UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
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On May 5, 2021, Arbutus Biopharma Corporation (the "Company") issued a press release announcing its financial results for the first quarter ended March 31, 2021 and certain other information. A copy of the press release is furnished as Exhibit 99.1 hereto.
On May 5, 2021, the Company posted an updated corporate presentation on its website at www.arbutusbio.com. A copy of the presentation is filed herewith as Exhibit 99.2 and is incorporated by reference herein.
(d) Exhibits.
| Exhibit Number | Description | |
| 99.1 | Press release dated May 5, 2021 | |
| 99.2 | Corporate Presentation dated May 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 5, 2021 | By: | /s/ David C. Hastings |
| David C. Hastings | ||
| Chief Financial Officer | ||
EXHIBIT 99.1
Arbutus Reports First Quarter 2021 Financial Results and Provides Corporate Update
AB-729, Arbutus’ proprietary subcutaneously delivered RNAi agent, continues to demonstrate robust and continuous declines in hepatitis B surface antigen (HBsAg) in subjects with chronic hepatitis B (HBV) with favorable safety and tolerability data
Additional data from the ongoing Phase 1a/1b clinical trial of AB-729, including 60 mg multi-dose data (dosing interval every 4 and 8 weeks) and 90 mg multi-dose data (dosing interval every 8 weeks), expected in 2Q/2021
A proof-of-concept Phase 2 triple combination clinical trial evaluating AB-729, and Assembly Biosciences’ core inhibitor candidate, vebicorvir (VBR), with an approved standard of care nucleoside/nucleotide reverse transcript (NRTI) initiated by Arbutus and Assembly in 1Q/2021
Phase 1a/1b clinical trial with AB-836, Arbutus’ proprietary oral capsid inhibitor, initiated with initial data expected in 2H/2021
Arbutus, X-Chem, and Proteros biostructures announced an innovative Pan-Coronavirus Discovery Research and License Agreement in April 2021
Conference Call and Webcast Scheduled Today at 8:45 AM ET
WARMINSTER, Pa., May 05, 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 first quarter 2021 financial results and provides a corporate update.
William Collier, President and Chief Executive Officer of Arbutus, stated, “We had a productive first quarter of 2021. With the initiation of the Phase 1a/1b clinical trial of AB-836, our oral capsid inhibitor, together with the ongoing clinical development of AB-729, we now have two proprietary HBV agents in development. This progress reflects our objective to develop a combination regimen that provides a functional cure for people living with HBV. We were also gratified to establish an innovative collaboration with X-Chem, Inc. and Proteros biostructures GmbH. The objective of this alliance is to expedite our efforts to discover an effective oral antiviral therapy against coronaviruses including SARS-CoV-2 targeting the main protease.”
Mr. Collier added, “Looking ahead, we expect an eventful 2021 including: continued longer term Phase 1a/1b dosing results for AB-729; initiation of two Phase 2 proof-of-concept clinical trials for AB-729 with one or more approved or investigational agents; and initial Phase 1a/1b data from our proprietary oral capsid inhibitor, AB-836.”
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 (-1.39 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.
- Arbutus expects to provide additional data from ongoing cohorts of the Phase 1a/1b clinical trial in the second quarter of 2021, including 60 mg multi-dose data (dosing interval every 4 and 8 weeks) and 90 mg multi-dose data (dosing interval every 8 weeks). Data from the 90 mg every 12 weeks in HBV DNA negative subjects and the 90 mg every 8 weeks in the HBV DNA positive subjects is expected in the second half of 2021. Arbutus also intends to advance AB-729 into two additional proof-of-concept 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 a Phase 2 proof-of-concept combination clinical trial to evaluate AB-729 in combination with Assembly’s lead core (capsid) inhibitor candidate VBR and an NrtI 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 initiated a Phase 1a/1b clinical trial for AB-836 in the first quarter of 2021, with initial data expected in second half of 2021.
