Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — EASL Congress 2024 Investor Conference Call
27 slides from Vir Biotechnology's conference presentation, Jun 5, 2024
Slide 1: Phase 2 SOLSTICE Hepatitis Delta Trial Data Update at EASL 2024 Investor Conference Call
Phase 2 SOLSTICE Hepatitis Delta Trial Data Update at EASL 2024 Investor Conference Call June 5, 2024
Slide 2: Legal Disclaimer
Legal Disclaimer 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 the near-term financial performance of Vir Biotechnology, Inc. (the
Slide 3: EASL Investor Conference Call Agenda
EASL Investor Conference Call Agenda Speaker Topic Marianne De Backer, M.Sc., Ph.D., MBA Opening Remarks Vir’s Chief Executive Officer Tarik Asselah, M.D., Ph.D. Summary of Phase 2 SOLSTICE Trial Data Update at EASL Congress Professor of Medicine, Université de Paris; Hepatology Department, INSERM
Slide 4: Opening Remarks
EASL 2024 Investor Conference Call Opening Remarks Marianne De Backer, M.Sc., Ph.D., MBA © 2024 Vir Biotechnology, Inc. 4
Slide 5: Vir: Powering the Immune System to Transform Lives
Vir: Powering the Immune System to Transform Lives Our Scientific Capabilities Strategy Infectious Disease Uniquely discovered and engineered human & mouse mAbs • Hepatitis Delta • COVID • Influenza • Hepatitis B • RSV +/- MPV World-class immunology • HIV & virology expertise Beyond Infectious Disea
Slide 6: Hepatitis Delta: The Most Severe Form of Viral Hepatitis
Hepatitis Delta: The Most Severe Form of Viral Hepatitis Severe unmet need Irreversible progression to cirrhosis1 At least 12M living with hepatitis delta globally1-5 300K patients across U.S. (~100k) and Europe (~200k)6 • No approved therapy in U.S. ~41% develop cirrhosis2 >50% mortality from liver
Slide 7: Our Ambition: Transformative Viral Suppression with 1-2X/Month Dosing
Our Ambition: Transformative Viral Suppression with 1-2X/Month Dosing HBsAg is the key viral protein responsible for recognition, Inhibition of viral entry binding, and entry of HBV and (tobevibart) HDV virions to hepatocytes Complementary mechanisms of action in combination: Degradation of HBV RNA
Slide 8: Summary of Phase 2 SOLSTICE Trial Data Update at EASL Congress
Summary of Phase 2 SOLSTICE Trial Data Update at EASL Congress Tarik Asselah, M.D., Ph.D. © 2024 Vir Biotechnology, Inc. 8
Slide 9: Efficacy and safety of tobevibart alone or in combination with elebsiran
Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR- 2218) in participants with chronic hepatitis delta virus infection: Preliminary results from the Phase 2 SOLSTICE trial in non-cirrhotic and compensated cirrhotic participants © 2024 Vir Biotechnology, Inc. 9
Slide 10: Preliminary Data from Three Cohorts in the Phase 2 SOLSTICE Trial
Preliminary Data from Three Cohorts in the Phase 2 SOLSTICE Trial Combination and Monotherapy for the Chronic Treatment of Hepatitis Delta Infection Combination Cohort: Rollover Combination Cohort: De Novo Monotherapy Cohort Tobevibart 300mg Tobevibart 300mg SC Tobevibart Elebsiran + Elebsiran 200mg
Slide 11: SOLSTICE Trial Endpoints Include Virologic Response and ALT Normalization at Week 24
SOLSTICE Trial Endpoints Include Virologic Response and ALT Normalization at Week 24 Participant Criteria: • Male or female ages 18-70 y/o • ULN < ALT < 5x ULN • HDV RNA > 500 IU/Ml • On NRTI Primary Endpoints Key Secondary Endpoints ► Combined Endpoint (CE) = virologic response and ALT normalizatio
Slide 12: Dispositions for De Novo Combination and Monotherapy Cohorts as of May 2024
Dispositions for De Novo Combination and Monotherapy Cohorts as of May 2024 Cohort Completed Week 12 Completed Week 24 Combination Cohort N=32 N=27 N=11 All participants All participants All participants De Novo N=18 N=13 N=5 Cirrhotic Cirrhotic Cirrhotic Discontinued due to AE N=0 Monotherapy Cohor
Slide 13: Sustained HDV RNA Virologic Suppression Observed for Combination Rollover
