ABUS Arbutus Biopharma Corporation

3.94
-0.01  -0%
Previous Close 3.95
Open 4.03
52 Week Low 0.88
52 Week High 9.02
Market Cap $334,542,477
Shares 84,909,258
Float 67,225,565
Enterprise Value $369,887,939
Volume 2,119,816
Av. Daily Volume 1,504,935
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Upcoming Catalysts

Drug Stage Catalyst Date
AB-729
Hepatitis B (HBV)
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
AB-452
Hepatitis B
Phase 1
Phase 1
Program to be discontinued - February 10, 2020.
AB-506
Hepatitis B (HBV)
Phase 1
Phase 1
Development to be discontinued - noted October 3, 2019.

Latest News

  1. Data released today expands on November 15, 2020 AASLD presentation

    Repeat dosing of 60 mg AB-729 every 4 weeks resulted in robust and continuous mean declines in HBsAg decline at week 20 (-1.71 log10IU/mL, N=7) and further reductions continued beyond week 20 (-1.84 log10 IU/mL, N=3)

    In HBV DNA positive subjects, a single 90 mg AB-729 dose resulted in robust mean declines in HBsAg (-1.02 log10 IU/mL), HBV DNA (-1.53 log10 IU/mL), HBV RNA and HBcrAg at week 12

    Results support advancement into Phase 2 combination clinical trials with AB-729 dosing as infrequently as every 8 or 12 weeks

    Conference Call and Webcast Scheduled Today at 8:00 am ET

    WARMINSTER, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) --  Arbutus Biopharma Corporation (NASDAQ:ABUS

    Data released today expands on November 15, 2020 AASLD presentation

    Repeat dosing of 60 mg AB-729 every 4 weeks resulted in robust and continuous mean declines in HBsAg decline at week 20 (-1.71 log10IU/mL, N=7) and further reductions continued beyond week 20 (-1.84 log10 IU/mL, N=3)



    In HBV DNA positive subjects, a single 90 mg AB-729 dose resulted in robust mean declines in HBsAg (-1.02 log10 IU/mL), HBV DNA (-1.53 log10 IU/mL), HBV RNA and HBcrAg at week 12



    Results support advancement into Phase 2 combination clinical trials with AB-729 dosing as infrequently as every 8 or 12 weeks

    Conference Call and Webcast Scheduled Today at 8:00 am ET

    WARMINSTER, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) --  Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced additional clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound.

    The new data described today expands on the presentation entitled Safety and pharmacodynamics of the GalNAc-siRNA AB-729 in subjects with chronic hepatitis B infection, recorded on October 14, 2020 and presented on November 15, 2020 by Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., from the University of Hong Kong at The Liver Meeting Digital ExperienceTM, The American Association for the Study of Liver Diseases (AASLD) Meeting.

    The new data summarized below include HBsAg data for the complete 60 mg every 4 weeks multi-dose cohort (N=7) at week 20, and the first results for the AB-729 90 mg single-dose cohort of HBV DNA positive subjects (N=5).

    William Collier, President and Chief Executive Officer of Arbutus, stated, "The positive data described today, together with the strong safety and efficacy results presented by Professor Yuen at AASLD yesterday, are encouraging and continue to support our confidence in the therapeutic value of AB-729 as we plan to move into Phase 2 clinical trials."

    Summary of new data

    Repeat dosing of AB-729 60 mg every 4 weeks results in continuous declines in mean HBsAg through week 20 (Cohort E)

     Mean (SE) Week 16

    N=7
    Mean (SE) Week 20

    N=7
    Mean (SE) Week 24

    N=3
     Δlog10 HBsAg (IU/mL)-1.44 (0.18)-1.71 (0.18)-1.84 (0.10)

    Dr. Gaston Picchio, Chief Development Officer at Arbutus stated, "Further follow up of the 60 mg every 4 weeks multi-dose cohort confirmed continuous reductions in mean HBsAg at week 20 (N=7), and in a subset of subjects (N=3) beyond this time point, while being generally safe and well tolerated. Additionally, the mean HBsAg declines and slopes of declines are similar between single doses and repeat doses of AB-729 up to week 12. Importantly, this suggests that dosing AB-729 as frequently as every 4 weeks may not be necessary, and that AB-729 has the potential to be dosed every 8 weeks or even every 12 weeks. This dosing strategy is being investigated in other cohorts of the trial with results from the 60 mg every 8 week cohort expected before the end of 2020."



