UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 18, 2020
Arbutus Biopharma Corporation
(Exact name of registrant as specified in charter)
British Columbia, Canada | 001-34949 | 98-0597776 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||
701 Veterans Circle Warminster, Pennsylvania | 18974 | |
(Address of principal executive offices) | (Zip Code) | |
(267) 469-0914
Registrant’s telephone number, including area code
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Shares, without par value | ABUS | The Nasdaq Stock Market LLC | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 8.01. Other Events.
On May 18, 2020, Arbutus Biopharma Corporation (the "Company") issued a press release and held a conference call with a slide presentation announcing positive 60 mg AB-729 single-dose week 12 data in patients with chronic hepatitis B. A copy of the press release and the slide presentation are filed herewith as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated by reference herein.
On May 18, 2020, the Company posted an updated corporate presentation on its website at www.arbutusbio.com. A copy of the presentation is filed herewith as Exhibit 99.3 and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number | Description | |
99.1 | ||
99.2 | ||
99.3 | ||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Arbutus Biopharma Corporation | ||
Date: May 18, 2020 | By: | /s/ David C. Hastings |
Name: | David C. Hastings | |
Title: | Chief Financial Officer | |
Exhibit 99.1 | ||
Arbutus Announces Single-Dose Week 12 Data in Chronic Hepatitis B Subjects with 60 mg AB-729 Demonstrating a Significant and Continuous Reduction in HBsAg
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 - 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.”
Exhibit 99.1 | ||
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.
Exhibit 99.1 | ||
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: ir@arbutusbio.com
Pam Murphy
Investor Relations Consultant
Phone: 604-419-3200
Email: ir@arbutusbio.com
AB-729-001 60mg Week 12 Results May 18, 2020 NASDAQ: ABUS www.arbutusbio.com
Forward Looking Statements This presentation 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 presentation include statements about our expectations regarding the timing and clinical development of our product candidates, including the anticipated release of preliminary data for multiple-dose and additional single-dose cohorts in our Phase 1a/1b clinical trial for AB-729 in the second half of 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 presentation, 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. 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. NASDAQ: ABUS www.arbutusbio.com
AB-729-001 Study Design PART 1: Single Ascending Dose PART 2: Single Doses PART 3: Multiple Doses In Healthy Subjects In Chronic Hepatitis B Subjects In Chronic Hepatitis B Subjects Dose 1 (60mg) Cohort A: 180mg Cohort E: 60mg Q4W n=6; 4 active : 2 placebo HBV DNA - n=6 HBV DNA - n=7 (≥ Day 15 Safety) (≥ Day 15 Safety) Dose 2 (180mg) Cohort B: 60mg Cohort F: 60mg Q8W n=6; 4 active : 2 placebo HBV DNA - n=6 HBV DNA - n=7 (≥ Day 15 Safety) (≥ Day 15 Safety) Dose 3 (360mg) Cohort C: 90mg Cohort G: TBD + TDF n=6; 4 active : 2 placebo HBV DNA - n=6 HBV DNA + n=7 HBV: Hepatitis B Virus Cohort D: TBD Optional Cohort I: TBD TDF: Tenofovir Disoproxil Fumarate HBV DNA + HBV DNA - n=7 TBD: To Be Determined n=6 Optional Cohort H: TBD Optional Cohort J: TBD NASDAQ: ABUS www.arbutusbio.com HBV DNA - n=6 HBV DNA - n=7
