1. Collaboration formed to accelerate the discovery of novel oral inhibitors targeting the SARS-CoV-2 nsp5 main protease for the treatment of COVID-19 and potential future coronavirus outbreaks

    WARMINSTER, Pa. and WALTHAM, Mass. and MUNICH, Germany, April 01, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), X-Chem, Inc. (X-Chem) and Proteros biostructures GmbH (Proteros) announced today that they have entered into a discovery research and license agreement focused on the discovery of novel inhibitors targeting the SARS-CoV-2 nsp5 main protease (Mpro). The agreement is designed to accelerate the development of pan-coronavirus agents to treat COVID-19 and potential future coronavirus outbreaks.

    This collaboration brings together…

    Collaboration formed to accelerate the discovery of novel oral inhibitors targeting the SARS-CoV-2 nsp5 main protease for the treatment of COVID-19 and potential future coronavirus outbreaks

    WARMINSTER, Pa. and WALTHAM, Mass. and MUNICH, Germany, April 01, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), X-Chem, Inc. (X-Chem) and Proteros biostructures GmbH (Proteros) announced today that they have entered into a discovery research and license agreement focused on the discovery of novel inhibitors targeting the SARS-CoV-2 nsp5 main protease (Mpro). The agreement is designed to accelerate the development of pan-coronavirus agents to treat COVID-19 and potential future coronavirus outbreaks.

    This collaboration brings together Arbutus' expertise in the discovery and development of antiviral agents with X-Chem's industry leading DNA-encoded library (DEL) technology and Proteros' protein sciences, biophysics and structural biology capabilities and provides important synergies to potentially identify safe and effective therapies against coronaviruses including SARS-CoV-2. The collaboration will allow for the rapid screening of one of the largest small molecule libraries against Mpro (an essential protein required for the virus to replicate itself) and the use of state-of-the-art structure guided methods to rapidly optimize Mpro inhibitors, which Arbutus could potentially progress to clinical candidates. Financial terms of the transaction were not disclosed.

    "It is well accepted that in addition to the availability of vaccines, effective and safe therapies are needed to successfully combat the COVID-19 pandemic and any future coronavirus outbreaks," stated Dr. Michael Sofia, Arbutus's Chief Scientific Officer. "Arbutus, X-Chem and Proteros have complementary and valuable expertise that makes this collaboration particularly well-suited for small molecule drug discovery targeting coronaviruses. Our goal is to identify unique and differentiated pan-coronavirus assets targeting the main coronavirus protease which, when combined with assets arising from our internal nucleoside program targeting the SARS-CoV-2 nsp12 viral polymerase, could deliver a much-needed all-oral antiviral treatment for SARS-CoV-2 and any potential future coronavirus outbreaks."

    "We are delighted of this joint discovery research collaboration with Arbutus and X-Chem, which has the potential to identify unique small molecule treatment options for COVID-19 and other possible coronavirus related respiratory diseases," said Dr. Torsten Neuefeind, Proteros' CEO. "The complementary strengths of all parties gives us a strong position to potentially inhibit a key enzyme with a central role in the viral life cycle in a specific and effective manner."

    "The discovery and development of novel drugs to combat infections caused by coronavirus is an incredibly important and challenging task," added Matt Clark, PhD, Chief Executive Officer of X-Chem. "We are exhilarated to join forces with industry leaders Arbutus and Proteros in this effort and bring our drug discovery expertise to this important area of antiviral research."

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. Arbutus 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.

    About Proteros biostructures GmbH

    Proteros is a privately held early-stage drug discovery services provider committed to helping pharmaceutical and biotech companies unlock even the most challenging drug targets.

    Proteros pioneered the industrialization of structural biology, and has developed a cutting-edge drug discovery platform that encompasses protein sciences, protein crystallography and cryo-EM, assays, biophysics and screening, positioned to open the door to lead optimization and clinical programs for technically demanding targets. The company works continuously with most of the world's 20 largest pharma companies and its global client base spans more than 200 pharmaceutical and biotech partners in the US, Europe and Japan.

    For more information please visit www.proteros.com.

    About X-Chem

    X-Chem is the industry-leading provider of DNA-Encoded Library (DEL)-based discovery services. X-Chem has entered into drug discovery partnerships with numerous pharmaceutical companies, established and early-stage biotechnology companies, as well as research institutes and universities resulting in the licensing of hundreds of novel hits and leads across many target classes and therapeutic areas. X-Chem's clients and licensees include AbbVie, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Genentech, Gilead, Janssen, Maruho, MD Anderson Cancer Center, Otsuka, and Vertex, among others. For further information, please visit www.x-chemrx.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 expectations for the collaboration, including the ability to allow for the rapid screening of one of the largest small molecule libraries against Mpro and the use of state-of-the-art structure guided methods to rapidly optimize Mpro inhibitors, which Arbutus could potentially progress to clinical candidates; our goal for the collaboration to identify unique and differentiated pan-coronavirus assets targeting the main coronavirus protease which, when combined with assets arising from our internal nucleoside program targeting the SARS-CoV-2 nsp12 viral polymerase, could deliver a much-needed all-oral antiviral treatment for SARS-CoV-2 and any potential future coronavirus outbreaks; and the potential benefits from the collaboration.

    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: the parties may never release the expected benefits of the collaboration; anticipated research activities and pre-clinical studies 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 candidate; Arbutus may elect to change its 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 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.

    Arbutus 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: 

    X-Chem and Proteros Contact Information:

    Steffen Helmling, PhD

    Chief Business Officer

    Phone: 781-419-6900

    Email:

    Dr. Torsten Neuefeind

    Chief Executive Officer

    Phone: +49 89 700761-0

    Email:



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  2. WARMINSTER, Pa., March 16, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has received regulatory approval to initiate a Phase 1a/1b clinical trial with AB-836, its proprietary oral capsid inhibitor for the treatment of HBV infection.

    "We are pleased that we have received regulatory approval to proceed with our Phase 1a/1b clinical trial for AB-836, and we expect to begin dosing shortly. Initiation of this trial is an important step towards potential future proprietary combinations with…

    WARMINSTER, Pa., March 16, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has received regulatory approval to initiate a Phase 1a/1b clinical trial with AB-836, its proprietary oral capsid inhibitor for the treatment of HBV infection.

    "We are pleased that we have received regulatory approval to proceed with our Phase 1a/1b clinical trial for AB-836, and we expect to begin dosing shortly. Initiation of this trial is an important step towards potential future proprietary combinations with AB-729 and other mechanisms," said William Collier, President and Chief Executive Officer of Arbutus.

    Dr. Michael Sofia, Chief Scientific Officer of Arbutus, added, "Based on pre-clinical studies with AB-836, which is derived from a novel chemical series in this class, we believe it has the potential for improved clinical efficacy and safety as well as a favorable resistance profile relative to earlier generation capsid inhibitors. In addition, we believe that the strong potency of AB-836 as shown in in vitro testing should allow active engagement of the second mechanism of inhibiting cccDNA replenishment at clinically relevant doses."

    About AB-836

    AB-836 is an oral capsid inhibitor for the treatment of chronic hepatitis B infection. It is from a novel chemical series that is differentiated from competitor compounds and has the potential for increased efficacy and an enhanced resistance profile. AB-836 binds to a novel site within the core protein dimer-dimer interface and has shown in in vitro testing to be active against nucleotide analog resistant variants and also has the potential to address certain known capsid resistant variants. AB-836 has been shown in in vitro studies to be active against nucleoside resistant variants and therapeutically relevant activity against key core protein resistant variants I105T and T33N. AB-836 is anticipated to be combinable with other drugs having different mechanisms of action for treating HBV, including AB-729, and is also anticipated to be dosed once daily.

    About HBV

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

    Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements about the Company's expectation to begin dosing in a Phase 1a/1b clinical trial for AB-836 shortly; the Company's belief that AB-836 has the potential for improved clinical efficacy and safety as well as a favorable resistance profile relative to earlier generation capsid inhibitors; the Company's belief regarding the strong potency of AB-836 and its ability to allow active engagement of the second mechanism of inhibiting cccDNA replenishment at clinically relevant doses; AB-836's potential to address certain known capsid resistant variants; and the Company's anticipation for AB-836 to be combinable with other drugs having different mechanisms of action for treating HBV and to be dosed once daily.

    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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  3. AB-729, Arbutus' proprietary subcutaneously delivered RNAi agent, demonstrates robust and continuous declines in hepatitis B surface antigen (HBsAg) in subjects with chronic hepatitis B (HBV) with favorable safety and tolerability data

    Reductions in HBsAg seen in both HBV DNA negative and HBV DNA positive subjects support a potential dosing schedule for AB-729 as infrequently as every 8 to 12 weeks

    Several AB-729 Phase 2 proof-of-concept combination clinical trials expected to initiate this year

    AB-836, Arbutus' proprietary oral capsid inhibitor, on track to begin a Phase 1a/1b clinical trial in healthy volunteers and subjects with HBV in the first half of 2021

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

    WARMINSTER, Pa…

    AB-729, Arbutus' proprietary subcutaneously delivered RNAi agent, demonstrates robust and continuous declines in hepatitis B surface antigen (HBsAg) in subjects with chronic hepatitis B (HBV) with favorable safety and tolerability data

    Reductions in HBsAg seen in both HBV DNA negative and HBV DNA positive subjects support a potential dosing schedule for AB-729 as infrequently as every 8 to 12 weeks

    Several AB-729 Phase 2 proof-of-concept combination clinical trials expected to initiate this year

    AB-836, Arbutus' proprietary oral capsid inhibitor, on track to begin a Phase 1a/1b clinical trial in healthy volunteers and subjects with HBV in the first half of 2021

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

    WARMINSTER, Pa., March 04, 2021 (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 fourth quarter and year-end 2020 financial results and provides a corporate update.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "Our current data set for AB-729, our lead compound in development for HBV, has grown substantially over the past 12 months and increases our confidence that it has the potential to be a cornerstone drug in future HBV combination regimens."

    Mr. Collier added, "Looking ahead, 2021 is expected to provide us with important insights regarding the potential therapeutic value of several compounds in our proprietary HBV pipeline including: longer term Phase 1a/1b dosing results for AB-729; the initiation of a Phase 2 combination clinical trial with AB-729 and Assembly Biosciences' lead core inhibitor; initiation of Phase 2 clinical trials for AB-729 and one or more approved or investigational agents; and initial Phase 1a/1b data from our proprietary oral capsid inhibitor, AB-836."

    Dr. Gaston Picchio, Chief Development Officer of Arbutus, commented, "AB-729 has shown impressive reductions in HBsAg with an unremarkable longer term safety profile in the clinical data from our Phase 1a/1b clinical trial. The data that has emerged from this clinical trial so far is encouraging and it suggests that AB-729 could potentially be dosed less frequently than every 4 weeks potentially providing a competitive advantage. As a matter of fact, we are testing a dosing schedule of every 8 weeks in our Phase 2 clinical trial in collaboration with Assembly."

    Dr. Picchio added, "We are pleased that we have initiated screening for our proof-of-concept Phase 2 clinical trial combining AB-729 with Assembly Biosciences' lead core inhibitor candidate, also known as a capsid inhibitor, vebicorvir, and a nucleos(t)ide reverse transcriptase inhibitor."

    Pipeline Update

    AB-729

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



    • Results to date demonstrate that treatment of AB-729 using the 60 mg and 90 mg doses has been well tolerated after a single dose. Efficacy results to date suggest that repeat dosing using the 60 mg dose every 4 weeks resulted in a continuous and robust mean HBsAg decline at week 24 (-1.84 log10 IU/mL, N=7). Repeat dosing using the 60 mg dose every 8 weeks results in comparable mean HBsAg declines relative to the 60 mg dose every 4 weeks at week 16 (-1.37 log10 IU/mL vs -1.44 log10 IU/mL, p<0.7). In HBV DNA positive CHB subjects, a single 90 mg AB-729 dose resulted in robust mean HBsAg (-1.02 log10 IU/mL) and HBV DNA (-1.53 log10 IU/mL) declines at week 12, as well as decreases in HBV RNA and core-related antigen. Similar mean HBsAg reductions were observed in HBV DNA positive and negative CHB subjects supporting complete target engagement by AB-729.



    • Arbutus expects to provide additional data from ongoing cohorts of the Phase 1a/1b clinical trial in the first half of 2021, except for initial data from the 90 mg every 12 week cohort which is expected in the second half of 2021. Based on these results, Arbutus intends to advance AB-729 into two Phase 2 combination trials with one or more approved or investigational agents in the second half of 2021 with dosing of AB-729 as infrequently as every 8 or 12 weeks.