    AB-729 90 mg single-dose reduces HBsAg and HBV DNA in HBV DNA positive chronic Hepatitis B (CHB) subjects with mean HBsAg declines similar to those seen in HBV DNA negative subjects (Cohort D)

     Mean (SE) Week 12

    N=5
     
     Δlog10 HBsAg (IU/mL)-1.02 (0.13) 
     Δlog10 HBV DNA (IU/mL)-1.53 (0.24) 

    Dr. Picchio added, "It is also encouraging to observe that a single 90 mg dose of AB-729 is capable of reducing HBsAg in HBV DNA positive subjects to the same extent achieved in other single-dose HBV DNA negative cohorts. Further, a single 90 mg AB-729 dose substantially reduced HBV DNA as well as HBV RNA and HBcrAg."

    AB-729 was safe and well tolerated after single and repeat doses

    • No serious adverse events or discontinuations due to adverse events
    • No treatment-related Grade 3 or 4 adverse events

    Summary of clinical trial design 

    AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts:

    In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.

    In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg to 180 mg) of AB-729. An additional cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.

    In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, are receiving multi-doses of AB-729 for up to six months.

    About AB-729 

    AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. In an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

    About HBV

    Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.

    The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

    Conference Call and Webcast Today

    Arbutus will hold a conference call and webcast today, Monday, November 16, 2020 at 8:00 am Eastern Time to provide an AB-729 clinical update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 7791835.

    An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 7791835.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, please visit www.arbutusbio.com.

    Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements about the Company's expectations to conduct Phase 2 combination studies with AB-729 dosing as infrequently as every 8 or 12 weeks; the Company's expectation that AB-729 could be effective at dosing intervals of every 8 or even every 12 weeks; the Company's expectations that additional data results from the AB-729 60 mg 8 week cohort will be available before the end of 2020; and the Company's expectation that AB-729 could be the cornerstone of future combination regimens for the treatment of chronic hepatitis B infection.

    With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus' assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

    Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus' products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus' clinical development programs.

    A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K, Arbutus' Quarterly Reports on Form 10-Q and Arbutus' continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

    Contact Information



    Investors and Media



    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



    Primary Logo

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  2. Across all single-dose cohorts, mean HBsAg concentrations continuously declined up to week 12 before reaching a plateau, suggesting dosing of AB-729 less frequently than every 4 weeks may be warranted

            In the 60 mg every 4 weeks multi-dose cohort, HBsAg concentrations continued to decline steadily beyond week 12 with no plateau in response observed to date

              Both HBV RNA and HBcrAg concentrations declined after single- and multi-dose administration of AB-729

              AB-729 was generally safe and well tolerated

    Conference Call and Webcast Scheduled for Monday, November 16, 2020 at 8:00 am ET

    WARMINSTER, Pa., Nov. 15, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical…

    Across all single-dose cohorts, mean HBsAg concentrations continuously declined up to week 12 before reaching a plateau, suggesting dosing of AB-729 less frequently than every 4 weeks may be warranted

            In the 60 mg every 4 weeks multi-dose cohort, HBsAg concentrations continued to decline steadily beyond week 12 with no plateau in response observed to date

              Both HBV RNA and HBcrAg concentrations declined after single- and multi-dose administration of AB-729

              AB-729 was generally safe and well tolerated

    Conference Call and Webcast Scheduled for Monday, November 16, 2020 at 8:00 am ET

    WARMINSTER, Pa., Nov. 15, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced the presentation of updated clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound. The presentation, entitled Safety and pharmacodynamics of the GalNAc-siRNA AB-729 in subjects with chronic hepatitis B infection, was presented by Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., Chief of Division of Gastroenterology and Hepatology, Department of Medicine, The University of Hong Kong, Hong Kong, during a virtual oral session: Hepatitis B: Therapeutics (New) at The Liver Meeting Digital ExperienceTM, The American Association for the Study of Liver Diseases Meeting.              

