ABUS Arbutus Biopharma Corporation

3.14
+0.16  (+5%)
Previous Close 2.98
Open 2.99
52 Week Low 0.8214
52 Week High 9.02
Market Cap $263,990,033
Shares 84,073,259
Float 65,225,566
Enterprise Value $328,091,033
Volume 3,745,455
Av. Daily Volume 11,392,389
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Drug Pipeline

Drug Stage Notes
AB-729
Hepatitis B (HBV)
Phase 1
Phase 1
Phase 1a/b data released September 15, 2020 noted favorable safety and tolerability profile.
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. Mean HBsAg reduction of 1.23 log10 IU/mL at week 12 with a favorable safety and tolerability profile 

    WARMINSTER, Pa., Sept. 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 reports continued positive data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound. These new data demonstrate that in chronic HBV subjects, a single subcutaneous injection of 90 mg of AB-729 resulted in a mean HBsAg reduction of 1.23 log10 IU/mL at week 12.

    William Collier…

    Mean HBsAg reduction of 1.23 log10 IU/mL at week 12 with a favorable safety and tolerability profile 

    WARMINSTER, Pa., Sept. 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 reports continued positive data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound. These new data demonstrate that in chronic HBV subjects, a single subcutaneous injection of 90 mg of AB-729 resulted in a mean HBsAg reduction of 1.23 log10 IU/mL at week 12.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "The 90 mg single-dose 12-week data coupled with our previously disclosed 60 mg single-dose 12-week data mean that we now have two doses which have demonstrated meaningful reductions in HBsAg with a favorable safety and tolerability profile. We are currently dosing chronic HBV subjects in four multi-dose cohorts using both the 60 mg (every 4- and 8-weeks) and 90 mg (every 8- and 12-weeks) doses to determine the optimal dosing regimen for AB-729. We believe AB-729 will potentially offer people with chronic HBV a well-tolerated low dose treatment with a minimum of injections."

    Arbutus expects to present initial results from its ongoing Phase 1a/1b clinical trial for the 60 mg multi-dose cohorts, the 90 mg single-dose cohort in HBV DNA positive subjects, as well as longer-term follow up of the 60 and 90 mg single-dose cohorts, at an upcoming scientific meeting later this year. In addition to the ongoing 60 mg multi-dose cohorts with subjects dosed at 4- and 8-weeks, the Company has also initiated 90 mg multi-dose cohorts with subjects dosed at 8- and 12-week intervals.

    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)

    Dr. Gaston Picchio, Chief Development Officer of Arbutus, stated, "The mean HBsAg decline seen in the 90 mg single-dose cohort is consistent with that seen in prior single-dose cohorts. Importantly, the data demonstrate consistent efficacy and a favorable safety profile at this intermediate dose. These findings support the continued evaluation of the 90 mg dose in the multi-dose portion of our ongoing clinical trial."

    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.

    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, please visit www.arbutusbio.com.

    COVID-19

    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 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.

    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; the potential for AB-729 to be a well-tolerated low dose treatment for HBV with a minimum of injections; Arbutus' expectation to present AB-729 60 mg multi-dose data and 90 mg single-dose data in HBV DNA positive subjects, as well as longer-term follow up of the 60 and 90 mg single-dose cohorts at an upcoming scientific meeting later this year; 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 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:

     

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  2. WARMINSTER, Pa., Sept. 09, 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 the Company will participate in a virtual fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 10:30 am ET.

    Arbutus Fireside Chat Presenters:

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

    A live webcast of the virtual fireside chat can…

    WARMINSTER, Pa., Sept. 09, 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 the Company will participate in a virtual fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 10:30 am ET.

    Arbutus Fireside Chat Presenters:

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

    A live webcast of the virtual fireside chat 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 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

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  3. SOUTH SAN FRANCISCO, Calif. and WARMINSTER, Pa., Aug. 27, 2020 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB) and Arbutus Biopharma Corporation (NASDAQ:ABUS), today announced that the companies have entered into a clinical collaboration agreement to evaluate Assembly's lead hepatitis B virus (HBV) core inhibitor candidate ABI-H0731 in combination with Arbutus' proprietary GalNAc delivered RNAi therapeutic AB-729 and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy for the treatment of patients with chronic HBV infection.