HBV Discovery Programs
- Arbutus’ drug discovery efforts are focused on follow-on compounds for its current HBV pipeline. Arbutus expects to continue to advance its research in its oral PD-L1 inhibitor and RNA-destabilizer programs.
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 recently entered into a discovery research and license agreement with X-Chem, Inc. and Proteros biostructures GmbH 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.
Financial Results
Cash, Cash Equivalents and Investments
Arbutus had cash, cash equivalents and investments totaling $132.0 million as of March 31, 2021, as compared to $123.3 million as of December 31, 2020. During the three months ended March 31, 2021, Arbutus used $17.9 million in operating activities, which was offset by $26.4 million of net proceeds from the issuance of common shares under Arbutus’s ATM program. The Company believes its cash, cash equivalents and investments of $132.0 million as of March 31, 2021 are sufficient to fund the Company’s operations through the third quarter of 2022.
Net Loss
Net loss attributable to common shares for the three months ended March 31, 2021 was $19.6 million ($0.21 basic and diluted loss per common share) as compared to $16.8 million ($0.25 basic and diluted loss per common share) for the three months ended March 31, 2020. Net loss attributable to common shares for the three months ended March 31, 2021 and 2020 included non-cash expense for the accrual of coupon on the Company’s convertible preferred shares of $3.2 million and $3.0 million, respectively.
Operating Expenses
Research and development expenses were $13.4 million for the three months ended March 31, 2021 compared to $10.4 million in the same period in 2020. The increase in research and development expenses for the three months ended March 31, 2021 versus the same period in 2020 was due primarily to higher expenses for the Company’s clinical development and discovery programs, including activities under our collaboration with Assembly and internal research efforts to treat COVID-19 and future coronavirus outbreaks, both of which initiated in mid-2020. General and administrative expenses were $3.8 million for the three months ended March 31, 2021 compared to $3.6 million for the same period in 2020. This increase was due primarily to an increase in non-cash stock-based compensation expense.
Outstanding Shares
The Company had approximately 96.2 million common shares issued and outstanding as of March 31, 2021. In addition, the Company had approximately 13.4 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)
| Three Months Ended March 31, | |||||||
| 2021 | 2020 | ||||||
| Revenue | |||||||
| Collaborations and licenses | $ | 1,154 | $ | 835 | |||
| Non-cash royalty revenue | 959 | 656 | |||||
| Total Revenue | 2,113 | 1,491 | |||||
| Operating expenses | |||||||
| Research and development | 13,370 | 10,416 | |||||
| General and administrative | 3,847 | 3,553 | |||||
| Depreciation | 443 | 500 | |||||
| Change in fair value of contingent consideration | 129 | 112 | |||||
| Site consolidation | — | 57 | |||||
| Loss from operations | (15,676 | ) | (13,147 | ) | |||
| Other income (loss) | |||||||
| Interest income | 39 | 345 | |||||
| Interest expense | (772 | ) | (1,041 | ) | |||
| Foreign exchange gain (loss) | 28 | (18 | ) | ||||
| Total other loss | (705 | ) | (714 | ) | |||
| Net loss | $ | (16,381 | ) | $ | (13,861 | ) | |
| Dividend accretion of convertible preferred shares | (3,212 | ) | (2,978 | ) | |||
| Net loss attributable to common shares | $ | (19,593 | ) | $ | (16,839 | ) | |
| Loss per share | |||||||
| Basic and diluted | $ | (0.21 | ) | $ | (0.25 | ) | |
| Weighted average number of common shares | |||||||
| Basic and diluted | 93,434,378 | 67,683,586 | |||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| March 31, 2021 | December 31, 2020 | ||||||
| Cash, cash equivalents and marketable securities, current | $ | 131,961 | $ | 123,268 | |||
| Accounts receivable and other current assets | 5,380 | 4,436 | |||||
| Total current assets | 137,341 | 127,704 | |||||
| Property and equipment, net of accumulated depreciation | 6,584 | 6,927 | |||||
| Right of use asset | 2,315 | 2,405 | |||||
| Other non-current assets | — | 44 | |||||
| Total assets | $ | 146,240 | $ | 137,080 | |||
| Accounts payable and accrued liabilities | $ | 6,063 | $ | 8,901 | |||
| Liability-classified options | 198 | 250 | |||||
| Lease liability, current | 432 | 390 | |||||
| Total current liabilities | 6,693 | 9,541 | |||||
| Liability related to sale of future royalties | 19,366 | 19,554 | |||||
| Contingent consideration | 3,555 | 3,426 | |||||
