Arbutus Biopharma Corporation · NASDAQ:ABUS
Arbutus Biopharma — Investor Presentation (August 2021)
30 slides from Arbutus Biopharma's investor presentation, Aug 5, 2021
Slide 1: Corporate Presentation August 2021
Corporate Presentation August 2021 NASDAQ: ABUS www.arbutusbio.com
Slide 2: Forward-Looking Statements
NASDAQ: ABUS www.arbutusbio.com Forward - Looking Statements 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
Slide 3: Investment Highlights
NASDAQ: ABUS www.arbutusbio.com Investment Highlights Therapeutic focus – curing chronic Hepatitis B Virus (HBV) Infection 3 HCV: Hepatitis C Virus | HIV Human Immunodeficiency Virus Significant Unmet Medical Need in HBV Undetectable HBV DNA and HBsAg delivered through finite duration treatment with
Slide 4: Proven Leadership Team
NASDAQ: ABUS www.arbutusbio.com NASDAQ: ABUS www.arbutusbio.com Proven Leadership Team 4 Successful track records in the discovery, development, and commercialization of multiple antivirals including sofosbuvir, etravirine, rilpivirine , telaprevir and simeprevir William H. Collier Chief Development
Slide 5: HBV Presents a Significant Unmet Medical Need
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 HBV Prese
Slide 6: Significant Opportunity to Improve HBV Cure Rates
NASDAQ: ABUS www.arbutusbio.com New HBV Therapies rate of Undetectable HBV DNA rate of HBsAg Loss HIGHER CURES RATES SOC: Standard Of Care | HBsAg : HBV Surface Antigen | PegIFN : P egylated Interferon Source: EASL HBV Clinical Practice Guidelines, 2017 - Pegasys, PEG - Intron, Baraclude and Viread
Slide 7: Compelling Growth Opportunity in the HBV Market
NASDAQ: ABUS www.arbutusbio.com An HBV curative regimen would substantially increase diagnosis and treatment rates to unlock significant market growth opportunities. diagnosis Compelling Growth Opportunity in the HBV Market 7 SOC: Standard Of Care Source: Global Hepatitis Report and Hepatitis B Fact
Slide 8: HBV Lifecycle Illustrates Key Points for Intervention
NASDAQ: ABUS www.arbutusbio.com 3 2 1 2 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 NASDAQ: ABUS www.arbutusbio.com MOA: Mechanism of Action
Slide 9: Keys to Therapeutic Success
NASDAQ: ABUS www.arbutusbio.com 9 Block Replication ▪ NA ▪ Capsid Inhibitor ▪ RNAi ▪ RNA Destabilizer Reduce cccDNA Pool ▪ Capsid Inhibitor Block HBsAg ▪ RNAi ▪ RNA Destabilizer Immuno - modulation ▪ PD - L1 Inhibitor ▪ Interferon ▪ Therapeutic vaccines Leading to an HBV CURE Keys to Therapeutic Suc
Slide 10: Arbutus Pipeline
NASDAQ: ABUS www.arbutusbio.com Arbutus Pipeline 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/Coronavi
Slide 11: RNAi Therapeutic
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 activi
Slide 12: Phase 1a/1b Study Design
NASDAQ: ABUS www.arbutusbio.com Cohort J: 90 mg Q12W HBV DNA - AB - 729 - 001 Study Part 1: Single Ascending Dose In Healthy Subjects Dose 1 (60 mg) Dose 2 (180 mg) Dose 3 (360 mg) (≥ Day 15 Safety) n=6; 4 active : 2 placebo n=6; 4 active : 2 placebo n=6; 4 active : 2 placebo Cohort A: 180 mg HBV DN
Slide 13: Single Doses Result in Comparable Mean HBsAg Declines at Week 12
NASDAQ: ABUS www.arbutusbio.com Single Doses of AB - 729 Result in Comparable Mean HBsAg Declines at Week 12 Followed by a Sustained Plateau Phase W e e k 1 2 -2.5 -2 -1.5 -1 -0.5 0 0.5 0 4 8 12 16 20 24 28 32 Cohort=A W e e k 1 2 -2.5 -2 -1.5 -1 -0.5 0 0.5 0 4 8 12 16 20 24 28 32 Cohort=C W e e k 1
Slide 14: Repeat Dosing Results in Comparable HBsAg Decline Profiles
NASDAQ: ABUS www.arbutusbio.com 14 -3 -2.5 -2 -1.5 -1 -0.5 0 0.5 0 4 8 1216202428323640444852 CHG vs NominalWeek 3006-3027 5004-3034 6001-3011 6001-3019 6001-3021 6001-3022 8001-3018 mean Repeat dosing of AB - 729 60 mg and 90 mg results in comparable HBsAg decline profiles with 75 percent of subjec
Slide 15: No Significant Differences in Mean HBsAg Response Between Doses
NASDAQ: ABUS www.arbutusbio.com There are no significant differences in mean HBsAg response between AB - 729 doses and dosing intervals to date Visit Cohort E AB - 729 60 mg Q4W ⱡ Cohort F AB - 729 60 mg Q8W Cohort I AB - 729 90 mg Q8W p value between Cohorts Week 16 - 1.44 ( - 0.71 to - 1.95) - 1.3
Slide 16: Single Dose Reduces HBsAg and HBV DNA in HBV DNA Positive Subjects
NASDAQ: ABUS www.arbutusbio.com AB - 729 90 mg Single Dose Reduces HBsAg and HBV DNA in HBV DNA Positive CHB subjects 16 Figure 1. Individual and mean change from baseline HBsAg following a single dose of AB - 729 90 mg in HBV DNA+ subjects -3 -2 -1 0 1 2 0 4 8 12162024283236404448 Figure 2. Individ
