Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — H.C. Wainwright 22nd Annual Global Investment Conference (September 2020)
28 slides from Vir Biotechnology's conference presentation, Sep 16, 2020
Slide 1: Vir Biotechnology, Inc. H.C. Wainwright 22nd Annual Global Investment Conference
A W O R L D W I T H O U T I N F E C T I O U S D I S E A S E Vir Biotechnology, Inc. H.C. Wainwright 22nd Annual Global Investment Conference September 16, 2020
Slide 2: Legal disclaimers
Legal disclaimers Forward-Looking Statements Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding our research and clinical development plans, expected timing of co
Slide 3: Vir is stimulating and enhancing the immune system to treat and prevent infectious diseases
Vir is stimulating and enhancing the immune system to treat and prevent infectious diseases Invading organism VIR-2218 (HBV) VIR-2703 (COVID-19) Targeting host proteins Innate Immunity Research stage Antibodies Antibodies VIR-3434 (HBV) VIR-2482 (Flu A) VIR-7831 (COVID-19) VIR-7832 (COVID-19) Pathog
Slide 4: Our development pipeline
Our development pipeline Disease Area Product Candidate Treatment/ Prophylaxis Platform Pre-clinical Phase 1 Phase 2 Phase 3 Collaborator Anticipated Milestones VIR-2218 Treatment siRNA VIR-2218 + HBV PEG-IFN-⺠Treatment siRNA VIR-3434 Treatment mAb Influenza A VIR-2482 Prophylaxis mAb Early treatm
Slide 5: Vir COVID-19 antibody program
Vir COVID-19 antibody program Role of antibodies in the context of vaccines and convalescent plasma • We believe the medical need for VIR-7831 will continue to be significant Clinical trial design and execution is critical • We believe both the endpoint and the population selected matter • We believ
Slide 6: Medical need example: antibodies for treatment
Medical need example: antibodies for treatment 35,000 COVID-19 cases a day in USA: up to ~13 million cases a year In the absence of herd immunity, a hypothetical vaccine that is 70% efficacious, with 50% of the population vaccinated: up to ~65% of cases might remain Even with such a hypothetical vac
Slide 7: Medical need example: antibodies for prophylaxis
Medical need example: antibodies for prophylaxis Numerous examples of vaccines performing worse in the elderly compared to the broader population (e.g. Flu, HBV) Even if vaccinated, anyone over the age of 75 is potentially high-risk and therefore a potential candidate for mAb prophylaxis • The repor
Slide 8: Limitations of convalescent plasma
Limitations of convalescent plasma No clear benefit based on a randomized clinical trial Inconsistent potency: titer can range from 1:10 to 1:10,000 Limited to hospitalized use Cannot be mass produced Based on in vitro neutralization estimates, we believe VIR-7831 has the potential to be at least 30
Slide 9: Vir COVID-19 antibody program
Vir COVID-19 antibody program Role of antibodies in the context of vaccines and convalescent plasma • We believe the medical need for VIR-7831 will continue to be significant Clinical trial design and execution is critical • We believe both the endpoint and the population selected matter • We believ
Slide 10: Our perspective on the competitive landscape
Our perspective on the competitive landscape It matters when one finishes, not when one starts . . . . . . it only matters when one finishes, if one meets one’s primary endpoint . . . meeting the primary endpoint only matters if it leads to approval Competitor A example: • Multiple and ongoing chang
Slide 11: Speed of enrollment is critical
Speed of enrollment is critical Right Molecule Neutralization, resistance, effector high barrier function, to LS mutation Right Place Large non-overlapping number of sites unique, on multiple continents Proactive Outreach Outreach under-represented is focusing on communities Right Equipment Cephied
Slide 12: Vir COVID-19 antibody program
Vir COVID-19 antibody program Role of antibodies in the context of vaccines and convalescent plasma • We believe the medical need for VIR-7831 will continue to be significant Clinical trial design and execution is critical • We believe both the endpoint and the population selected matter • We believ
Slide 13: Infection with SARS-CoV-2
Infection with SARS-CoV-2 VIRUS INFECTED PNEUMOCYTES UNINFECTED PNEUMOCYTES © 2020 Vir Biotechnology, Inc.
Slide 14: Importance of neutralization
Antibodies for treatment: importance of neutralization Monoclonal antibodies that neutralize the virus VIRUS INFECTED PNEUMOCYTES UNINFECTED PNEUMOCYTES block uninfected cells from becoming infected © 2020 Vir Biotechnology, Inc.
Slide 15: Neutralization is not enough
Antibodies for treatment: neutralization is not enough Unfortunately, already infected cells remain INFECTED PNEUMOCYTES UNINFECTED PNEUMOCYTES © 2020 Vir Biotechnology, Inc.