| Lease liability, non-current | 2,477 | 2,593 | |||||
| Total stockholders’ equity | 114,149 | 101,966 | |||||
| Total liabilities and stockholders’ equity | $ | 146,240 | $ | 137,080 | |||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(in thousands)
| Three Months Ended March 31, | |||||||
| 2021 | 2020 | ||||||
| Net loss | $ | (16,381 | ) | $ | (13,861 | ) | |
| Other non-cash items | 2,222 | 2,448 | |||||
| Changes in working capital | (3,722 | ) | (4,040 | ) | |||
| Net cash used in operating activities | (17,881 | ) | (15,453 | ) | |||
| Net cash provided by (used in) investing activities | 18,221 | (2,401 | ) | ||||
| Net cash provided by financing activities | 26,874 | 12,481 | |||||
| Effect of foreign exchange rate changes on cash and cash equivalents | (44 | ) | (10 | ) | |||
| Increase (decrease) in cash and cash equivalents | $ | 27,170 | $ | (5,383 | ) | ||
| Cash and cash equivalents, beginning of period | 52,251 | 31,799 | |||||
| Cash and cash equivalents, end of period | $ | 79,421 | $ | 26,416 | |||
| Investments in marketable securities | 52,540 | 61,690 | |||||
| Cash, cash equivalents and marketable securities, end of period | $ | 131,961 | $ | 88,106 | |||
Conference Call and Webcast Today
Arbutus will hold a conference call and webcast today, Wednesday, May 5, 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 www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 4445858.
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 4445858.
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 objective to develop a combination regimen that provides a functional cure for people living with HBV; our expectation to provide additional data from the ongoing cohorts of the Phase 1a/1b clinical trials of AB-729 in the second quarter of 2021, including 60 mg multi-dose data (dosing interval every 4 and 8 weeks) and 90 mg multi-dose data (dosing interval every 8 weeks); our expectation to provide data from the 90 mg every 12 weeks in HBV DNA negative subjects and the 90 mg every 8 weeks in the HBV DNA positive subjects of Phase 1a/1b clinical trial of AB-729 in the second half of 2021; our intention to advance AB-729 into two additional proof-of-concept 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; 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 VBR and an NrtI 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; our expectation for initial data from the Phase 1a/1b clinical trial for AB-836 in the second half of 2021; the expected continued advancement of our research in the oral PD-LE inhibitor and RNA-destabilizer programs; our expectations and goals for the collaboration with X-Chem and Proteros and any potential benefits related thereto, including our expectation that the alliance will expedite our efforts to discover an effective oral antiviral therapy against coronaviruses including SARS-CoV-2 targeting the main protease; our expected cash runway through the third quarter of 2022; and our expectations regarding the impact of the COVID-19 pandemic on our business and clinical trials.
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.
Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; Arbutus, X-Chem and Proteros may never realize the expected benefits of the collaboration; 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: ir@arbutusbio.com
Pam Murphy
Investor Relations Consultant
Phone: 267-469-0914
Email: ir@arbutusbio.com
EXHIBIT 99.2
Corporate P r ese n t a ti o n May 2021 NASDAQ: ABUS www.arbutusbio.com
NASDAQ: ABUS www.arbutusbio.com F o r w a r d - Loo k i n g S t a t eme n t s 2 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 market opportunity for HBV ; Arbutus’ ability to meet a significant unmet medical need ; the sufficiency of Arbutus’ cash and cash equivalents to extend through the third quarter of 2022 ; the potential for AB - 729 to be a well - tolerated low dose treatment for HBV with a minimum of injections ; the potential for AB - 836 to be low dose with a greater therapeutic window and to address known capsid resistant variants T 33 N and I 105 T ; the potential for AB - 836 to be once daily dosing ; Arbutus’ expectations regarding the timing and clinical development of Arbutus’ product candidates including its 2021 key clinical objectives with respect to AB - 729 and AB - 836 and its clinical collaboration with Assembly Biosciences ; the timeline to a combination cure for HBV ; Arbutus’ coronavirus strategy ; Arbutus’ expectations regarding its technology licensed to Genevant ; 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 . 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 .
