Arbutus Biopharma Corporation · NASDAQ:ABUS
Arbutus Biopharma — Investor Presentation (November 2022)
29 slides from Arbutus Biopharma's investor presentation, Nov 9, 2022
Slide 1: Corporate Presentation
NASDAQ: ABUS www.arbutusbio.com November 9, 2022 Corporate Presentation
Slide 2: Forward-Looking Statements
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 fo
Slide 3: Our Strategy
Our Strategy Leverage the proven track record of success established with our team's expertise in understanding and treating viral infections by discovering and developing a broad, differentiated pipeline of therapies targeting chronic HBV, COVID - 19, and future coronavirus outbreaks. Develop a com
Slide 4: Investment Highlights
Investment Highlights Strong financial position Indications with significant unmet medical need & large market opportunities Patented LNP technology Broad portfolio of internally discovered assets with distinct MOAs Lead HBV compound – AB - 729 RNAi therapeutic in multiple Phase 2a combination clini
Slide 5: Broad Pipeline
Broad Pipeline HBV AB - 729 - 001 single - ascending dose / multiple - ascending dose RNAi Therapeutic AB - 729 AB - 729 - 201 Combo trial (AB - 729 + Peg - IFNa - 2a + NA) Combo trial (AB - 729 + core inhibitor + NA) AB - 729 - 202 Combo trial (AB - 729 + vaccine + NA ) PD - L1 Inhibitor (oral) AB
Slide 6: HBV Overview
HBV Overview Life - threatening liver infection caused by hepatitis B virus (HBV) Transmitted through body fluids and from mother to child Long - term chronic infection ( cHBV ) leads to higher risk of cirrhosis and/or liver cancer Cause & Symptoms Diagnosis HBsAg detection Additional biomarkers nec
Slide 7: HBV Presents a Significant Unmet Medical Need
Africa 60M E Mediterranean 21M SE Asia 39M W Pacific 115M EU 15M Americas 7M ~820k people die every year as a consequence despite the availability of effective vaccines and antivirals. people are chronically infected with HBV, globally. >290M >290M Chronic HBV Sources: https://www.who.int/news - roo
Slide 8: 3-Pronged Approach to Therapeutic Success
Suppress Reduce Boost Viral DNA and cccDNA Pool Viral Antigen - HBsAg Host Immune System Leading to an HBV Cure 3 - Pronged Approach to Therapeutic Success Therapeutic success will require a combination of agents with complementary MOAs. Suppress HBV DNA Reduce viral antigens Boost host immune respo
Slide 9: Key Attributes
Single trigger agent targeting all HBV transcripts Unique, proprietary GalNAc delivery technology AB - 729 Key Attributes 1.8 to 2.1 log 10 and 1.0 to 2.35 log 10 HBsAg decline in cHBV patients irrespective of dose, dosing interval or baseline characteristics Robust and sustained HBsAg decline at en
Slide 10: Proprietary GalNAc-conjugate delivery technology RNAi therapeutic
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 cap
Slide 11: Phase 1a/1b Clinical Trial
AB - 729 - 001 Phase 1a/1b Clinical Trial HBeAg : HBV E antigen | TDF: tenofovir disoproxil fumarate Part 3: Multiple Ascending Dose in cHBV Patients E: 60mg Q4W HBV DNA - F: 60mg Q8W HBV DNA - G: 90mg Q8W + TDF HBV DNA+ I: 90mg Q8W HBV DNA - J: 90mg Q12W HBV DNA - K: 90mg Q8W HBV DNA - , HBeAg + on
Slide 12: Robust HBsAg Declines Irrespective of Dose, Dosing Schedule, HBeAg or HBV DNA Status
Robust HBsAg Declines Irrespective of Dose, Dosing Schedule, HBeAg or HBV DNA Status Mean (SE) Baseline and Δ log 10 HBsAg by Visit Data shown as mean (SE) log 10 IU/mL; HBsAg LLOQ = 0.07 IU/mL, <LLOQ defined as 0.035 IU/mL Last AB - 729 dose in Cohort K was at Week 40 *N=6; # N=5, 2 patients did no
Slide 13: Robust HBsAg Declines Persist After Stopping
Data presented at AASLD 2022 13 Change in HBsAg vs time Robust HBsAg Declines Persist After Stopping AB - 729 33 of 41 patients had HBsAg < 100 IU/mL at some point during the trial 1 patient in Cohort E (baseline HBsAg = 583.5 IU/mL) who qualified but declined to participate in NA discontinuation se
Slide 14: HBV Control Maintained While Off-Treatment
HBV Control Maintained While Off - Treatment Pt. 46 Pt. 51 Pt. 52 Pt. 53 Pt. 56 Pt. 58 Pt. 59 Pt. 60 Pt. 61 No patients have met virologic or clinical relapse criteria or restarted NA therapy to date HBV DNA has transiently increased in some patients and subsequently decreased with no intervention 1
Slide 15: Increased HBV-Specific T-Cell Activation and Decreased Exhausted T-Cells
Subjects Treated with AB - 729 Showed Increased HBV - Specific T - Cell Activation and Decreased Exhausted T - Cells 15 Subject 42 60 mg Q4W 0 4 812162024283236404448525660 0 1 2 3 4 5 0 20 40 60 H B s A g ( L o g 1 0 I U / m L ) Subject 43 60 mg Q4W 0 4 8 1216202428323640444852 0 1 2 3 4 0 10 20 30