    • Arbutus and Assembly initiated screening in a Phase 2 proof-of-concept combination clinical trial to evaluate AB-729 in combination with Assembly Biosciences' lead core (capsid) inhibitor candidate vebicorvir and a nucleos(t)ide reverse transcriptase inhibitor for the treatment of subjects with chronic HBV infection. The randomized, multi-center, open-label Phase 2 clinical trial will evaluate the safety, pharmacokinetics, and antiviral activity of the triple combination of VBR, AB-729 and an NrtI compared to the double combinations of VBR with an NrtI and AB-729 with an NrtI. Approximately 60 virologically-suppressed subjects with HBeAg negative chronic HBV are expected to be enrolled in the first cohort of the trial. Subjects will be dosed for 48 weeks with VBR 300 mg orally once daily and AB-729 60 mg subcutaneously every 8 weeks, with a 48-week follow-up period.

    AB-836: Oral Capsid Inhibitor

    • In January 2020, Arbutus selected AB-836 as its next-generation oral capsid inhibitor. AB-836 is from a novel chemical series differentiated from competitor compounds with the potential for increased efficacy and an enhanced resistance profile. Arbutus completed CTA/IND-enabling studies in the fourth quarter of 2020 and anticipates initiating a Phase 1a/1b clinical trial for AB-836 in the first half of 2021.

    Early R&D Programs

    • Arbutus' drug discovery efforts are focused on follow-on compounds for its current HBV pipeline and new small molecule antiviral medicines to treat COVID-19 and future coronavirus outbreaks. Arbutus expects to continue to advance its research in its oral PD-L1 inhibitor, RNA-destabilizer and coronavirus programs.

    Genevant Sciences Ltd.

    Arbutus owns approximately 16% of the common equity of Genevant Sciences Ltd. ("Genevant"), a company Arbutus launched with Roivant Sciences, Ltd. and to which Arbutus licensed exclusive rights to its lipid nanoparticle ("LNP") and ligand conjugate delivery technologies for RNA-based applications outside of HBV. We are 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 us to Genevant, we are entitled to 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.

    Financial Results

    Cash, Cash Equivalents and Investments

    Arbutus had cash, cash equivalents and investments totaling $123.3 million as of December 31, 2020, as compared to $90.8 million as of December 31, 2019. During the twelve months ended December 31, 2020, Arbutus used $51.4 million in operating activities and made a $2.5 million equity investment in Genevant, which was offset by $86.3 million of net proceeds from the issuance of common shares under Arbutus' ATM program. Thus far during the first quarter of 2021, Arbutus has received an additional $24.3 million of net proceeds from the issuance of common shares under its ATM program. Arbutus expects a net cash burn between $70 to $75 million in 2021 and therefore the Company believes its cash runway extends through the third quarter of 2022.

    Net Loss

    Net loss attributable to common shares for the twelve months ended December 31, 2020 was $75.9 million ($1.00 basic and diluted loss per common share) as compared to $164.9 million ($2.89 basic and diluted loss per common share) for the twelve months ended December 31, 2019. The decrease in the net loss was due primarily to: i) non-cash impairment charges in 2019 of $43.8 million for an in-process research and development ("IPR&D") intangible asset and $22.5 million for goodwill to reduce their carrying values to zero, as well as a corresponding income tax benefit of $12.7 million related to the decrease in the deferred tax liability associated with the IPR&D intangible assets; ii) a $20.0 million decrease in non-cash equity losses associated with the Company's investment in Genevant; iii) a $10.1 million decrease in research and development expenses; and iv) a $6.3 million expense in 2019 related to an arbitration award from the Company's arbitration with the University of British Columbia.

    Net loss attributable to common shares for the twelve months ended December 31, 2020 and 2019 also included non-cash expense for the accrual of coupon on the Company's convertible preferred shares of $12.1 million and $11.1 million, respectively.

    Operating Expenses

    Research and development expenses were $47.5 million for the twelve months ended December 31, 2020 compared to $57.6 million in 2019. The decrease in research and development expenses for the year ended December 31, 2020 versus the same period in 2019 was due primarily to lower clinical expenses in 2020. General and administrative expenses were $14.7 million for the twelve months ended December 31, 2020 compared to $17.7 million for the same period in 2019. This decrease was due primarily to $2.3 million in cash severance and $1.1 million of non-cash stock-based compensation expense related to our former President and Chief Executive Officer's departure from the Company in June 2019.

    Outstanding Shares

    The Company had approximately 89.7 million common shares issued and outstanding as of December 31, 2020. In addition, the Company had approximately 10.7 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 million common shares on October 18, 2021.

    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.

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS

    (in thousands, except share and per share data)

     Year ended December 31,
     2020 2019
    Revenue   
    Collaborations and licenses$3,519  $4,355 
    Non-cash royalty revenue3,395  1,656 
    Total revenue6,914  6,011 
    Operating expenses   
    Research and development47,481  57,601 
    General and administrative14,724  17,727 
    Depreciation1,978  2,028 
    Change in fair value of contingent consideration473  (173)
    Site consolidation64  156 
    Impairment of intangible assets  43,836 
    Impairment of goodwill  22,471 
    Arbitration  6,266 
    Loss from operations(57,806) (143,901)
    Other income (loss)   
    Interest income741  2,111 
    Interest expense(4,011) (2,108)
    Equity investment loss(2,545) (22,522)
    Foreign exchange gain (loss)(124) 41 
    Total other loss(5,939) (22,478)
    Income tax benefit  12,656 
    Net loss$(63,745) $(153,723)
    Dividend accretion of convertible preferred shares(12,123) (11,149)
    Net loss attributable to common shares$(75,868) $(164,872)
    Loss per share   
    Basic and diluted$(1.00) $(2.89)
    Weighted average number of common shares   
    Basic and diluted75,835,378  57,093,454 



     

    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     December 31, 2020 December 31, 2019
    Cash, cash equivalents and marketable securities, current$123,268 $90,834
    Accounts receivable and other current assets4,436 2,994
    Total current assets127,704 93,828
    Property and equipment, net of accumulated depreciation6,927 8,676
    Right of use asset2,405 2,738
    Other non-current assets 44  293
    Total assets$

    137,080 $

    105,535
    Accounts payable and accrued liabilities$8,901 $7,235
    Liability-classified options 

    250  

    253
    Lease liability, current390 340
    Total current liabilities9,541 7,828
    Liability related to sale of future royalties19,554 18,992
    Contingent consideration3,426 2,953
    Lease liability, non-current2,593 3,018
    Total stockholders' equity101,966 72,744
    Total liabilities and stockholders' equity$137,080 $105,535





    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

    (in thousands)

     Year ended December 31,
     2020 2019
    Net loss$(63,745) $(153,723)
    Deferred income tax benefit  (12,661)
    Impairment of intangible assets and goodwill  66,307 
    Net equity investment loss2,545  22,522 
    Other non-cash items9,328  8,774 
    Changes in working capital431  (2,225)
    Net cash used in operating activities$(51,441) $(71,006)
    Net cash provided by (used in) investing activities(14,909) 28,338 
    Net cash provided by financing activities86,746  37,457 
    Effect of foreign exchange rate changes on cash and cash equivalents56  68 
    Increase (decrease) in cash and cash equivalents$20,452  $(5,143)
    Cash and cash equivalents, beginning of period31,799  36,942 
    Cash and cash equivalents, end of period$52,251  $31,799 
    Investments$71,017  $59,035 
    Total cash, cash equivalents and investments, end of period$123,268  $90,834 

    Conference Call and Webcast Today

    Arbutus will hold a conference call and webcast today, Thursday, March 4, 2021 at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus' website at http://www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 4084504.

    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 4084504.

    About AB-729

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

    About AB-836

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

    About HBV

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

    Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements about our confidence that AB-729 has the potential to be a cornerstone drug in future HBV combination regimens; the potential that AB-729 could potentially be dosed less frequently than every 4 weeks potentially providing a competitive advantage; our expectation to provide additional data from ongoing cohorts of the Phase 1a/1b clinical trial of AB-729 in the first half of 2021, except for initial data from the 90 mg every 12 week cohort which is expected in the second half of 2021; our intention to advance AB-729 into two Phase 2 combination trials with one or more approved or investigational agents in the second half of 2021 with dosing of AB-729 as infrequently as every 8 to 12 weeks; our plans with respect to the Phase 2 proof-of-concept combination clinical trial to evaluate AB-729 in combination with Assembly Biosciences' lead core/capsid inhibitor candidate vebicorvir and a nucleos(t)ide reverse transcriptase inhibitor for the treatment of subjects with chronic HBV infection, including the expected trial design, the expected number and type of patients to be enrolled in the trial and the expected dosing schedule; the potential for AB-836 to have increased efficacy and an enhanced resistance profile; the expected initiation, in the first half of 2021, of a Phase 1a/1b clinical trial of AB-836; the expected continued advancement of our research in the oral PD-LE inhibitor, RNA-destabilizer and coronavirus programs; our expectation regarding the impact of the COVID-19 pandemic on our business and clinical trials; our expected net cash burn between $70 to $75 million for 2021; and our expected cash runway through the third quarter of 2022.

    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; 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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  4. WARMINSTER, Pa., March 02, 2021 (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 H.C. Wainwright Global Life Sciences Conference held virtually from March 9-10, 2021.

    A webcast of the virtual presentation will be available starting at 7:00 am (EST) on March 9, 2021, and can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Webcast.   An archived replay of the webcast…

    WARMINSTER, Pa., March 02, 2021 (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 H.C. Wainwright Global Life Sciences Conference held virtually from March 9-10, 2021.

    A webcast of the virtual presentation will be available starting at 7:00 am (EST) on March 9, 2021, and can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Webcast.   An archived replay of the webcast will be available on the Company's website after the conference.

    About Arbutus

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

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:



    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



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  5. Trial will evaluate Assembly's core inhibitor candidate, vebicorvir, with Arbutus' RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy

    SOUTH SAN FRANCISCO, Calif., and WARMINSTER, Pa., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB) and Arbutus Biopharma Corporation (NASDAQ:ABUS) today announced the initiation of a Phase 2 clinical trial of Assembly Bio's investigational hepatitis B virus (HBV) core inhibitor candidate, also known as a capsid inhibitor, vebicorvir (VBR), in combination with Arbutus' proprietary GalNAc delivered RNAi therapeutic candidate, AB-729, and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy for the treatment of patients with chronic HBV infection…

    Trial will evaluate Assembly's core inhibitor candidate, vebicorvir, with Arbutus' RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy

    SOUTH SAN FRANCISCO, Calif., and WARMINSTER, Pa., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB) and Arbutus Biopharma Corporation (NASDAQ:ABUS) today announced the initiation of a Phase 2 clinical trial of Assembly Bio's investigational hepatitis B virus (HBV) core inhibitor candidate, also known as a capsid inhibitor, vebicorvir (VBR), in combination with Arbutus' proprietary GalNAc delivered RNAi therapeutic candidate, AB-729, and standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy for the treatment of patients with chronic HBV infection. The companies announced a clinical collaboration agreement in August 2020.

    The randomized, multi-center, open-label Phase 2 clinical trial will evaluate the safety, pharmacokinetics, and antiviral activity of the triple combination of VBR, AB-729 and an NrtI compared to the double combinations of VBR with an NrtI and AB-729 with an NrtI. Approximately 60 virologically-suppressed patients with HBeAg negative chronic HBV are expected to be enrolled across these three treatment arms. Patients will be dosed for 48 weeks with VBR 300 mg orally once daily and AB-729 60 mg subcutaneously every 8 weeks, with a 48-week follow-up period. The primary objective of the trial is to evaluate the safety and tolerability of the triple combination, while secondary objectives of the trial include evaluating the effect of the triple combination in reducing HBV viral biomarkers such as HBV DNA, HBV pgRNA and HBsAg. Additional cohorts may be added in the future to evaluate other patient populations and/or combinations.

    "We are excited to move forward with our collaborators in this proof-of-concept Phase 2 clinical trial designed to evaluate multiple complementary mechanisms of action. Importantly, this trial supports our long-standing belief that multi-drug combinations will be needed to provide patients with chronic hepatitis B a much needed and durable functional cure," stated Gaston Picchio, PhD, Chief Development Officer at Arbutus. "We believe reducing HBsAg will be a key component of future HBV curative therapies. AB-729, Arbutus' lead HBV asset, has demonstrated competitive HBsAg reductions and a favorable safety and tolerability profile in an ongoing Phase 1b clinical trial, and we are gratified to have it progress in this combination trial."

    "Our lead core inhibitor candidate, vebicorvir, in combination with standard-of-care NrtI therapy, demonstrates enhanced antiviral activity with a favorable safety profile fueling our belief that core inhibitors will become a central component of finite and curative therapies for patients with HBV," said Luisa Stamm, MD, PhD, Chief Medical Officer at Assembly Bio. "We also believe that exploring multi-drug combinations with complementary mechanisms of action could increase response rates. We look forward to exploring the promise of combination therapies in our work with Arbutus."

    About Vebicorvir, Assembly's Lead HBV Core Inhibitor

    Assembly Bio's HBV portfolio includes three clinical-stage small molecule candidates, all of which are HBV core inhibitors that target multiple steps of the HBV replication cycle. In Phase 2 clinical trials, first-generation core inhibitor vebicorvir (VBR) administered with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy demonstrated a favorable safety profile and led to greater viral suppression of both HBV DNA and HBV pgRNA than NrtI therapy alone. VBR is advancing in multiple Phase 2 combination studies.