    Summary of presented data

    Single-doses of AB-729 studied to date, 60 mg, 90 mg and 180 mg, resulted in comparable mean HBsAg declines at week 12, followed by a sustained plateau phase. During the multiple-dose portion of the trial, 60 mg of AB-729 dosed every 4 weeks resulted in continuous declines in HBsAg, reaching a mean of –1.44 log10 IU/ML at week 16. Data beyond week 16 demonstrate further declines in HBsAg with no plateau seen to date. AB-729 also resulted in meaningful decreases in both HBV RNA and HBcrAg. AB-729 was generally safe and well tolerated. The presentation can be accessed through the Investors section under Events & Presentations of Arbutus' website at www.arbutusbio.com.

    Repeat dosing of AB-729 60 mg every 4 weeks results in continuous HBsAg declines beyond week 12

     Mean (SE) Week 12

    N=7
    Mean (SE) Week 16

    N=7
    Mean (SE) Week 20

    N=3
    Δlog10 HBsAg (IU/mL)-1.10 (0.15)-1.44 (0.18)-1.73 (0.12)

    Professor Yuen stated "These are the first multi-dose data for AB-729 and show continuous decline of HBsAg throughout the dosing period. Importantly, AB-729 was generally safe and well tolerated. These encouraging data support the continued development of AB-729 as a potential cornerstone of future combination regimens for the treatment of chronic hepatitis B infection."

    Summary of clinical trial design 

    AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts:

    In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.

    In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg to 180 mg) of AB-729. An additional cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.

    In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, are receiving multi-doses of AB-729 for up to six months.

    About AB-729 

    AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. In an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

    About HBV

    Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.

    The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

    Conference Call and Webcast

    Arbutus will hold a conference call and webcast on Monday, November 16, 2020 at 8:00 am Eastern Time to provide an AB-729 clinical update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 7791835.

    An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 7791835.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, please visit www.arbutusbio.com.

    Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements regarding the Company's expectation that AB-729 could be the cornerstone of future combination regimens for the treatment of chronic hepatitis B infection.

    With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus' assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

    Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus' products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus' clinical development programs.

    A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K, Arbutus' Quarterly Reports on Form 10-Q and Arbutus' continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:

     



    Primary Logo

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  3. WARMINSTER, Penn., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that William Collier, Arbutus' President and Chief Executive Officer, will present at the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 12:35 pm EST (5:35 pm GMT).

    A live webcast of the presentation can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast. An archived replay of the webcast will be available on the Company's website…

    WARMINSTER, Penn., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that William Collier, Arbutus' President and Chief Executive Officer, will present at the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 12:35 pm EST (5:35 pm GMT).

    A live webcast of the presentation can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast. An archived replay of the webcast will be available on the Company's website after the conference.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:

    Primary Logo

    View Full Article Hide Full Article
  4. Results from an ongoing Phase 1a/1b clinical trial for Arbutus' AB-729, a subcutaneously delivered RNAi agent, in subjects with chronic hepatitis B virus (HBV) infection, to be presented at the upcoming American Association for the Study of Liver Disease (AASLD) Conference

    Clinical collaboration with Assembly Biosciences, Inc. established to evaluate Arbutus' AB-729 in combination with vebicorvir, Assembly's oral core/capsid inhibitor

    AB-836, Arbutus' oral capsid inhibitor, remains on track for completion of CTA/IND-enabling studies by the end of 2020

    Conference Call and Webcast Scheduled Today at 8:45 AM ET

    WARMINSTER, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company…

    Results from an ongoing Phase 1a/1b clinical trial for Arbutus' AB-729, a subcutaneously delivered RNAi agent, in subjects with chronic hepatitis B virus (HBV) infection, to be presented at the upcoming American Association for the Study of Liver Disease (AASLD) Conference

    Clinical collaboration with Assembly Biosciences, Inc. established to evaluate Arbutus' AB-729 in combination with vebicorvir, Assembly's oral core/capsid inhibitor

    AB-836, Arbutus' oral capsid inhibitor, remains on track for completion of CTA/IND-enabling studies by the end of 2020