Slide 16: Neutralization is not enough
Antibodies for treatment: neutralization is not enough Unfortunately, already infected cells remain INFECTED PNEUMOCYTES UNINFECTED PNEUMOCYTES and continue to mass produce SARS-CoV-2 virus © 2020 Vir Biotechnology, Inc.
Slide 17: Killing already infected cells is potentially critical
Antibodies for treatment: killing already infected cells is potentially critical VIR-7831 MACROPHAGE DYING PNEUMOCYTES UNINFECTED PNEUMOCYTES VIR-7831 can recruit macrophages and NK cells to kill already infected cells (in vitro effector function assays), NK, natural killer. © 2020 Vir Biotechnology
Slide 18: Killing already infected cells is potentially critical
Antibodies for treatment: killing already infected cells is potentially critical VIR-7831 MACROPHAGE DYING PNEUMOCYTES UNINFECTED PNEUMOCYTES VIR-7831 can recruit macrophages and NK cells to kill already infected cells (in vitro effector function assays), while also protecting uninfected cells NK, n
Slide 19: Other antibodies
Antibodies for treatment: other antibodies VIRUS INFECTED PNEUMOCYTES UNINFECTED PNEUMOCYTES Antibodies with limited or no effector function may leave these virus factories intact . . . © 2020 Vir Biotechnology, Inc.
Slide 20: Other antibodies
Antibodies for treatment: other antibodies VIRUS MUTANT VIRUS INFECTED PNEUMOCYTES UNINFECTED PNEUMOCYTES . . . allowing mutants to potentially arise © 2020 Vir Biotechnology, Inc.
Slide 21: Other antibodies
Antibodies for treatment: other antibodies VIRUS MUTANT VIRUS INFECTED PNEUMOCYTES INFECTED PNEUMOCYTES Antibodies with limited strain coverage and/or a low barrier to resistance may be unable to protect uninfected cells from the mutant virus © 2020 Vir Biotechnology, Inc.
Slide 22: VIR-7831 has the potential to break the cycle
Antibodies for treatment: VIR-7831 has the potential to break the cycle VIR-7831 MACROPHAGE DYING PNEUMOCYTES UNINFECTED PNEUMOCYTES 1. Neutralizes virus 2. Kills infected cells 3. Has a high barrier to resistance NK, natural killer; the neutralization potency, ability to kill infected cells, and hi
Slide 23: Viral drift and escape mutants
Antibodies for treatment: viral drift and escape mutants INFECTED PNEUMOCYTES UNINFECTED PNEUMOCYTES Conversely, cocktails of antibodies are needed when using antibodies with a low barrier to resistance © 2020 Vir Biotechnology, Inc.
Slide 24: How VIR-7831 is potentially differentiated
How VIR-7831 is potentially differentiated Potent neutralization Effector function High barrier to resistance “LS” modification • Half-life extension could mean one dose potentially lasts up to 6 months for prophylaxis • Potential for increased lung bioavailability The neutralization potency, abilit
Slide 25: VIR-7831 In vivo evaluation
VIR-7831 In vivo evaluation Syrian Hamster model: • evaluates the neutralization capacity of VIR-7831 • no evaluation of effector function (no human Fc receptors) • no evaluation of impact of LS mutation on lung bioavailability Potent neutralization with no evidence of ADE © 2020 Vir Biotechnology,
Slide 26: Anticipated VIR-7831 COMET program milestones
Anticipated VIR-7831 COMET program milestones Initiation of Phase III (expansion phase) of early treatment (COMET-ICE) study: • October 2020 Initiation of Phase III hospitalized study: • October 2020 Initiation of prophylaxis study: • December/ January 2021 COMET-ICE complete results from primary en
Slide 27: Our development pipeline
Our development pipeline Disease Product Treatment/ Area Candidate Prophylaxis Platform VIR-2218 Treatment siRNA VIR-2218 + HBV PEG-IFN-⺠Treatment siRNA VIR-3434 Treatment mAb Influenza A VIR-2482 Prophylaxis mAb Early treatment VIR-7831 mAb (Ambulatory) Late treatment VIR-7831 mAb (Hospitalized)
Slide 28: 2020–2021 anticipated catalysts
2020–2021 anticipated catalysts Catalyst Disease area Anticipated timing VIR-7831 (mAb) Phase 3 (Early Treatment, COMET-ICE) start COVID-19 October 2020 VIR-7831 (mAb) Phase 3 (Hospitalized) start COVID-19 October 2020 VIR-7831 (mAb) Phase 3 (Prophylaxis) start COVID-19 January 2021 VIR-7832 (mAb) P
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