    About Arbutus' AB-729

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

    About HBV

    Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts approximately 270 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 Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio's approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio's strategy toward cure includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies and a research program focused on the discovery of novel HBV targets. For more information, visit assemblybio.com.

    About Arbutus

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

    Assembly Bio'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. These risks and uncertainties include:  Assembly Bio's ability to initiate and complete clinical trials involving its HBV therapeutic product candidates, including trials contemplated by Assembly Bio's clinical collaboration agreements, in the currently anticipated timeframes; safety and efficacy data from clinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio's product candidates from other companies' candidates; continued development and commercialization of Assembly Bio's HBV product candidates, if successful, in the China territory will be dependent on, and subject to, Assembly Bio's collaboration agreement governing its activity in the China territory; Assembly Bio's ability to maintain financial resources necessary to continue its clinical trials and fund business operations; any impact that the COVID-19 pandemic may have on Assembly Bio's business and operations, including initiation and continuation of its clinical studies or timing of discussions with regulatory authorities; and other risks identified from time to time in Assembly Bio's reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio 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 Assembly Bio's risks and uncertainties are more fully detailed under the heading "Risk Factors" in Assembly Bio's filings with the SEC, 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 Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of 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 the anticipated trial design of Assembly Bio's and Arbutus' Phase 2 clinical trial; 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 to provide patients with chronic hepatitis B a much needed and durable functional cure; and expectations regarding the safety and efficacy of Arbutus' 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 the Phase 2 clinical trial with Assembly, 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: the Phase 2 clinical trial may be more costly or take longer to complete than anticipated, and may never be completed, or may not generate results that warrant future development; 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 and/or Assembly's 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 Bio Contacts

    Investor Contact

    Assembly Bio

    Lauren Glaser

    Senior Vice President, Investor Relations and Corporate Affairs

    (415) 521-3828

    Media Contact

    Sam Brown Inc.

    Audra Friis

    (917) 519-9577

    Arbutus Contacts

    Investors and Media:

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914



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  6. WARMINSTER, Pa., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has scheduled its fourth quarter and year end 2020 financial results and corporate update for Thursday, March 4, 2021. The schedule for the press release and conference call/webcast are as follows:

    Q4 and Year End 2020 Press Release:March 4, 2021 at 7:30 a.m. ET
    Q4 and Year End 2020 Conference Call/Webcast:March 4, 2021 at 8:45 a.m. ET
    Domestic Dial-In Number:(866) 393-1607
    International Dial-In Number:(914) 495-8556

    WARMINSTER, Pa., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has scheduled its fourth quarter and year end 2020 financial results and corporate update for Thursday, March 4, 2021. The schedule for the press release and conference call/webcast are as follows:

    Q4 and Year End 2020 Press Release:March 4, 2021 at 7:30 a.m. ET
    Q4 and Year End 2020 Conference Call/Webcast:March 4, 2021 at 8:45 a.m. ET
    Domestic Dial-In Number:(866) 393-1607
    International Dial-In Number:(914) 495-8556
    Conference ID Number:4084504

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

    An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID: 4084504.

    About Arbutus

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

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:



    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



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  7. 2021 objectives leverage positive momentum in Arbutus' Hepatitis B research and development programs

    WARMINSTER, Pa., Jan. 25, 2021 (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 its 2021 corporate objectives and provided a financial update.

    William Collier, President and CEO, stated, "We begin 2021 on solid footing from both a pipeline and financial perspective. Our lead clinical asset, AB-729, continues to demonstrate positive data in an ongoing Phase 1a/b clinical trial and we look forward to initiating…

    2021 objectives leverage positive momentum in Arbutus' Hepatitis B research and development programs

    WARMINSTER, Pa., Jan. 25, 2021 (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 its 2021 corporate objectives and provided a financial update.

    William Collier, President and CEO, stated, "We begin 2021 on solid footing from both a pipeline and financial perspective. Our lead clinical asset, AB-729, continues to demonstrate positive data in an ongoing Phase 1a/b clinical trial and we look forward to initiating several Phase 2a clinical trials in 2021. We believe AB-729 could become a cornerstone drug in future combination regimens to cure chronic hepatitis B." Mr. Collier added, "AB-836, our oral capsid inhibitor, is expected to enter a Phase 1a/1b clinical trial in the first half of this year."

    Summary of 2021 Corporate Objectives:

    • Provide additional data from ongoing cohorts of the Phase 1a/1b clinical trial of AB-729 in the first half of 2021 (except for initial data from the 90 mg every 12 week cohort which is expected in the second half of 2021).



    • Initiate a Phase 2a combination clinical trial to evaluate AB-729 in combination with Assembly Biosciences' lead core/capsid inhibitor candidate vebicorvir (VBR) and a nucleos(t)ide reverse transcriptase inhibitor (NrtI) for the treatment of subjects with chronic HBV infection in the first half of 2021.



    • Initiate two Phase 2a combination clinical trials in HBV subjects, both including AB-729 with one or more approved or investigational agents, in the second half of 2021.



    • Initiate a Phase 1a/1b clinical trial of AB-836, our next-generation oral capsid inhibitor, in the first half of 2021.



    • The company expects to continue to advance its research in the oral PD-L1 inhibitor, RNA-destabilizer and coronavirus programs.

    Financial Update:

    • Arbutus had approximately $123.3 million (unaudited) in cash, cash equivalents and investments as of December 31, 2020. The preliminary cash, cash equivalents and investments as of December 31, 2020 were calculated prior to the completion of a review by Arbutus' independent registered public accounting firm and are therefore subject to adjustment.



    • We expect our net cash burn to range from $70 to $75 million in 2021 and therefore our cash runway extends to mid-2022.

    About AB-729

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

    About AB-836

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

    About HBV

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

    About Arbutus

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

    Forward-Looking Statements and Information.

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements about the expected receipt of additional data from ongoing cohorts of the Phase 1a/1b clinical trial of AB-729 in the first half of 2021 (except for initial data from the 90 mg every 12 week cohort which is expected in the second half of 2021); the expected initiation, in the first half of 2021, of a Phase 2a combination clinical trial to evaluate AB-729 in combination with Assembly Biosciences' lead core/capsid inhibitor candidate vebicorvir (VBR) and an NrtI for the treatment of subjects with chronic HBV infection; the expected initiation, in the second half of 2021, of two Phase 2a combination clinical trials in HBV subjects, both including AB-729 with one or more approved or investigational agents; the expected initiation, in the first half of 2021, of a Phase 1a/1b clinical trial of AB-836; the expected continued advancement of our research in the oral PD-LE inhibitor RNA-destabilizer and coronavirus programs; our preliminary financial information as of December 31, 2020; and our expected net cash burn for 2021 and expected cash runway into mid-2022.

    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; and the potential for our preliminary financial information to change in connection with the finalization of our financial results for the fourth quarter of 2020.

    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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  8. WARMINSTER, Pa., Jan. 04, 2021 (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 BioConnect 2021 Conference taking place from January 11 – 14, 2021.

    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 webcast of the virtual fireside chat will be available starting…

    WARMINSTER, Pa., Jan. 04, 2021 (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 BioConnect 2021 Conference taking place from January 11 – 14, 2021.

    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 webcast of the virtual fireside chat will be available starting at 6:00 am (EST) on January 11, 2021, and can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Webcast. An archived replay of the webcast will be available on the Company's website after the conference.

    About Arbutus

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

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



    Primary Logo

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  9. Repeat dosing of 60 mg AB-729 every 8 weeks resulted in mean HBsAg declines of –1.37 log10 (N=6) comparable to AB-729 dosed every 4 weeks (

    AB-729 remains generally safe and well tolerated with no SAEs or treatment discontinuations in any cohort

    WARMINSTER, Pa., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced additional clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound.

    William Collier…

    Repeat dosing of 60 mg AB-729 every 8 weeks resulted in mean HBsAg declines of –1.37 log10 (N=6) comparable to AB-729 dosed every 4 weeks (–1.44 log10, N=7, p<0.7)

    AB-729 remains generally safe and well tolerated with no SAEs or treatment discontinuations in any cohort

    WARMINSTER, Pa., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced additional clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "Throughout 2020, Arbutus has reported data that demonstrate the robust safety and efficacy of AB-729 in multiple patient cohorts. These data support advancing AB-729 into phase 2a clinical studies in 2021 and further support our confidence in its potential to become a cornerstone drug in future combination regimens to cure chronic hepatitis B."

    Summary of new data

    Repeat dosing of AB-729 60 mg every 4 and 8 weeks results in comparable declines in mean HBsAg through week 16

    Δlog10 HBsAg/(SE)

    (IU/
    mL)
    Mean (SE) Week 12Mean (SE) Week 16Mean (SE) Week 24
    Cohort E Q4W (N=7)-1.10 (0.15)-1.44 (0.18)-1.84 (0.16)
    Cohort F Q8W (N=7)-1.02 (0.11)-1.37* (0.08)N/A**

    *Mean determined based on N=6 since one subject has not reached week 16.

    **Data not yet available since none of the subjects have reached week 24.

    Dr. Gaston Picchio, Chief Development Officer of Arbutus, commented, "The mean reduction in HBsAg seen at week 16 in Cohort F suggests that AB-729 could offer patients the advantage of being dosed every 8 weeks versus every 4 weeks. Further dosing should allow us to confirm this finding."

    Dr. Picchio added, "Importantly, safety continues to be unremarkable. We have not seen any related Grade 3/4 AEs or treatment-related discontinuations in any cohorts to date. In Cohort F, two subjects had asymptomatic ALT elevations not considered AEs; one subject with Grade 1 ALT elevations prior to trial entry has had intermittent Grade 2 elevations, while another subject had a transient Grade 1 elevation which resolved with continued treatment.

    Further, in Cohort E, the two subjects previously reported with Grade 2 and two subjects with Grade 1 ALT elevations have improved to Grade 1 and Grade 0, respectively, after week 24. All seven subjects in the cohort have consented to continue dosing with AB-729 for an additional 6 months." 

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

    Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements in this press release include statements about advancing AB-729 into phase 2a clinical studies in 2021; the Company's suggestion that suggests that AB-729 could offer patients the advantage of being dosed every 8 weeks versus every 4 weeks, which could be confirmed via further dosing; and the potential that AB-729 could be a cornerstone drug in future combination regimens to cure chronic hepatitis B infection.

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

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

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

    Contact Information



    Investors and Media



    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



    Primary Logo

    View Full Article Hide Full Article
  10. Data released today expands on November 15, 2020 AASLD presentation

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

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

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

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

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

    Data released today expands on November 15, 2020 AASLD presentation

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



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



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

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

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

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

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

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

    Summary of new data

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

     Mean (SE) Week 16

    N=7
    Mean (SE) Week 20

    N=7
    Mean (SE) Week 24

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

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



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

     Mean (SE) Week 12

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

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

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

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

    Summary of clinical trial design 

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

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

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

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

    About AB-729 

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

    About HBV

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

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

    Conference Call and Webcast Today

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

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

    About Arbutus

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

    Forward-Looking Statements and Information

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

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

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

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

    Contact Information



    Investors and Media



    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:



    Primary Logo

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

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

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

              AB-729 was generally safe and well tolerated

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

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

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

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

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

              AB-729 was generally safe and well tolerated

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

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

    Summary of presented data

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

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

     Mean (SE) Week 12

    N=7
    Mean (SE) Week 16

    N=7
    Mean (SE) Week 20

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

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

    Summary of clinical trial design 

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

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

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

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

    About AB-729 

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

    About HBV

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

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

    Conference Call and Webcast

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

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

    About Arbutus

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

    Forward-Looking Statements and Information

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

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

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

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

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:

     



    Primary Logo

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

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

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

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

    About Arbutus

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

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:

    Primary Logo

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

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

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

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

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

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

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

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

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

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

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

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

    Pipeline Update

    AB-729

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



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



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



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



      Mean HBsAg changes from baseline:
     60 mg Single-Dose

    Cohort (B)

    (N=6)
    90 mg Single-Dose

    Cohort (C)

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

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

    AB-836: Oral Capsid Inhibitor

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

    Early HBV R&D Programs

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

    Clinical Collaboration with Assembly Biosciences, Inc.

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

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

    Research Efforts to Combat COVID-19 and Future Coronavirus Outbreaks

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

    Genevant Sciences Ltd. Update

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

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

    COVID-19 Impact

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

    Financial Results

    Cash, Cash Equivalents and Investments

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

    Net Loss

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

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

    Operating Expenses

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

    Outstanding Shares

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



    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS

    (in thousands, except share and per share data)

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





    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

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





    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

    (in thousands)

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



    Conference Call and Webcast Today

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

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

    About AB-729

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

    About AB-836

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

    About HBV

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

    About Arbutus

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

    Forward-Looking Statements and Information

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

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

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

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

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:

    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:

    Primary Logo

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

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

    A live…

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

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

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

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

    About Arbutus

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

    Contact Information

    Investors and Media

    William H. Collier

    President and CEO

    Phone: 267-469-0914

    Email:



    Pam Murphy

    Investor Relations Consultant

    Phone: 267-469-0914

    Email:  

    Primary Logo

    View Full Article Hide Full Article
  15. WARMINSTER, Pa., Oct. 13, 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 HBV Mini-Conference on Tuesday, October 20, 2020 at 10:00 am ET.