    A randomized, multi-center, open-label Phase 2 clinical trial will explore the safety, pharmacokinetics, and antiviral activity of the triple combination of HBV core inhibitor…

    SOUTH SAN FRANCISCO, Calif. and WARMINSTER, Pa., Aug. 27, 2020 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB) and Arbutus Biopharma Corporation (NASDAQ:ABUS), today announced that the companies have entered into a clinical collaboration agreement to evaluate Assembly's lead hepatitis B virus (HBV) core inhibitor candidate ABI-H0731 in combination with Arbutus' proprietary GalNAc delivered RNAi therapeutic AB-729 and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy for the treatment of patients with chronic HBV infection.

    A randomized, multi-center, open-label Phase 2 clinical trial will explore the safety, pharmacokinetics, and antiviral activity of the triple combination of HBV core inhibitor ABI-H0731, RNAi therapeutic AB-729 and an NrtI compared to the double combinations of ABI-H0731 with an NrtI and AB-729 with an NrtI. This clinical trial is projected to initiate in the first half of 2021 and enroll approximately 60 virologically-suppressed patients with HBeAg negative or positive chronic HBV infection. Patients will be dosed for 48 weeks, with a 24 week follow-up period. As part of the collaboration, the companies may add cohorts in the future, to evaluate other patient populations and/or combinations. 

    "Our team at Assembly is committed to driving the field of HBV research toward the ultimate goals of finite therapy and cure," said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Biosciences. "One of our key priorities for this year has been to execute a clinical collaboration to initiate a new combination therapy trial, as we believe that multi-drug combinations with non-overlapping mechanisms may result in higher response rates and potentially shorten the duration of treatment. We are excited to combine what we view as the most advanced core inhibitor with a promising RNAi therapeutic in this new trial as we continue to work to advance novel treatment options for patients living with this chronic disease."

    William Collier, President and Chief Executive Officer of Arbutus, stated, "Arbutus is focused on discovering and developing a cure for chronic hepatitis B. We maintain this can best be accomplished through a combination of agents with different mechanisms of action that target distinct parts of the virus lifecycle. To this end, we are advancing a proprietary portfolio of compounds at various stages of clinical and preclinical development that have the potential to lead to a functional cure with a finite treatment duration."

    Mr. Collier added, "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 some of the most promising drug candidates and expedite efforts to advance a much needed HBV treatment regimen." 

    About ABI-H0731, Assembly's Lead HBV Core Inhibitor

    Assembly's HBV portfolio includes three clinical-stage small molecule candidates, all of which are HBV core inhibitors that target multiple steps of the HBV lifecycle. In Phase 2 clinical trials, first-generation core inhibitor ABI-H0731 administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression compared to NrtI therapy alone, and has demonstrated significant declines in HBV pgRNA that may indicate decreased cccDNA levels. In the ongoing Phase 2 open-label extension trial, Assembly has begun transitioning patients off combination therapy, to then monitor for sustained virologic response (SVR).

    About Arbutus' AB-729 (Gal-Nac-RNAi)

    AB-729 is a 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 preliminary 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.

    About Assembly Biosciences

    Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly's fully integrated platform, including a robust process for strain identification and selection, GMP manufacturing expertise and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com.

    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, please visit www.arbutusbio.com.

    Assembly's Forward-Looking Statements

    The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ from those projected or implied. These risks and uncertainties include: Assembly and Arbutus' ability to initiate and complete clinical trials for ABI-H0731, AB-729, and NrtI in the currently anticipated timeframes; whether the contemplated clinical trials meet their primary endpoint(s); safety and efficacy data from clinical trials may not warrant further development of ABI-H0731 or the combination of ABI-H0731 with AB-729 and NrtI; clinical data with respect to the ABI-H0731, AB-729 and NrtI combination, may not be differentiated from other companies' clinical data; Assembly may not observe sustained virologic response (SVR) in patients who are treated with its core inhibitors; any impact that the spread of the coronavirus and resulting COVID-19 pandemic may have on initiation and continuation of the clinical trials under the collaboration; and other risks identified from time to time in Assembly's reports filed with the U.S. Securities and Exchange Commission (the SEC). All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Readers are cautioned not to rely on these forward-looking statements. Assembly intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading "Risk Factors" in Assembly's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly assumes no obligation to update publicly any forward-looking statements, whether resulting from new information, future events or otherwise.

    Arbutus' 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 Assembly and Arbutus' ability to initiate and complete clinical trials for AB-729, ABI-H0731 and an NrtI in the currently anticipated timeframes; expectations regarding the timing and number of patients enrolled in the Phase 2 clinical trial; the expected dosing of the Phase 2 clinical trial; the possibility of including additional cohorts under the collaboration agreement; the potential for multi-drug combinations with non-overlapping mechanisms to result in higher response rates and shorten the duration of treatment; and expectations regarding the safety and efficacy of Arbutus' and Assembly's product candidates.