NASDAQ: ABUS www.arbutusbio.com I n v e s t me n t Hi g h li g h t s Therapeutic focus – curing chronic Hepatitis B Virus (HBV) Infection 3 HCV: Hepatitis C Virus | HIV Human Immunodeficiency Virus Significant Unmet Medical N ee d i n H B V Undetectable HBV DNA and HBsAg delivered through finite duration treatment with a combination of drugs with different modes of action G o a l o f H B V Functional Cure Broad HBV P o r t f o li o HBV assets include: RNAi C a ps i d I nh i b i t o r s PD - L1 HBV RNA Destabilizers C o r o n a vi r u s Research Initiative Focused on direct acting antivirals targeting the viral polymerase and protease T e a m w it h Antiviral Ex p e r ti s e & P r ov e n T r ac k Record Applying knowledge gained from HIV and HCV success to HBV and C o r on a v i r uses Global HBV prevalence double that of HCV, potential for larger market opportunity 1 6 % Ow n e r s hi p i n Genevant Rights to potential future royalties and sublicense revenues for LNP Technology
NASDAQ: ABUS www.arbutusbio.com Proven Lea d e r s h i p Team 4 Successful track records in the discovery, development, and commercialization of multiple antivirals including sofosbuvir, etravirine, rilpivirine, telaprevir and simeprevir William H. Collier President and CEO David C. Hastings Chief Financial Officer Gaston Picchio, PhD Chief Development Officer Michael J. Sofia, PhD Chief Scientific Officer Michael J. McElhaugh Chief Business Officer Elizabeth Howard, PhD, JD EVP, General Counsel and Chief Compliance Officer
NASDAQ: ABUS www.arbutusbio.com Sources : Global Hepatitis Report and Hepatitis B Fact Sheet, WHO (2017) http://www.who.int/mediacentre/factsheets/fs204/en/ Kowdley et al. Hepatology (2012) Prevalence of Chronic Hepatitis B Among Foreign - Born Persons Living in the US by Country of Origin H B V P r e s e n t s a S i gn i f i c a n t U n m e t Med i c a l N ee d 5 ~ 900k people die every y ear as a consequence despite the availability of effective vaccines and antivirals. >257M people are chronically infected with HBV, globally. 90M China 15M Europe 2M United States
NASDAQ: ABUS www.arbutusbio.com N e w H B V T he r a p i e s rate of HBsAg Loss rate of Undetectable HBV DNA + SOC: Standard Of Care | HBsAg : HBV Surface Antigen | PegIFN: Pegylated Interferon Source: EASL HBV Clinical Practice Guidelines, 2017 - Pegasys, PEG - Intron, Baraclude and Viread Package Inserts Significant Opportunity t o I m p r o v e H B V C u r e R a t e s PegIFN Entecavir Tenofovir Dosing Duration 48 - weeks Chronic Chronic HBV DNA Undetectable (<60 - 80 IU/ml) 7 - 19% 67 - 90% 76 - 93% HBsAg Loss ~3 - 7% ~1 - 2% ~1 - 3% Achievable HBV Cure Rates with Current SOC = HIGHER CURES RATES HBV cures are achievable with today’s SOC in <5% of patients . Sustained HBsAg and HBV DNA loss after end - of - treatment* is rare. *undetectable HBsAg and HBV DNA 6 months after end - of - treatment accepted as a functional cure. 6 STANDARD OF CARE THERAPIES FOR CHRONIC HBV