Sustained HDV RNA Virologic Suppression Observed for Tobevibart + Elebsiran Combination Rollover Following Monotherapy Lead-in Durable Anti-HDV Activity SOLSTICE TRIAL: rollover tobevibart + elebsiran combination therapy 1 Monotherapy (from day 0) Combination therapy (from day 113) Rollover cohort:
Slide 14: De Novo Tobevibart + Elebsiran: Rapid Virologic Response and High Rates of Suppression
De Novo Tobevibart + Elebsiran: Rapid Virologic Response and High Rates of HDV RNA Virologic Suppression and ALT Normalization Rapid Virologic Response Demonstrated ALT normalization Week 12 Week 24 De novo tobevibart + elebsiran combination therapy De novo tobevibart + elebsiran combination therapy
Slide 15: Tobevibart Monotherapy: High Rates of HDV RNA Virologic Suppression and ALT Normalization
Tobevibart Monotherapy: High Rates of HDV RNA Virologic Suppression and ALT Normalization High Rate of Virologic Response1 Demonstrated ALT normalization Week 12 Week 24 tobevibart monotherapy tobevibart monotherapy n=264 n=114 8 Virologic 19/26 6/11 tobevibart 90 tobevibart Response2 (73%) (55%) 7
Slide 16: Summary of Preliminary Safety and Tolerability
Summary of Preliminary Safety and Tolerability No ALT flares observed in participants receiving tobevibart alone, or in combination with elebsiran No treatment related serious adverse events to tobevibart alone, or in combination with elebsiran, were observed The majority of AEs were Grade 1-2 and t
Slide 17: Conclusions: Preliminary results from the Phase 2 SOLSTICE Trial
Conclusions: Preliminary results from the Phase 2 SOLSTICE Trial Sustained HDV RNA virologic suppression for tobevibart + elebsiran combination rollover High rates of virologic suppression achieved in participants receiving tobevibart alone, or in combination with elebsiran, with >50% achieving HDV
Slide 18: Conclusions and Next Steps for Clinical Development
EASL 2024 Investor Conference Call Conclusions and Next Steps for Clinical Development Carey Hwang, M.D., Ph.D. © 2024 Vir Biotechnology, Inc. 18
Slide 19: Conclusions and Next Steps for Clinical Development in Hepatitis Delta
Conclusions and Next Steps for Clinical Development in Hepatitis Delta Q2 Q3 Q4 EASL Presentation Regulatory Engagement Additional Data • Oral presentation on • Next steps on development • ~30 participants per Saturday 8th June • Explore appropriate regimen at 24 weeks will • Latest SOLSTICE data ac
Slide 20: Current U.S. Treatment Landscape for Chronic Hepatitis Delta
U.S. KOL Perspective Current U.S. Treatment Landscape for Chronic Hepatitis Delta Nancy Reau, M.D. © 2024 Vir Biotechnology, Inc. 20
Slide 21: Closing Remarks
EASL 2024 Investor Conference Call Closing Remarks Marianne De Backer, M.Sc., Ph.D., MBA © 2024 Vir Biotechnology, Inc. 21
Slide 22: Closing Remarks: Key Data Summary
Closing Remarks: Key Data Summary Preliminary data from SOLSTICE Trial Suggest the Potential for a Transformative Treatment Option Combination Cohort: De Novo Monotherapy Cohort Tobevibart 300mg + Elebsiran 200mg, Q4W to 96 weeks Tobevibart 300 mg, Q2W, to 96 weeks (Non-Cirrhotic or CPT-A) (Non-Cirr
Slide 23: Thank you!
Thank you! © 2024 Vir Biotechnology, Inc. 23
Slide 24: Q&A
Q&A © 2024 Vir Biotechnology, Inc. 24
Slide 25: Appendix
EASL 2024 Investor Conference Call Appendix © 2024 Vir Biotechnology, Inc. 25
Slide 26: Summary of Encouraging Preliminary Antiviral and ALT Normalization Response Rates
Summary of Encouraging Preliminary Antiviral and ALT Normalization Response Rates Combo Q4W de Combo Q4W rollover1 Tobevibart Q2W novo N=6 N = 33 N = 32 Week 12 Week 24 Week 48 Week 12 Week 24 Week 12 Week 24 n=6 n=6 n=52 n=27 n=11 n=263 n=113 1) n (%) Virologic Response (HDV RNA < 6/6 6/6 5/5 27/27
Slide 27: Cumulative Summary of Preliminary Safety and Tolerability
Cumulative Summary of Preliminary Safety and Tolerability Combo Q4W rollover Combo Q4W de novo Tobevibart Q2W N=6 N = 32 N = 33 Any TEAE, n (%) 4 (66.7) 25 (78.1) 29 (87.9) TEAE by maximum severity grade, n (%) Grade 1 0 9 (28.1) 11 (33.3) Grade 2 4(66.7) 16 (50) 17 (51.5) Grade ≥3 0 0 1 (3) Related
Vir Biotechnology — EASL Congress 2024 Investor Conference Call on 6ix