    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 clinical trials for AB-729, ABI-H0731 and an NrtI, and the usefulness of the data; the continued demand for Arbutus' and Assembly's 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 clinical trials for AB-729, ABI-H0731 and an NrtI 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 AB-729, ABI-H0731, and an NrtI; changes in Arbutus' or Assembly's strategy regarding its product candidates and clinical development activities; economic and market conditions may worsen; 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.

    Assembly Contacts

    Investors and Media:

    Lauren Glaser

    Senior Vice President, Investor Relations and Corporate Affairs

    (415) 521-3828

    Arbutus Contacts

    Investors and Media:

    William H. Collier

    President and CEO

    Phone: 604-419-3200

    Pam Murphy

    Investor Relations Consultant

    Phone: 604-419-3200

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  4. Phase 1a/1b clinical trial for AB-729, a subcutaneously delivered RNAi agent, remains on track with results from additional cohorts expected in the second half of 2020

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

    Actively screening multiple new molecular entities in recently initiated COVID-19 research program

    Cash runway guidance extended into mid-2022

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

    WARMINSTER, Pa., Aug. 07, 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…

    Phase 1a/1b clinical trial for AB-729, a subcutaneously delivered RNAi agent, remains on track with results from additional cohorts expected in the second half of 2020

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

    Actively screening multiple new molecular entities in recently initiated COVID-19 research program

    Cash runway guidance extended into mid-2022

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

    WARMINSTER, Pa., Aug. 07, 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 second quarter 2020 financial results and provides a corporate update.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "Despite the challenging conditions resulting from the COVID-19 pandemic, we continue to make steady progress in our Phase 1a/1b clinical trial of AB-729, a subcutaneously delivered RNAi agent, and have recently initiated an additional AB-729 90 mg single-dose cohort in HBV DNA positive subjects. We also intend to initiate two 90 mg multi-dose cohorts in the second half of this year."

    Mr. Collier added, "Importantly, in March and May of this year we announced positive preliminary results from this trial, and we look forward to providing additional clinical updates in the second half of 2020. We anticipate these updates will include data from 60 mg multi-dose cohorts with dosing intervals every four and eight weeks and 90 mg single-dose week 12 data in HBV DNA negative and positive subjects. We continue to believe AB-729 is a potent RNAi agent capable of reducing HBsAg plasma levels."

    Pipeline Update

    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 (HBsAg), in preclinical models. Reducing HBsAg is thought to be essential to enable the reawakening of a patient's immune system so that it can respond to the virus.

       
    • 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.

       
    • Preliminary positive safety data in single-dose cohorts of healthy subjects and safety and efficacy data in the 60 mg and 180 mg single-dose cohorts in subjects with chronic HBV infection were reported in March 2020. Additional follow-on week 12 data for the 60 mg single-dose cohort were reported in May 2020. The data demonstrate the robust activity of AB-729 and, at week 12, the 60 mg single-dose achieved equivalent reductions in HBsAg as the 180 mg single-dose and did so while remaining generally safe and well tolerated with no abnormal transaminase values in any of the six subjects.

     Mean HBsAg changes from baseline:
      60 mg Single-Dose Cohort (N=6)180 mg Single-Dose Cohort (N=4)
     Day 29 mean log10 IU/mL

    (Standard Error of the Mean)
    -0.24 (0.13)-0.8 (0.38)
     Week 12 (day 84) mean log10 IU/mL

    (Standard Error of the Mean)
    -0.99 (0.24)-0.98 (0.22)
    • Arbutus is dosing two 60 mg multi-dose cohorts of subjects with chronic HBV infection with dosing intervals of every four and eight weeks, respectively. Arbutus is also dosing subjects in a 90 mg single-dose cohort. Results from these cohorts are expected in the second half of 2020. We also intend to initiate two 90 mg multi-dose cohorts in the second half of this year.

       
    • Arbutus has also initiated an additional AB-729 90 mg single-dose cohort in HBV DNA positive subjects with results expected in the second half of 2020.

    AB-836: Oral Capsid Inhibitor

    • 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.

       
    • In January 2020, Arbutus selected AB-836 as its next-generation oral capsid inhibitor. AB-836 is from a novel chemical series differentiated from Arbutus' second generation capsid inhibitor candidate, AB-506, as well as competitor compounds. AB-836 has the potential for increased potency and an enhanced resistance profile as compared to AB-506. Arbutus continues to expect completion of 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 next-generation oral RNA-destabilizers with chemical scaffolds distinct from Arbutus' prior generation HBV RNA destabilizer candidate, AB-452, through lead optimization. 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.

