Arbutus Biopharma Corporation · NASDAQ:ABUS
Arbutus Biopharma — Investor Presentation (November 2021)
30 slides from Arbutus Biopharma's investor presentation, Nov 4, 2021
Slide 1: Corporate Presentation
November 4, 2021 NASDAQ: ABUS www.arbutusbio.com Corporate Presentation
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 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 a combination of drugs with different modes of action Goal of HBV Fu
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: A Combination of Agents with Complementary MOA is Needed for HBV Cure
NASDAQ: ABUS www.arbutusbio.com 3 2 1 2 A Combination of Agents with Complementary MOA is Needed for HBV Cure HBV lifecycle illustrates key points for intervention 1. Nucleoside Analogue 2. Capsid Inhibitor 3. RNAi & RNA Destabilizer NASDAQ: ABUS www.arbutusbio.com MOA: Mechanism of Action
Slide 9: 3-Prong Approach to Therapeutic Success
NASDAQ: ABUS www.arbutusbio.com 9 Block HBsAg ▪ RNAi ▪ RNA Destabilizer Immuno - modulation ▪ PD - L1 Inhibitor ▪ Interferon ▪ Therapeutic vaccines Leading to an HBV CURE 3 - Prong Approach to Therapeutic Success MOA: Mechanism of Action | NA: Nucleoside Analogue | HBsAg : HBV Surface Antigen Suppre
Slide 10: Wholly-Owned Pipeline of Products
NASDAQ: ABUS www.arbutusbio.com Wholly - Owned Pipeline of Products 10 Phase I HBV Lead Optimization CTA/I ND Enabling Healthy Subjects HBV Patients 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
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 Trial
NASDAQ: ABUS www.arbutusbio.com AB - 729 - 001 Phase 1a/1b Trial HBV: Hepatitis B Virus | TDF: tenofovir disoproxil fumarate | cHBV: chronic HBV 12 Part 1 & 2: Single - Ascending Dose Dosing Completed Part 3: Multiple Doses In cHBV Patients (n=7) - Ongoing E: 60 mg Q4W HBV DNA - F: 60 mg Q8W HBV DNA
Slide 13: Repeat Dosing Reduces HBsAg
NASDAQ: ABUS www.arbutusbio.com 13 Repeat dosing of AB - 729 60 mg and 90 mg Reduces HBsAg CE: 60 mg Q4W (n=7) * CI: 90 mg Q8W (n=6) *Due to prolonged PD activity after single dose of AB - 729 (Yuen, AASLD 2020), subjects switched to 60mg Q12W after Week 20 CF: 60 mg Q8W (n=7) Data presented at EASL
Slide 14: Mean HBsAg response similar regardless of dose and dosing intervals
NASDAQ: ABUS www.arbutusbio.com Mean HBsAg response similar regardless of AB - 729 dose and dosing intervals to date Visit Cohort E 60 mg Q4W ⱡ Cohort F 60 mg Q8W Cohort I 90 mg Q8W p value between Cohorts Week 16 - 1.44 ( - 0.71 to - 1.95) - 1.39 ( - 1.61 to - 1.08) - 1.63 ( - 0.89 to - 2.44) p ≥ 0
Slide 15: 90mg Suppresses HBsAg and Reduces HBV DNA in HBV DNA+ CHB patients
NASDAQ: ABUS www.arbutusbio.com 90mg AB - 729 Suppresses HBsAg and Reduces HBV DNA in HBV DNA+ CHB patients 15 Individual and mean change from baseline HBsAg Single dose AB - 729 90 mg HBV DNA+ patients Individual and mean change from baseline HBV DNA Single dose AB - 729 90 mg HBV DNA+ patients Wee
Slide 16: Safe and Well Tolerated After Single and Repeat Doses
NASDAQ: ABUS www.arbutusbio.com AB - 729 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 treatment
Slide 17: Key Takeaways
NASDAQ: ABUS www.arbutusbio.com Key Takeaways ▪ Clinical data supports evaluating AB - 729 60 mg every 8 weeks in Phase 2a combination trials ▪ Long - term dosing with AB - 729 resulted in 75% of patients reaching <100 IU/mL of HBsAg, a clinically relevant threshold which could inform when to stop a
Slide 18: Next Steps – Combine with Different Compounds in Phase 2a
NASDAQ: ABUS www.arbutusbio.com ▪ First patient dosed in a Phase 2a trial in combination with ongoing NA therapy and short courses of Peg - IFNα - 2a in cHBV patients ▪ Three Phase 2a proof - of - concept clinical collaborations are on - going or expected to initiate shortly to accelerate key combin
Slide 19: Phase 2a POC Clinical Trial Design
NASDAQ: ABUS www.arbutusbio.com 19 Phase 2a POC clinical trial n=40 stably NA - suppressed, HBeAg negative, non - cirrhotic CHB patients After a 24 - week dosing period of AB - 729 ( 60 mg every 8 weeks), patients will be randomized into one of 4 groups : ▪ A1: AB - 729 + NA + weekly Peg - IFNα - 2a
Slide 20: Clinical Collaboration with Assembly Biosciences
NASDAQ: ABUS www.arbutusbio.com NA: Nucleoside Analogue 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 Baseline Wk 72 Wk 48 Wk 24 Phas
Slide 21: Clinical Collaboration with Vaccitech
NASDAQ: ABUS www.arbutusbio.com 21 Evaluate safety, pharmacokinetics, immunogenicity and anti - viral activity of triple combination - AB - 729, VTP - 300 and an NA compared to double combinations of AB - 729 with an NA and VTP - 300 with an NA Expected to file CTA in the second half of 2021 and ini
Slide 22: Clinical Collaboration with Antios
NASDAQ: ABUS www.arbutusbio.com 22 AB - 729 Clinical Collaboration 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 Trial cohort will include 10 patients with chronic HBV assigned 8:2 to ac
Slide 23: AB-836 Next-Generation 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 24: AB-836: Next Generation Capsid Inhibitor
NASDAQ: ABUS www.arbutusbio.com AB - 836: 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 He
Slide 25: AB-836 Phase 1a/1b Trial Design
NASDAQ: ABUS www.arbutusbio.com AB - 836 - 001 Trial 25 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 26: Next Gen Oral RNA Destabilizer Program
NASDAQ: ABUS www.arbutusbio.com Next Gen Oral 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 redu
Slide 27: Oral PD-L1 Inhibitor Program for HBV Immune Reactivation
NASDAQ: ABUS www.arbutusbio.com Oral 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 robu
Slide 28: 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 29: 2021 Key Objectives
NASDAQ: ABUS www.arbutusbio.com 2021 Key Objectives Cash balance of $151.9M as of September 30, 2021, cash runway into Q2 2023 Objective Anticipated Timing 2021 Additional data from AB - 729 90 mg single - dose in HBV DNA positive patients 1H Initiate a Phase 2 combination clinical trial to evaluate
Slide 30: Thank You
NASDAQ: ABUS www.ArbutusBio.com Thank You
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