ABUS Arbutus Biopharma Corporation

3.13
-0.06  -2%
Previous Close 3.19
Open 3.18
52 Week Low 2.43
52 Week High 5.87
Market Cap $427,036,063
Shares 136,433,247
Float 116,276,685
Enterprise Value $624,306,935
Volume 652,962
Av. Daily Volume 2,120,859
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Upcoming Catalysts

Drug Stage Catalyst Date
AB-836
Hepatitis B
Phase 1a
Phase 1a
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AB-729 and Vebicorvir (ABI-H0731)
Hepatitis B virus (HBV)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
AB-729 and VTP-300
Hepatitis B
Phase 2a
Phase 2a
Phase 2 trial to be initiated early 2022.
AB-729
Hepatitis B (HBV)
Phase 1
Phase 1
Phase 1a/b data at EASL meeting June 26, 2021 - HBsAg declines below 100 IU/ml in 75% of treated subjects. Favorable safety and tolerability profile. Noted that HBsAg suppression at levels <100 IU/mL is maintained in some patients up to 20 weeks following the last dose of treatment, November 1, 2021. Phase 1a/b data noted suppression of HBsAg to levels <100 IU/mL were maintained up to 24 weeks off-treatment in 3 of 7 patients in cohort E and 1 of 3 patients in cohort F, noted November 10, 2021.

Latest News

  1. WARMINSTER, Pa., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today announced that Tram Tran, M.D. has been appointed to the Arbutus Board of Directors effective immediately. Dr. Tran is a renowned liver and viral specialist with over 20 years of academic and industry experience as a physician scientist.

    "We are excited to welcome Dr. Tran to the Arbutus Board," said William Collier, President and Chief Executive…

    WARMINSTER, Pa., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today announced that Tram Tran, M.D. has been appointed to the Arbutus Board of Directors effective immediately. Dr. Tran is a renowned liver and viral specialist with over 20 years of academic and industry experience as a physician scientist.

    "We are excited to welcome Dr. Tran to the Arbutus Board," said William Collier, President and Chief Executive Officer of Arbutus. "Her extensive medical and scientific expertise in the field of hepatology will be invaluable as Arbutus continues to advance its broad portfolio of diverse assets to find a curative regimen for patients with chronic Hepatitis B."

    Dr. Tran currently serves as Chief Medical Officer at Glympse, a biotech company focused on optimizing disease diagnosis and monitoring. Previously, she worked at Gilead Sciences as the Vice President of Medical Affairs, Global Head, Liver Diseases (HBV, HCV, HDV), Fibrosis (NASH, PSC) and COVID-19. Prior to her work at Gilead, Dr. Tran was the Medical Director of Liver Transplantation, GI Fellowship Program Director at Cedars-Sinai Medical Center, and a Professor of Medicine at the Geffen School of Medicine at the University of California, Los Angeles (UCLA). She has authored and co-authored over 150 abstracts, published manuscripts and book chapters, and has been extensively involved in clinical trials and National Institutes of Health (NIH) funded research. Dr. Tran earned her undergraduate degree at UCLA, received her medical degree (M.D.) from New York Medical College, continued her training in internal medicine at Cedars Sinai Medical Center, and completed Gastroenterology and Transplant Hepatology fellowships at UCLA, where she maintains clinical and teaching activities.

    "It's an honor to join an organization with a strong commitment to addressing the unmet medical needs of Hepatitis B patients," said Dr. Tran. "I look forward to sharing my expertise and working with my fellow board members to support Arbutus in its continued efforts to develop treatments for HBV and coronaviruses."

    About Arbutus

    Arbutus Biopharma Corporation (NASDAQ:ABUS) is a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that suppress viral replication, reduce surface antigen and reawaken the immune system. Arbutus believes this three-prong approach is key to transforming the treatment and developing a potential cure for chronic HBV infection. Arbutus' HBV product pipeline includes RNA interference (RNAi) therapeutics, oral capsid inhibitors, oral compounds that inhibit PD-L1 and oral HBV RNA destabilizers. In addition, Arbutus has an ongoing drug discovery and development program directed to identifying orally active agents 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 our future development plans for our product candidates; and the potential for our product candidates to achieve success in clinical trials.

