Vir Biotechnology, Inc. · NASDAQ:VIR

Vir Biotechnology — AASLD Late Breaking Data Update Call 2023

32 slides from Vir Biotechnology's conference presentation, Nov 13, 2023

  1. Slide 1: AASLD Late Breaking Data Update Call

    AASLD Late Breaking Data Update Call November 13, 2023

  2. Slide 2: Introductions

    Introductions Ed Gane M.D., Professor of Medicine at the University of Auckland, New Zealand, and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital Jordan Feld M.D., MPH, Professor of Medicine, Interim Director Toronto Cen

  3. Slide 3: 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

  4. Slide 4: AASLD Insights

    AASLD Insights Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer 4

  5. Slide 5: Vir's Approach to Achieving a Chronic Suppressive Therapy for Chronic Hepatitis Delta

    Vir’s Approach to Achieving a Chronic Suppressive Therapy for Chronic Hepatitis Delta Phil Pang, M.D., Ph.D., Vir’s Chief Medical Officer 5

  6. Slide 6: Hepatitis Delta: Background

    Hepatitis Delta: Background Liver virus that occurs only in those with HBV • Requires the HBV surface antigen to be infectious Rapidly progressive liver disease: of those with cirrhosis, ~50% develop HCC, liver decompensation, require transplantation or die within 5 years1 • In Europe, more people a

  7. Slide 7: Chronic Hepatitis Delta: Limited Options

    Chronic Hepatitis Delta: Limited Options “On the basis of surrogate end points used for other chronic viral infections, sustained suppression of HDV viremia should represent the best marker of treatment efficacy. If undetectable HDV viremia is required for clinical • 45% Achieved Composite Response*

  8. Slide 8: Hepatitis Delta: Robust Biological Rationale for Vir Candidates

    Hepatitis Delta: Robust Biological Rationale for Vir Candidates VIR-3434 VIR-2218 VIR-3434 + VIR-2218 Lowering HDV RNA in vivo* Lowering infectious HDV in vitro* Combination efficacy in vivo** HDV Viremia HDV HDV RNA *VIR-2218 and VIR-3434 therapy Is efficacious in preclinical models of hepatitis de

  9. Slide 9: VIR-3434 and VIR-2218 for Chronic Hepatitis D: Preliminary Phase 2 SOLSTICE Results

    The monoclonal antibody VIR-3434 and siRNA VIR-2218 for the treatment of chronic Hepatitis D Virus: preliminary results from the Phase 2 SOLSTICE trial

  10. Slide 10: SOLSTICE Trial Design – First Cohorts

    SOLSTICE Trial Design – First Cohorts 0 Study Week 12a Study Week 24 96 VIR-2218 Q4W x3 Combo Therapy VIR-2218 + VIR-3434 Q4W (Cohort 1A) (Cohort 2C) Monotherapy, extended dosing Q8W VIR-3434 Q4W x3 (Cohort 1B) Follow-up (48 weeks) • Participants achieving combined endpoint at Week 12 transition to

  11. Slide 11: Week 12 Preliminary Results

    Week 12 Preliminary Results VIR-2218 Q4W VIR-3434 Q4W VIR-2218+3434 Q4W (Cohort 1A) (Cohort 1B) (Cohort 2C) N=5 N=6 N = 6a HDV Virologic Responseb, n (%) 1 (20) 3 (50) 5 (100) Reduction from Baseline in HDV RNA -1.39 (-1.51, -1.04) -1.98 (-2.82, -0.94) -4.29 (-5.47, -3.93) (log10 IU/mL), Median (IQR

  12. Slide 12: VIR-2218 or VIR-3434 Monotherapy Antiviral Activity

    VIR-2218 or VIR-3434 Monotherapy Antiviral Activity VIR-2218 Q4W (Cohort 1A) VIR-3434 Q4W (Cohort 1B) Week 12 Median HDV decline (IQR) Week 12 Median HDV decline (IQR) -1.4 log10 (-1.5, -1.0) -2.0 log10 (-2.8, -0.9) LLOQ LLOQ = 63 IU/mL LOD LOD = 14 IU/mL (Wk 12) (Wk 12) Transitioned to combination