AB-729-001 Key Inclusion/Exclusion Criteria 1. Documented chronic hepatitis B infection; confirmed HBeAg positive or negative 2. HBV-DNA at screening: a) For HBV-DNA negative subjects (on a NA for at least 6 months): HBV-DNA <LLOQ b) For HBV-DNA positive subjects: HBV-DNA ≥1,000 IU/mL 3. HBsAg ≥250 IU/mL at screening 4. Non-cirrhotic with mild/moderate fibrosis defined by: a) Liver biopsy Metavir Fibrosis Score of F0-2 (or equivalent) within 12 months OR Fibroscan® result of ≤10 kPa within 6 months 5. ALT/AST <5x ULN for Part 2 and <2x ULN for Part 3; Tbili <1.5x ULN for all Parts NASDAQ: ABUS www.arbutusbio.com
AB-729-001 Chronic Hepatitis B Subject Demographics Cohort A: 180mg (n=4) Cohort B: 60mg (n=6) Age (mean, range) 42.8 (35-53) 48.2 (33-56) Male Gender (n, percentage) 3 (75%) 3 (50%) Asian Race (n, percentage) 0 (0%) 3 (50%) Hepatitis B e-Antigen Negative (n, percentage) 3 (75%) 6 (100%) Baseline Hepatitis B Surface Antigen (mean, 8,577 (4,720 - 10,289) IU/mL 2,095 (405 – 5,110) IU/mL range) NASDAQ: ABUS www.arbutusbio.com
Continuous Mean HBsAg Decline of ~1 log10 with a Single 60 mg Dose Matching HBsAg Decline of 180 mg at Week 12 0.25 AB-729 60 mg (N=6) 0.25 AB-729 180 mg (N=4) 0 0 - 0.99 log10 - 0.98 log -0.25 -0.25 10 IU/mL IU/mL -0.5 -0.5 -0.75 -0.75 -1 -1 -1.25 -1.25 -1.5 -1.5 0 14 28 42 56 70 84 0 14 28 42 56 70 84 NASDAQ: ABUS www.arbutusbio.com 60 mg week 6 data (N=2) excluded for consistency as Week 6 not collected in 180 mg cohort
All Subjects Responded in the 60mg Single-Dose Cohort Minimum HBsAg decline of -0.62 log10 and maximum HBsAg decline of -2.14 log10 at week 12 AB-729 60 mg (N=6) AB-729 180 mg (N=4) 0.5 0.5 0 0 -0.5 -0.5 -1 -1 -1.5 -1.5 -2 -2 -2.5 -2.5 0 14 28 42 56 70 84 0 14 28 42 56 70 84 NASDAQ: ABUS www.arbutusbio.com
AB-729 60mg Single-dose Generally Safe and Well Tolerated with Normal ALT/AST Through 12 Weeks Alanine Aminotransferase Aspartate Aminotransferase 450 450 400 400 350 350 300 300 250 250 200 200 150 150 100 100 Upper Limit Normal = 48 Upper Limit Normal = 40 50 50 0 0 0 14 28 42 56 70 84 0 14 28 42 56 70 84 NASDAQ: ABUS www.arbutusbio.com Samples from week 8 and week 12 from one subject collected by local lab where Upper Limit Normal = 34 U/L for both ALT and AST
AB-729 Next Steps Preliminary Data Cohort Status Anticipated 60 mg multi-dose (Dose Interval = 4 weeks) Ongoing 2H 2020 60 mg multi-dose (Dose Interval = 8 weeks) Initiate ASAP 2H 2020 90 mg single-dose Ongoing 2H 2020 NASDAQ: ABUS www.arbutusbio.com
Q&A
Corporate Presentation May 2020 NASDAQ: ABUS www.arbutusbio.com
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential for HBV to have a larger market opportunity than HCV; our ability to meet a significant unmet medical need; the sufficiency of our cash and cash equivalents to extend into mid 2021; our expectation for multiple 60 mg dose and 90 mg single-dose data in the second half of 2020; the potential for an oral HBsAg reducing agent and potential all oral combination therapy; our objective to complete IND enabling studies for AB-836 in the second half of 2020; the potential for AB-836 to be low dose with a greater therapeutic window and to address known capsid resistant variants T33N and I105T; the potential for AB-836 to be once daily dosing; our expectations regarding the timing and clinical development of our product candidates; the timeline to a combination cure for HBV; our coronavirus strategy; and other statements relating to our future operations, future financial performance, future financial condition, prospects or other future events. With respect to the forward-looking statements contained in this presentation, 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. Forward-looking statements herein involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others: anticipated pre-clinical 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, Quarterly Report on Form 10-Q and Arbutus' periodic disclosure filings which are available at www.sec.gov and at www.sedar.com. The forward-looking statements made in connection with this presentation represent our views only as of the date of this presentation (or any earlier date indicated in such statement). While we may update certain forward-looking statements from time to time, we specifically disclaim any obligation to do so, even if new information becomes available in the future. 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. NASDAQ: ABUS www.arbutusbio.com 2