    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, may never be initiated or completed, or may not generate results that warrant future development of the tested product 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:

    Lisa M. Caperelli

    Vice President, Investor Relations

    Phone: 215-206-1822

    Email:



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  2. Arbutus' Lead Compound AB-729 Continues to be Safe and Effective at Reducing HBsAg in Patients with Chronic Hepatitis B

    HBsAg remains suppressed up to 28 weeks after discontinuation of AB-729

    Repeat dosing of both 60 mg and 90 mg of AB-729 results in comparable HBsAg reductions

    WARMINSTER, Pa., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today announced new AB-729 safety and efficacy data, as well as long-term…

    Arbutus' Lead Compound AB-729 Continues to be Safe and Effective at Reducing HBsAg in Patients with Chronic Hepatitis B

    HBsAg remains suppressed up to 28 weeks after discontinuation of AB-729

    Repeat dosing of both 60 mg and 90 mg of AB-729 results in comparable HBsAg reductions

    WARMINSTER, Pa., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today announced new AB-729 safety and efficacy data, as well as long-term data from HBV patients following discontinuation of treatment with AB-729. The data are from part 3 of the Company's ongoing Phase 1a/1b clinical trial with 60 mg or 90 mg of AB-729 dosed every four, eight or 12 weeks. The data will be presented at AASLD in a poster entitled, "Low HBsAg levels maintained following cessation of the GalNAc-siRNA, AB-729, in chronic hepatitis B subjects on nucleos(t)ide analogue therapy".

    Data from the poster presentation include long-term follow-up data for patients in cohort E (60 mg every four weeks) and cohort F (60 mg every eight weeks) who had been off AB-729 treatment for six months. Suppression of HBsAg to levels <100 IU/mL were maintained up to 24 weeks off-treatment in 3 of 7 patients in cohort E and 1 of 3 patients with available data in cohort F. Patients who remain below this clinically relevant threshold for six months after stopping AB-729 treatment could consider discontinuing their nucleos(t)ide analogue ("NA") therapy to assess the potential for functional cure.

    Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., Deputy Head of Department Medicine and Chief of Division of Gastroenterology and Hepatology, University of Hong Kong, and lead investigator of Arbutus' Phase 1a/1b clinical trial, stated, "I find this long-term off-treatment data very encouraging. Albeit small patient numbers, these data give us confidence that AB-729 is capable of reducing and maintaining suppression of HBsAg even after its discontinuation. We look forward to providing additional long-term follow up data on these patients, especially as some of them may elect to discontinue their NA therapy."

    Also included in the poster presentation are data showing that robust mean declines (ranging from 1.8-2.0 log10 at week 40) in HBsAg were sustained with repeat dosing of AB-729 up to 48 weeks, with no statistically significant differences observed to date between the 60 mg and 90 mg dose and/or dosing intervals.