    Research Efforts to Combat COVID-19 and Future Coronavirus Outbreaks

    • Earlier this year, the Company initiated an internal research program to identify new small molecule antiviral medicines to treat COVID-19 and future coronavirus outbreaks. Dr. Michael Sofia, Arbutus' Chief Scientific Officer, who was awarded the Lasker-DeBakey Award for his discovery of sofosbuvir, brings extensive antiviral drug discovery experience to this new program. Arbutus has also joined forces with the COVID R&D consortium to further support and expedite efforts to address the COVID-19 pandemic. At this time, Arbutus' COVID-19 research program will focus on the discovery and development of new molecular entities that address specific viral targets including the nsp12 viral polymerase and the viral protease. These targets are essential viral proteins which Arbutus has experience in targeting. The Company is actively screening multiple new oral molecular entities. The establishment of the COVID-19 effort does not impact Arbutus' current cash burn guidance for 2020 of $54 to $58 million.

    Genevant Sciences Ltd. Update

    On July 23, 2020, the United States Patent and Trademark Office before the Patent Trial and Appeal Board (PTAB) announced their decision in Moderna Therapeutics, Inc.'s challenge of the validity of U.S. Patent 8,058,069 ("the '069 Patent"). In this decision, the PTAB determined no challenged claims were unpatentable. While Arbutus is the patent holder, this patent has been licensed to Genevant. The '069 Patent was included in this license agreement between Genevant and Arbutus. Arbutus is gratified by the recent decision of the PTAB, upholding the validity of one of the patents protecting Arbutus' LNP technology that Arbutus licensed to Genevant. This decision reinforces Arbutus' continuing belief in the potential of this technology.

    Arbutus is entitled to receive tiered low single digit royalties on future sales of Genevant products covered by the licensed patents. If Genevant sub-licenses the intellectual property licensed by Arbutus to Genevant, Arbutus would receive upon the commercialization of a product developed by such sub-licensee the lesser of (i) twenty percent of the revenue received by Genevant for such sublicensing and (ii) tiered low single digit royalties on product sales by the sublicensee.

    On July 31, 2020, Roivant recapitalized Genevant through an equity investment and conversion of previously issued convertible debt securities held by Roivant. 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.

    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 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 $84.0 million as of June 30, 2020, as compared to $90.8 million as of December 31, 2019. During the six months ended June 30, 2020, Arbutus used $24.3 million in operating activities, which was partially offset by $17.4 million of net proceeds from the issuance of common shares under Arbutus's ATM program. During July 2020, Arbutus fully utilized the remaining availability under the ATM program resulting in an additional $36.5 million of net proceeds from the issuance of 9.5 million common shares. The Company believes its ending second quarter cash, cash equivalents and investments of $84.0 million plus the additional $36.5 million of proceeds received under the ATM program during July 2020 are sufficient to fund the Company's operations into mid-2022 versus prior guidance of mid-2021.

    Net Loss

    Net loss attributable to common shares for the three months ended June 30, 2020 was $17.1 million ($0.25 basic and diluted loss per common share) as compared to $26.1 million ($0.46 basic and diluted loss per common share) in 2019. Net loss attributable to common shares for the three months ended June 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. Additionally, net loss attributable to common shares for the three months ended June 30, 2019 included $3.3 million of non-cash equity losses associated with our investment in Genevant Sciences Ltd. ("Genevant"), a company launched with Roivant Sciences Ltd., Arbutus's largest shareholder, in April 2018.

    Operating Expenses

    Research and development expenses were $10.5 million for the three months ended June 30, 2020 compared to $12.7 million in 2019. The decrease in research and development expenses for the three months ended June 30, 2020 versus the same period in 2019 was due primarily to lower clinical expenses. General and administrative expenses were $3.6 million for the three months ended June 30, 2020 compared to $8.2 million in 2019. The decrease in general and administrative expenses was due primarily to the departure of the Company's former President and Chief Executive Officer in June 2019 and a decrease in legal fees. In accordance with the terms of his legacy employment agreement, the Company's former President and Chief Executive Officer received $2.3 million in cash severance and the Company recognized $1.1 million of non-cash stock-based compensation expense for accelerated vesting of his stock options in 2019.

