Arbutus Biopharma Corporation · NASDAQ:ABUS
Arbutus Biopharma — Investor Presentation (May 2021)
26 slides from Arbutus Biopharma's investor presentation, May 5, 2021
Slide 1: Corporate Presentation May 2021
Corporate P r ese n t a ti o n May 2021 NASDAQ: ABUS www.arbutusbio.com
Slide 2: Forward-Looking Statements
NASDAQ: ABUS www.arbutusbio.com F o r w a r d - Loo k i n g S t a t eme n t s 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 h
Slide 3: Investment Highlights
NASDAQ: ABUS www.arbutusbio.com I n v e s t me n t Hi g h li g h t s Therapeutic focus – curing chronic Hepatitis B Virus (HBV) Infection 3 HCV: Hepatitis C Virus | HIV Human Immunodeficiency Virus Significant Unmet Medical N ee d i n H B V Undetectable HBV DNA and HBsAg delivered through finite dur
Slide 4: Proven Leadership Team
NASDAQ: ABUS www.arbutusbio.com Proven Lea d e r s h i p Team 4 Successful track records in the discovery, development, and commercialization of multiple antivirals including sofosbuvir, etravirine, rilpivirine, telaprevir and simeprevir William H. Collier President and CEO David C. Hastings Chief F
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 H B V P r
Slide 6: Significant Opportunity to Improve HBV Cure Rates
NASDAQ: ABUS www.arbutusbio.com N e w H B V T he r a p i e s rate of HBsAg Loss rate of Undetectable HBV DNA + SOC: Standard Of Care | HBsAg : HBV Surface Antigen | PegIFN: Pegylated Interferon Source: EASL HBV Clinical Practice Guidelines, 2017 - Pegasys, PEG - Intron, Baraclude and Viread Package
Slide 7: Compelling Growth Opportunity in the HBV Market
NASDAQ: ABUS www.arbutusbio.com An HBV curative regimen would substantially increase diagnosis Compelling Growth Opportunity in the HBV Market 7 SOC: Standard Of Care Source: Global Hepatitis Report and Hepatitis B Fact Sheet, WHO (2017) http://www.who.int/mediacentre/factsheets/fs204/en/ 10.5% Diag
Slide 8: HBV Lifecycle Illustrates Key Points for Intervention
NASDAQ: ABUS www . a r bu t usb i o . c o m 3 2 1 2 H B V L i f ec y c l e I ll u s t r a t e s K e y P o i n t s f o r I nt e r v e n t i o n A combination of agents with complementary MOA is needed to cure HBV 1. Nucleoside Analogue 2. C a p s i d Inhibi t o r 3. R N A i & R N A Destabilizer NASDA
Slide 9: Keys to Therapeutic Success
NASDAQ: ABUS www.arbutusbio.com 9 Block Replication ▪ NA ▪ Ca p s i d In h i b i t or ▪ RNAi ▪ RNA Destabilizer Reduce cccDNA Pool ▪ Capsid Inhibitor Block HBsAg ▪ RNAi ▪ RNA Destabilizer Immuno - modulation ▪ PD - L1 Inhibitor ▪ Interferon Leading to an HBV CURE K e y s t o T h e r a p e ut i c Suc
Slide 10: Arbutus Pipeline
NASDAQ: ABUS www.arbutusbio.com Ar butu s P i p e li n e 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/
Slide 11: AB-729 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: AB-729 Clinical Study Design
NASDAQ: ABUS www.arbutusbio.com Cohort J: 90 mg Q12W HBV DNA - AB - 729 - 00 1 St ud y Part 1: Single Ascending Dose In Healthy Subjects Dose 1 (60 mg) n=6; 4 active : 2 placebo Dose 2 (180 mg) n=6; 4 active : 2 placebo Dose 3 (360 mg) n=6; 4 active : 2 placebo (≥ Day 15 Safety) Cohort A: 180 mg HBV
Slide 13: Single Doses of AB-729 Result in Comparable Mean HBsAg Declines
NASDAQ: ABUS www.arbutusbio.com S i n gl e D os e s o f A B - 72 9 R e s u l t i n C o mp a r a b l e M e a n H B s A g Declines at Week 12 Followed by a Sustained Plateau Phase AB - 729 60 mg single dose (N=6) * AB - 729 90 mg single dose (N=6) ** AB - 729 180 mg single dose (N=4) # Week 12 mean (S
Slide 14: Repeat Dosing of AB-729 Results in Continuous Mean HBsAg Declines
NASDAQ: ABUS www.arbutusbio.com R e p e a t D osi n g o f A B - 72 9 6 0 m g E v e r y 4 W ee k s R e s u l t s i n Continuous Mean HBsAg Declines Beyond Week 12 Mean ( “ SE) HBsAg declines across single and repeat dose Cohorts *N=5 at Week 10, 14, 18 and 22 **N=4 at Week 14 - 20; N=3 at Weeks 22 –