    Mean (SE) Baseline Change in HBsAg with Repeat Dosing of AB-729

    Nominal Visit



    HBV DNA-HBV DNA+



    Cohort E

    60 mg Q4W

    (n=7)
    Cohort F

    60 mg Q8W

    (n=7)
    Cohort I

    90 mg Q8W

    (n=6)
    Cohort J

    90 mg Q12W

    (n=7)
    Cohort G

    90 mg Q8W

    (n=7)
    Baseline (IU/mL)3.51

    (0.20)
    3.53

    (0.17)
    3.36

    (0.23)
    3.37

    (0.28)
    3.14

    (0.14)
    Week 12-1.10

    (0.15)
    -1.02

    (0.11)
    -1.30

    (0.19)
    -1.06

    (0.31)
    -1.56

    (0.32)
    Week 24-1.84

    (0.16)
    -1.57

    (0.09)
    -1.79

    (0.22)
    -1.56

    (0.25)
    -1.82#

    (0.29)
    Week 40-1.84

    (0.19)
    -1.78

    (0.10)
    -1.93

    (0.25)
    -1.89^

    (0.35)
    -2.03+

    (0.33)
    Week 44-1.81

    (0.17)
    -1.88

    (0.13)
    -2.16

    (0.31)
    -1.86^

    (0.38)
    ---
    Week 48-1.89

    (0.18)
    -1.90

    (0.14)
    ---------
    Week 16 Post Last Dose-1.74

    (0.20)
    -1.76

    (0.19)
    ---------
    Week 20 Post Last Dose-1.61

    (0.20)
    -1.55*

    (0.28)
    ---------
    Week 24 Post Last Dose-1.54

    (0.19)
    ------------

    NOTE: Mean (SE) values presented only if n>3; there are no statistically significant differences between cohorts (data not shown); *n=5; ^n=6, one patient in Cohort J chose not to extend treatment; #6 of 7 patients had HBV DNA <LLOQ by Week 8, the 7th patient became <LLOQ at Week 16; +n=6.

    Repeat dosing of both the 60 mg and 90 mg doses of AB-729 continues to be generally safe and well- tolerated. There were no treatment related serious adverse events or discontinuations. The most common treatment emergent adverse events were injection site related of which all were grade one and did not appear to be dose or interval dependent. ALT and AST elevations were asymptomatic and not considered adverse events by the study investigators.

    Gaston Picchio, Ph.D., Chief Development Officer at Arbutus, commented, "AB-729 consistently delivers impressive efficacy and safety data at both the 60 mg and 90 mg doses at all dosing intervals. AB-729 represents a therapeutic option with a consistent profile that can suppress HBsAg and has the potential to be a cornerstone agent in combination with other agents to cure HBV. I look forward to continuing to evaluate AB-729 in future clinical trials."   

    A total of 34 patients were enrolled in cohorts E, F, G, I, and J, all of which met the eligibility criteria (>0.5 log10 HBsAg reduction at week 20) to participate in the treatment extension and 33 of which agreed to continue treatment. HBV DNA negative patients on stable NA therapy were enrolled in part 3 of this trial to receive 60 mg of AB-729 every 4 weeks (cohort E) or 8 weeks (cohort F) or 90 mg of AB-729 every 8 weeks (cohort I) or 12 weeks (cohort J). HBV DNA positive patients received 90 mg of AB-729 every 8 weeks in addition to current standard of care treatment, tenofovir disoproxil fumarate (cohort G). HBV DNA negative/HBeAg positive patients are continuing to be dosed with 90 mg of AB-729 every 8 weeks (cohort K).

    The meeting platform with posters is now open and the e-poster is also available through the Investors section under Events & Presentations of Arbutus' website at www.arbutusbio.com.

    About AB-729

    AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. AB-729 targets hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. Clinical data generated thus far has shown single- and multi-doses of AB-729 to be generally safe and well-tolerated while providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA.

    About HBV

    Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

    About Arbutus

    Arbutus Biopharma Corporation (NASDAQ:ABUS) is a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that suppress viral replication, reduce surface antigen and reawaken the immune system. Arbutus believes this three-prong approach is key to transforming the treatment and developing a potential cure for chronic HBV infection. Arbutus' HBV product pipeline includes RNA interference (RNAi) therapeutics, oral capsid inhibitors, oral compounds that inhibit PD-L1 and oral HBV RNA destabilizers. In addition, Arbutus has an ongoing drug discovery and development program directed to identifying orally active agents 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 our future development plans for our product candidates; the expected cost, timing and results of our clinical development plans and clinical trials with respect to our product candidates; our expectations and goals for our collaborations with third parties and any potential benefits related thereto; the potential for our product candidates to achieve success in clinical trials; our expected financial condition, including the anticipated duration of cash runways and timing regarding needs for additional capital; and our expectations regarding the impact of the COVID-19 pandemic on our business and clinical trials.