Investment Highlights Therapeutic focus – curing chronic Hepatitis B Virus (HBV) Infection Team with Significant Goal of HBV Broad Coronavirus Antiviral Unmet Medical Functional HBV Research Expertise & Need in HBV Cure Portfolio Initiative Proven Track Record Global HBV Undetectable HBV HBV assets include: Focused on direct Applying prevalence double DNA and HBsAg RNAi acting antivirals knowledge gained from that of HCV, delivered through targeting the viral HIV and HCV success to potential for finite duration Capsid Inhibitors polymerase and HBV larger market treatment with a PD-L1 protease and Coronaviruses opportunity combination of HBV RNA drugs with different Destabilizers modes of action NASDAQ: ABUS www.arbutusbio.com HCV: Hepatitis C Virus | HIV Human Immunodeficiency Virus 3
Proven Leadership Team William H. Collier Michael J. Sofia, PhD Gaston Picchio, PhD President and CEO Chief Scientific Officer Chief Development Officer Successful track records in the discovery, development, and commercialization of multiple antivirals including sofosbuvir, etravirine, rilpivirine, telaprevir and simeprevir David C. Hastings Elizabeth Howard, PhD, JD Michael J. McElhaugh Chief Financial Officer EVP, General Counsel and Chief Business Officer Chief Compliance Officer NASDAQ: ABUS www.arbutusbio.com 4
HBV Presents a Significant Unmet Medical Need >257Mpeople are chronically 15M infected with HBV, globally. Europe 2M United States 90M China ~ people900k die every year as a consequence despite the availability of effective vaccines and antivirals. : Global Hepatitis Report and Hepatitis B Fact Sheet, WHO (2017) http://www.who.int/mediacentre/factsheets/fs204/en/ NASDAQ: ABUS Sources www.arbutusbio.com Kowdley et al. Hepatology (2012) Prevalence of Chronic Hepatitis B Among Foreign-Born Persons Living in the US by Country of Origin 5
Significant Opportunity STANDARD OF CARE THERAPIES FOR CHRONIC HBV to Improve New HBV HBV Cure Rates PegIFN Entecavir Tenofovir Therapies rate of Dosing Duration 48-weeks Chronic Chronic Undetectable HBV DNA + HBV DNA rate of Undetectable 7-19% 67-90% 76-93% HBV cures are achievable with (<60-80 IU/ml) HBsAg Loss today’s SOC in <5% of patients. = HIGHER Sustained HBsAg and HBV DNA loss HBsAg Loss ~3-7% ~1-2% ~1-3% after end-of-treatment* is rare. CURES RATES *undetectable HBsAg and HBV DNA 6 months after end-of-treatment accepted as a functional cure.. Achievable HBV Cure Rates with Current SOC SOC: Standard Of Care | HBsAg: HBV Surface Antigen | PegIFN: Pegylated Interferon NASDAQ: ABUS EASL HBV Clinical Practice Guidelines, 2017 - Pegasys, PEG-Intron, Baraclude and Viread Package Inserts www.arbutusbio.com Source: 6
Compelling Growth Opportunity in the HBV Market 257M chronic HBV 10.5% Diagnosed 27M An HBV curative regimen 1.8% Treated 4.5M would substantially increase diagnosisdiagnosis and treatmenttreatment rates to unlock significant Low due to sub- optimal SOC cure rate market growth opportunities. and asymptomatic nature of disease. NASDAQ: ABUS SOC: Standard Of Care www.arbutusbio.com Source: Global Hepatitis Report and Hepatitis B Fact Sheet, WHO (2017) http://www.who.int/mediacentre/factsheets/fs204/en/ 7
HBV Lifecycle Illustrates Key Points for Intervention A combination of agents with complementary MOA is needed to cure HBV 1. Nucleoside Analogue 2. Capsid Inhibitor 3. RNAi & RNA Destabilizer 2 3 1 2 NASDAQ: ABUS www.arbutusbio.com
