Arbutus Biopharma(ABUS)
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Arbutus Biopharma: LNP Litigation And Imdusiran Drive Near-Term Catalysts
Seeking Alpha· 2026-02-03 12:48
分组1 - Arbutus Biopharma Corporation (ABUS) has experienced a decline of approximately 10% in its stock price over the past month due to a patent dispute with Moderna [1] - The company is involved in the biotechnology sector, focusing on innovative drug development and unique therapeutic approaches [1] - The analyst emphasizes the importance of evaluating the scientific basis of drug candidates, competitive landscape, clinical trial design, and market opportunities while considering financial fundamentals [1]
Arbutus (ABUS) Upgraded to Buy: Here's What You Should Know
ZACKS· 2026-01-12 18:01
Core Viewpoint - Arbutus Biopharma (ABUS) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with near-term stock price movements [4][6]. - Rising earnings estimates indicate an improvement in the company's underlying business, suggesting that investors may respond positively by driving the stock price higher [5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Only the top 20% of Zacks-covered stocks receive a "Strong Buy" or "Buy" rating, indicating superior earnings estimate revisions [10]. Specifics on Arbutus - For the fiscal year ending December 2025, Arbutus is expected to earn -$0.19 per share, with no year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Arbutus has increased by 5.9%, reflecting positive sentiment among analysts [8].
Arbutus Biopharma GAAP EPS of -$0.04 misses by $0.01, revenue of $0.53M misses by $0.42M (NASDAQ:ABUS)
Seeking Alpha· 2025-11-13 13:04
Group 1 - The article does not provide any specific content related to a company or industry [1]
Arbutus Biopharma(ABUS) - 2025 Q3 - Quarterly Results
2025-11-13 12:31
Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $93.7 million, down from $122.6 million as of December 31, 2024[8]. - Total revenue for the third quarter of 2025 was $0.5 million, a decrease of $0.8 million compared to $1.3 million in the same period of 2024, primarily due to a decline in license royalty revenues[9]. - The company's net loss for Q3 2025 was $7.7 million, or a loss of $0.04 per share, compared to a net loss of $19.7 million, or a loss of $0.10 per share, in Q3 2024[12]. - The company reported a total operating expense of $9.2 million for Q3 2025, down from $22.8 million in Q3 2024[16]. Research and Development - Research and development expenses decreased to $5.8 million in Q3 2025 from $14.3 million in Q3 2024, reflecting cost-saving measures[10]. - The company is developing two product candidates: imdusiran (AB-729) and an oral PD-L1 inhibitor (AB-101) for cHBV treatment[24]. - Arbutus Biopharma is focused on developing treatments for chronic Hepatitis B virus (cHBV) infection, addressing a significant unmet medical need affecting over 250 million people globally[22]. - Approximately 1.1 million people die annually from complications related to cHBV infection, highlighting the urgency for effective therapies[23]. Clinical Trials and Outcomes - 46% of Phase 2a patients (48 out of 105) achieved functional cure or remained off nucleos(t)ide analogue therapy for at least 48 weeks after treatment with imdusiran[14]. - 94% of long-term follow-up patients from the imdusiran trials have remained off all treatment for over 58 weeks[14]. - 100% of HBV DNA positive patients in Phase 1b achieved HBV DNA levels below quantification after 18 weeks of treatment with imdusiran and nucleos(t)ide analogue therapy[5]. - The company showcased data from its hepatitis B virus programs at AASLD 2025, highlighting beneficial clinical outcomes across all evaluated HBV genotypes[4]. Legal Matters - The company is actively pursuing litigation against Moderna and Pfizer/BioNTech regarding its patented LNP technology, with a jury trial scheduled for March 2026[6]. - Arbutus is involved in ongoing patent litigation against Moderna and Pfizer/BioNTech regarding its patented LNP technology used in COVID-19 vaccines[24]. Risks and Uncertainties - The company has made numerous assumptions regarding the effectiveness and timeliness of clinical trials, which are subject to significant uncertainties[26]. - Known risk factors include potential delays and increased costs in clinical trials, which may affect the development of product candidates[26]. - Arbutus plans to reduce its net cash burn and workforce, which may impact its operating results and investor perceptions[26]. - The company emphasizes the importance of regulatory approvals for its product candidates in the clinical development process[26]. - Arbutus' forward-looking statements are subject to various risks and uncertainties, which could lead to materially different outcomes[27]. - The company disclaims any obligation to update forward-looking statements unless required by law[27].