    Arbutus Fireside Chat Presenters:

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

    A live webcast of the virtual…

    WARMINSTER, Pa., Oct. 13, 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 HBV Mini-Conference on Tuesday, October 20, 2020 at 10:00 am ET.

    Arbutus Fireside Chat Presenters:

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

    View Full Article Hide Full Article
  16. WARMINSTER, Pa., Sept. 28, 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 Chardan's 4th Annual Genetic Medicines Conference on Monday, October 5, 2020 at 1:00 pm 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…

    WARMINSTER, Pa., Sept. 28, 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 Chardan's 4th Annual Genetic Medicines Conference on Monday, October 5, 2020 at 1:00 pm 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:

     

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  17. 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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  18. 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:



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  19. 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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  20. 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:

     

    Primary Logo

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  21. 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
  22. WARMINSTER, Pa., July 29, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has scheduled its second quarter financial results, conference call and webcast for Friday, August 7, 2020.  The schedule for the press release and conference call/webcast are as follows:

     Q2 2020 Press Release: August 7, 2020 at 7:30 a.m. ET
     Q2 2020 Conference Call/Webcast: August 7, 2020 at 8:45 a.m. ET
     Domestic Dial-In Number: (866) 393-1607
     International Dial-In Number: (914) 495-8556
     Conference ID Number: 4974547

    WARMINSTER, Pa., July 29, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that it has scheduled its second quarter financial results, conference call and webcast for Friday, August 7, 2020.  The schedule for the press release and conference call/webcast are as follows:

     Q2 2020 Press Release: August 7, 2020 at 7:30 a.m. ET
     Q2 2020 Conference Call/Webcast: August 7, 2020 at 8:45 a.m. ET
     Domestic Dial-In Number: (866) 393-1607
     International Dial-In Number: (914) 495-8556
     Conference ID Number: 4974547

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

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

    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
  23.  Mean 60 mg HBsAg reduction of 0.99 log10 IU/mL at week 12, with normal ALT and AST values throughout the follow-up period

    90 mg single-dose and 60 mg multi-dose cohorts initiated with data expected in the second half of 2020

    Conference Call and Webcast Scheduled Today at 4:30 PM ET

    WARMINSTER, Pa., May 18, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, today reports positive follow-up data from a Phase 1a/1b clinical trial (AB-729-001) in chronic HBV subjects on nucleos(t)ide therapy who received a single subcutaneous injection of 60 mg of AB-729, a proprietary GalNAc delivered RNAi compound…

     Mean 60 mg HBsAg reduction of 0.99 log10 IU/mL at week 12, with normal ALT and AST values throughout the follow-up period

    90 mg single-dose and 60 mg multi-dose cohorts initiated with data expected in the second half of 2020

    Conference Call and Webcast Scheduled Today at 4:30 PM ET

    WARMINSTER, Pa., May 18, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, today reports positive follow-up data from a Phase 1a/1b clinical trial (AB-729-001) in chronic HBV subjects on nucleos(t)ide therapy who received a single subcutaneous injection of 60 mg of AB-729, a proprietary GalNAc delivered RNAi compound. 

    William Collier, President and Chief Executive Officer of Arbutus, stated, "These new data further demonstrate the robust activity of AB-729. At week 12, the 60 mg single-dose achieved equivalent reductions in HBsAg as the 180 mg single-dose. We are currently dosing chronic HBV subjects in a multi-dose cohort with 60 mg of AB-729. These data keep us on track for achieving our goal of delivering a combination therapy that includes HBsAg reduction in chronic hepatitis B 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)

    Dr. Gaston Picchio, Chief Development Officer of Arbutus, stated, "Importantly, throughout the 12 week period, not only does AB-729 demonstrate robust HBsAg reduction, it does so while remaining generally safe and well tolerated with no abnormal transaminase values in any of the six subjects."

    Dr. Picchio added, "We are impressed by both the magnitude and continuous reduction in HBsAg achieved with a single 60 mg dose. We believe that these features could provide a competitive advantage with a low dose and reduced frequency of injections. To this end, we are currently dosing chronic HBV subjects in a multi-dose cohort with 60 mg at 4 week intervals and also intend to evaluate 60 mg at 8 week intervals, which will begin as soon as possible.  As we previously announced we are also exploring an additional 90 mg single-dose cohort. We expect data from both the 60 mg multi-dose cohorts in the second half of the year. We also expect week 12 90 mg single-dose data in the second half of 2020."

    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 or 180 mg) of AB-729. An additional cohort in Part 2 is designed to include 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, will receive multi-doses of AB-729 for up to six months.

    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.  

    Conference Call and Webcast Today

    Arbutus will hold a conference call and webcast today, Monday, May 18, 2020 at 4:30 pm Eastern Time to provide a corporate update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 8186276.

    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 8186276.

    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 (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. 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 expectations regarding the timing and clinical development of our product candidates; our expectation that certain data from the 60 mg multi-dose and 90 mg single-dose cohorts will be available in the second half of 2020; our plans to evaluate 60 mg at 8 week intervals as soon as possible; and our expectations regarding the effect of the COVID-19 pandemic on our 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: 604-419-3200
    Email:  

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:  

    Primary Logo

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  24. WARMINSTER, Pa., May 12, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, today announced that William Collier, Arbutus' President and Chief Executive Officer, will present at the UBS Virtual Global Healthcare Conference on Tuesday, May 19, 2020 at 11:40 AM 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…

    WARMINSTER, Pa., May 12, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, today announced that William Collier, Arbutus' President and Chief Executive Officer, will present at the UBS Virtual Global Healthcare Conference on Tuesday, May 19, 2020 at 11:40 AM 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. For more information, visit www.arbutusbio.com.

    Contact Information

    Investors and Media
    William H. Collier
    President and CEO
    Phone: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

    Primary Logo

    View Full Article Hide Full Article
  25. Arbutus remains on track to achieve its key 2020 objectives despite COVID-19 challenges

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

    WARMINSTER, Pa., May 11, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, today reports its first quarter 2020 financial results, provides a pipeline update and announces the establishment of a new research initiative focused on the identification of novel therapies to combat COVID-19.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "As we announced in March, preliminary results from an ongoing Phase 1a/1b clinical trial…

    Arbutus remains on track to achieve its key 2020 objectives despite COVID-19 challenges

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

    WARMINSTER, Pa., May 11, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, today reports its first quarter 2020 financial results, provides a pipeline update and announces the establishment of a new research initiative focused on the identification of novel therapies to combat COVID-19.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "As we announced in March, preliminary results from an ongoing Phase 1a/1b clinical trial for our lead compound, AB-729, demonstrate that it is a potent RNAi agent capable of reducing HBsAg plasma levels. We are on track to have additional results from the week 12 portion of the 60 mg single-dose cohort in the second quarter of 2020."

    Mr. Collier added, "Despite the challenges of COVID-19, we have not had to alter our objectives for 2020. However, future disruptions related to the COVID-19 pandemic could negatively impact our plans and timelines, including enrolling and monitoring subjects in the trial. We remain focused on developing a portfolio of products, with different mechanisms of action, that when used in combination could result in a functional cure for HBV."

    The Arbutus 2020 objectives include:

    • advancing the Phase 1a/1b clinical trial of AB-729, a proprietary GalNAc delivered RNAi compound;

    • progressing our next-generation capsid inhibitor AB-836 through IND-enabling studies; and,

    • continuing our preclinical research to develop an oral HBV RNA-destabilizer and an oral anti-PD-L1 inhibitor.

    Also, during the first quarter, and under the direction of Arbutus' Chief Scientific Officer, Dr. Michael Sofia, the Company has initiated an internal research program to identify new small molecule antiviral medicines to treat COVID-19 and future coronavirus outbreaks. Dr. Sofia, 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.

    The establishment of the COVID-19 effort does not impact Arbutus' current cash burn guidance for 2020 of $54 to $58 million.

    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.

    ° Additional week 12 results for the 60 mg single-dose cohort are expected in the second quarter of 2020.

    ° Results from the multi-dose 60 mg and single-dose 90 mg cohorts are 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 compared to AB-506.  Arbutus continues to expect completion of IND-enabling studies by the end of 2020.

    Early R&D Programs

    • Arbutus continues a focused discovery effort 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.

    New Research Efforts Initiated to Combat COVID-19

    Dr. Michael Sofia, Chief Scientific Officer of Arbutus stated, "While our core mission at Arbutus is to find a cure for hepatitis B, the magnitude of the coronavirus pandemic is undeniable. Given our proven expertise in the discovery of new antiviral therapies, we feel compelled to work towards the discovery of a new treatment. To that end, we have assembled an internal team of expert scientists, with proven track records in bringing new antiviral medicines to market, to identify novel small molecule therapies to treat COVID-19. We have also recently joined forces with the COVID R&D consortium to further support and expedite efforts to address the SARS-CoV-2 pandemic and any future coronavirus outbreaks."

    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.

    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.

    Financial Results

    Cash, Cash Equivalents and Investments

    Arbutus had cash, cash equivalents and investments totaling $88.1 million as of March 31, 2020, as compared to $90.8 million as of December 31, 2019.  We believe our ending first quarter cash, cash equivalents and investments of $88.1 million is sufficient to fund operations into mid-2021. Arbutus used $15.5 million in operating activities during the three months ended March 31, 2020. In addition, we received $12.3 million of net proceeds during the three months ended March 31, 2020 from the issuance of common shares under Arbutus's ATM program.

    Net Loss

    Net loss attributable to common shares for the three months ended March 31, 2020 was $16.8 million ($0.25 basic and diluted loss per common share) as compared to $26.0 million ($0.47 basic and diluted loss per common share) in 2019.  Net loss attributable to common shares for the three months ended March 31, 2020 and 2019 included non-cash expense for the accrual of coupon on the Company's convertible preferred shares of $3.0 million and $2.7 million, respectively.  Additionally, net loss attributable to common shares for the three months ended March 31, 2019 included $4.7 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 $10.4 million for the three months ended March 31, 2020 compared to $14.7 million in 2019.  The decrease in research and development expenses for the three months ended March 31, 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 March 31, 2020 compared to $4.4 million in 2019.  The decrease in general and administrative expenses was due primarily to a decrease in legal fees and non-cash stock based compensation expense.

    Outstanding Shares

    The Company had 68,961,395 common shares issued and outstanding as of March 31, 2020. In addition, the Company had approximately 10.6 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 million common shares on October 18, 2021.


    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
    (in thousands, except share and per share data)

      Three Months Ended March 31,
      2020   2019
    Revenue      
    Revenue from collaborations and licenses $ 835     $ 508  
    Non-cash royalty revenue 656     171  
    Total Revenue 1,491     679  
    Operating expenses      
    Research and development 10,416     14,712  
    General and administrative 3,553     4,412  
    Depreciation 500     509  
    Change in fair value of contingent consideration 112     125  
    Site consolidation 57     117  
    Loss from operations (13,147 )   (19,196 )
    Other income (loss)      
    Interest income 345     600  
    Interest expense (1,041 )   (12 )
    Foreign exchange (losses) / gains (18 )   8  
    Net equity investment loss     (4,651 )
    Total other loss (714 )   (4,055 )
    Net loss $ (13,861 )   $ (23,251 )
    Dividend accretion of convertible preferred shares (2,978 )   (2,715 )
    Net loss attributable to common shares $ (16,839 )   $ (25,966 )
    Net loss per common share      
    Basic and diluted $ (0.25 )   $ (0.47 )
    Weighted average number of common shares      
    Basic and diluted 67,683,586     55,740,121  
               


    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
    (in thousands)

      March 31, 2020   December 31, 2019
    Cash and cash equivalents $ 26,416     $ 31,799  
    Investments in marketable securities, current 58,475     59,035  
    Accounts receivable and other current assets 3,442     2,994  
    Total current assets 88,333     93,828  
    Property and equipment, net of accumulated depreciation 8,176     8,676  
    Investments in marketable securities, non-current 3,215      
    Right of use asset 2,657     2,738  
    Other non-current assets 233     293  
    Total assets $ 102,614     $ 105,535  
    Accounts payable and accrued liabilities $ 3,565     $ 7,235  
    Liability-classified options 58     253  
    Lease liability, current 408     340  
    Total current liabilities 4,031     7,828  
    Liability related to sale of future royalties 19,375     18,992  
    Contingent consideration 3,065     2,953  
    Lease liability, non-current 2,887     3,018  
    Total stockholders' equity 73,256     72,744  
    Total liabilities and stockholders' equity $ 102,614     $ 105,535  
     


    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
    (in thousands)

      Three Months Ended March 31,
      2020   2019
    Net loss $ (13,861 )   $ (23,251 )
    Non-cash items 2,448     6,589  
    Changes in working capital (4,040 )   82  
    Net cash used in operating activities (15,453 )   (16,580 )
    Net cash provided by / (used in) investing activities (2,401 )   61,033  
    Net cash provided by financing activities 12,481     2,536  
    Effect of foreign exchange rate changes on cash and cash equivalents (10 )   38  
    Increase / (decrease) in cash and cash equivalents $ (5,383 )   $ 47,027  
    Cash and cash equivalents, beginning of period 31,799     36,942  
    Cash and cash equivalents, end of period $ 26,416     $ 83,969  
    Investments in marketable securities 61,690     26,621  
    Cash, cash equivalents and investments, end of period $ 88,106     $ 110,590  
                   


    Conference Call and Webcast Today

    Arbutus will hold a conference call and webcast today, Monday, May 11, 2020 at 8:00 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 2993486.