    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, may never be initiated or completed, or may not generate results that warrant future development of the tested product 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; Arbutus and its collaborators may never realize the expected benefits of the collaborations; 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: 

    Lisa M. Caperelli

    Vice President, Investor Relations

    Phone: 215-206-1822

    Email:



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  3. WARMINSTER, Pa., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today announced that the Company will participate in a virtual fireside chat at the Jefferies London Healthcare Conference.

    Presenters:
    William Collier, President and Chief Executive Officer; Dr. Michael Sofia, Chief Scientific Officer; Dr. Gaston Picchio, Chief Development Officer; and David Hastings, Chief Financial Officer

    A webcast of the virtual…

    WARMINSTER, Pa., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today announced that the Company will participate in a virtual fireside chat at the Jefferies London Healthcare Conference.

    Presenters:

    William Collier, President and Chief Executive Officer; Dr. Michael Sofia, Chief Scientific Officer; Dr. Gaston Picchio, Chief Development Officer; and David Hastings, Chief Financial Officer

    A webcast of the virtual fireside chat will be available beginning on Thursday, November 18, 2021 at 8:00 am GMT / 3:00 am ET, and can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com. An archived replay of the webcast will be available on the Company's website after the conference.

    About Arbutus

    Arbutus Biopharma Corporation (NASDAQ:ABUS) is a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that suppress viral replication, reduce surface antigen and reawaken the immune system. Arbutus believes this three-prong approach is key to transforming the treatment and developing a potential cure for chronic HBV infection. Arbutus' HBV product pipeline includes RNA interference (RNAi) therapeutics, oral capsid inhibitors, oral compounds that inhibit PD-L1 and oral HBV RNA destabilizers. In addition, Arbutus has an ongoing drug discovery and development program directed to identifying orally active agents 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:

    Lisa M. Caperelli

    Vice President, Investor Relations

    Phone: 215-206-1822

    Email:



    Primary Logo

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  4.  On-track for multiple data readouts of AB-729 and AB-836 in Q4 2021

            First patient dosed in Phase 2a clinical trial combining AB-729, Peg-IFNα-2a and nucleos(t)ide analog ("NA") therapy

             On-track to initiate several proof-of-concept Phase 2a clinical trials with AB-729 as a cornerstone agent in combination with other approved or investigational compounds

            Commenced IND enabling studies for Arbutus' oral PD-L1 program

    Cash runway guidance extended into the second quarter of 2023

    Conference call and webcast scheduled today at 8:45 AM ET

    WARMINSTER, Pa., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing…

     On-track for multiple data readouts of AB-729 and AB-836 in Q4 2021

            First patient dosed in Phase 2a clinical trial combining AB-729, Peg-IFNα-2a and nucleos(t)ide analog ("NA") therapy

             On-track to initiate several proof-of-concept Phase 2a clinical trials with AB-729 as a cornerstone agent in combination with other approved or investigational compounds

            Commenced IND enabling studies for Arbutus' oral PD-L1 program

    Cash runway guidance extended into the second quarter of 2023

    Conference call and webcast scheduled today at 8:45 AM ET

    WARMINSTER, Pa., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different mechanisms of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today reports its third quarter 2021 financial results and provides a corporate update.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "We are impressed with the continued development of our proprietary HBV assets that align with our novel three-pronged approach to develop an HBV functional cure by suppressing HBV DNA, reducing HBV surface antigen and boosting the host immune system. We have clinical trials underway assessing our RNAi therapeutic and capsid inhibitor in both healthy subjects and patients with chronic HBV infection and are poised for multiple data readouts in the fourth quarter of this year. We expect these data will further inform the design of future combination clinical trials with AB-729 as a cornerstone agent in HBV treatment."  

    Mr. Collier continued, "Importantly, we have now moved forward with IND enabling studies for our internally-discovered oral PD-L1 program intended to address the third arm of our three-prong approach, reawakening the host immune response. In addition, we are continuing to conduct lead optimization activities for our oral RNA destabilizer in HBV and to progress our efforts to identify lead candidates for our pan-coronavirus program. We intend to provide additional updates on these programs early next year."  