NASDAQ: ABUS www.arbutusbio.com An HBV curative regimen would substantially increase diagnosis Compelling Growth Opportunity in the HBV Market 7 SOC: Standard Of Care Source: Global Hepatitis Report and Hepatitis B Fact Sheet, WHO (2017) http://www.who.int/mediacentre/factsheets/fs204/en/ 10.5% Diagnosed 1.8% Treated Low due to sub - optimal SOC cure rate and asymptomatic nature of disease. and treatment rates to unlock significant market growth opportunities. 27M 257M c h r on i c H B V 4 . 5 M
NASDAQ: ABUS www . a r bu t usb i o . c o m 3 2 1 2 H B V L i f ec y c l e I ll u s t r a t e s K e y P o i n t s f o r I nt e r v e n t i o n A combination of agents with complementary MOA is needed to cure HBV 1. Nucleoside Analogue 2. C a p s i d Inhibi t o r 3. R N A i & R N A Destabilizer NASDAQ: ABUS www.arbutusbio.com MOA: Mechanism of Action
NASDAQ: ABUS www.arbutusbio.com 9 Block Replication ▪ NA ▪ Ca p s i d In h i b i t or ▪ RNAi ▪ RNA Destabilizer Reduce cccDNA Pool ▪ Capsid Inhibitor Block HBsAg ▪ RNAi ▪ RNA Destabilizer Immuno - modulation ▪ PD - L1 Inhibitor ▪ Interferon Leading to an HBV CURE K e y s t o T h e r a p e ut i c Success MOA: Mechanism of Action | NA: Nucleoside Analogue | HBsAg : HBV Surface Antigen Suppress HBV DNA and viral antigens Reawaken host immune response Therapeutic success will require a combination of agents with complementary MOAs R e duc e / Supp r ess Viral DNA 1 Reawaken / Boost Host Immune Response 3 Block HBsAg ▪ RNAi ▪ RNA Destabilizer Reduce/Suppress Viral Antigens 2
NASDAQ: ABUS www.arbutusbio.com Ar butu s P i p e li n e 10 Phase I HBV Lead Optimization CTA/I ND 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 COVID - 19/Coronaviruses Lead Optimization CTA/I ND Enabling Phase I Phase II Pan - Coronavirus Agents
NASDAQ: ABUS www.arbutusbio.com AB - 729 RNAi Therapeutic 11 Proprietary GalNAc - conjugate delivery technology provides liver targeting and enables subcutaneous dosing Single trigger RNAi agent targeting all HBV transcripts Inhibits HBV replication and lowers all HBV antigens Pan - genotypic activity across HBV genotypes Demonstrated complementarity with capsid inhibitors Actively targets the liver Active against cccDNA derived and integrated HBsAg transcripts Clean profile in long term preclinical safety studies Linker Gal N A c n sAg Polymerase, Core Ag, eAg, pgRNA s A g H B x
NASDAQ: ABUS www.arbutusbio.com Cohort J: 90 mg Q12W HBV DNA - AB - 729 - 00 1 St ud y Part 1: Single Ascending Dose In Healthy Subjects Dose 1 (60 mg) n=6; 4 active : 2 placebo Dose 2 (180 mg) n=6; 4 active : 2 placebo Dose 3 (360 mg) n=6; 4 active : 2 placebo (≥ Day 15 Safety) Cohort A: 180 mg HBV DNA - Cohort B: 60 mg HBV DNA - Cohort C: 90 mg HBV DNA - (≥ Day 15 Safety) (≥ Day 15 Safety) (≥ Day 15 Safety) Cohort D: 90 mg HBV DNA + n =6 n =6 n =6 n =6 Cohort E: 60 mg Q4W HBV DNA - Cohort F: 60 mg Q8W HBV DNA - n =7 n =7 n =7 Part 2: Single Doses In Chronic Hepatitis B Subjects Part 3: Multiple Doses In Chronic Hepatitis B Subjects HBV: Hepatitis B Virus | TDF: tenofovir disoproxil fumarate | TBD: to be determined Cohort I: 90 mg Q8W HBV DNA - n =7 n =7 12 Cohort G: 90 mg Q8W + TDF HBV DNA +