    Conference Call and Webcast Scheduled Today at 8:45 AM ET

    WARMINSTER, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today reports its third quarter 2020 financial results and provides a corporate update.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "Arbutus is focused on discovering and developing a functional cure with a finite treatment duration for chronic HBV by developing a combination of agents, with different mechanisms of action, that target distinct parts of the virus lifecycle. To this end, we continue to make steady progress in our ongoing Phase 1a/1b clinical trial of our lead clinical candidate, AB-729, a subcutaneously delivered RNAi agent. AB-729 is currently being dosed in chronic HBV subjects in four multi-dose cohorts using both the 60 mg dose every 4- and 8-weeks and the 90 mg dose every 8- and 12-weeks."

    "Based upon the clinical data generated thus far, AB-729 has demonstrated meaningful reductions in HBsAg with a favorable safety and tolerability profile. We look forward to presenting additional results from the ongoing Phase 1a/1b clinical trial as part of an oral presentation at the upcoming AASLD conference in November."

    Pipeline Update

    AB-729

    • Arbutus is currently conducting a single- and multi-dose Phase 1a/1b clinical trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 in healthy subjects and in subjects with chronic HBV infection.



    • Arbutus is currently dosing two 60 mg multi-dose cohorts of subjects with chronic HBV infection with dosing intervals of every four and eight weeks, respectively. Results from the 60 mg multi-dose cohort with a dosing interval of every four weeks and additional follow-up data on the 60 mg and 90 mg single-dose cohorts are expected to be disclosed as part of an oral presentation at the upcoming AASLD conference in November.



    • Separately, results from the 60 mg multi-dose cohort with a dosing interval of every eight weeks and a 90 mg single-dose cohort in HBV DNA positive subjects are expected in the fourth quarter of 2020.



    • In September 2020, Arbutus reported additional data from its ongoing Phase 1a/1b clinical trial for AB-729. The clinical data generated thus far demonstrate the robust activity of AB-729 and, at week 12, the 60 mg and 90 mg single-doses achieved meaningful reductions in HBsAg while remaining generally safe and well tolerated.



      Mean HBsAg changes from baseline:
     60 mg Single-Dose

    Cohort (B)

    (N=6)
    90 mg Single-Dose

    Cohort (C)

    (N=6)
    Week 12 (day 84) mean log10 IU/mL

    (Standard Error of the Mean)
    -0.99 (0.24)-1.23 (0.18)
    • Arbutus is also currently dosing two 90 mg multi-dose cohorts of subjects with dosing intervals of every eight and twelve weeks, respectively.

    AB-836: Oral Capsid Inhibitor

    • In January 2020, Arbutus selected AB-836 as its next-generation oral capsid inhibitor. AB-836 is from a novel chemical series differentiated from competitor compounds with the potential for increased efficacy and an enhanced resistance profile. Arbutus continues to expect completion of CTA/IND-enabling studies by the end of 2020.

    Early HBV R&D Programs

    • Arbutus' drug discovery efforts are focused on follow-on compounds for its current HBV pipeline, including the development of oral RNA-destabilizers that have shown compelling antiviral effects in multiple HBV preclinical models. Arbutus is now focused on advancing through lead optimization next-generation oral RNA-destabilizers with chemical scaffolds distinct from Arbutus' prior generation HBV RNA destabilizer candidate. Arbutus also has several oral anti-PD-L1 inhibitors in lead optimization that are potentially capable of reawakening the immune response to HBV in infected patients.

    Clinical Collaboration with Assembly Biosciences, Inc.

    • In August 2020, the Company entered into a clinical collaboration agreement with Assembly Biosciences, Inc. (Assembly) to evaluate Arbutus' AB-729 clinical candidate in combination with Assembly's lead hepatitis B virus (HBV) core/capsid inhibitor candidate vebicorvir (VBR) and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy for the treatment of patients with chronic HBV infection. This collaboration will include a randomized, multi-center, open-label Phase 2 clinical trial that will explore the safety, pharmacokinetics, and antiviral activity of the triple combination of AB-729, VBR, and an NrtI compared to the double combinations of VBR with an NrtI and AB-729 with an NrtI. This trial is expected to initiate in the first half of 2021 and enroll approximately 60 virologically-suppressed patients with chronic HBV infection.

