Arbutus Biopharma Corporation · NASDAQ:ABUS
Arbutus Biopharma — Investor Presentation (January 2023)
29 slides from Arbutus Biopharma's investor presentation, Jan 5, 2023
Slide 1: Corporate Presentation
NASDAQ: ABUS www.arbutusbio.com January 5, 2023 Corporate Presentation © 2023 Arbutus Biopharma, Inc.
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: 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 oth
Slide 10: 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 11: Robust HBsAg Declines Irrespective of Dose, 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; Last AB - 729 dose Cohort E: Week 44, Cohorts F, I, G, K: Week 40, Cohort J: Week 36; HBsAg Assay LLOQ = 0.07 IU/mL; *N=6; # N=5 1
Slide 12: Robust & Sustained HBsAg Declines On- or Off-Treatment
Data presented at EASL 2022 and AASLD 2022 12 Change in HBsAg vs time AB - 729 - 001: Robust & Sustained HBsAg Declines While On - or Off - Treatment with 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 qualifie
Slide 13: HBV Control Maintained in cHBV Patients While Off-Treatment
AB - 729 - 001: HBV Control Maintained in cHBV Patients While Off - Treatment 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 13 Data presented at AASLD 2022
Slide 14: Treatment Reactivates HBV Specific Immunity in Some Patients
AB - 729 - 001: Treatment with AB - 729 Reactivates HBV Specific Immunity in Some Patients 14 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 ) Patient 43 60 mg Q4W 0 4 8 1216202428323640444852 0 1 2 3 4 0 10 20 30 40 50 60 H B s A g ( L o g 1 0 I U / m L ) Pat
Slide 15: Safety Summary
AB - 729 - 001 Safety Summary AB - 729 is generally safe and well - tolerated after repeat dosing for up to 48 weeks No treatment - related SAEs or discontinuations due to AEs No treatment - related Grade 3 or 4 AEs No treatment - related Grade 3 or 4 laboratory abnormalities • Grade 1 and Grade 2 A
Slide 16: 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 17: Phase 2a POC Trial with NA Therapy and 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 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 (60mg Q8W) n=40 HBeAg - Randomize
Slide 18: 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 19: Phase 2a POC 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 AB - 729 - 202: Primary objective: evaluate safety and reactogenicity of AB - 729 followed by VTP - 300 or placebo At week 48 all participants who are el
Slide 20: Strategic Collaboration: Exclusive Licensing and Partnership 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 (received in 2022) $15M Equity investment (received in 2022) Up to $245M Commercialization and milestone
Slide 21: AB-161: Next Generation Oral RNA Destabilizer
AB - 161: Next Generation Oral RNA Destabilizer AB - 161 is advancing into Phase 1 clinical trial in 1H 2023 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
Slide 22: AB-161 Reduces HBsAg in AAV-HBV Mouse Model
AB - 161 Reduces HBsAg in AAV - HBV Mouse Model 22 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] free : plasma [AB - 161] free : liver AAV - HBV mo
Slide 23: 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 advancing into Phase 1 clinical trial in 1H 2023 Rationale • HBV immune tolerance is a critical driver of cHBV infection • PD - 1:PD - L1 checkpoint axis plays a key rol
Slide 24: 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 PD - L1 in 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 p
Slide 25: Coronavirus Program Overview
Coronavirus Program 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 SARS - CoV - 2 Spreads through breathing out droplets and small parti
Slide 26: 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 27: AB-343: M PRO Coronavirus Candidate
AB - 343: M PRO Coronavirus Candidate AB - 343 is currently in IND - enabling studies • Highly potent (IC 50 < 8nM) • Equipotent against all known COVID - 19 variants • Robust activity against M pro resistant variants • Highly selective for coronavirus M pro vs human proteases • Clean cell toxicity
Slide 28: 2023 Key Milestones
2023 Key Milestones Cash balance * of $185M (unaudited) as of December 31, 2022, cash runway into Q4 2024; 2023 net cash burn of between $95 and $100M ; *Consists of cash, cash equivalents and marketable securities 28 Milestone Anticipated Timing 2023 AB - 729: Dose f irst patient in the AB - 729+VT
Slide 29: Thank You
Thank You © 2023 Arbutus Biopharma, Inc.
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