Arbutus Biopharma Corporation · NASDAQ:ABUS
Arbutus Biopharma — Corporate Update (February 2019)
19 slides from Arbutus Biopharma's corporate update, Feb 14, 2019
Slide 1: 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 for this pur
Slide 2: Investment Highlights
Investment Highlights Singular therapeutic focus - curing chronic Hepatitis B Virus (HBV) Genevant provides value from delivery technology Team with antiviral Most Robust HBV Pipeline Strong Financial Position Significant unmet medical need in HBV exp ertise/pro ven track record Applying knowledge g
Slide 3: Proven Leadership Team
Proven Leadership Team Successful track records both the discovery and Mark J. Murray, PhD Gaston Picchio, PhD Chief Development Officer in President & CEO development of multiple antivirals: sofosbuvir etravirine, rilpivirine, telaprevir and simeprevir David C. Hastings Chief Financial Officer Mich
Slide 4: Significant Opportunity To Improve HBV Cure Rates
Significant Opportunity To Improve HBV Cure Rates SOC THERAPIES FOR CHRONIC HBV New HBV Therapies Pegasys (PegIFN) Baraclude (Entecavir) Viread (TDF) rate of Undetectable HBV DNA + Dosing Duration 48-weeks Chronic Chronic HBV DNA Undetectable rate of HBsAg Loss = 14-19% 67-90% 76-93% HBV cures are a
Slide 5: HBV Lifecycle Illustrates Key Points for Intervention
HBV Lifecycle Illustrates Key Points for A combination of agents with complementary MOA is needed to cure HBV Intervention 1 – NA 2 – AB-506 3 – AB-729 3 – RNA destabilizer 2 3 1 2 NASDAQ: ABUS www.arbutusbio.com 6
Slide 6: Keys to Therapeutic Success
Keys to Therapeutic Success - Suppress HBV DNA and viral antigens - Reawaken host immune response Therapeutic success will require a combination of drugs with complementary MOAs. Reduce/Suppress Viral DNA & Antigens 1 Block Replication NA Capsid Inhibitor RNAi Block HBsAg RNAi RNA Destabilizer Addre
Slide 7: Arbutus HBV Pipeline
Arbutus HBV Pipeline Lead Op Phase I Development IND Enabling HV HBV Phase II HBV DNA Suppression Capsid inhibitor in HBV subjects AB-506 Phas e 2 i ni ti ati on Q4 ’1 9 , in support of long term combo Capsid Inhibitors 3rd gen study HBsAg Reduction Subcutaneous RNAi agent undergoing IND enabling wo
Slide 8: Path to a Combination Cure
Path to a Combination Cure Drive to undetectable HBV DNA and HBsAg 2018 2019 2020 2021 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 AB-506 Capsid inhibitor PH I HV HBV Pts POC Phase II combo study (AB-506 & AB-729) AB-729 GalNac-RNAi HV / HBV Pts POC HBV Pts POC PH I ‘AB-452’ go / no-go NASDAQ: ABUS www.arbu
Slide 9: Capsid Inhibitor: Blocking Viral Replication
Capsid Inhibitor: Blocking Viral Replication Reduce/Suppress Viral DNA & Antigens Viral Replication HBsAg cccDNA Formation/Function Driving HBV DNA to undetectable is a key to therapeutic success in HBV - in the serum and - in the liver Reduced HBsAg Immunotherapy Reawaken/Boost Immune Response NASD
Slide 10: Capsid Inhibitors – Dual Action HBV MOA
Capsid Inhibitors – Dual Action HBV MOA, distinct from but complementary to approved SOC NAs. Antiviral Agent Capsid + NA combination drives deeper HBV DNA reductions Competitive Landscape All capsid inhibitors bind to the same site on HBV Core protein All have a dual MOA: Block DNA replication by i
Slide 11: AB-506 – Capsid Inhibitor
AB-506 – Capsid Inhibitor AB-506 shows preclinical potency and PK profile consistent with best in class agents Active across multiple genotypes and against NA resistant variants Once daily dosing Complementary with HBsAg targeting agents AB-506 Potently Reduces HBV DNA in Serum and Inhibits Liver HB
Slide 12: AB-452 and RNA Destabilizer Program
AB-452 and RNA Destabilizer Program Multiple evaluations underway to clarify AB-452 and RNA destabilizer program next steps Completed: IND enabling studies and 28 day toxicology, in two species, supporting initial clinical studies AB-452 mechanism of action studies demonstrate AB-452 causes HBV mRNA
Slide 13: AB-729 - RNAi Therapeutic
AB-729 - RNAi Therapeutic Proprietary GalNAc-conjugate delivery technology – Liver targeting for efficient hepatocyte uptake – Enables subcutaneous dosing Single trigger RNAi agent targeting all HBV transcripts Inhibits HBV replication and lowers all HBV antigens – Potent HBsAg reduction in preclini
Slide 14: AB-729 - In Vivo Single Dose Response & Duration
AB-729 - In Vivo Single Dose Response & Duration 4 Clear dose response in model AAV mouse 3 Saline 1 mg/kg 3 mg/kg 9 mg/kg 2 Achieves maximal HBsAg reduction possible in this model 1 Mean (n=5) ± SD 0 Duration supports frequency of once a clinical dosing per month -1 0 1 dose siRNA 2 4 6 8 10 Weeks
Slide 15: Inhibition of Multiple HBV Markers by AB-729 In Vivo
Inhibition of Multiple HBV Markers by AB-729 In Vivo Results validate RNAi mechanism of action Liver 3.5 kb Liver Total Liver Serum Serum Serum 5 4 Dose response reductions of all 3 measured HBV and serum markers in liver * * 2 – – – – HBsAg HBV RNA HBV eAg HBV DNA 1 0 -1 Control siRNA 9 mg/kg '729
Slide 16: Preclinical Combination In Humanized Mouse Model
Preclinical Combination In Humanized Mouse Model RNAi + Capsid inhibitor containing regimens result in HBV DNA and HBsAg reductions Serum HBsAg Serum HBV DNA 8 3 Capsid Inhibitor 100 mg/kg PO BID 7 ETV 1.2 µg/kg PO QD PegIFN 30 µg/kg SQ 2×/wk 2 6 RNAi 3 mg/kg IV biweekly Vehicle Capsid Inhibitor + P
Slide 17: Path to a Combination Cure
Path to a Combination Cure Drive to undetectable HBV DNA and HBsAg 2018 2019 2020 2021 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 AB-506 Capsid inhibitor PH I HV HBV Pts POC Phase II combo study (AB-506 & AB-729) AB-729 GalNac-RNAi HV / HBV Pts POC HBV Pts POC PH I ‘AB-452’ go / no-go NASDAQ: ABUS www.arbu
Slide 18: Key Catalysts for 2019
Key Catalysts for 2019 Initiation of HBV Initiation of RNA Destabilizer study NASDAQ: ABUS www.arbutusbio.com 20 2Q 20192H 2019 AB-729AB-506 Initiation ofTop line Phase Phase 1a/1b1a/1b data AB-452AB-729AB-506 program updatesubject dosingPhase 2 study
Slide 19: Key Catalysts for 2019
Key Catalysts for 2019 2Q 2019 N572) AB-506 Initiation of Top line Phase 1a/1b data Phase 1a/1b study be YWArbutus 0:00 BIOPHARMA wiv arbutusbio.corn 2H 2019 ABA52 AB-729 RNA Destabilizer Initiation of HBV program update subject dosing AB-506 Initiation of Phase 2 study