1 Reduce/Suppress 2 Reduce/Suppress Keys to Viral DNA Viral Antigens Therapeutic Block Replication Block HBsAg . NA . RNAi . Capsid Inhibitor . RNA Destabilizer Success . RNAi . RNA Destabilizer Reduce cccDNA Pool . Capsid Inhibitor Suppress HBV DNA and viral antigens Leading to an Reawaken host HBV CURE immune response Therapeutic success will Block HBsAg require a combination . RNAi . RNA Destabilizer of agents with Immuno-modulation complementary MOAs . PD-L1 Inhibitor . Interferon Reawaken/Boost Host 3 Immune Response NASDAQ: ABUS www.arbutusbio.com MOA: Mechanism Of Action | NA: Nucleoside Analogue | HBsAg: HBV Surface Antigen 9
Arbutus HBV Pipeline Phase I Lead Optimization IND Enabling Healthy Subjects HBV Subjects Phase II HBsAg Reduction RNAi AB-729 HBV RNA Destabilizers Next Gen HBV DNA Suppression Capsid Inhibitor AB-836 Immune Reawakening PD-L1 1st gen NASDAQ: ABUS www.arbutusbio.com 10
AB-729 RNAi Single trigger RNAi agent targeting all HBV transcripts Therapeutic Inhibits HBV replication and lowers all HBV antigens Pan-genotypic activity across HBV genotypes Demonstrated complementarity with capsid inhibitors Proprietary GalNAc-conjugate delivery technology provides Actively targets the liver liver targeting and enables subcutaneous dosing Active against cccDNA derived and integrated HBsAg transcripts Clean profile in long term preclinical safety studies GalNAc Linker HBx n sAg sAg Polymerase, Core Ag, eAg, pgRNA NASDAQ: ABUS www.arbutusbio.com 11
AB-729 RNAi Continuous HBsAg All subjects responded to decline with a single 60 therapy with everyone Therapeutic mg dose through week 12 achieving at least a -0.62 with mean HBsAg decline log reduction in HBsAg at of approximately 1.0 log week 12 in the 60 mg dose In May 2020, matching the 180 mg group with a maximum cohort at week 12. decline of -2.14 log. Arbutus announced additional positive single- dose Phase 1a/1b clinical All subjects had normal AB-729 may provide a trial results for AB-729 ALTs/ASTs throughout the competitive advantage 12 week follow up period. through low dose and reduced frequency of injections. NASDAQ: ABUS www.arbutusbio.com 12
AB-729-001 Study Design Part 1: Single Ascending Part 2: Single Doses In Dose In Healthy Subjects Chronic Hepatitis B Subjects Dose 1 (60 mg) Cohort A: 180 mg n=6; 4 active : 2 placebo HBV DNA - n=6 (≥ Day 15 Safety) (≥ Day 15 Safety) Dose 2 (180 mg) Cohort B: 60 mg n=6; 4 active : 2 placebo HBV DNA - n=6 (≥ Day 15 Safety) (≥ Day 15 Safety) Dose 3 (360 mg) Cohort C: 90 mg n=6; 4 active : 2 placebo HBV DNA - n=6 Cohort D: TBD HBV DNA + n=6 NASDAQ: ABUS www.arbutusbio.com HBV: Hepatitis B Virus | TDF: tenofovir disoproxil fumarate | TBD: to be determined 13
Continuous Mean HBsAg Decline of ~1 log10 with a Single 60 mg Dose Matching HBsAg Decline of 180 mg at Week 12 AB-729 60 mg (N=6) AB-729 180 mg (N=4) 0.25 0.25 0 0 - 0.99 log10 - 0.98 log10 -0.25 IU/mL -0.25 IU/mL -0.5 -0.5 -0.75 -0.75 -1 -1 -1.25 -1.25 -1.5 -1.5 0 14 28 42 56 70 84 0 14 28 42 56 70 84 NASDAQ: ABUS www.arbutusbio.com 60 mg week 6 data (N=2) excluded for consistency as Week 6 not collected in 180 mg cohort 14
All Subjects Responded in the 60 mg Single-Dose Cohort Minimum HBsAg decline of -0.62 log10 and maximum HBsAg decline of -2.14 log10 at week 12 AB-729 60 mg (N=6) AB-729 180 mg (N=4) 0.5 0.5 0 0 -0.5 -0.5 -1 -1 -1.5 -1.5 -2 -2 -2.5 -2.5 0 14 28 42 56 70 84 0 14 28 42 56 70 84 NASDAQ: ABUS www.arbutusbio.com 15