Arbutus Biopharma(ABUS) - 2025 Q3 - Quarterly Report
2025-11-13 12:31
Financial Performance - Total revenue for the three months ended September 30, 2025, was $529,000, a decrease of $810,000 (60.5%) compared to $1,339,000 in the same period of 2024[157]. - Total revenue for the nine months ended September 30, 2025, increased by $8.4 million (182.3%) to $13,032,000, primarily due to recognizing $9.6 million of previously deferred revenue from a partnership with Qilu[159]. - Operating expenses for the three months ended September 30, 2025, were $9,188,000, a decrease of $13,591,000 (59.7%) compared to $22,779,000 in the same period of 2024[160]. - Research and development expenses decreased by $8.5 million (59.7%) for the three months ended September 30, 2025, compared to the same period in 2024, due to a workforce reduction and cessation of discovery efforts[162]. - General and administrative expenses decreased by $1.5 million (33.0%) for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to lower employee compensation and litigation-related legal fees[164]. - The net loss for the three months ended September 30, 2025, was $7,742,000, compared to a net loss of $19,717,000 in the same period of 2024[157]. - For the nine months ended September 30, 2025, the net loss was $29.7 million, a decrease of $27.6 million compared to a net loss of $57.4 million for the same period in 2024[171]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $35.0 million, down from $54.5 million in 2024, reflecting a decrease of $19.6 million[172]. - Net cash provided by investing activities was $16.9 million for the nine months ended September 30, 2025, compared to $9.5 million in 2024, primarily due to maturities of investments in marketable securities[173]. - As of September 30, 2025, the company had cash, cash equivalents, and investments in marketable securities totaling $93.7 million, with no outstanding debt[175]. - Net cash provided by financing activities was $4.1 million for the nine months ended September 30, 2025, significantly lower than $50.6 million in 2024, which included $44.1 million from common share sales[174]. Restructuring and Cost Management - Arbutus Biopharma Corporation 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 through ongoing cost management efforts[98]. - The company incurred a one-time restructuring charge of $12.4 million in Q1 2025, related to a 57% workforce reduction and exiting its corporate headquarters[166]. - As of September 30, 2025, there was $0.5 million of accrued restructuring costs for severance payments and $0.3 million for lease-related operating expenses[167]. - The company expects to significantly reduce net cash burn in 2025 compared to 2024 due to organizational changes and ongoing cost management efforts[180]. Clinical Development and Trials - Over 250 patients with chronic hepatitis B (cHBV) infection have been dosed with imdusiran in Phase 1 and Phase 2a clinical trials, showing meaningful reductions in HBsAg, HBV DNA, and HBV RNA[106]. - 46% (48 out of 105) of all Phase 2a patients achieved functional cure or remained off nucleos(t)ide analog (NA) therapy after treatment with imdusiran[106]. - The company is currently developing AB-101, a proprietary oral PD-L1 inhibitor, which is in a Phase 1a/1b clinical trial[106]. - The company has streamlined its organization to focus on advancing the clinical development of imdusiran and AB-101, ceasing all discovery efforts and in-house scientific research[98]. - The newly formed Scientific Advisory Board (SAB) will advise on the strategic evaluation of the cHBV pipeline[99]. - The company’s strategy emphasizes maximizing opportunities for its cHBV development programs