Slide 16: Safety Summary
AE: Adverse Event | TEAE: Treatment Emergent Adverse Event AB - 729 - 001 Safety Summary *1 patient (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) AB -
Slide 17: Clinical Trial Key Takeaways
AB - 729 - 001 Clinical Trial Key Takeaways AB - 729 provided robust and comparable HBsAg declines regardless of dose, dosing interval, HBeAg or DNA status ~75% (26 of 34) patients had HBsAg levels <100 at some point during the trial 50% (16 of 32) patients maintained HBsAg <100 IU/mL for 24 weeks a
Slide 18: Phase 2a POC Clinical Trial with Peg-IFNα-2a
Phase 2a POC Clinical Trial AB - 729 in combination with ongoing NA therapy and short courses of Peg - IFN α - 2 a in cHBV patients Initial data expected 2H 2022 AB - 729 - 201: Follow - up (24 - weeks) AB - 729 + NA + IFN (n=12) NA + IFN (n=12) AB - 729+NA+IFN (n=8) NA + IFN (n=8) AB - 729 + NA (60
Slide 19: Clinical Collaboration with Assembly
Clinical Collaboration Provides accelerated AB - 729 combination POC with Assembly’s capsid inhibitor and a NA AB - 729 Follow Up (24 - weeks) AB - 729 (60mg) + VBR (300mg) + NA (n=32) AB - 729 + NA (n=17) VBR + NA (n=16) Baseline Wk 48 Wk 24 Primary objective: evaluate safety and tolerability of ve
Slide 20: Phase 2a POC Clinical Trial with VTP-300
Phase 2a POC Clinical Trial POC Phase 2a clinical trial evaluating AB - 729 in combination with Vaccitech’s immunotherapeutic, VTP - 300, and a NA First patient dosed AB - 729 - 202: Follow - up (24 - 48 weeks) VTP - 300 + NA (n=20) NA + sham (n=20) 1 48 26 AB - 729 + NA (60mg Q8W) n=40 24 Randomize
Slide 21: Strategic Collaboration with Qilu
Strategic Collaboration Exclusive Licensing* and Strategic Partnership Develop, manufacture and commercialize AB - 729 in mainland China, Hong Kong, Macau and Taiwan AB - 729 $40M Upfront payment $15M Equity investment Up to $245M Commercialization and milestone payments Double - digit up to low twe
Slide 22: AB-161: Next Generation Oral RNA Destabilizer
AB - 161: Next Generation Oral RNA Destabilizer AB - 161 is currently in IND - enabling studies Next generation small molecule anticipated to circumvent non - clinical safety findings with first generation molecule Offers a novel mechanism of action to reduce HBsAg, other viral proteins and viral RN
Slide 23: AB-161 Reduces HBsAg in AAV-HBV Mouse Model
AB - 161 Reduces HBsAg in AAV - HBV Mouse Model Compound concentration in liver drives efficacy 23 Fraction Unbound Concentrations (C 24h ) 0 2 4 6 8 10 12 14 1 10 100 Days S e r u m H B s A g ( % B a s e l i n e ) Vehicle AB-161 0.3 mg/kg AB-161 1 mg/kg AB-161 10 mg/kg AB-161 30 mg/kg [AB - 161] fr
Slide 24: AB-101: Oral PD-L1 Inhibitor for HBV Immune Reactivation
AB - 101: Oral PD - L1 Inhibitor for HBV Immune Reactivation PD - 1: Programmed death ligand protein | Abs: Antibodies AB - 101 is currently in IND - enabling studies Rationale • HBV immune tolerance is a critical driver of cHBV infection • PD - 1:PD - L1 checkpoint axis plays a key role in immune t
Slide 25: AB-101: Small-Molecule Oral PD-L1 Inhibitor for HBV
AB - 101: Small - Molecule Oral PD - L1 Inhibitor for HBV AB - 101 is highly potent with demonstrated activity against cells from chronic HBV patients AB - 101 reduces PD - L1 on the surface of human primary myeloid cells AB - 101 reinvigorates HBV - specific cHBV patient T - cells Data presented at
Slide 26: Pan-Coronavirus Overview
Pan - Coronavirus Overview 1 https://www.healthdata.org/special - analysis/ estimation - excess - mortality - due - covid - 19 - and - scalars - reported - covid - 19 - deaths Coronavirus Infections, such as COVID - 19 caused by SAR - CoV - 2 Spreads through breathing out droplets and small particle
Slide 27: Coronavirus Strategy
Viral Polymerase nucleos (t)ides COVID - 19 Virus nsp12 Viral Protease de novo design COVID - 19 Virus nsp5 / M pro Leveraging our proven expertise and capabilities in antiviral drug discovery and development Coronaviru s Strategy Arbutus Strategy nsp5 protease & nsp12 polymerase essential enzymes f
Slide 28: 2022 Key Milestones
Milestone Anticipated Timing 2022 AB - 836, next generation oral capsid inhibitor: Data from Phase 1a/1b clinical trial in patients with chronic HBV 1H AB - 729, RNAi therapeutic: Initiate a triple combination Phase 2a POC clinical trial with VTP - 300 ( Vaccitech ) and a NA 1H AB - 729: Follow - up
Slide 29: Thank You
Thank You 29
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