AB-729 60 mg Single-Dose Generally Safe and Well Tolerated with Normal ALT/AST Through 12 Weeks Alanine Aminotransferase Aspartate Aminotransferase 450 450 400 400 350 350 300 300 250 250 200 200 150 150 100 100 Upper Limit Normal = 48 Upper Limit Normal = 40 50 50 0 0 0 14 28 42 56 70 84 0 14 28 42 56 70 84 NASDAQ: ABUS 16 www.arbutusbio.com Samples from week 8 and week 12 from one subject collected by local lab where Upper Limit Normal = 34 U/L for both ALT and AST
AB-729-001 Study – Next Steps Part 1: Single Ascending Part 2: Single Doses In Part 3: Multiple Doses In Dose In Healthy Subjects Chronic Hepatitis B Subjects Chronic Hepatitis B Subjects Dose 1 (60 mg) Cohort A: 180 mg Cohort E: 60 mg n=6; 4 active : 2 placebo HBV DNA - n=6 Q4W HBV DNA -n=7 (≥ Day 15 Safety) (≥ Day 15 Safety) Dose 2 (180 mg) Cohort B: 60 mg Cohort F: 60 mg n=6; 4 active : 2 placebo HBV DNA - n=6 Q8W HBV DNA -n=7 (≥ Day 15 Safety) (≥ Day 15 Safety) Cohort G: TBD + TDF HBV DNA + n=7 Dose 3 (360 mg) Cohort C: 90 mg n=6; 4 active : 2 placebo HBV DNA - n=6 Optional Cohort I: TBD HBV DNA - n=7 Cohort D: TBD Optional HBV DNA + n=6 Cohort J: TBD HBV DNA - n=7 NASDAQ: ABUS www.arbutusbio.com HBV: Hepatitis B Virus | TDF: tenofovir disoproxil fumarate | TBD: to be determined 17
AB-836 Novel chemical series differentiated from AB-506 and other competitor Capsid compounds in the Class II capsid inhibitor space Inhibitor Leverages a novel binding site within the core protein dimer-dimer interface Improved intrinsic potency with EC50 < 10 nM Active against NA resistant variants IND enabling studies ongoing Potential to address known capsid resistant variants T33N and I105T Potential for increased potency and enhanced Provides the potential for low dose and wide therapeutic window resistance profile Projected to be once daily dosing Pangenotypic Combinable with other MOA agents NASDAQ: ABUS www.arbutusbio.com 18
AB-836: A Next Generation Capsid Inhibitor cccDNA Formation / Human HBV DNA / 1o Mechanism 2o Mechanism Serum Shift HBV infected HBV infected Core I105T HBV infected HepDE19 (FC in EC in 40% Compound PHH HepG2-NTCP-C4 Mutation HepG2-NTCP-C4 50 (EC50 μM) Human Serum) (EC50 μM) (EC50 μM) (EC50 mM) (HBsAg EC50 μM) AB-506 0.077 0.032 0.101 1.26 1.430 6x AB-836 0.010 0.002 0.012 0.118 0.196 2x 4 Serum Activity 4 Liver Activity in HDI Mouse Model 3 3 2 2 AB-506 (Day Vehicle) 7 vs (Day Vehicle) 7 vs 1 1 AB-506 HBV Inhibition DNA LOG HBV Inhibition DNA LOG 0 0 3 10 100 (mg/kg QD) 3 10 100 (mg/kg QD) AB-836 AB-836 Unique Binding Site NASDAQ: ABUS www.arbutusbio.com HAP: Heteroaryldihydropyrimidine | SBA: Sulfamoylbenzamide I PHH: Primary Human Hepatocytes 19
Next Gen RNA Destabilizer Program We believe Offers a novel Continuing active and this approach offers mechanism of action research for an oral to reduce HBsAg and development of potential HBsAg reducing agent other viral proteins and a next generation and all oral combination viral RNA small molecule therapy NASDAQ: ABUS www.arbutusbio.com 20
Coronavirus Strategy Leveraging our proven expertise and capabilities in antiviral drug discovery and development Long term commitment Pan-coronavirus focused Small Molecule Direct-Acting Antivirals Directed Effort . nsp12 Virual Polymerase - nucleosid(t)es +RNA Virus . nsp5 Main Viral Protease - 31 kb Genome denovo design nsp5 protease & nsp12 polymerase Screening Effort essential enzymes COVID-19 Virus nsp5 / 3CLpro . Proprietary library screening for replication Viral Protease Viral Polymerase through COVID R&D consortium NASDAQ: ABUS www.arbutusbio.com 21
Key Objectives for 2020 Cash balance of $88.1M as March 31, 2020, cash runway into mid-2021 Objective Anticipated Timing AB-729 preliminary phase 1a/1b single-dose data Late 1Q 2020 AB-729 additional week 12 60 mg single-dose data May 2020 AB-729 multi-dose 60 mg data (4 and 8 wk dosing intervals) 2H 2020 AB-729 week 12 single-dose 90 mg data 2H 2020 AB-836 complete IND enabling studies 2H 2020 NASDAQ: ABUS www.arbutusbio.com 22