    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 2993486.

    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. 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 expectations regarding the timing and clinical development of our product candidates, including our expectations that certain data from the 60 mg single-dose cohort will be available in the second quarter of 2020, that results from the multi-dose 60 mg and single-dose 90 mg cohorts 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; our planned 2020 objectives and cash burn guidance; the potential safety and efficacy of our product candidates, including the potential for AB-836 to have increase potency and an enhanced resistance profile compared to AB-506; our expectations regarding our new internal and external research efforts to combat COVID-19; the expected sufficiency of our ending first quarter cash, cash equivalents and investments to fund operations into mid-2021; and our expectations regarding the effect of the COVID-19 pandemic on our 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: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

    Primary Logo

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  26. WARMINSTER, Pa., May 04, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced that it has scheduled its first quarter financial results, conference call and webcast for Monday, May 11, 2020. The schedule for the press release and conference call/webcast are as follows:

    Q1 2020 Press Release: May 11, 2020 at 6:00 a.m. ET
    Q1 2020 Conference Call/Webcast: May 11, 2020 at 8:00 a.m. ET
    Domestic Dial-In Number: (866) 393-1607
    International Dial-In Number: (914) 495-8556
    Conference ID Number: 2993486

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

    WARMINSTER, Pa., May 04, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced that it has scheduled its first quarter financial results, conference call and webcast for Monday, May 11, 2020. The schedule for the press release and conference call/webcast are as follows:

    Q1 2020 Press Release: May 11, 2020 at 6:00 a.m. ET
    Q1 2020 Conference Call/Webcast: May 11, 2020 at 8:00 a.m. ET
    Domestic Dial-In Number: (866) 393-1607
    International Dial-In Number: (914) 495-8556
    Conference ID Number: 2993486

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

    An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 2993486.

    About Arbutus
    Arbutus Biopharma Corporation is a publicly-traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic Hepatitis B (HBV) infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen. For more information, visit www.arbutusbio.com.

    Contact Information

    Investors and Media
    William H. Collier
    President and CEO
    Phone: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

    Primary Logo

    View Full Article Hide Full Article
  27. Positive single dose AB-729 data in chronic hepatitis B subjects supports further clinical development

    First multiple dose cohort results expected in second half of 2020

    One or more additional single dose cohorts planned to further optimize antiviral response and dosing frequency with results expected in the second half of 2020

    Conference call and webcast scheduled today at 4:30 PM ET

    WARMINSTER, Pa., March 26, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced positive preliminary results from a Phase 1a/1b clinical trial (AB-729-001) in healthy subjects and two cohorts of chronic hepatitis B subjects on nucleos(t)ide antiviral therapy, all of whom…

    Positive single dose AB-729 data in chronic hepatitis B subjects supports further clinical development

    First multiple dose cohort results expected in second half of 2020

    One or more additional single dose cohorts planned to further optimize antiviral response and dosing frequency with results expected in the second half of 2020

    Conference call and webcast scheduled today at 4:30 PM ET

    WARMINSTER, Pa., March 26, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced positive preliminary results from a Phase 1a/1b clinical trial (AB-729-001) in healthy subjects and two cohorts of chronic hepatitis B subjects on nucleos(t)ide antiviral therapy, all of whom received a single subcutaneous injection of AB-729. AB-729-001 is an ongoing Phase 1a/1b clinical trial designed to determine the most effective dose and dosing interval for use in future Phase 2 combination clinical trials.

    William Collier, President and Chief Executive Officer of Arbutus, stated, "These encouraging preliminary results demonstrate that AB-729 is a potent RNAi agent capable of reducing HBsAg plasma levels and support its further development as a treatment for people living with chronic hepatitis B.  Our plan is to move forward into the multiple dose portion of the clinical trial with the 60 mg dose and, in parallel, to explore additional single dose cohorts beginning with the 90 mg dose. We intend to initiate these cohorts as soon as possible; however, at this point, it is not possible to predict if the COVID-19 pandemic will negatively impact our plans and timelines. Provided we can execute our clinical trials as planned, we continue to expect these data sets in the second half of the year."

    Mean HBsAg changes from baseline:

      60 mg Cohort (N=6) 180 mg Cohort (N=4)
    Day 29 mean log10 IU/mL (SE) -0.24# (0.13) -0.81* (0.38)
    Week 12 mean log10 IU/mL (SE) NA -0.98 (0.22)

    #In the 60 mg cohort, the maximum Day 29 decline was -0.62 log10.  
    *In the 180 mg cohort, excluding one subject with a HBsAg decline of -1.94 log10, the mean (SE) reduction for the remaining 3 subjects was -0.44 log10 (0.07) at Day 29 and -0.77 log10 (0.06) at Week 12.

    Dr. Gaston Picchio, Chief Development Officer of Arbutus, stated, "AB-729 dosed at either 60 mg or 180 mg in chronic hepatitis B subjects was generally safe and well tolerated and resulted in meaningful reductions in HBsAg levels. Additionally, after a single 180 mg dose, HBsAg levels continued to decline well beyond Week 12, suggesting that AB-729 has the potential to be dosed less frequently than every four weeks."

    Dr. Picchio added, "The subject receiving the 180 mg dose who experienced the highest HBsAg decline also experienced a Grade 3 ALT/AST flare. While the flare may have been related to an acute gastroenteritis and self-medication, we believe evaluating at least one additional single dose cohort starting at 90 mg is appropriate and should allow us to determine if a mid-dose would provide the greatest benefit in terms of safety, efficacy and dosing interval."

    Preliminary safety summary in healthy subjects

    • In the 60 mg, 180 mg and 360 mg cohorts, no serious adverse events (SAEs) were observed; most adverse events (AEs) were mild (13/15) and considered unrelated (12/15) to AB-729.

    • Two subjects in the 360 mg cohort had asymptomatic, reversible Grade 3 ALT elevations assessed as related to AB-729. Neither subject had meaningful changes in any other laboratory parameter excepting Grade 1 or 2 AST elevation.

    • There were no other clinically relevant abnormalities in laboratory tests, ECGs, or vital signs.

    Preliminary safety and efficacy summary in chronic HBV subjects

    • HBsAg declines were observed in all 4 subjects (3 HBeAg negative, 1 HBeAg positive) in the 180 mg cohort, with a mean HBsAg (SE) log10 reduction of -0.81 (0.38) at Week 4 and -0.98 (0.22) at Week 12.

    • In the 180 mg cohort, maximum HBsAg decline of -1.94 log10 occurred at Week 4 in one subject (HBeAg negative). HBsAg declines continued beyond Week 12 for 2/3 subjects in the 180 mg cohort with available data, exceeding -1.00 log10 in both subjects. A 4th subject in the 180 mg cohort had continuous HBsAg decline up to 12 weeks post-dose, with a maximum decline of -0.73 log10 at Week 12 (the last available time point).

    • Mean log10 (SE) HBsAg decline in the 6 subjects in the 60 mg cohort (all HBeAg negative) was -0.24 (0.13) at Day 29. The maximum HBsAg decline in this cohort was -0.62 log10 at Day 29. Subjects in the 60 mg cohort will continue to be followed for twelve weeks. At this time only the four week data are available for the 60 mg cohort.

    • In chronic hepatitis B subjects administered 180 mg (N=4) or 60 mg (N=6) of AB-729 there were no SAEs. In the 180 mg cohort, 8 AEs were observed and included asymptomatic, transient Grade 1 ALT/AST in 1 subject, Grade 1 ALT only in 1 subject, and 1 subject with Grade 1 ALT /AST at baseline who experienced unrelated gastroenteritis and self-medicated associated with transient Grade 3 ALT/AST elevations. In the 60 mg cohort, 2 AEs were observed, and all subjects had normal ALT/AST levels.

    Summary of clinical trial design

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

    • In Part 1, 3 cohorts of healthy subjects were randomized 4:2 to receive single doses (60mg, 180mg or 360mg) of AB-729 or placebo.

    • In Part 2, non-cirrhotic, HBeAg positive or negative, chronic hepatitis B subjects (N=6) currently taking nucleos(t)ide antiviral therapy with HBV DNA below the limit of quantitation received single doses (60mg or 180mg) of AB-729. All subjects continued their nucleos(t)ide antiviral therapy throughout the trial. Part 2 is designed to include dosing of AB-729 in HBV DNA positive chronic hepatitis B subjects.

    • In Part 3, chronic hepatitis B subjects, HBV DNA negative first and HBV DNA positive later, will receive multiple doses of AB-729 for up to six months.

    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 (e.g. in Australia).  It is not possible to predict if the COVID-19 pandemic will negatively impact our plans and timelines.

    About AB-729

    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.

    Conference Call and Webcast Today

    Arbutus will hold a conference call and live webcast today, March 26, 2020 at 4:30 PM Eastern Time, to discuss the preliminary Phase 1a/1b clinical trial results for AB-729. You can access the live webcast, which will include presentation slides, through the Investors section of Arbutus' website at www.arbutusbio.com or directly at Live Webcast.  Alternatively, please dial (866) 393 - 1607 or (914) 495 - 8556 and reference conference ID 2169859.

    An archived webcast will be available on the Arbutus website after the event.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly-traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic hepatitis B (HBV) infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen. 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 expectations regarding the timing and clinical development of our product candidates, including the evaluation of multiple dose and additional single-dose cohorts in our Phase 1a/1b clinical trial for AB-729 during 2020; and the potential for our drug candidates to improve upon the standard of care and contribute to a curative combination regimen for chronic HBV.

    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; 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; 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: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

    Primary Logo

    View Full Article Hide Full Article
  28. Conference Call and Webcast Scheduled Today at 8:45 AM ET

    WARMINSTER, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today reports its fourth quarter and year end 2019 financial results, confirms 2020 corporate objectives and provides pipeline update.

    "Arbutus is focused on developing a portfolio of medicines with different mechanisms of action that we believe could provide a functional cure for people with chronic hepatitis B," said William Collier, Arbutus' President and Chief Executive Officer. "Our key objectives for 2020 are to complete and report results from the Phase 1a/b clinical trial of AB-729, our proprietary subcutaneous RNAi agent…

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

    WARMINSTER, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today reports its fourth quarter and year end 2019 financial results, confirms 2020 corporate objectives and provides pipeline update.

    "Arbutus is focused on developing a portfolio of medicines with different mechanisms of action that we believe could provide a functional cure for people with chronic hepatitis B," said William Collier, Arbutus' President and Chief Executive Officer. "Our key objectives for 2020 are to complete and report results from the Phase 1a/b clinical trial of AB-729, our proprietary subcutaneous RNAi agent, and rapidly advance our next-generation oral capsid inhibitor, AB-836, through IND-enabling studies by year end.

    Mr. Collier added, "We remain on track to announce preliminary safety and efficacy results from multiple single-dose cohorts in the Phase 1a/1b clinical trial for AB-729 later this month."

    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 a key prerequisite to enable reawakening of a patient's immune system to respond to the virus.
       
    • Arbutus is currently conducting a single- and multiple-dose Phase 1a/1b clinical trial for AB-729 to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 in healthy volunteers and in subjects with chronic hepatitis B (CHB) infection. 
       
    • Preliminary safety data in single-dose cohorts of healthy subjects and safety and efficacy data in single-dose cohorts of subjects with CHB infection are expected later this month.  Additional single-dose data and preliminary multi-dose data are expected in the second half of 2020.

    AB-836

    • AB-836 is an oral HBV capsid inhibitor. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily nucleoside 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 viral reservoir which resides in the cell nucleus.
       
    • In January 2020, Arbutus selected AB-836 as its next-generation oral capsid inhibitor.  AB-836 is a novel chemical series differentiated from Arbutus' previously discontinued capsid inhibitor candidate, AB-506, and other competitor compounds in the capsid inhibitor space.  AB-836 has the potential for increased potency and an enhanced resistance profile compared to AB-506, our previous generation capsid inhibitor that was discontinued in October 2019.  Arbutus anticipates completing IND-enabling studies by the end of 2020.

