Arbutus Biopharma Corporation · NASDAQ:ABUS
Arbutus Biopharma — Investor Presentation (May 2022)
30 slides from Arbutus Biopharma's investor presentation, May 24, 2022
Slide 1: Corporate Presentation
NASDAQ: ABUS www.arbutusbio.com May 24, 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 )* Capsid 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 of Each MOA to Combine to Develop a Cure for HBV
Key Attributes of Each MOA to Combine to Develop a Cure for HBV 9 Potent HBsAg reductions Less frequent dosing vs. other RNAi agents Re - awakening of immune response Potential for shorter course therapy vs. SOC Once - daily oral administration Demonstrates robust anti - viral activity Active agains
Slide 10: RNAi Therapeutic: GalNAc-conjugate delivery technology
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 (n=7) - Ongoing 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 DN
Slide 12: Post Treatment: HBsAg Suppression Maintained up to 28 Weeks
Post AB - 729 Treatment: HBsAg Suppression at Levels <100 IU/mL Maintained up to 28 Weeks ⱡ patients switched to AB - 729 60mg Q12W after Week 20 dose Data presented at AASLD 2021 Individual HBeAg - Individual HBeAg + Cohort E AB - 729 60mg Q4W + HBV DNA - patients Cohort F AB - 729 60mg Q8W HBV DNA
Slide 13: Reduces HBsAg in DNA- or DNA+ Patients
Data presented at AASLD 2021 Mean Individual HBeAg - Individual HBeAg + *at time of last visit The magnitude of HBsAg suppression (1.8 - 2.0 log reduction at wk 40) was similar across both dosing intervals 15 out of 20 patients achieved HBsAg <100 IU/mL HBsAg reduction is sustained over time Key Fin
Slide 14: Mean HBsAg change from baseline by cohort
HBV DNA - HBV DNA+ Visit Cohort E 60mg Q4W ⱡ ( n =7) Cohort F 60mg Q8W (n=7) Cohort I 90mg Q8W (n=6) Cohort J 90mg Q12W (n=7) Cohort G 90mg Q8W (n=7) Baseline 3.51 (0.20) 3.53 (0.17) 3.36 (0.23) 3.37 (0.28) 3.14 (0.14) Week 12 - 1.10 (0.15) - 1.02 (0.11) - 1.30 (0.19) - 1.06 (0.31) - 1.56 (0.32) Wee
Slide 15: Safety Summary
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 - 729 generally safe and well - tolerated after single and r
Slide 16: Clinical Trial Key Takeaways
AB - 729 - 001 Clinical Trial Key Takeaways AB - 729 dosed 60mg Q4W and Q8W and 90mg Q8W and Q12W resulted in robust and comparable HBsAg declines AB - 729 monotherapy resulted in robust HBsAg and HBV DNA declines in HBV DNA+ patients Long - term dosing with AB - 729 resulted in 75% of patients* rea
Slide 17: Phase 2a POC Clinical Trial with NA and Peg-IFN
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 18: Clinical Collaboration with Assembly
Clinical Collaboration Provides accelerated AB - 729 combination POC with Assembly’s capsid inhibitor and a NA Fully enrolled; initial data 2H 2022 AB - 729 Follow Up (24 - weeks) AB - 729 + vebicorvir + NA AB - 729 + NA vebicorvir + NA Baseline Wk 48 Wk 24 Primary objective: evaluate safety and tol
Slide 19: Phase 2a POC Clinical Trial with Vaccitech 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 Expected to initiate 1H 2022 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
Slide 20: Exclusive Licensing and Strategic Partnership with Qilu
Exclusive Licensing* and Strategic Partnership Develop, manufacture and commercialize AB - 729 in mainland China, Hong Kong, Macau and Taiwan $40M Upfront payment $15M Equity investment Up to $245M Commercialization and milestone payments Double - digit up to low twenties % Tiered royalties on annua
Slide 21: Next Generation Capsid Inhibitor AB-836
Novel chemical series differentiated from other Class II capsid inhibitors Leverages a novel binding site within the core protein dimer - dimer interface Improved intrinsic potency with EC 50 < 10 nM Active against NA - resistant variants Potential to address known capsid resistant variants T33N and
Slide 22: AB-836 Phase 1a/1b Clinical Trial
AB - 836 - 001 Phase 1a/1b Clinical Trial Part 1: Single Ascending Dose In Healthy Subjects Part 2: Multiple Ascending Dose in Healthy Subjects Part 3: Multiple Doses In Chronic Hepatitis B Patients Alternating Cohorts A and B n=8/cohort; 6 active: 2 placebo Cohort A Cohort B ongoing * FE: with Food
Slide 23: AB-836-001 Preliminary Data
Part 3: 50mg and 100mg of AB - 836 once daily for 28 days in patients with cHBV Parts 1 & 2: Single and multi - doses of AB - 836 in healthy subjects AB - 836 - 001 Preliminary Data Part 3 of the trial continues to enroll patients No deaths or SAEs 1 subject (50mg once daily) discontinued on day 13
Slide 24: 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 25: 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 26: 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 27: 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 28: 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 Coronavirus Strategy Arbutus Strategy nsp5 protease & nsp12 polymerase essential enzymes fo
Slide 29: 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 d
Slide 30: Thank You
Thank You “Warbutus BIOPHARMA