NASDAQ: ABUS www.arbutusbio.com S i n gl e D os e s o f A B - 72 9 R e s u l t i n C o mp a r a b l e M e a n H B s A g Declines at Week 12 Followed by a Sustained Plateau Phase AB - 729 60 mg single dose (N=6) * AB - 729 90 mg single dose (N=6) ** AB - 729 180 mg single dose (N=4) # Week 12 mean (SE): - 0.99 (0.24) Week 12 mean (SE): - 1.23 (0.18) Week 12 mean (SE): - 0.98 (0.43) 3/6 HBsAg <100 IU/mL 1/6 HBsAg <10 IU/mL 5/6 HBsAg <100 IU/mL 1/6 HBsAg <10 IU/mL 0/4 HBsAg <100 IU/mL mean in d ivid ua l *N=5 at Week 10, 14, 18, 22, 28, and 32 **N=4 at Week 14 and 16; N=3 at Weeks 18 – 24 # N = 3 a f te r W ee k 12; nom i n a l v isi t s “ 7 d a ys 13
NASDAQ: ABUS www.arbutusbio.com R e p e a t D osi n g o f A B - 72 9 6 0 m g E v e r y 4 W ee k s R e s u l t s i n Continuous Mean HBsAg Declines Beyond Week 12 Mean ( “ SE) HBsAg declines across single and repeat dose Cohorts *N=5 at Week 10, 14, 18 and 22 **N=4 at Week 14 - 20; N=3 at Weeks 22 – 24 # N=6 at Week 6 SD: single dose; Q4W: every 4 weeks 14 #
Mean (SE) Week 20 : - 1.71 (0.18) Mean (SE) Week 24 : - 1.84 (0.16) R e p e a t D osi n g o f A B - 72 9 6 0 m g E v e r y 8 W ee k s R e s u l t s i n C o mp a r a b l e Mean HBsAg Declines to 60 mg Every 4 Weeks at Week 16 Mean (SE) Week 12: - 1.10 (0.15) Mean (SE) Week 16: - 1.44 (0.18) at Week 24: 5/7 HBsAg <100 IU/mL 2/7 HBsAg <10 IU/mL Mean Individual NASDAQ: ABUS www.arbutusbio.com AB - 729 60 mg Q4W AB - 729 60 mg Q8W 15 Me a n I ndivid ua l Mean (SE) Week 12: - 1.02 (0.11) Mean (SE) Week 16: - 1.39 (0.07)
NASDAQ: ABUS www.arbutusbio.com 16 R e p e a t D osi n g o f AB - 72 9 6 0 m g E v e r y 8 W ee k s R e s u l t s i n C o mp a r a b l e M e a n H B s A g D e c li n e s t o 6 0 m g E v e r y 4 W ee k s a t W ee k 1 6 Mean ( “ SE) HBsAg declines across repeat dose Cohorts *N=6 at Week 6 Q4W: every 4 weeks; Q8W: every 8 weeks
NASDAQ: ABUS www.arbutusbio.com AB - 729 90 mg Single Dose Reduces HBsAg and HBV DNA in H B V DN A P osi t i v e C H B s ub j e c t s These data continue to support dosing intervals of up to 12 weeks 17 - 2.5 - 2.0 - 1.5 - 1.0 - 0.5 0.0 0.5 1.0 0 4 8 12 Week 16 2 0 24 individual mean (N=5) ∆log 10 HBsAg (IU/mL) - 2.5 - 2.0 - 1.5 - 1.0 - 0.5 0.0 0.5 1.0 0 4 8 12 Week 16 ∆log 10 HBV DNA (IU/mL) 2 0 24 individual mean (N=5) Week 12 mean (SE): - 1.02 (0.13) Week 12 mean (SE): - 1.53 (0.24)
NASDAQ: ABUS www.arbutusbio.com AB - 72 9 W a s S a f e a n d W e l l T o l e r a t e d A f t e r S i n g l e a n d R e p e a t D o s e s ▪ No SAEs or discontinuations due to AEs ▪ No treatment - related Grade 3 or 4 AEs* ▪ No Grade 3 or 4 laboratory abnormalities* ▪ Grade 1 and Grade 2 ALT elevations have decreased with continued treatment ▪ Injection site TEAEs were mild (erythema, pain, pruritis, bruising) or moderate (pain) and transient ▪ No clinically meaningful changes in ECGs or vital signs ▪ All subjects in cohort E consented to an additional 6 months of dosing * 1 subject (Cohort A) with rapid decline in HBsAg of ~2.0 log10 IU/mL had an unrelated Gr 2 AE of food poisoning resulting in unrelated transient Grade 3 AEs of ALT/AST elevation (without bilirubin changes) 18