    Early R&D Programs

    • Arbutus continues a focused discovery effort on follow-on compounds for its current HBV pipeline, including the development of oral RNA-destabilizers that have shown compelling anti-viral effects in multiple HBV preclinical models. Arbutus is now focused on advancing a next-generation oral HBV specific RNA-destabilizer with chemical scaffolds distinct from AB-452 through lead optimization.  Arbutus also has compounds in lead optimization that are potentially capable of reawakening patients' HBV-specific immune response by inhibiting PD-L1.

    Cash Position and 2020 Cash Guidance

    • Arbutus ended the year with $90.8 million in cash, cash equivalents and short-term investments which the Company believes is sufficient to fund operations into mid-2021. Arbutus expects to utilize between $54 to $58 million of cash and investments to fund operations in 2020.

    Financial Results

    Cash, Cash Equivalents and Investments

    Arbutus had cash, cash equivalents and short-term investments totaling $90.8 million as of December 31, 2019, as compared to $124.6 million as of December 31, 2018.  The decreased cash balance was due primarily to the $71.0 million used in operating activities during the year ended December 31, 2019, partially offset by $18.5 million in net proceeds from the sale of Arbutus' portion of a royalty entitlement on net sales of Alnylam Pharmaceuticals, Inc.'s ONPATTROTM (Partisiran) in the third quarter of 2019 and $18.6 million of net proceeds from the issuance of shares under Arbutus' ATM program.  Included in the $71.0 million used in operating activities is a $5.9 million payment in the third quarter of 2019 for an award rendered in an arbitration proceeding with the University of British Columbia.  Subsequent to year end, Arbutus has received an additional $12.3 million of net proceeds from the issuance of shares under Arbutus' ATM program during the first quarter of 2020 through March 4, 2020.

    Net Loss

    Net loss attributable to common shares for the year ended December 31, 2019, including non-cash charges of $43.8 million related to the impairment of an in-process research and development ("IPR&D") intangible asset and $22.5 million for the impairment of goodwill described further below, was $164.9 million ($2.89 basic and diluted loss per common share) as compared to $67.2 million ($1.21 basic and diluted loss per common share) in 2018.  Net loss attributable to common shares also included non-cash expense for the accrual of coupon on the Company's convertible preferred shares of $11.1 million in 2019 and $10.1 million in 2018, as well as non-cash equity losses associated with our investment in Genevant Sciences Ltd.'s ("Genevant") of $22.5 million in 2019 and non-cash equity gains of $19.3 million in 2018.  Genevant is a company launched with Roivant Sciences Ltd., Arbutus largest shareholder, in April 2018.

    ONPATTRO Royalty Entitlement

    Arbutus has a royalty entitlement on global net sales of ONPATTRO™ (Patisiran) for the lipid nanoparticle delivery (LNP) technology licensed by Arbutus to Alnylam for this product. ONPATTRO is an RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis that has been approved by the U.S. Food and Drug Administration and the European Medicines Agency. In July 2019, Arbutus sold this royalty entitlement to OCM IP Healthcare Portfolio LP, an affiliate of the Ontario Municipal Employees Retirement System (collectively, OMERS), effective as of January 1, 2019, for $20 million in gross proceeds before advisory fees. OMERS will retain this royalty entitlement until it has received $30 million in royalties, at which point 100% of this royalty entitlement will revert to Arbutus.  OMERS has assumed the risk of collecting up to $30 million of future royalty payments from Alnylam and Arbutus is not obligated to reimburse OMERS if they fail to collect any such future royalties.  Arbutus recognized the $20 million of gross proceeds from this transaction as a liability, net of transaction costs. The Company is amortizing the liability to non-cash interest expense and will continue to recognize the royalty revenue that Alnylam pays to OMERS as non-cash royalty revenue.

    In addition to the royalty entitlement from the Alnylam LNP license agreement, Arbutus is also receiving a second, lower royalty entitlement on global net sales of ONPATTRO originating from a settlement agreement and subsequent license agreement with Acuitas Therapeutics. The royalty entitlement from Acuitas has been retained by Arbutus and is not part of the royalty entitlement sale to OMERS.

    Operating Expenses

    Research and development expenses were $57.6 million for the year ended December 31, 2019 compared to $57.9 million in 2018.  Research and development expenses for the year ended December 31, 2019 included costs associated with the Company's Phase 1a/1b clinical trial for its RNAi agent (AB-729), Phase 1a/1b clinical trial for its oral capsid inhibitor (AB-506), which was discontinued in October 2019, and toxicology studies for its HBV RNA Destabilizer (AB-452), which was discontinued in February 2020.  General and administrative expenses were $17.7 million in 2019 compared to $16.0 million in 2018.  The increase in general and administrative expenses was due primarily to severance related to our former President and Chief Executive Officer's departure from the Company in June 2019, partially offset by a decrease in professional fees. In accordance with the terms of his legacy employment agreement, our 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.

    Additionally, the Company recorded a charge of $6.3 million in 2019 related to an arbitration award from the Company's arbitration with the University of British Columbia.

    Impairment of IPR&D Intangible Assets and Goodwill

    The Company has historically carried IPR&D and goodwill from its acquisition of technologies and business combination as assets.  All acquired IPR&D intangible assets relate to the Company's cccDNA program.  During the year ended December 31, 2019, the Company recorded a $43.8 million non-cash impairment expense to reduce the carrying value of its IPR&D intangible assets to zero.  The Company also recognized a corresponding income tax benefit of $12.7 million related to the decrease in its deferred tax liability associated with the IPR&D intangible assets.  The impairment was due to an indefinite delay in further development of the Company's cccDNA program while the Company focuses on its other development programs.

    Goodwill represents the excess of purchase price over the value assigned to the net tangible and identifiable intangible assets in connection with the business combination that formed Arbutus. The Company assessed changes in circumstances to determine if it was more likely than not that the fair value of the Company was below its carrying amount.  Due to a sustained decrease in the Company's share price during the year, the Company's market capitalization was reduced below the book value of its net assets and the Company concluded that its fair value was below its carrying amount by an amount in excess of the carrying value of the goodwill.  As a result, during the third quarter of 2019, the Company recorded a $22.5 million non-cash impairment expense to reduce the carrying value of its goodwill asset to zero.

    Outstanding Shares

    The Company had 64,780,314 common shares issued and outstanding as of December 31, 2019. In addition, the Company had approximately 8.6 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 million common shares on October 18, 2021.


    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
    (in thousands, except share and per share data)

      Year Ended December 31,
      2019   2018
    Revenue      
    Revenue from collaborations and licenses $ 4,355     $ 5,945  
    Non-cash revenue 1,656      
    Total revenue 6,011     5,945  
    Operating expenses      
    Research and development 57,601     57,934  
    General and administrative 17,727     16,002  
    Depreciation 2,028     2,181  
    Site consolidation 156     4,797  
    Impairment of intangible assets 43,836     14,811  
    Impairment of goodwill 22,471      
    Arbitration 6,266      
    Loss from operations (144,074 )   (89,780 )
    Other income (loss)      
    Interest income 2,111     3,047  
    Interest expense (2,108 )   (226 )
    Equity investment gains (losses) (22,522 )   19,322  
    Increase in fair value of contingent consideration 173     7,298  
    Foreign exchange gains (losses) 41     (1,003 )
    Total other income (loss) (22,305 )   28,438  
    Income tax benefit 12,656     4,282  
    Net loss (1) $ (153,723 )   $ (57,060 )
    Dividend accretion of convertible preferred shares (11,149 )   (10,091 )
    Net loss attributable to common shares $ (164,872 )   $ (67,151 )
    Net loss per common share      
    Basic and diluted $ (2.89 )   $ (1.21 )
    Weighted average number of common shares      
    Basic and diluted 57,093,454     55,304,083  

    (1)       Net loss for the year ended December 31, 2019 included $66.3 million of non-cash expenses related to the impairments of an IPR&D intangible asset and goodwill, partially offset by a corresponding income tax benefit of $12.7 million related to the decrease in a deferred tax liability associated with the IPR&D intangible asset.  Net loss for the year ended December 31, 2018 included $14.8 million of non-cash expense related to the impairment of an IPR&D intangible asset, partially offset by a corresponding income tax benefit of $4.3 million related to the decrease in a deferred tax liability associated with the IPR&D intangible asset.


    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
    (in thousands)

      December 31, 2019   December 31, 2018
    Cash and cash equivalents $ 31,799     $ 36,942  
    Investments in marketable securities 59,035     87,675  
    Accounts receivable and other current assets 2,994     4,612  
    Total current assets 93,828     129,229  
    Investment in Genevant     22,224  
    Property and equipment, net of accumulated depreciation 8,676     10,145  
    Right of use asset 2,738      
    Intangible assets     43,836  
    Goodwill     22,471  
    Other non-current assets 293      
    Total assets $ 105,535     $ 227,905  
    Accounts payable and accrued liabilities $ 7,098     $ 9,429  
    Site consolidation accrual 137     1,331  
    Liability-classified options 253     479  
    Lease liability, current 340      
    Total current liabilities 7,828     11,239  
    Liability related to sale of future royalties 18,992      
    Deferred rent and inducements, non-current     645  
    Contingent consideration 2,953     3,126  
    Lease liability, non-current 3,018      
    Deferred tax liability     12,661  
    Total stockholders' equity 72,744     200,234  
    Total liabilities and stockholders' equity $ 105,535     $ 227,905  


    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
    (in thousands)

      Year ended December 31,
      2019   2018
    Net loss for the period $ (153,723 )   $ (57,060 )
    Deferred income tax benefit (12,661 )   (4,282 )
    Impairment of intangible assets and goodwill 66,307     14,811  
    Net equity investment loss (gain) 22,522     (19,557 )
    Other non-cash items 8,774     2,497  
    Changes in working capital (2,225 )   (4,275 )
    Net cash used in operating activities (71,006 )   (67,866 )
    Net cash provided by (used in) investing activities 28,338     (4,127 )
    Net cash provided by financing activities 37,457     55,646  
    Effect of foreign exchange rate changes on cash and cash equivalents 68     (1,003 )
    Decrease in cash and cash equivalents $ (5,143 )   $ (17,350 )
    Cash and cash equivalents, beginning of period 36,942     54,292  
    Cash and cash equivalents, end of period $ 31,799     $ 36,942  
    Short-term investments 59,035     87,675  
    Total cash, cash equivalents and short-term investments, end of period $ 90,834     $ 124,617  


    Conference Call Today

    Arbutus will hold a conference call and webcast today, Thursday, March 5, 2020 at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call through the Investors section of Arbutus' website at www.arbutusbio.com. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 5084457.

    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 5084457.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic Hepatitis B infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen.  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 expectation that certain preliminary safety and efficacy data from the Phase 1a/1b clinical trial for AB-729 will be available in the first quarter of 2020 with additional preliminary data available in the second half of 2020; our expectation to complete IND-enabling studies for AB-836 by the end of 2020; our expectation to advance a next-generation oral HBV specific RNA-destabilizer into lead optimization; the sufficiency of our cash and cash equivalents to extend into mid-2021; our expectation to use approximately $54 to $58 million of cash and investments to fund operations in 2020; and the potential for our drug candidates to improve upon the standard of care and contribute to a curative combination regimen for chronic HBV.

    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 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.

    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.

    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: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

     

    Primary Logo

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  29. WARMINSTER, Pa., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced that it has scheduled its fourth quarter and Year-End 2019 financial results, conference call and webcast for Thursday, March 5, 2020.  The schedule for the press release and conference call/webcast are as follows:

    Q4 2019 Press Release: March 5, 2020 at 7:30 a.m. ET
    Q4 2019 Conference Call: March 5, 2020 at 8:45 a.m. ET
    Domestic Dial-In Number: (866) 393-1607
    International Dial-In Number: (914) 495-8556
    Conference ID Number: 5084457

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

    An archived…

    WARMINSTER, Pa., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced that it has scheduled its fourth quarter and Year-End 2019 financial results, conference call and webcast for Thursday, March 5, 2020.  The schedule for the press release and conference call/webcast are as follows:

    Q4 2019 Press Release: March 5, 2020 at 7:30 a.m. ET
    Q4 2019 Conference Call: March 5, 2020 at 8:45 a.m. ET
    Domestic Dial-In Number: (866) 393-1607
    International Dial-In Number: (914) 495-8556
    Conference ID Number: 5084457

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

    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 5084457.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly-traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic Hepatitis B (HBV) infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen. For more information, visit www.arbutusbio.com.