    Pipeline Update

    AB-729 (RNAi Therapeutic)

    • Arbutus is conducting a single- and multi-dose Phase 1a/b clinical trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 in healthy subjects and patients with chronic HBV infection. Data disclosed to-date show that AB-729 continues to reduce HBsAg across all doses and dosing intervals with a favorable safety and tolerability profile. Additionally, based on 3/5 evaluable patients, long term dosing of AB-729 showed increased HBV-specific immune responses, providing support for combination therapy including immunomodulatory agents.



    • Arbutus will be presenting data from additional cohorts in the AB-729 Phase 1a/1b clinical trial at the upcoming AASLD medical conference. The presentation, which was accepted as a late-breaker poster for the conference, will include data in HBV DNA negative patients that received 90 mg dosed every 12 weeks (cohort J) and data in HBV DNA positive patients that received 90 mg dosed every 8 weeks (cohort G). In addition, the company will provide follow-up data from HBV DNA negative patients that received the 60 mg dose every 4 or 8 weeks or the 90 mg dose every 8 weeks (cohort E, F, and I respectively). Key findings include:



      • AB-729 repeat dosing is generally safe and well tolerated.
      • Robust mean declines in HBsAg were sustained with repeat dosing of AB-729, with no meaningful differences observed to date between doses (60 mg or 90 mg) and/or dosing intervals (every 4, 8 or 12 weeks).
      • HBsAg suppression at levels <100 IU/mL is maintained in some patients up to 20 weeks following the last dose of AB-729.
    • In-line with our strategy to combine multiple therapies that target different points of the viral replication cycle to develop a curative treatment regimen in HBV, Arbutus has dosed the first patient in its Phase 2a randomized, open-label, proof-of-concept clinical trial designed to evaluate AB-729 in combination with ongoing standard-of-care NA therapy and short courses of Peg-IFNα-2a in 40 patients with chronic HBV infection. The primary objective of the clinical trial is to evaluate the safety and tolerability of AB-729 plus Peg-IFNα-2a in subjects with NA-suppressed chronic HBV infection. After 24-weeks of dosing with AB-729, patients will be randomized into one of four groups to receive either AB-729 plus NA therapy plus Peg-IFNα-2a or NA therapy plus Peg-IFNα-2a for either 24 or 12 weeks. After completion of the assigned interferon treatment period, all patients will remain on NA therapy for the initial 24-week follow-up period, and then discontinue NA treatment, provided they meet certain stopping criteria.
    • Also, in line with our strategy, we have entered into separate clinical collaboration agreements with Assembly Biosciences, Inc. ("Assembly"), Vaccitech plc ("Vaccitech") and Antios Therapeutics, Inc. ("Antios") to evaluate AB-729 as the cornerstone agent in combination with Assembly's capsid inhibitor, Vaccitech's T cell stimulating therapeutic vaccine, and Antios' active site polymerase inhibitor nucleotide, respectively.



      • Enrollment is on-going in the Phase 2 proof-of-concept triple combination clinical trial evaluating AB-729, vebicorvir ("VBR"), Assembly's lead HBV core inhibitor (capsid inhibitor), and an NA. Assembly is conducting this clinical trial and expecting initial data in 2022.
      • Arbutus is on-track to file a Clinical Trial Application (CTA) in the fourth quarter of 2021 with plans to initiate a triple combination Phase 2 trial in early 2022 to evaluate AB-729, combined with VTP-300, Vaccitech's therapeutic vaccine and a NA.
      • In the fourth quarter of 2021, Antios is planning to add a cohort to its on-going Phase 2 clinical trial to evaluate AB-729, ATI-2173, Antios' proprietary active site polymerase inhibitor nucleotide (ASPIN) and Viread (tenofovir disoproxil fumarate), which is currently approved by the FDA for the treatment of chronic hepatitis B.

    AB-836 (Oral Capsid Inhibitor)

    • AB-836 is Arbutus' novel, next generation oral capsid inhibitor with improved intrinsic potency, activity against resistant variants and an enhanced ability to starve replenishment of cccDNA which is responsible for HBV recurrence.