NASDAQ: ABUS www.arbutusbio.com 19 AB - 72 9 C li n i c a l S u mma r y Repeat 60 mg Q4W dosing with AB - 729 resulted in a continuous and robust mean HBsAg decline at week 24 ( - 1.84 log10 IU/mL, N=7) Repeat dosing of AB - 729 60 mg every 8 weeks results in comparable mean HBsAg declines relative to 60 mg every 4 weeks at week 16 ( - 1.44 log10 IU/mL vs - 1.37 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 ▪ These findings support complete target engagement by AB - 729 AB - 729 remains generally safe and well tolerated These results support advancing AB - 729 to Phase 2 combination studies with AB - 729 dosing as infrequently as every 8 or 12 weeks
NASDAQ: ABUS www.arbutusbio.com NA: Nucleoside Analogue | HBeAg : HBV e Antigen AB - 72 9 C li n i c a l Collaboration w i t h A ss e m b l y Biosciences Provides accelerated AB - 729 combination proof of concept (POC) with a capsid inhibitor and NA with the potential for functional cure 20 F o l l ow U p AB - 729 + vebicorvir + NA AB - 729 + NA vebicorvir + NA Initiated Phase 2 Clinical Trial Feb 2021 Baseline Wk 72 Wk 48 Wk 24 ~60 virologically - suppressed subjects with chronic HBV infection Equal sharing of expertise and costs for this POC open - label trial No financial requirements or restrictions and no business requirements or restrictions
NASDAQ: ABUS www.arbutusbio.com Novel chemical series differentiated from AB - 506 and other competitor compounds in the Class II capsid inhibitor space Leverages a novel binding site within the core protein dimer - dimer interface Improved intrinsic potency with EC50 < 10 nM Active against NA resistant variants Potential to address known capsid resistant variants T33N and I105T Provides the potential for low dose and wide therapeutic window Projected to be once daily dosing Pangenotypic Combinable with other MOA agents AB - 836 Capsid Inh i b i t o r In March 2021, received regulatory approval to initiate Phase 1a/1b clinical trial Potential for increased efficacy and enhanced resistance profile relative to earlier generation capsid inhibitors 21
NASDAQ: ABUS www.arbutusbio.com AB - 836 : A N e x t G ene r a t i o n Ca p s i d Inh i b i t o r HBV DNA / 1 o Mechanism cccDNA Formation / 2 o Mechanism Human Serum Shift Compound HepDE19 ( E C 5 0 μ M ) HBV infected PHH (EC 50 μM) HBV infected He pG 2 - N T CP - C4 (EC 50 μM) Core I 105 T Mutation (EC 50 μM) HBV infected HepG2 - NTCP - C4 (HBsAg EC 50 μM) (FC in EC 50 in 40% Human Serum) 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 3 1 0 100 0 1 2 3 4 HBV DNA LOG Inhibition (Day 7 vs Vehicle) (mg/kg QD) A B - 8 3 6 A B - 5 0 6 Serum Activity 3 10 100 0 1 2 3 4 HBV DNA LOG Inhibition (Day 7 vs Vehicle) (mg/kg QD) A B - 8 3 6 A B - 5 0 6 Liver Activity in HDI Mouse Model Unique Binding Site HAP: Heteroaryldihydropyrimidine | SBA: Sulfamoylbenzamide I PHH: Primary Human Hepatocytes HAP AB - 506 SBA 22