    Contact Information

    Investors and Media
    William H. Collier
    President and CEO
    Phone: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

     

    Primary Logo

    View Full Article Hide Full Article
  30. Arbutus expects to announce AB-729 Preliminary Phase 1a/1b Data late Q12020

    WARMINSTER, Pa., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), announced today its decision to discontinue AB-452, its first generation orally available hepatitis B (HBV) specific RNA-destabilizer, and to continue research and development of a next generation oral HBV RNA-destabilizer. In October 2018, Arbutus announced its decision to delay the initiation of a planned 28-day Phase 1a/1b clinical trial for AB-452 in order to further evaluate the safety of the compound. This decision was based on findings in 90-day preclinical safety studies in two species. Since that time Arbutus has extensively reviewed and further characterized these…

    Arbutus expects to announce AB-729 Preliminary Phase 1a/1b Data late Q12020

    WARMINSTER, Pa., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), announced today its decision to discontinue AB-452, its first generation orally available hepatitis B (HBV) specific RNA-destabilizer, and to continue research and development of a next generation oral HBV RNA-destabilizer. In October 2018, Arbutus announced its decision to delay the initiation of a planned 28-day Phase 1a/1b clinical trial for AB-452 in order to further evaluate the safety of the compound. This decision was based on findings in 90-day preclinical safety studies in two species. Since that time Arbutus has extensively reviewed and further characterized these preclinical findings, including repeating the 90-day safety studies.

    Michael J. Sofia, Ph.D., Chief Scientific Officer of Arbutus, added, "After reviewing all the data from the preclinical studies, and in consultation with external regulatory and pre-clinical experts, we have decided to not move AB-452 forward. We continue to believe, however, that the HBV RNA destabilizer mechanism of action is very compelling and has the potential to lead to an oral therapy. We intend to vigorously pursue next generation compounds in this area."

    Arbutus also reiterated its earlier guidance for both AB-729 and AB-836. AB-729 is a subcutaneously delivered RNAi agent which has been shown in preclinical models to reduce viral antigens, including hepatitis B surface antigen (HBsAg) expression, and to inhibit HBV replication. In July 2019, the Company initiated a single and multiple dose Phase 1a/1b clinical trial for AB-729, designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 in healthy volunteers and in subjects with chronic hepatitis B (CHB) infection. Preliminary safety data in single-dose cohorts of healthy subjects and safety and efficacy data in single-dose cohorts of subjects with CHB infection are expected late this quarter. For AB-836, Arbutus' next generation capsid inhibitor, the Company expects to complete investigational new drug enabling studies by the end of the year.

    The Company believes that this compound has the potential for increased efficacy and an enhanced resistance profile relative to its previous generation capsid inhibitor, AB-506.

    William H. Collier, President and Chief Executive Officer of Arbutus, stated, "Arbutus remains committed to developing a range of medicines with differing mechanisms of action that can be used in combination for treatment of chronic HBV infection. The Company is on track to deliver on its key pipeline objectives for 2020; we look forward to announcing our preliminary safety and efficacy data for AB-729 later this quarter and to completing IND enabling studies for AB-836 by the end of the year."

    About Oral RNA-Destabilizers

    Small molecule HBV RNA destabilizers are orally active agents that cause the destabilization and ultimate degradation of HBV RNAs. These agents result in the reduction of HBsAg, HBeAg, pgRNA, and core protein in both whole cell systems and animal models. They have the potential to selectively impact HBV versus other RNA or DNA viruses and demonstrate pangenotypic characteristics. HBV RNA destabilizers have demonstrated additive effects in combination with other mechanism of action anti-HBV agents.

    About AB-729

    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 (HBsAg) in preclinical models. Reducing HBsAg is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus.

    About AB-836

    AB-836 is an oral HBV capsid inhibitor. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily nucleoside 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 viral reservoir which resides in the cell nucleus.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly-traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic Hepatitis B (HBV) infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen. For more information, visit www.arbutusbio.com.

    Forward-Looking Statements and Information

    This press release contains forward-looking statements within the meaning of 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 expectations regarding the timing and clinical development of our product candidates; our expectation to announce AB-729 preliminary Phase 1a/1b data late in the first quarter of 2020; our belief that the HBV RNA destabilizer mechanism of action is very compelling and has the potential to lead to an oral therapy; our intention to vigorously pursue additional next generation compounds; our guidance for AB-729 and AB-836, including our expectation to complete investigational new drug enabling studies by the end of the year; our belief that AB-836 has the potential for increased efficacy and an enhanced resistance profile relative to AB-506; and our belief that we are on track to deliver on our key pipeline objectives for 2020.

    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 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.

    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: delays in the selection of and the advancement of an additional capsid inhibitor compound into lead optimization, 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 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.

    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: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

     

    Primary Logo

    View Full Article Hide Full Article
  31. WARMINSTER, Pa., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today reports its third quarter 2019 financial results and provides a corporate update.

    "We remain committed to our mission of developing a portfolio of assets with differing mechanisms of action that we believe will form the basis for a functional cure of chronic Hepatitis B", said William Collier, Arbutus' President and Chief Executive Officer. "Our current efforts are focused on completing the Phase 1a/b clinical trial of AB-729, rapidly selecting a next-generation capsid inhibitor for IND-enabling studies to replace our recently discontinued AB-506, evaluating our oral RNA destabilizer…

    WARMINSTER, Pa., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today reports its third quarter 2019 financial results and provides a corporate update.

    "We remain committed to our mission of developing a portfolio of assets with differing mechanisms of action that we believe will form the basis for a functional cure of chronic Hepatitis B", said William Collier, Arbutus' President and Chief Executive Officer. "Our current efforts are focused on completing the Phase 1a/b clinical trial of AB-729, rapidly selecting a next-generation capsid inhibitor for IND-enabling studies to replace our recently discontinued AB-506, evaluating our oral RNA destabilizer, AB-452, as well as next-generation compounds in this class, and research on compounds that inhibit PD-L1."

    Recent Corporate Updates

    AB-729

    • In July 2019, the Company initiated a single and multiple dose Phase 1a/1b clinical trial for AB-729, a subcutaneously delivered RNAi agent which has been shown in preclinical models to span all HBV transcripts, reduce all viral antigens, including hepatitis B surface antigen (HBsAg) expression, and inhibit HBV replication.  In this trial, which is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 in healthy volunteers and in subjects with chronic hepatitis B (CHB) infection, AB-729 will be dosed monthly. 
       
    • Preliminary safety data in single-dose cohorts of healthy subjects and safety and efficacy data in single-dose cohorts of subjects with CHB infection are expected in the first quarter of 2020.

    Capsid Inhibitors

    • In October 2019, Arbutus announced its decision to discontinue the clinical development of AB-506, an oral capsid inhibitor, in Phase 1a/1b clinical development for the treatment of CHB due to safety observations in a Phase 1a 28-day clinical trial in healthy volunteers.  Arbutus intends to present results from the AB-506 Phase 1a/1b clinical trial program at the American Association for the Study of Liver Diseases meeting later this month.
       
    • Arbutus is evaluating a number of oral next-generation capsid inhibitor compounds with chemical scaffolding different from AB-506 that the Company believes have the potential to contribute to the inhibition of HBV replication as part of a combination regimen. The Company's objective is to select one of several lead compounds for IND-enabling studies in December of this year. 

    AB 452

    • Arbutus remains committed to the development of oral RNA-destabilizers that have shown compelling anti-viral effects in multiple HBV preclinical models. AB-452, Arbutus' lead oral RNA-destabilizer is being evaluated in a repeat 90-day preclinical safety study in two species before making a go/no-go decision. We expect that the results of this study will allow us to make that decision early in 2020.  The Company is also continuing to advance back-up compounds with chemical scaffolding different from that of AB-452.

    Early R&D Programs

    • Arbutus continues a focused discovery effort on follow-on compounds for its current HBV pipeline, including efforts to identify compounds potentially capable of reawakening patients' HBV-specific immune response by inhibiting PD-L1.

    New Appointment to Arbutus' Board of Directors

    • Andrew Cheng, M.D., Ph.D., was appointed to the Arbutus Board of Directors.  Previously, Dr. Cheng spent nearly two decades at Gilead Sciences, Inc., where he most recently served as Chief Medical Officer and Executive Vice President.  Dr. Cheng is currently President and Chief Executive Officer of Akero Therapeutics (NASDAQ:AKRO).

    Cash Position and Cash Guidance

    • The Company had approximately $90.1 million in cash and cash equivalents as of September 30, 2019.  The discontinuation of the AB-506 development program is anticipated to reduce cash burn in the short term and the Company believes its existing cash and cash equivalents balance is sufficient to fund operations into early 2021.

    Financial Results

    Cash, Cash Equivalents and Investments

    Arbutus had cash, cash equivalents and short-term investments totaling $90.1 million as of September 30, 2019, as compared to $124.6 million as of December 31, 2018.  The decreased cash balance was due primarily to the $57.7 million used in operating activities during the first nine months of 2019, partially offset by $18.5 million in net proceeds from the sale of a portion of its royalty entitlement on net sales of ONPATTRO in the third quarter of 2019 and $4.7 million of net proceeds from the issuance of shares under its ATM program.  Included in the $57.7 million used in operating activities is a $5.9 million payment for the award rendered in the arbitration proceeding with the University of British Columbia in the third quarter of 2019.

    Net Loss

    Net loss attributable to common shares for the third quarter of 2019, including non-cash charges of $43.8 million related to the impairment of an in-process research and development ("IPR&D") intangible asset and $22.5 million for the impairment of goodwill described further below, was $85.3 million ($1.50 basic and diluted loss per common share) as compared to $27.1 million ($0.49 basic and diluted loss per common share) for the third quarter of 2018.  Net loss attributable to common shares also included non-cash expense for the accrual of coupon on the Company's convertible preferred shares of $2.8 million in the third quarter of 2019 and $2.6 million in the third quarter of 2018, as well as non-cash expense for a proportionate share of Genevant's net losses of $3.5 million in the third quarter of 2019 and $2.8 million in the third quarter of 2018.

    ONPATTRO Royalty Entitlement

    Arbutus has a royalty entitlement on global net sales of ONPATTRO™ (Patisiran) for the lipid nanoparticle delivery (LNP) technology licensed by Arbutus to Alnylam Pharmaceuticals, Inc. (Alnylam) for this product. ONPATTRO is an RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis that has been approved by the U.S. Food and Drug Administration and the European Medical Agency. In July 2019, Arbutus sold this royalty entitlement to OCM IP Healthcare Portfolio LP, an affiliate of the Ontario Municipal Employees Retirement System (collectively, OMERS), effective as of January 1, 2019, for $20 million in gross proceeds before advisory fees. OMERS will retain this royalty entitlement until it has received $30 million in royalties, at which point 100% of this royalty entitlement will revert to Arbutus.  OMERS has assumed the risk of collecting up to $30 million of future royalty payments from Alnylam and Arbutus is not obligated to reimburse OMERS if they fail to collect any such future royalties.  Arbutus recognized the $20 million of gross proceeds from this transaction as a liability, net of transaction costs. The Company is amortizing the liability to non-cash interest expense and will continue to recognize the royalty revenue that Alnylam pays to OMERS as non-cash royalty revenue.

    In addition to the royalty entitlement from the Alnylam LNP license agreement, Arbutus is also receiving a second, lower royalty entitlement on global net sales of ONPATTRO originating from a settlement agreement and subsequent license agreement with Acuitas Therapeutics. The royalty entitlement from Acuitas has been retained by Arbutus and is not part of the royalty entitlement sale to OMERS.

    Operating Expenses

    Research and development expenses were $17.7 million in the third quarter of 2019 compared to $16.6 million in the third quarter of 2018.  Research and development expenses in the third quarter of 2019 included costs associated with the Company's Phase 1a/1b clinical trial for its RNAi agent (AB-729), costs associated with the Company's Phase 1a/1b clinical trial for its oral capsid inhibitor (AB-506) that was discontinued in October 2019, and toxicology studies for its HBV RNA Destabilizer (AB-452).  The increase in research and development expenses was due primarily to increased spending in 2019 for the two Phase 1a/1b clinical trials for AB-729 and AB-506.  General and administrative expenses were $3.3 million in the third quarter of 2019 compared to $2.6 million in the third quarter of 2018.  The increase in general and administrative expenses was due primarily to increased stock compensation expense and an increase in insurance premiums.

    In the third quarter of 2019, the Company also recorded a charge of $6.5 million related to an arbitration award from the Company's arbitration with the University of British Columbia.

    Impairment of IPR&D Intangible Assets and Goodwill

    The Company has historically carried IPR&D and goodwill from its acquisition of technologies and business combination as assets.  All acquired IPR&D intangible assets relate to the Company's covalently closed circular DNA ("cccDNA") program.  During the three months ended September 30, 2019, the Company recorded a $43.8 million non-cash impairment expense to reduce the carrying value of its IPR&D intangible assets to zero as of September 30, 2019.  The Company also recognized a corresponding income tax benefit of $12.7 million related to the decrease in its deferred tax liability associated with the IPR&D intangible assets.  The impairment was due to an indefinite delay in further development of the Company's cccDNA program while the Company focuses on its other development programs.

    Goodwill represents the excess of purchase price over the value assigned to the net tangible and identifiable intangible assets in connection with the business combination that formed Arbutus.  For the third quarter of 2019, the Company assessed the changes in circumstances that occurred during the quarter to determine if it was more likely than not that the fair value of the Company was below its carrying amount.  Due to a sustained decrease in the Company's share price in recent months, the Company's market capitalization was reduced below the book value of its net assets and the Company concluded that its fair value was below its carrying amount by an amount in excess of the carrying value of the goodwill.  As a result, the Company recorded a $22.5 million non-cash impairment expense to reduce the carrying value of its goodwill asset to zero as of September 30, 2019.