    • Arbutus is conducting a double-blind, randomized, placebo-controlled, single and multiple dose Phase 1a/1b clinical trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AB-836. The Company is on-track to report initial data from healthy subjects and HBV patients in the fourth quarter of 2021.

    HBV Discovery Programs

    • Arbutus' drug discovery efforts are focused on developing small molecules to create an all-oral treatment regimen to cure HBV. Research efforts are continuing with the oral RNA-destabilizer program, where Arbutus is currently in late-stage lead optimization.

    Oral PD-L1 Program

    • Arbutus' oral PD-L1 program is designed to reawaken the immune system, which Arbutus believes is a key component in developing a cure for HBV. Arbutus has commenced IND-enabling studies for its oral PD-L1 program.

    Research Efforts to Combat COVID-19 and Future Coronavirus Outbreaks

    • Leveraging its extensive antiviral drug discovery experience, Arbutus is focused on the discovery and development of new pan-coronavirus molecular entities to treat COVID-19 and future coronavirus outbreaks by targeting essential viral proteins including the nsp12 viral polymerase and the nsp5 viral protease. Through its discovery research and license agreement with X-Chem, Inc. and Proteros biostructures GmbH, Arbutus is progressing lead candidates to nomination.

    Financial Results

    Cash, Cash Equivalents and Investments

    Arbutus had cash, cash equivalents and investments in marketable securities totaling $151.9 million as of September 30, 2021, as compared to $123.3 million as of December 31, 2020. During the nine months ended September 30, 2021, Arbutus used $47.9 million in operating activities, which was offset by $75.4 million of net proceeds from the issuance of common shares under Arbutus's "at-the-market" offering program. The Company believes its cash, cash equivalents and investments in marketable securities of $151.9 million as of September 30, 2021 are sufficient to fund the Company's operations into the second quarter of 2023.

    Net Loss

    Net loss attributable to common shares for the three months ended September 30, 2021 was $24.2 million ($0.24 basic and diluted loss per common share) as compared to $21.8 million ($0.27 basic and diluted loss per common share) for the three months ended September 30, 2020. Net loss attributable to common shares for the three months ended September 30, 2021 and 2020 included non-cash expense for the accrual of coupon on the Company's convertible preferred shares of $5.1 million and $3.0 million, respectively.

    Operating Expenses

    Research and development expenses were $16.3 million for the three months ended September 30, 2021 compared to $12.1 million for the same period in 2020. The increase in research and development expenses for the three months ended September 30, 2021 versus the same period in 2020 was due primarily to higher expenses for the Company's clinical development and discovery programs, including activities under the collaboration with Assembly and internal research efforts to treat COVID-19 and future coronavirus outbreaks, both of which initiated in mid-2020. General and administrative expenses were $4.1 million for the three months ended September 30, 2021 compared to $4.1 million for the same period in 2020.

    Outstanding Shares

    As of September 30, 2021, the Company had approximately 110.3 million common shares issued and outstanding, approximately 11.4 million stock options outstanding and 1.164 million convertible preferred shares outstanding. On October 18, 2021, all 1.164 million convertible preferred shares (including the annual 8.75% coupon) converted into 22,833,922 common shares. Following the conversion, Roivant owns approximately 29% of the Company's outstanding common shares.

    COVID-19 Impact

    In December 2019 an outbreak of a novel strain of coronavirus (COVID-19) was identified in Wuhan, China. This virus 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 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 Arbutus has been able to progress with its clinical and pre-clinical activities to date, it is not possible to predict if the COVID-19 pandemic will materially impact its plans and timelines in the future.