  13. Slide 13: Antiviral Activity of Combination VIR-2218 and VIR-3434 Therapy

    Antiviral Activity of Combination VIR-2218 and VIR-3434 Therapy LLOQ = 63 IU/mL LOD = 14 IU/mL Monotherapy Combination Therapy (Wk 12) Baseline is the most recent non-missing measurement before the initial study intervention. Participants not achieving ALT normalization and virologic response at Wee

  14. Slide 14: ALT Profiles

    ALT Profiles VIR-2218 Q4W VIR-3434 Q4W VIR-2218+VIR-3434 Q4W (Cohort 1A) (Cohort 1B) (Cohort 2C) * ** Baseline is the most recent non-missing measurement before the initial study intervention. ULN Male = 40 U/L; Female = 33 U/L *Baseline HBsAg 21,547 IU/mL; Baseline HDV RNA 241,993 IU/mL; Baseline A

  15. Slide 15: Conclusion & Key Takeaways

    Conclusion & Key Takeaways Early data demonstrate tolerability and potent antiviral activity after 12 weeks of VIR-2218 + VIR-3434 combination therapy At week 12, VIR-2218 and VIR-3434 monotherapy Q4W achieved median HDV RNA reductions of -1.4 log10 and -2.0 log10, respectively Combination therapy a

  16. Slide 16: Key Takeaway

    Key Takeaway These early results from SOLSTICE are unprecedented, with 80% of participants being undetectable at Week 12 of combination therapy,” said Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris, and Head of Viral H

  17. Slide 17: Vir's Approach to Achieving a Potential Functional Cure for Chronic Hepatitis B

    Vir’s Approach to Achieving a Potential Functional Cure for Chronic Hepatitis B Phil Pang, M.D., Ph.D., Vir’s Chief Medical Officer 17

  18. Slide 18: Hepatitis B: In Pursuit of a Functional Cure

    Hepatitis B: In Pursuit of a Functional Cure Unmet Need Vir Solution Multiple combination regimens to ~300M STOP the virus and CLEAR the infection people in the world live with VIR-3434 VIR-2218 chronic hepatitis B1 a neutralizing mAb HBV-targeted siRNA as a engineered for potential “backbone” immun

  19. Slide 19: Hepatitis B: Progress in Our Pursuit

    Hepatitis B: Progress in Our Pursuit VIR-2218-1001 TRIAL MARCH TRIAL PART A 24 Weeks following End of Treatment* End of Treatment** Sustained HBsAg loss Log HBsAg decline 16 % (N=5 of 31) ≥2.7 VIR-2218 + IFNα VIR-3434 + VIR-2218 200 mg x6 or x13 Q4W 180 µg ≤44 weeks 18 or 75 mg 200 mg Cohorts 4&5 (N

  20. Slide 20: VIR-3434 Questions

    VIR-3434 Questions: When VIR-3434 is given for 24 weeks as part of a cocktail with VIR-2218 +/- peginterferon alpha: • Does VIR-3434 enhance the end of treatment response rates? • Are there indications that VIR-3434 is immunostimulatory (vaccinal effect?) mAb:antigen Immune complex Phagocytosis, Gen

  21. Slide 21: VIR-2218 and VIR-3434 With or Without PEG-IFN Alfa-2A: MARCH Part B EOT Results

    VIR-2218 and VIR-3434 With or Without Pegylated Interferon Alfa-2A for the Treatment of Chronic HBV Infection: End of Treatment (EOT) Results After 24 Weeks of Therapy (March Study Part B)