Slide 15: Repeat Dosing of AB-729 60 mg Every 8 Weeks
Mean (SE) Week 20 : - 1.71 (0.18) Mean (SE) Week 24 : - 1.84 (0.16) R e p e a t D osi n g o f A B - 72 9 6 0 m g E v e r y 8 W ee k s R e s u l t s i n C o mp a r a b l e Mean HBsAg Declines to 60 mg Every 4 Weeks at Week 16 Mean (SE) Week 12: - 1.10 (0.15) Mean (SE) Week 16: - 1.44 (0.18) at Week 2
Slide 16: Repeat Dosing of AB-729 Results in Comparable Mean HBsAg Declines
NASDAQ: ABUS www.arbutusbio.com 16 R e p e a t D osi n g o f AB - 72 9 6 0 m g E v e r y 8 W ee k s R e s u l t s i n C o mp a r a b l e M e a n H B s A g D e c li n e s t o 6 0 m g E v e r y 4 W ee k s a t W ee k 1 6 Mean ( “ SE) HBsAg declines across repeat dose Cohorts *N=6 at Week 6 Q4W: every 4
Slide 17: AB-729 90 mg Single Dose Reduces HBsAg and HBV DNA
NASDAQ: ABUS www.arbutusbio.com AB - 729 90 mg Single Dose Reduces HBsAg and HBV DNA in H B V DN A P osi t i v e C H B s ub j e c t s These data continue to support dosing intervals of up to 12 weeks 17 - 2.5 - 2.0 - 1.5 - 1.0 - 0.5 0.0 0.5 1.0 0 4 8 12 Week 16 2 0 24 individual mean (N=5) ∆log 10 H
Slide 18: AB-729 Was Safe and Well Tolerated
NASDAQ: ABUS www.arbutusbio.com AB - 72 9 W a s S a f e a n d W e l l T o l e r a t e d A f t e r S i n g l e a n d R e p e a t D o s e s ▪ 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 elevatio
Slide 19: AB-729 Clinical Summary
NASDAQ: ABUS www.arbutusbio.com 19 AB - 72 9 C li n i c a l S u mma r y Repeat 60 mg Q4W dosing with AB - 729 resulted in a continuous and robust mean HBsAg decline at week 24 ( - 1.84 log10 IU/mL, N=7) Repeat dosing of AB - 729 60 mg every 8 weeks results in comparable mean HBsAg declines relative
Slide 20: AB-729 Clinical Collaboration with Assembly Biosciences
NASDAQ: ABUS www.arbutusbio.com NA: Nucleoside Analogue | HBeAg : HBV e Antigen AB - 72 9 C li n i c a l Collaboration w i t h A ss e m b l y Biosciences Provides accelerated AB - 729 combination proof of concept (POC) with a capsid inhibitor and NA with the potential for functional cure 20 F o l l
Slide 21: 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 22: AB-836: A Next Generation Capsid Inhibitor
NASDAQ: ABUS www.arbutusbio.com AB - 836 : A N e x t G ene r a t i o n Ca p s i d Inh i b i t o r HBV DNA / 1 o Mechanism cccDNA Formation / 2 o Mechanism Human Serum Shift Compound HepDE19 ( E C 5 0 μ M ) HBV infected PHH (EC 50 μM) HBV infected He pG 2 - N T CP - C4 (EC 50 μM) Core I 105 T Mutatio
Slide 23: AB-836 Phase 1a/1b Study Design
NASDAQ: ABUS www.arbutusbio.com AB - 836 - 00 1 St ud y 23 Dose 6 ≤ 6 00 mg Dose 4 ≤ 2 00 mg Dose 3 ≤ 100 mg Dose 1 10mg Dose 5 ≤ 4 00 mg C o ho r t B Dose 2 ≤35mg C o ho r t A Dose 5 FE ≤400mg Dose 7 ≤ 8 00 mg Part 1: Single Ascending Dose In Healthy Subjects Alternating Cohorts A and B n=8/cohort;
Slide 24: Next Gen RNA Destabilizer Program
NASDAQ: ABUS www.arbutusbio.com N e x t G e n R N A D e s t a b ili z e r P r o g r a m W e beli e v e t hi s a pp r o ac h o f f e r s p o t e n t i a l f o r a n o r a l H B s A g r edu c in g a g e n t an d al l o r a l c o m bin a ti o n therapy C o n t inuin g ac t i v e r e s e a r c h an d d
Slide 25: Coronavirus Strategy
NASDAQ: ABUS www.arbutusbio.com Leveraging our proven expertise and capabilities in antiviral drug discovery and development Long term commitment Pan - coronavirus focused Small Molecule Direct - Acting Antivirals Directed Effort ▪ nsp12 Viral Polymerase - nucleos(t)ides ▪ nsp5 Main Viral Protease -
Slide 26: Key Objectives
NASDAQ: ABUS www.arbutusbio.com 202 1 K e y Ob j ec t i v e s Cash balance of ~ $132M as of March 31, 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 x Initiate a Phase 2 combination clinical trial