans to initiate a Phase 2b clinical trial for imdusiran combined with IFN in 2025[47] - The ongoing IM-PROVE II trial is evaluating imdusiran in combination with Barinthus Bio's immunotherapeutic, VTP-300, and low dose nivolumab[26] - The company expects to present preliminary data from Cohort 3A of the AB-101 trial in the first half of 2025[47] - Preliminary data from the AB-101 Phase 1a/1b trial indicates that all evaluable subjects in the 25mg cohort showed receptor occupancy between 50-100%[42] Financial Position - The company has a strong financial position with a cash runway through Q1 2028, fully funding the Phase 2b clinical trial[5] - As of December 31, 2024, the company reported a cash balance of $123M, with a projected cash runway through Q1 2028[49] - The anticipated costs to complete the Phase 2b clinical trial are estimated to be between $30 million and $40 million[24] - The company anticipates a cash burn of $47-50M in 2025 as it advances its clinical trials and litigation efforts[49] Legal Matters - The company is seeking damages from patent litigation against Moderna and Pfizer/BioNTech related to COVID-19 vaccine sales[5] - The ongoing litigation with Pfizer and Moderna could result in royalties of 20% to Arbutus from related damages[44] - The strategic collaboration with Qilu Pharmaceutical includes a $40M upfront payment and potential commercialization payments up to $245M[30] Future Presentations - The company plans to present additional data at AASLD 2024, subject to regulatory approval[23]