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS

    (in thousands, except share and per share data)

     Three Months Ended September 30, Nine Months Ended September 30,
     2021 2020  2021  2020
    Revenue       
    Collaborations and licenses$1,480   $827   $3,819   $2,487   
    Non-cash royalty revenue1,860   696    3,963    2,041   
    Total Revenue3,340   1,523    7,782    4,528   
    Operating expenses       
    Research and development16,299   12,065    45,065    32,946   
    General and administrative4,146   4,065    12,438    11,184   
    Depreciation447   490    1,326    1,491   
    Change in fair value of contingent consideration856   120    1,679    348   
    Site consolidation           64   
    Loss from operations(18,408)  (15,217)   (52,726)   (41,505)  
    Other income (loss)       
    Interest income27   100    97    645   
    Interest expense(762)  (1,074)   (2,297)   (3,214)  
    Foreign exchange (loss) gain(15)  (19)       (84)  
    Equity investment loss   (2,545)       (2,545)  
    Total other loss(750)  (3,538)   (2,200)   (5,198)  
    Net loss(19,158)  (18,755)   (54,926)   (46,703)  
    Dividend accretion of convertible preferred shares(5,087)  (3,027)   (11,565)   (9,000)  
    Net loss attributable to common shares$(24,245)  $(21,782)  $(66,491)  $(55,703)  
    Loss per share       
    Basic and diluted$(0.24)  $(0.27)  $(0.68)  $(0.77)  
    Weighted average number of common shares       
    Basic and diluted101,286,351   79,487,444    97,174,253    72,342,070   



     

    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     September 30, 2021 December 31, 2020
    Cash, cash equivalents and marketable securities, current$121,403  $123,268 
    Accounts receivable and other current assets5,133  4,436 
    Total current assets126,536  127,704 
    Property and equipment, net of accumulated depreciation6,352  6,927 
    Investments in marketable securities, non-current30,534   
    Right of use asset2,174  2,405 
    Other non-current assets  44 
    Total assets$165,596  $137,080 
    Accounts payable and accrued liabilities$9,727  $9,151 
    Lease liability, current386  390 
    Total current liabilities10,113  9,541 
    Liability related to sale of future royalties17,883  19,554 
    Contingent consideration5,105  3,426 
    Lease liability, non-current2,355  2,593 
    Total stockholders' equity130,140  101,966 
    Total liabilities and stockholders' equity$165,596  $137,080 

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

    (in thousands)

     Nine Months Ended September 30,
     2021 2020
    Net loss$(54,926)  $(46,703) 
    Other non-cash items7,080   10,365  
    Changes in working capital(80)  (90) 
    Net cash used in operating activities(47,926)  (36,428) 
    Net cash (used in) provided by investing activities(4,557)  35,067  
    Net cash provided by financing activities78,115   66,536  
    Effect of foreign exchange rate changes on cash and cash equivalents   (56) 
    Increase in cash and cash equivalents25,632   65,119  
    Cash and cash equivalents, beginning of period52,251   31,799  
    Cash and cash equivalents, end of period77,883   96,918  
    Investments in marketable securities74,054   21,378  
    Cash, cash equivalents and marketable securities, end of period$151,937   $118,296  

    Conference Call and Webcast Today

    Arbutus will hold a conference call and webcast today, Thursday, November 4, 2021 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. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID: 5035306.

    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: 5035306.

    About AB-729

    AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. AB-729 targets hepatocytes using Arbutus' novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. Clinical data generated thus far has shown single- and multi-doses of AB-729 to be generally safe and well-tolerated while providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA.

    About AB-836

    AB-836 is a next generation oral hepatitis B virus (HBV) capsid inhibitor that interacts with HBV core protein, which in turn is required for viral replication. The current standard-of-care therapy for HBV is primarily nucleos(t)ide analogues that inhibit the viral polymerase and significantly reduce, but do not eliminate viral replication. AB-836 in combination with nucleos(t)ide analogues is designed to completely eliminate viral replication in infected cells by preventing the assembly of functional viral capsids. In addition, AB-836 has been shown to inhibit the replenishment of covalently closed circular DNA (cccDNA), the viral genetic reservoir which the virus needs to replicate itself.