NASDAQ: ABUS www.arbutusbio.com AB - 836 - 00 1 St ud y 23 Dose 6 ≤ 6 00 mg Dose 4 ≤ 2 00 mg Dose 3 ≤ 100 mg Dose 1 10mg Dose 5 ≤ 4 00 mg C o ho r t B Dose 2 ≤35mg C o ho r t A Dose 5 FE ≤400mg Dose 7 ≤ 8 00 mg Part 1: Single Ascending Dose In Healthy Subjects Alternating Cohorts A and B n=8/cohort; 6 active: 2 placebo Part 2: Multiple Ascending Dose in Healthy Subjects Cohort C (≤ 75mg QD) x 10 days N = 10; 8 active: 2 placebo Cohort D (≤200mg QD) x 10 days N = 10; 8 active: 2 placebo Cohort E (≤ 400mg QD) x 10 days N = 10; 8 active: 2 placebo Part 3: Multiple Doses In Chronic Hepatitis B Subjects Cohort F (≤ Cohort C) x 28 days DNA + N = 12; 10 active: 2 placebo Cohort G (≤ Cohort D) x 28 days DNA+ N = 12; 10 active: 2 placebo Cohort H (Dose TBD) x 28 days DNA+ N = 12; 10 active: 2 placebo Cohort I (Dose TBD) + NA x 28 days DNA - N = 12; 10 active: 2 placebo Cohort J (Dose TBD) + TDF x 28 days DNA+ N = 12; 10 active: 2 placebo
NASDAQ: ABUS www.arbutusbio.com N e x t G e n R N A D e s t a b ili z e r P r o g r a m W e beli e v e t hi s a pp r o ac h o f f e r s p o t e n t i a l f o r a n o r a l H B s A g r edu c in g a g e n t an d al l o r a l c o m bin a ti o n therapy C o n t inuin g ac t i v e r e s e a r c h an d d e v el o p m e n t o f a n e x t g ene r a ti o n s m al l m o le c ul e O f f e r s a n o v e l m e c h a ni s m o f ac t i o n t o r edu c e H B s A g an d o the r v i r a l p r o t ein s an d v i r a l R N A 24
NASDAQ: ABUS www.arbutusbio.com 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 Viral Polymerase - nucleos(t)ides ▪ nsp5 Main Viral Protease - de novo design Screening Effort ▪ Proprietary library screening through COVID R&D consortium C o r o n a v ir u s St r a t eg y COVID - 19 Virus nsp5 / 3CLpro Viral Polymerase Viral Protease +RNA Virus 31 kb Genome nsp 5 protease & nsp 12 polymerase essential enzymes for replication 25
NASDAQ: ABUS www.arbutusbio.com 202 1 K e y Ob j ec t i v e s Cash balance of ~ $132M as of March 31, 2021, cash runway through 3Q 2022 Objective Anticipated Timing 2021 Additional data from AB - 729 90 mg single - dose in HBV DNA positive subjects 1H x Initiate a Phase 2 combination clinical trial to evaluate AB - 729 in combination with Assembly Biosciences’ lead core/capsid inhibitor candidate vebicorvir (VBR) and an NrtI 1H x Initiate a Phase 1a/1b clinical trial of AB - 836, our next - generation oral capsid inhibitor 1H x Additional data from AB - 729 60 mg multi - dose (4 wk / 8 wk dosing intervals) 1H / 1H Initial data from AB - 729 90 mg multi - dose (8 wk / 12 wk dosing intervals) 1H / 2H Initial data from AB - 729 90 mg multi - dose (8 wk dosing interval) in HBV DNA positive subjects 2H Initiate two Phase 2 combination clinical trials in HBV subjects; both including AB - 729, with one or more approved or investigational agents 2H 26