Slide 17: Safe and Well Tolerated After Single and Repeat Doses
NASDAQ: ABUS www.arbutusbio.com AB - 729 Was Safe and Well Tolerated After Single and Repeat Doses ▪ 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 treatm
Slide 18: Takeaways
NASDAQ: ABUS www.arbutusbio.com Takeaways ▪ Clinical data supports our view that AB - 729 60 mg every 8 weeks is an appropriate and convenient dose to explore in Phase 2a combination trials ▪ Long - term dosing with AB - 729 resulted in 75 percent of subjects reaching <100 IU/mL of HBsAg, a clinical
Slide 19: Three Clinical Collaborations Executed and IND Authorized
NASDAQ: ABUS www.arbutusbio.com ▪ Accomplished key strategic initiative by announcing three Phase 2a proof - of - concept clinical collaborations to accelerate key combination data read - outs ▪ Assembly Biosciences, Inc. - Phase 2a initiated in the first half of 2021 ▪ Antios Therapeutics, Inc. - c
Slide 20: Clinical Collaboration with Assembly Biosciences
NASDAQ: ABUS www.arbutusbio.com NA: Nucleoside Analogue | HBeAg : HBV e Antigen AB - 729 Clinical Collaboration Provides accelerated AB - 729 combination proof - of - concept (POC) with Assembly’s capsid inhibitor and a NA 20 Follow Up AB - 729 + vebicorvir + NA AB - 729 + NA vebicorvir + NA Baselin
Slide 21: Clinical Collaboration with Vaccitech
NASDAQ: ABUS www.arbutusbio.com 21 Clinical trial will evaluate the safety, pharmacokinetics, immunogenicity and anti - viral activity of the triple combination of AB - 729, VTP - 300 and an NA compared to the double combinations of AB - 729 with an NA and VTP - 300 with an NA Expected to file CTA i
Slide 22: Clinical Collaboration with Antios
NASDAQ: ABUS www.arbutusbio.com 22 AB - 729 Clinical Collaboration Clinical trial will evaluate AB - 729, ATI - 2173 and a NA in a single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial Expected to initiate in the second half of 2021 Antios will be responsible for the costs and Arbutus
Slide 23: IND Authorized for a Phase 2a POC Clinical Trial
NASDAQ: ABUS www.arbutusbio.com 23 IND Authorized for a Phase 2a POC clinical trial The trial is expected to enroll 40 stably NA - suppressed, HBeAg negative, non - cirrhotic CHB subjects* After a 24 - week dosing period of AB - 729 ( 60 mg every 8 weeks (Q 8 W)), subjects will be randomized into on
Slide 24: AB-836 Capsid Inhibitor
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 resis
Slide 25: AB-836: A Next Generation Capsid Inhibitor
NASDAQ: ABUS www.arbutusbio.com AB - 836: A Next Generation Capsid Inhibitor HBV DNA / 1 o Mechanism cccDNA Formation / 2 o Mechanism Human Serum Shift Compound HepDE19 ; EC 50 μM Ϳ HBV infected PHH ; EC 50 μM Ϳ HBV infected HepG2 - NTCP - C4 ; EC 50 μM) Core I105T Mutation (EC 50 μM ) HBV infected
Slide 26: AB-836 Phase 1a/1b Study Design
NASDAQ: ABUS www.arbutusbio.com AB - 836 - 001 Study 26 Dose 6 ≤600mg Dose 4 ≤200mg Dose 3 ≤100mg Dose 2 ≤35mg Dose 1 10mg Dose 5 ≤400mg Cohort A Cohort B Dose 5 FE ≤400mg Dose 7 ≤800mg Part 1: Single Ascending Dose In Healthy Subjects Alternating Cohorts A and B n=8/cohort; 6 active: 2 placebo Part
Slide 27: Next Gen RNA Destabilizer Program
NASDAQ: ABUS www.arbutusbio.com Next Gen RNA Destabilizer Program We believe this approach offers potential for an oral HBsAg reducing agent and all oral combination therapy Continuing active research and development of a next generation small molecule Offers a novel mechanism of action to reduce HB
Slide 28: PD-L1 Inhibitor Program for HBV Immune Reactivation
NASDAQ: ABUS www.arbutusbio.com PD - L1 Inhibitor Program for HBV Immune Reactivation Current Lead Candidates ▪ Block PD - L1/PD1 interaction at sub - nM concentrations ▪ Activate HBV - specific immune responses in T - cells from CHB patients in vitro ▪ Novel MOA identified ▪ Demonstrate a robust ch
Slide 29: Coronavirus Strategy
NASDAQ: ABUS www.arbutusbio.com 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 X - Chem/ Proteros ▪ Proprietary DEL library screening and structural biolog
Slide 30: 2021 Key Objectives
NASDAQ: ABUS www.arbutusbio.com 2021 Key Objectives Cash balance of $121.3M as of June 30, 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 Initiate a Phase 2 combination clinical trial to evaluate A
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