    Outstanding Shares

    The Company had approximately 71.3 million common shares issued and outstanding as of June 30, 2020. During July 2020, Arbutus issued an additional 9.5 million common shares under the ATM program. In addition, the Company had approximately 11.0 million stock options outstanding and 1.164 million convertible preferred shares outstanding, which (including the annual 8.75% coupon) 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 June 30, Six Months Ended June 30,
     2020 2019 2020 2019
    Revenue       
    Collaborations and licenses$825  $398  $1,660  $814 
    Non-cash royalty revenue689  255  1,345  518 
    Total Revenue1,514  653  3,005  1,332 
    Operating expenses       
    Research and development10,465  12,740  20,881  27,452 
    General and administrative3,566  8,189  7,119  12,601 
    Depreciation and amortization501  505  1,001  1,014 
    Change in fair value of contingent consideration116  130  228  255 
    Site consolidation7  (266) 64  (149)
    Loss from operations(13,141) (20,645) (26,288) (39,841)
    Other income (loss)       
    Interest income200  606  545  1,206 
    Interest expense(1,099) (2) (2,140) (14)
    Foreign exchange gain (loss)(47) 60  (65) 68 
    Equity investment loss  (3,334)   (7,985)
    Total other loss(946) (2,670) (1,660) (6,725)
    Net loss$(14,087) $(23,315) $(27,948) $(46,566)
    Dividend accretion of convertible preferred shares(2,995) (2,762) (5,973) (5,477)
    Net loss attributable to common shares$(17,082) $(26,077) $(33,921) $(52,043)
    Loss per share       
    Basic and diluted$(0.25) $(0.46) $(0.49) $(0.92)
    Weighted average number of common shares       
    Basic and diluted69,604,726  56,805,583  68,656,566  56,275,795 
      



    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     June 30, 2020 December 31, 2019
    Cash and cash equivalents$45,899  $31,799 
    Investments in marketable securities, current36,489  59,035 
    Accounts receivable and other current assets3,148  2,994 
    Total current assets85,536  93,828 
    Property and equipment, net of accumulated depreciation7,741  8,676 
    Investments in marketable securities, non-current1,600   
    Right of use asset2,575  2,738 
    Other non-current assets173  293 
    Total assets$97,625  $105,535 
    Accounts payable and accrued liabilities$5,813  $7,235 
    Liability-classified options150  253 
    Lease liability, current364  340 
    Total current liabilities6,327  7,828 
    Liability related to sale of future royalties19,739  18,992 
    Contingent consideration3,181  2,953 
    Lease liability, non-current2,867  3,018 
    Total stockholders' equity65,511  72,744 
    Total liabilities and stockholders' equity$97,625  $105,535 



    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW


    (in thousands)

     Six Months Ended June 30,
     2020 2019
    Net loss$(27,948) $(46,566)
    Non-cash items5,114  13,936 
    Changes in working capital(1,420) (1,555)
    Net cash used in operating activities(24,254) (34,185)
    Net cash provided by investing activities20,970  71,005 
    Net cash provided by financing activities17,440  5,015 
    Effect of foreign exchange rate changes on cash and cash equivalents(56) 95 
    Increase in cash and cash equivalents$14,100  $41,930 
    Cash and cash equivalents, beginning of period31,799  36,942 
    Cash and cash equivalents, end of period$45,899  $78,872 
    Investments in marketable securities38,089  16,410 
    Cash, cash equivalents and investments, end of period$83,988  $95,282 



    Conference Call and Webcast Today

    Arbutus will hold a conference call and webcast today, Friday, August 7, 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 4974547.

    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 4974547.

    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.

    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 negative and positive subjects will be available in the second half of 2020 and that IND-enabling studies for AB-836 will be complete by the end of 2020; Arbutus' planned 2020 cash burn guidance; the potential safety and efficacy of Arbutus' product candidates, including the potential for AB-836 to have increase potency and an enhanced resistance profile compared to AB-506; Arbutus' expectations regarding its internal and external research efforts to combat COVID-19 and future coronavirus outbreaks;  Arbutus' expectation to dose two 90 mg multi-dose cohorts in the second half of this year; the expected sufficiency of Arbutus' ending second quarter cash, cash equivalents and investments plus additional proceeds received under Arbutus' ATM program during July 2020 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:

     

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  5. WARMINSTER, Pa., Aug. 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 announced that William Collier, Arbutus' President and Chief Executive Officer, will present at the Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 3:30 PM ET.

    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…

    WARMINSTER, Pa., Aug. 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 announced that William Collier, Arbutus' President and Chief Executive Officer, will present at the Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 3:30 PM ET.

    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 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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