    Equity Investment Loss in Genevant

    As of September 30, 2019, the Company owned approximately 40% of the common equity of Genevant Sciences Ltd. (Genevant), a company launched with Roivant Sciences Ltd. in April 2018.  Arbutus recorded a loss of $3.5 million in the third quarter of 2019 for its proportionate share of Genevant's net loss.  Financial results of Genevant are recorded on a one-quarter lag basis.

    Outstanding Shares

    The Company had 56,850,172 common shares issued and outstanding as of September 30, 2019. In addition, the Company had approximately 9.1 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 million common shares on October 18, 2021.



    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
    (in millions, except share and per share data)

      Three Months Ended
     September 30,
      Nine Months Ended
     September 30,
      2019   2018   2019   2018
    Total revenue $ 3.1     $ 1.6     $ 4.4     $ 4.3  
    Operating expenses              
    Research and development 17.7     16.6     45.2     46.9  
    General and administrative 3.3     2.6     15.9     10.1  
    Depreciation 0.5     0.5     1.5     1.7  
    Site consolidation 0.2     (0.5 )       3.7  
    Impairment of intangible assets 43.8     14.8     43.8     14.8  
    Impairment of goodwill 22.5         22.5      
    Arbitration settlement 6.5         6.5      
    Loss from operations $ (91.4 )   $ (32.4 )   $ (131.0 )   $ (72.9 )
    Other income (loss)              
    Interest income (expense), net (0.6 )   0.7     0.6     2.2  
    Foreign exchange gain (loss)     0.1     0.1     (0.8 )
    Gain on investment             24.9  
    Equity investment loss (3.5 )   (2.8 )   (11.5 )   (2.8 )
    Change in fair value of contingent consideration 0.3     5.6     0.1     6.3  
    Total other income (loss) $ (3.8 )   $ 3.6     $ (10.7 )   $ 29.8  
    Income tax benefit 12.7     4.3     12.7     4.3  
    Net loss (1) $ (82.5 )   $ (24.5 )   $ (129.0 )   $ (38.8 )
    Accrual of coupon on convertible preferred shares (2.8 )   (2.6 )   (8.3 )   (7.5 )
    Net loss attributable to common shareholders $ (85.3 )   $ (27.1 )   $ (137.3 )   $ (46.3 )
    Loss per share              
    Basic and diluted $ (1.50 )   $ (0.49 )   $ (2.43 )   $ (0.84 )
    Weighted average number of common shares              
    Basic and diluted 56,850,172     55,421,504     56,469,358     55,241,284  

    (1)     Net loss for the three and nine months ended September 30, 2019 included $66.3 million of non-cash expenses related to the impairments of an IPR&D intangible asset and goodwill, partially offset by a corresponding income tax benefit of $12.7 million related to the decrease in a deferred tax liability associated with the IPR&D intangible asset. Net loss for the three and nine months ended September 30, 2018 included $14.8 million of non-cash expense related to the impairment of an IPR&D intangible asset, partially offset by a corresponding income tax benefit of $4.3 million related to the decrease in a deferred tax liability associated with the IPR&D intangible asset.



    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
    (in millions)

      September 30, 2019   December 31, 2018
    Cash and cash equivalents $ 90.1     $ 36.9  
    Short-term investments     87.7  
    Accounts receivable and other current assets 4.2     4.6  
    Current assets 94.3     129.2  
    Investment in Genevant 11.0     22.2  
    Property and equipment, net 9.2     10.2  
    Right of use asset 2.8      
    Intangible assets     43.8  
    Goodwill     22.5  
    Total assets $ 117.3     $ 227.9  
     Accounts payable and accrued liabilities $ 8.2     $ 9.5  
    Site consolidation accrual 0.2     1.3  
    Liability-classified options 0.1     0.5  
    Lease liability, current 0.3      
    Current liabilities 8.8     11.3  
    Liability related to sale of future royalties 18.7      
    Deferred rent and inducements, non-current     0.6  
    Contingent consideration 3.0     3.1  
    Lease liability, non-current 3.1      
    Deferred tax liability     12.7  
    Total stockholders' equity 83.7     200.2  
    Total liabilities and stockholders' equity $ 117.3     $ 227.9  



    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
    (in millions)

      Three Months Ended September 30,   Nine Months Ended September 30,
      2019   2018   2019   2018
    Net loss for the period $ (82.5 )   $ (24.5 )   $ (129.0 )   $ (38.8 )
      Impairment of intangible assets and goodwill 66.3     14.8     66.3     14.8  
      Deferred income tax benefit (12.7 )   (4.3 )   (12.7 )   (4.3 )
      Gain on investment             (24.9 )
      Equity investment loss 3.5     2.8     11.5     2.8  
      Other non-cash items 1.8     (3.4 )   8.3     2.0  
      Changes in working capital 0.1     1.4     (2.1 )   (2.4 )
    Net cash used in operating activities (23.5 )   (13.2 )   (57.7 )   (50.8 )
    Net cash provided by (used) in investing activities 16.2     24.4     87.2     (48.9 )
    Net cash provided by financing activities 18.5     0.4     23.6     55.5  
    Effect of foreign exchange rate changes on cash and cash equivalents     0.1     0.1     (0.8 )
    Net increase (decrease) in cash and cash equivalents $ 11.2     $ 11.7     $ 53.2     $ (45.0 )
    Cash and cash equivalents, beginning of period 78.9     10.2     36.9     66.9  
    Cash and cash equivalents, end of period $ 90.1     $ 21.9     $ 90.1     $ 21.9  
    Short-term investments     120.1         120.1  
    Total cash, cash equivalents and short-term investments, end of period $ 90.1     $ 142.0     $ 90.1     $ 142.0  

    Conference Call Today

    Arbutus will hold a conference call and webcast today, Wednesday, November 6, 2019 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 7279188.

    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 7279188.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic Hepatitis B infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen.  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 expectation that certain preliminary safety and efficacy data from the Phase 1a/1b clinical trial for AB-729 will be available in the first quarter of 2020; our intention to present results from the AB-506 Phase 1a/1b clinical trial at the AASLD meeting later this month; our objective to select one of several lead capsid inhibitor compounds for IND-enabling studies in December of this year; our expectation that the results from our AB-452 study will allow us to make a go/no-go decision early in 2020; our expectations regarding the initiation, timing and completion of preclinical studies and clinical trials; the sufficiency of our cash and cash equivalents to extend into early 2021; and the potential for our drug candidates to improve upon the standard of care and contribute to a curative combination regimen for chronic HBV.

    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 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.

    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.

    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: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

     

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  32. WARMINSTER, Pa., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced that it has scheduled its third quarter financial results, conference call and webcast for Wednesday, November 6, 2019.  The schedule for the press release and conference call/webcast are as follows:

    Q3 2019 Press Release: November 6, 2019 at 7:30 a.m. ET
    Q3 2019 Conference Call: November 6, 2019 at 8:45 a.m. ET
    Domestic Dial-In Number: (866) 393-1607
    International Dial-In Number: (914) 495-8556
    Conference ID Number: 7279188

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

    An archived webcast…

    WARMINSTER, Pa., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced that it has scheduled its third quarter financial results, conference call and webcast for Wednesday, November 6, 2019.  The schedule for the press release and conference call/webcast are as follows:

    Q3 2019 Press Release: November 6, 2019 at 7:30 a.m. ET
    Q3 2019 Conference Call: November 6, 2019 at 8:45 a.m. ET
    Domestic Dial-In Number: (866) 393-1607
    International Dial-In Number: (914) 495-8556
    Conference ID Number: 7279188

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

    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 7279188.

    About Arbutus
    Arbutus Biopharma Corporation is a publicly-traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic Hepatitis B (HBV) infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen. For more information, visit www.arbutusbio.com.

    Contact Information

    Investors and Media
    William H. Collier
    President and CEO
    Phone: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

     

    Primary Logo

    View Full Article Hide Full Article
  33. WARMINSTER, Pa., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced its decision to discontinue the clinical development of AB-506, an oral capsid inhibitor. AB-506 was in a Phase 1a/1b clinical trial for the treatment of chronic hepatitis B (CHB).

    William H. Collier, President and Chief Executive Officer of Arbutus, stated, "We have observed two cases of acute hepatitis in our Phase 1a 28-day clinical trial in healthy volunteers. Consequently, the clinical trial and further development of AB-506 have been stopped."

    "The two subjects are experiencing resolution of their acute hepatitis. We will continue to follow them and the other study participants…

    WARMINSTER, Pa., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today announced its decision to discontinue the clinical development of AB-506, an oral capsid inhibitor. AB-506 was in a Phase 1a/1b clinical trial for the treatment of chronic hepatitis B (CHB).

    William H. Collier, President and Chief Executive Officer of Arbutus, stated, "We have observed two cases of acute hepatitis in our Phase 1a 28-day clinical trial in healthy volunteers. Consequently, the clinical trial and further development of AB-506 have been stopped."

    "The two subjects are experiencing resolution of their acute hepatitis. We will continue to follow them and the other study participants, as safety is our highest priority at Arbutus," said Gaston Picchio, Ph.D. Chief Development Officer of Arbutus. "We intend to present results from the AB-506 Phase 1a/1b clinical trial along with further details regarding the two cases of acute hepatitis at an appropriate scientific meeting later in 2019."

    Michael J. Sofia, Ph.D., Chief Scientific Officer of Arbutus, added, "While we are disappointed in these recent clinical findings, we have a number of oral follow-on capsid inhibitor compounds with distinct chemical scaffolds that we believe have the potential to contribute to the inhibition of HBV replication as part of a combination regimen. Our objective is to select one of several lead compounds for IND-enabling studies by December of this year."

    As a result of the decision to discontinue further development of AB-506, Arbutus no longer expects to initiate a combination study of AB-506 and AB-729 in the second half of 2020.

    About AB-506

    AB-506 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 nucleoside analogues that work by stopping the viral polymerase, significantly reduce virus replication, but not completely. Capsid inhibitors inhibit replication by preventing the assembly of functional viral capsids and also by inhibiting the uncoating step of the viral life cycle thus reducing the formation of new covalently closed circular DNA ("cccDNA"), the viral reservoir which resides in the cell nucleus.

    About AB-729

    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 with expected monthly dosing. 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 a key prerequisite to enable reawakening of a patient's immune system to respond to the virus.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic Hepatitis B infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen.  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 ability to deliver a cure for people with chronic HBV; our expectations regarding the timing and clinical development of our product candidates; our intention to present results from the AB-506 Phase 1a/1b clinical trial along with further details regarding the two cases of acute hepatitis at an appropriate scientific meeting; our confidence that capsid inhibition is important to achieve a potential cure for CHB; our belief that our oral follow on capsid inhibitor compounds have the potential to contribute to the inhibition of HBV replication as part of a combination regimen; our objective to select one of several lead capsid inhibitor compounds for IND-enabling studies by December of this year; and our expectation that we will no longer initiate a combination study of AB-506 and AB-729 in the second half of 2020.

    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 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.

    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: delays in the selection of and the advancement of an additional capsid inhibitor compound into lead optimization, 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 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.

    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
    William H. Collier
    President and CEO
    Phone: 604-419-3200
    Email:

    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

    Primary Logo

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  34. WARMINSTER, Pa., Sept. 26, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced that the Company will be participating in the following investor conferences in October 2019:

    Cantor Fitzgerald Global Healthcare Conference – New York
    Friday, October 4, 2019, 1:10 PM ET
    Presentation: William H. Collier

    Chardan Genetic Medicines Conference – New York
    Monday, October 7, 2019, 8:00 AM ET
    Fireside Chat: William H. Collier and Dr. Gaston Picchio

    Live webcasts of the presentations can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com.  A replay of the webcasts will be available for 90 days following the live presentations…

    WARMINSTER, Pa., Sept. 26, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced that the Company will be participating in the following investor conferences in October 2019:

    Cantor Fitzgerald Global Healthcare Conference – New York
    Friday, October 4, 2019, 1:10 PM ET
    Presentation: William H. Collier

    Chardan Genetic Medicines Conference – New York
    Monday, October 7, 2019, 8:00 AM ET
    Fireside Chat: William H. Collier and Dr. Gaston Picchio

    Live webcasts of the presentations can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com.  A replay of the webcasts will be available for 90 days following the live presentations.

    About Arbutus

    Arbutus Biopharma Corporation is a publicly-traded (NASDAQ:ABUS) biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic Hepatitis B infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care and contribute to a curative combination regimen. For more information, visit www.arbutusbio.com.

    Contact Information

    Investors
    William H. Collier
    President and CEO
    Phone: 604-419-3200
    Email:

    Media
    Pam Murphy
    Investor Relations Consultant
    Phone: 604-419-3200
    Email:

    Primary Logo

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