    Dr. Gaston Picchio, Chief Development Officer of Arbutus, stated, "This clinical collaboration in which both companies share expertise and costs has the potential to provide proof of concept data regarding the safety and efficacy of combining two promising drug candidates and to expedite efforts to advance a much needed HBV treatment regimen."

    Research Efforts to Combat COVID-19 and Future Coronavirus Outbreaks

    • Based on its extensive antiviral drug discovery experience, Arbutus has established an internal research program to identify new small molecule antiviral medicines to treat COVID-19 and future coronavirus outbreaks. This effort, led by Dr. Michael Sofia, Arbutus' Chief Scientific Officer, is focused on the discovery and development of new molecular entities that address specific viral targets including the nsp12 viral polymerase and the nsp5 viral protease. These targets are essential viral proteins which Arbutus has experience in targeting. Arbutus has also joined forces with the COVID R&D consortium to further support and expedite efforts to address the COVID-19 pandemic.

    Genevant Sciences Ltd. Update

    • On July 31, 2020, Genevant Sciences Ltd. (Genevant) was recapitalized through an equity investment and conversion of previously issued convertible debt securities held by Roivant Sciences Ltd. (Roivant), Arbutus' largest shareholder. Arbutus participated in the recapitalization of Genevant with an equity investment of $2.5 million. Following the recapitalization, Arbutus owns approximately 16% of the common equity of Genevant. Arbutus' entitlement to receive future royalties or sublicensing revenue from Genevant remains unchanged.

       
    • As previously disclosed, in April 2018 Arbutus entered into an agreement with Roivant to launch Genevant, a company focused on the discovery, development, and commercialization of a broad range of RNA-based therapeutics enabled by Arbutus' lipid nanoparticle ("LNP") and ligand conjugate delivery technologies. Arbutus licensed exclusive rights to its LNP and ligand conjugate delivery platforms to Genevant for RNA-based applications outside of HBV, except to the extent certain rights had already been licensed to other third parties

    COVID-19 Impact

    In December 2019 an outbreak of a novel strain of coronavirus (COVID-19) was identified in Wuhan, China. This virus continues to spread globally, has been declared a pandemic by the World Health Organization and has spread to nearly every country in the world. The impact of this pandemic has been, and will likely continue to be, extensive in many aspects of society. The pandemic has resulted in and will also likely continue to result in significant disruptions to businesses. A number of countries and other jurisdictions around the world have implemented extreme measures to try and slow the spread of the virus. These measures include the closing of businesses and requiring people to stay in their homes, the latter of which raises uncertainty regarding the ability to travel to hospitals in order to participate in clinical trials. Additional measures that have had, and will likely continue to have, a major impact on clinical development, at least in the near-term, include shortages and delays in the supply chain, and prohibitions in certain countries on enrolling subjects in new clinical trials. While we have been able to progress with our clinical and pre-clinical activities to date, it is not possible to predict if the COVID-19 pandemic will negatively impact our plans and timelines in the future.

    Financial Results

    Cash, Cash Equivalents and Investments

    Arbutus had cash, cash equivalents and investments totaling $118.3 million as of September 30, 2020, as compared to $90.8 million as of December 31, 2019. During the nine months ended September 30, 2020, Arbutus used $36.4 million in operating activities and made a $2.5 million equity investment in Genevant. These cash outflows were offset by $66.1 million of net proceeds from the issuance of common shares under Arbutus's ATM program. The Company believes its ending third quarter cash, cash equivalents and investments of $118.3 million are sufficient to fund the Company's operations into mid-2022.

    Net Loss

    Net loss attributable to common shares for the three months ended September 30, 2020 was $21.8 million ($0.27 basic and diluted loss per common share) as compared to $85.3 million ($1.50 basic and diluted loss per common share) for the three months ended September 30, 2019. Net loss attributable to common shares for the three months ended September 30, 2019 included: i) non-cash impairment charges of $43.8 million for an in-process research and development ("IPR&D") intangible asset and $22.5 million for goodwill to reduce their carrying values to zero, as well as a corresponding income tax benefit of $12.7 million related to the decrease in the deferred tax liability associated with the IPR&D intangible assets; and ii) a $6.5 million expense related to an arbitration award from the Company's arbitration with the University of British Columbia.

