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): August 10, 2020
(Exact name of registrant as specified in charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
| (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:
| Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| 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:
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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 ☐
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 August 10, 2020, Arbutus Biopharma Corporation posted an updated corporate presentation on its website at www.arbutusbio.com. A copy of the presentation is filed herewith as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover page interactive data file (formatted as inline XBRL) | |||||||
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: August 10, 2020 | By: | /s/ David C. Hastings | ||||||
| Name: | David C. Hastings | |||||||
| Title: | Chief Financial Officer | |||||||
Corporate Presentation August 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; Arbutus’ ability to meet a significant unmet medical need; the sufficiency of Arbutus’ cash and cash equivalents to extend into mid 2021; Arbutus’ expectation for multiple 60 mg dose and 90 mg single-dose data in the second half of 2020; Arbutus’ expectation to dose two 90 mg multi-dose cohorts in the second half of 2020; the potential for an oral HBsAg reducing agent and potential all oral combination therapy; Arbutus’ 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 Arbutus’ product candidates; 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. NASDAQ: ABUS www.arbutusbio.com 2
Investment Highlights Therapeutic focus – curing chronic Hepatitis B Virus (HBV) Infection Significant Team with Unmet Goal of HBV Broad Coronavirus Antiviral 16 % Medical Need Functional HBV Research Expertise & Ownership in Cure Portfolio in HBV Initiative Proven Track Genevant Record Global HBV Undetectable HBV HBV assets include: Focused on Applying Rights to potential prevalence DNA and HBsAg RNAi direct acting knowledge gained future royalties double that of delivered through antivirals from HIV and HCV and sublicense HCV, potential for finite duration Capsid Inhibitors targeting the success to revenues for larger market treatment with a PD-L1 viral HBV and LNP Technology opportunity combination of HBV RNA polymerase Coronaviruses drugs with different Destabilizers and protease 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 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 Q4W n=6; 4 active : 2 placebo HBV DNA - n=6 HBV DNA - n=7 (≥ Day 15 Safety) (≥ Day 15 Safety) Dose 2 (180 mg) Cohort B: 60 mg Cohort F: 60 mg Q8W n=6; 4 active : 2 placebo HBV DNA - n=6 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 Cohort I: 90 mg HBV DNA - n=7 Cohort D: 90 mg HBV DNA + n=6 Cohort J: 90 mg HBV DNA - n=7 NASDAQ: ABUS 17 www.arbutusbio.com HBV: Hepatitis B Virus | TDF: tenofovir disoproxil fumarate | TBD: to be determined
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 Viral 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 $115M as July 31, 2020, cash runway into mid-2022 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 (in HBV DNA 2H 2020 positive and negative subjects) Initiate two AB-729 90 mg multi-dose cohorts 2H 2020 Complete AB-836 IND enabling studies 2H 2020 NASDAQ: ABUS www.arbutusbio.com Arbutus received $36.5 million of net proceeds under the ATM program during July 2020 22