and its in-house developed lipid nanoparticle technology[101]. - In the IM-PROVE I trial, 50% (3/6) of patients with baseline HBsAg <1000 IU/mL achieved a functional cure, with an overall rate of 25% (3/12)[108]. - In the IM-PROVE II trial, 25% (2/8) of patients with low dose nivolumab and baseline HBsAg <1000 IU/mL achieved functional cure[122]. - Across all cohorts in the IM-PROVE II trial, 52% (32/62) of patients either achieved functional cure or remained off NA therapy for at least 48 weeks after treatment with imdusiran[123]. - In the IM-PROVE I trial, 37% (16/43) of patients either achieved functional cure or remained off NA therapy for at least 48 weeks after treatment with imdusiran[117]. - Imdusiran treatment was generally safe and well-tolerated, with no serious adverse events reported in the IM-PROVE I and II trials[118][123]. - The IM-PROVE I trial demonstrated that patients who achieved functional cure experienced HBsAg seroclearance associated with immune activation markers[116]. - The IM-PROVE II trial included a cohort with low dose nivolumab, which showed increased rates of HBsAg seroclearance[120]. - Imdusiran is designed to reduce HBV DNA, HBV RNA, and HBsAg, potentially allowing cHBV patients to become treatment-free[112]. - AB-101 clinical trial demonstrated 100% receptor occupancy in all five evaluable subjects at the 40mg dose level in Part 1[130]. - In Part 2, 100% receptor occupancy was achieved by six out of eight subjects at the 40mg daily dose over seven days[130]. - Part 3 of the trial showed that a single 10mg dose of AB-101 for 28 days in cHBV patients was well tolerated, with PD-L1 receptor occupancy similar to healthy subjects[131]. Legal Matters - The ongoing lawsuits against Moderna and Pfizer/BioNTech for patent infringement involve the use of Arbutus's lipid nanoparticle technology in their COVID-19 vaccines[97]. - A trial date for the Moderna lawsuit in the U.S. has been set for March 2026, with public oral hearings for related cases scheduled for May 2026[97]. - A lawsuit against Moderna for patent infringement related to lipid nanoparticle technology was filed, with a jury trial scheduled for March 2026[144]. - Five international lawsuits against Moderna were filed in March 2025, targeting alleged infringing activities in 30 countries[145]. - The company is currently preparing responses to multiple revocation actions against its patents filed by Moderna and Merck[150]. Strategic Partnerships - Qilu Pharmaceutical paid a one-time upfront cash payment of $40 million and agreed to pay up to $245 million upon achieving certain milestones related to imdusiran[133]. - Qilu is responsible for all costs related to the development and commercialization of imdusiran in Greater China and Taiwan[134]. - The strategic partnership with Qilu was mutually concluded in June 2025, allowing the company to regain global rights for imdusiran[136]. - The company is exploring strategic alliances to accelerate the development of its pipeline programs[111]. - The company has a royalty entitlement on ONPATTRO, with an aggregate of $26.3 million recorded as non-cash royalty revenue since the inception of the royalty sale through September 30, 2025[178]. - In June 2025, the company concluded its strategic partnership with Qilu, regaining global rights for imdusiran, which had previously been licensed for development in Greater China and Taiwan[179]. - The company may seek funding from various sources, including public or private equity or debt financing, to maintain and advance its business[181]. - The company does not have any off-balance sheet arrangements that could materially affect its financial condition or results of operations[183].