    Net loss attributable to common shares for the three months ended September 30, 2020 and 2019 included non-cash expense for the accrual of coupon on the Company's convertible preferred shares of $3.0 million and $2.8 million, respectively, and non-cash expense for a proportionate share of Genevant's net losses of $2.5 million in the third quarter of 2020 and $3.5 million in the third quarter of 2019.

    Operating Expenses

    Research and development expenses were $12.1 million for the three months ended September 30, 2020 compared to $17.7 million in 2019. The decrease in research and development expenses for the three months ended September 30, 2020 versus the same period in 2019 was due primarily to lower clinical expenses in 2020. General and administrative expenses were $4.1 million for the three months ended September 30, 2020 compared to $3.2 million for the same period in 2019. This increase was due primarily to increased compensation-related expenses and an increase in insurance premiums.

    Outstanding Shares

    The Company had approximately 84.6 million common shares issued and outstanding as of September 30, 2020. In addition, the Company had approximately 10.9 million stock options outstanding and 1.164 million convertible preferred shares outstanding, which (including the 8.75% annual interest in the form of additional preferred shares) will be mandatorily convertible into approximately 23.0 million common shares on October 18, 2021.



    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS

    (in thousands, except share and per share data)

     Three Months Ended September 30, Nine Months Ended September 30,
     2020 2019 2020 2019
    Revenue       
    Collaborations and licenses$827  $2,600  $2,487  $3,414 
    Non-cash royalty revenue696  461  2,041  979 
    Total Revenue1,523  3,061  4,528  4,393 
    Operating expenses       
    Research and development12,065  17,731  32,946  45,183 
    General and administrative4,065  3,249  11,184  15,850 
    Depreciation and amortization490  507  1,491  1,521 
    Change in fair value of contingent consideration120  (376)  348  (121) 
    Site consolidation  182  64  33 
    Impairment of intangible assets  43,836    43,836 
    Impairment of goodwill  22,471    22,471 
    Arbitration  6,486    6,486 
    Loss from operations(15,217)  (91,025)  (41,505)  (130,866) 
    Other income (loss)       
    Interest income100  503  645  1,709 
    Interest expense(1,074)  (1,100)  (3,214)  (1,114) 
    Foreign exchange gain (loss)(19)  (25)  (84)  43 
    Equity investment loss(2,545)  (3,512)  (2,545)  (11,497) 
    Total other loss(3,538)  (4,134)  (5,198)  (10,859) 
    Loss before income taxes$(18,755)  $(95,159)  $(46,703)  $(141,725) 
    Income tax benefit  12,656    12,656 
    Net loss$(18,755)  $(82,503)  $(46,703)  $(129,069) 
    Dividend accretion of convertible preferred shares(3,027)  (2,792)  (9,000)  (8,269) 
    Net loss attributable to common shares$(21,782)  $(85,295)  $(55,703)  $(137,338) 
    Loss per share       
    Basic and diluted$(0.27)  $(1.50)  $(0.77)  $(2.43) 
    Weighted average number of common shares       
    Basic and diluted79,487,444  56,850,172  72,342,070  56,469,358 





    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     September 30, 2020 December 31, 2019
    Cash and cash equivalents$96,918  $31,799 
    Investments in marketable securities, current21,378  59,035 
    Accounts receivable and other current assets$2,946  2,994 
    Total current assets121,242  93,828 
    Property and equipment, net of accumulated depreciation7,262  8,676 
    Right of use asset2,491  2,738 
    Other non-current assets109  293 
    Total assets$131,104  $105,535 
    Accounts payable and accrued liabilities$6,913  $7,235 
    Liability-classified options317  253 
    Lease liability, current378  340 
    Total current liabilities7,608  7,828 
    Liability related to sale of future royalties20,117  18,992 
    Contingent consideration3,301  2,953 
    Lease liability, non-current2,733  3,018 
    Total stockholders' equity97,345  72,744 
    Total liabilities and stockholders' equity$131,104  $105,535 





    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

    (in thousands)