  22. Slide 22: MARCH Part B Study Design

    MARCH Part B Study Design © 2023 Vir Biotechnology, Inc. 22

  23. Slide 23: Participant Baseline Characteristics

    Participant Baseline Characteristics VIR-2218 + VIR-2218 + VIR-3434 VIR-3434 VIR-3434 + PEG-IFNα 20 Weeks 20 Weeks 24 Weeks Parameter n = 10 n = 20 n = 21 HBsAg (log10 IU/mL), 2.91 3.14 2.98 median (range) (0.79, 3.96) (1.29, 4.50) (−0.35, 4.45) Baseline HBsAg, n (%) < 100 IU/mL 2 (20.0) 1 (5.0) 3 (

  24. Slide 24: VIR-3434 Enhances the Rate of HBsAg Loss at EOT

    VIR-3434 Enhances the Rate of HBsAg Loss at EOT 12 Weeks 20–24 Weeks 24 Weeks Previously Previously MARCH Part B Reported Reported VIR-2218 + VIR-2218 + VIR-2218 + VIR-2218 + VIR-2218 + VIR-3434 VIR-2218 + Participants with VIR-3434 PEG-IFNα PEG-IFNα VIR-3434 VIR-3434 + PEG-IFNα PEG-IFNα HBsAg Loss,

  25. Slide 25: HBsAg Distribution: Baseline, EOT, and 12 Weeks Post-EOT

    HBsAg Distribution: Baseline, EOT, and 12 Weeks Post-EOT At 12 weeks post-EOT, 2 participants in the VIR-2218 + VIR-3434 + PEG- IFNα cohort maintained HBsAg loss; all other participants with HBsAg loss at EOT experienced a rebound EOT, end of treatment; HBsAg, hepatitis B surface antigen; LLOQ, lowe

  26. Slide 26: VIR-3434 Regimen Stimulates Anti-HBs Antibodies: Concentrations by Cohort

    Data Suggests VIR-3434 Containing Regimen Stimulates Anti-HBs Antibodies: Anti-HBs Concentrations by Cohort Anti-HBs antibody concentrations > 10 mIU/mL at EOT: • VIR-2218 + VIR-3434 + PEG-IFNα: 11 of 21 (52.4%) participants at EOT • VIR-2218 + PEG-IFNα treatment6: 2 of 18 (11.1%) The highest anti-H

  27. Slide 27: Summary

    Summary VIR-3434 may play an important role in achieving a functional cure for chronic hepatitis B: • Increases EOT response rates (HbsAg Loss) from ~6% to ~15% • Evidence that VIR-3434 is capable of de novo immune activation (ie, a vaccinal effect) Data demonstrate the ability of VIR-2218 + VIR-343

  28. Slide 28: Cumulative Incidence of HBsAg Loss

    HBsAg Loss Predominantly Occurs Between Week 24 to 48 of the Treatment Period with VIR-2218 + PEG-IFNα-Containing Regimens Kaplan Meier Estimate of HBsAg Loss 0.5 End of treatment Censored 0.4 Cumulative Incidence of HBsAg Loss We hypothesize that 0.3 immunostimulants may be more effective when give

  29. Slide 29: MARCH Part B Study Design – 48 Weeks

    MARCH Part B Study Design – 48 Weeks © 2023 Vir Biotechnology, Inc. 29

  30. Slide 30: Powering the Immune System to Transform Lives

    POWERING THE IMMUNE SYSTEM TO TRANSFORM LIVES

  31. Slide 31: Multiple Anticipated CHD & CHB Data Catalysts

    Multiple Anticipated CHD & CHB Data Catalysts 2023 Drug Candidates/Regimen Catalyst Timing VIR-2218 (siRNA) + VIR-3434 (mAb) +/- Hepatitis B Phase 2: End of Treatment clinical data (MARCH Part B) TODAY PEG-IFN-⍺ for 24 weeks VIR-3434 (mAb) monotherapy Hepatitis Delta VIR-2218 (siRNA) monotherapy Pha

  32. Slide 32: Thank You

    POWERING THE IMMUNE SYSTEM TO TRANSFORM LIVES THANK YOU

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