Arbutus Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-13 12:30
Core Insights - Arbutus Biopharma Corporation reported a strong financial position with cash, cash equivalents, and marketable securities totaling $93.7 million as of September 30, 2025, down from $122.6 million at the end of 2024 [7][15] - The company is focused on the development of imdusiran (AB-729) for chronic hepatitis B virus (cHBV) infection, with promising clinical trial results indicating that 46% of Phase 2a patients were able to discontinue all treatment [2][13] - Ongoing litigation against Moderna and Pfizer/BioNTech regarding the use of Arbutus's patented LNP technology is a significant aspect of the company's corporate strategy, with a jury trial scheduled for March 2026 [6][21] Financial Results - Total revenue for Q3 2025 was $0.5 million, a decrease from $1.3 million in Q3 2024, primarily due to reduced license royalty revenues [8][14] - Research and development expenses decreased to $5.8 million in Q3 2025 from $14.3 million in Q3 2024, reflecting cost-saving measures [9][14] - The net loss for Q3 2025 was $7.7 million, or $0.04 per share, compared to a net loss of $19.7 million, or $0.10 per share, in Q3 2024 [11][14] Clinical Development - Imdusiran has shown sustained benefits in chronic hepatitis B patients, with 94% of long-term follow-up patients remaining off all treatment for over two years [2][5] - In Phase 1b trials, 100% of HBV DNA positive patients achieved HBV DNA levels below quantification after 18 weeks of treatment with imdusiran and nucleos(t)ide analogue therapy [5][13] - The company is dedicated to accelerating the development and potential approval of imdusiran, which targets all hepatitis B viral proteins and antigens [18][21] Corporate Updates - The company is actively consulting with Genevant Sciences to protect its intellectual property amid ongoing lawsuits [6][21] - A favorable claim construction ruling was issued in the Pfizer-BioNTech litigation in September 2025, which the company views positively [6] - Arbutus showcased data from its hepatitis B virus programs at AASLD 2025, highlighting beneficial clinical outcomes across all evaluated HBV genotypes [6]
Arbutus Announces Four Abstracts Accepted for Presentation at AASLD - The Liver Meeting® 2025
Globenewswire· 2025-10-07 12:00
Core Insights - Arbutus Biopharma Corporation has made significant progress in its clinical research for chronic hepatitis B virus (cHBV), with multiple abstracts accepted for presentation at the AASLD – The Liver Meeting 2025, indicating advancements towards a potential functional cure for cHBV [1] Group 1: Imdusiran Clinical Data - Imdusiran (AB-729) has shown to be safe and well-tolerated in chronic hepatitis B patients, with a study reporting positive results from Phase 1 and 2 clinical trials [2] - A study suggests that imdusiran may enhance the responsiveness of pegylated interferon alfa-2a treatment in patients with specific HBV genotypes, particularly genotypes B and C [3] - Increases in soluble immune biomarkers were observed in subjects who lost HBsAg after treatment with imdusiran, indicating a potential immune response [4] Group 2: AB-101 Clinical Data - AB-101, an oral PD-L1 inhibitor, was well tolerated in chronic hepatitis B patients, with preliminary data showing significant receptor occupancy at higher doses [5][6] - The ongoing clinical trial for AB-101 is expected to provide further insights into its safety and pharmacodynamics [6] Group 3: Conference Details - The accepted abstracts will be publicly available on the AASLD website and published in the October supplement of HEPATOLOGY, with poster presentations accessible during the conference [7][8] Group 4: Company Overview - Arbutus Biopharma is focused on developing innovative therapies for infectious diseases, particularly cHBV, and is involved in legal actions to protect its intellectual property related to its patented LNP technology [12]
Is Aquestive Therapeutics (AQST) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2025-08-14 14:41
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 Biopharma (ABUS) Beats Q2 Earnings and Revenue Estimates
ZACKS· 2025-08-06 13:41
分组1 - Arbutus Biopharma reported quarterly earnings of $0.01 per share, exceeding the Zacks Consensus Estimate of a loss of $0.02 per share, and showing improvement from a loss of $0.11 per share a year ago, resulting in an earnings surprise of +150.00% [1] - The company posted revenues of $10.74 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 496.61%, compared to revenues of $1.73 million in the same quarter last year [2] - Over the last four quarters, Arbutus has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] 分组2 - The stock's immediate price movement will depend on management's commentary during the earnings call and the sustainability of earnings expectations [3][4] - Arbutus shares have increased by approximately 4.3% since the beginning of the year, while the S&P 500 has gained 7.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $1.8 million, and for the current fiscal year, it is -$0.23 on revenues of $5.85 million [7] 分组3 - The Zacks Industry Rank indicates that the Medical - Biomedical and Genetics sector is currently in the bottom 42% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [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][6]
Arbutus Biopharma(ABUS) - 2025 Q2 - Quarterly Report
2025-08-06 11:32
Financial 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].