     Nine Months Ended September 30,
     2020 2019
    Net loss$(46,703) $(129,069)
    Impairment of intangible assets and goodwill  66,307 
    Deferred income tax benefit  (12,661)
    Other non-cash items10,365  19,764 
    Changes in working capital(90) (1,996)
    Net cash used in operating activities(36,428) (57,655)
    Net cash provided by investing activities35,067  87,160 
    Net cash provided by financing activities66,536  23,564 
    Effect of foreign exchange rate changes on cash and cash equivalents(56) 71 
    Increase in cash and cash equivalents$65,119  $53,140 
    Cash and cash equivalents, beginning of period31,799  36,942 
    Cash and cash equivalents, end of period$96,918  $90,082 
    Investments in marketable securities21,378   
    Cash, cash equivalents and investments, end of period$118,296  $90,082 



    Conference Call and Webcast Today

    Arbutus will hold a conference call and webcast today, Thursday, November 5, 2020 at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 7161816.

    An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 7161816.

    About AB-729

    AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

    About AB-836

    AB-836 is an oral HBV capsid inhibitor. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily nucleos(t)ide analogues that work by inhibiting the viral polymerase, significantly reduce virus replication, but not completely. Capsid inhibitors inhibit replication by preventing the assembly of functional viral capsids. They also have been shown to inhibit the uncoating step of the viral life cycle thus reducing the formation of new covalently closed circular DNA (cccDNA), the genetic reservoir which the virus uses to replicate itself.

    About HBV

    Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes. The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

    Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements about Arbutus' expectations regarding the timing and clinical development of its product candidates, including Arbutus' expectations that results from the multi-dose 60 mg cohorts and single-dose 90 mg cohorts in HBV DNA positive subjects will be disclosed as part of an oral presentation at the upcoming ASSLD conference in November, that results from the 60 mg multi-dose cohort with a dosing interval of every eight weeks and a 90 mg single-dose cohort in HBV DNA positive subjects are expected in the fourth quarter of 2020, and that CTA/IND-enabling studies for AB-836 will be complete by the end of 2020; Arbutus' expectation to initiate a Phase 2 clinical trial for AB-729, VBR and an NrtI in the first half of 2021 and enroll approximately 60 virologically-suppressed patients with chronic HBV infection; Arbutus' planned 2020 cash burn guidance; the potential safety and efficacy of Arbutus' product candidates; Arbutus' expectations regarding its internal and external research efforts to combat COVID-19 and future coronavirus outbreaks; the expected sufficiency of Arbutus' ending third quarter cash, cash equivalents and investments are sufficient to fund operations into mid-2022; Arbutus' expectations regarding its technology licensed to Genevant and Arbutus' expectations regarding the effect of the COVID-19 pandemic on its business.

    With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the timely receipt of expected payments; the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus' assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

    Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; changes in Arbutus' strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus' products; economic and market conditions may worsen; and market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt our clinical development programs.

    A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K, Arbutus' Quarterly Reports on Form 10-Q and Arbutus' continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:

    Primary Logo

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  5. WARMINSTER, Pa., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has scheduled its third quarter 2020 financial results and corporate update for Thursday, November 5, 2020. The schedule for the press release and conference call/webcast are as follows:

    Q3 2020 Press Release:November 5, 2020 at 7:30 a.m. ET
    Q3 2020 Conference Call/Webcast:November 5, 2020 at 8:45 a.m. ET
    Domestic Dial-In Number:(866) 393-1607
    International Dial-In Number:(914) 495-8556
    Conference ID Number:7161816

    A live…

    WARMINSTER, Pa., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has scheduled its third quarter 2020 financial results and corporate update for Thursday, November 5, 2020. The schedule for the press release and conference call/webcast are as follows:

    Q3 2020 Press Release:November 5, 2020 at 7:30 a.m. ET
    Q3 2020 Conference Call/Webcast:November 5, 2020 at 8:45 a.m. ET
    Domestic Dial-In Number:(866) 393-1607
    International Dial-In Number:(914) 495-8556
    Conference ID Number:7161816

    A live webcast of the conference call can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast.

    An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 7161816.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:



    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:  

    Primary Logo

    View Full Article Hide Full Article
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