    About HBV

    Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

    About Arbutus

    Arbutus Biopharma Corporation (NASDAQ:ABUS) is a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that suppress viral replication, reduce surface antigen and reawaken the immune system. Arbutus believes this three-prong approach is key to transforming the treatment and developing a potential cure for chronic HBV infection. Arbutus' HBV product pipeline includes RNA interference (RNAi) therapeutics, oral capsid inhibitors, oral compounds that inhibit PD-L1 and oral HBV RNA destabilizers. In addition, Arbutus has an ongoing drug discovery and development program directed to identifying orally active agents 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 our future development plans for our product candidates; the expected cost, timing and results of our clinical development plans and clinical trials with respect to our product candidates; our expectations and goals for our collaborations with third parties and any potential benefits related thereto; the potential for our product candidates to achieve success in clinical trials; our expected financial condition, including the anticipated duration of cash runways and timing regarding needs for additional capital; and our expectations regarding the impact of the COVID-19 pandemic on our business and clinical trials.

    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 product 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; Arbutus and its collaborators may never realize the expected benefits of the collaborations; 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:

    Lisa M. Caperelli

    Vice President, Investor Relations

    Phone: 215-206-1822

    Email:



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  5. WARMINSTER, Pa., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different mechanisms of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today announced that the Company will be presenting data on the effects of its GalNAc-siRNA, AB-729, in chronic hepatitis B patients on nucleos(t)ide analogue therapy at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2021 – The Digital Experience™, taking place from November 12-15, 2021.

    Poster Presentation

    WARMINSTER, Pa., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different mechanisms of action to provide a cure for people with chronic hepatitis B virus (HBV) infection and to treat coronaviruses (including COVID-19), today announced that the Company will be presenting data on the effects of its GalNAc-siRNA, AB-729, in chronic hepatitis B patients on nucleos(t)ide analogue therapy at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2021 – The Digital Experience™, taking place from November 12-15, 2021.

    Poster Presentation Details:

    Title: Low HBsAg levels maintained following cessation of the GalNAc-siRNA, AB-729, in chronic hepatitis B subjects on nucleos(t)ide analogue therapy

    Publication Number: LP20

    Session Title: Late-Breaking Abstract Posters

    Authors: MF Yuen, E Berliba, W Sukeepaisarnjaroen, P Tangkijvanich, A Leerapun, J Holmes, E Gane, A Jucov, EP Thi, M Sofia, H Sevinsky, T Eley, E Medvedeva, K Gray, D Antoniello, G Picchio, KD Sims, SI Strasser

    Poster Session Schedule:

    Friday, November 12 - 1:00 PM – 3:00 PM ET

    Saturday, November 13 - 8:00 AM – 9:00 AM ET

    Sunday, November 14 - 8:00 AM – 9:00 AM ET

    Monday, November 15 - 2:00 PM – 3:00 PM ET

    The poster will be available at the start of the The Liver Meeting® on November 12, 2021.

    Key Findings:

    • AB-729 repeat dosing is generally safe and well tolerated.
    • Robust mean declines in HBsAg were sustained with repeat dosing of AB-729, with no meaningful differences observed to date between doses (60 mg or 90 mg) and/or dosing intervals (every 4, 8 or 12 weeks).
    • HBsAg suppression at levels <100 IU/mL is maintained in some patients up to 20 weeks following the last dose of AB-729.

    About Arbutus

    Arbutus Biopharma Corporation (NASDAQ:ABUS) is a clinical-stage biopharmaceutical company primarily focused on discovering, developing and commercializing a broad portfolio of wholly-owned assets with different modes of action to provide a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that suppress viral replication, reduce surface antigen and reawaken the immune system. Arbutus believes this three-prong approach is key to transforming the treatment and potential cure for chronic HBV infection. Arbutus' HBV product pipeline includes RNA interference (RNAi) therapeutics, oral capsid inhibitors, oral compounds that inhibit PD-L1 and oral HBV RNA destabilizers. In addition, Arbutus has an ongoing drug discovery and development program directed to identifying orally active agents for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.

    Forward-Looking Statements

    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 our future development plans for our product candidates; and the potential for our product candidates to achieve success in clinical trials.

    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 product 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; Arbutus and its collaborators may never realize the expected benefits of the collaborations; 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:



    Lisa M. Caperelli

    Vice President, Investor Relations

    Phone: 215-206-1822

    Email:



    Primary Logo

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