Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — Investor Presentation (June 2024)
36 slides from Vir Biotechnology's investor presentation, Jun 8, 2024
Slide 1: Corporate Overview
Corporate Overview June 8, 2024 Confidential © 2024 Vir Biotechnology, Inc.™
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: Vir Biotechnology: Powering the Immune System to Transform Lives
Vir Biotechnology: 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 In
Slide 4: Vir in 2024: Anticipated Value-Driving Catalysts
Vir in 2024: Anticipated Value-Driving Catalysts Program Drug Candidates/Regimen Catalyst Timing HIV VIR-1388 (T cell vaccine) Phase 1: Initial immunogenicity data H2 Chronic tobevibart (mAb) monotherapy Phase 2: Additional SOLSTICE clinical data Hepatitis tobevibart (mAb) + elebsiran (siRNA) 30 par
Slide 5: Broad Pipeline to Deliver Near-Term Growth
Broad Pipeline to Deliver Near-Term Growth siRNA Antibody T-cell Tr e a t m e n t / Disease Area Product Candidate Preclinical Phase 1 Phase 2 Phase 3 A u t h o r i ze d Collaborator P r e ve n t i o n Chronic tobevibart +/- elebsiran Treatment Alnylam Hepatitis Delta Chronic elebsiran + PEG-IFN-⍺ T
Slide 6: Potentially Transformative Treatment for Chronic Hepatitis Delta
PHASE 2 CATALYST: Potentially Transformative Treatment for Chronic Hepatitis Delta (Delta) © 2024 Vir Biotechnology, Inc. 6
Slide 7: 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 8: 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 9: Preliminary Data From the Ongoing Phase 2 SOLSTICE Trial
Preliminary Data From the Ongoing Phase 2 SOLSTICE Trial Based on preliminary data presented at the European Association for the Study of the Liver, EASL Congress 2024 Sustained HDV RNA virologic suppression for tobevibart + elebsiran combination rollover High rates of virologic suppression achieved
Slide 10: Key Data Summary
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-Cirrhotic or CPT-A) H
Slide 11: Next Steps for Clinical Development in Hepatitis Delta
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 accelerated develo
Slide 12: 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 13: 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 14: Dispositions for De Novo Combination and Monotherapy Cohorts
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 15: Sustained HDV RNA Virologic Suppression 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 16: De Novo Tobevibart + Elebsiran: Rapid Virologic Response
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 17: De Novo Combination: Response in Cirrhotic and Non-Cirrhotic Participants
De Novo Tobevibart + Elebsiran: virologic and ALT response across both cirrhotic and non-cirrhotic participants Virologic Response ALT Response Non-cirrhotic Cirrhotic De novo tobevibart + elebsiran combination therapy De novo tobevibart + elebsiran combination therapy Week Week Week Week 6 100 12 2
Slide 18: Tobevibart Monotherapy: High Rates of HDV RNA Virologic Suppression
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 19: HBsAg Responses: All Three Cohorts Show Rapid Suppression
HBsAg Response Responses: All Three Cohorts Show Rapid Response and Suppression of HBsAg Sustained HBsAg Suppression Change in HBsAg relative to Day 1 SOLSTICE TRIAL: Tobevibart monotherapy, de novo tobevibart + elebsiran (Mean ± SD)2, log10 IU/mL combination therapy, and rollover tobevibart + elebs
Slide 20: 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 21: Pursuit of a Functional Cure in Chronic Hepatitis B (CHB)
PHASE 2 CATALYST: Pursuit of a Functional Cure in Chronic Hepatitis B (CHB) © 2024 Vir Biotechnology, Inc. 21
Slide 22: CHB: Two Approaches with Potential for Achieving a Functional Cure
CHB: Two Approaches with Potential for Achieving a Functional Cure Unmet Need Vir's Approach NEED FOR FUNCTIONAL CURE tobevibart + elebsiran + PEG-IFN-⍺ Investigational neutralizing mAb Investigational Immunomodulator to engineered for immune engagement HBV-targeted siRNA augment immune response ~25
Slide 23: CHB: Two Approaches with Potential for Achieving a Functional Cure
CHB: Two Approaches with Potential for Achieving a Functional Cure VIR-2218-1001 TRIAL MARCH TRIAL elebsiran PEG-IFN- tobevibart elebsiran tobevibart elebsiran PEG-IFN- EOT after 5.6% 15.0 % 14.3% 24w Tx (N=1 of 18) (N=3 of 20) (N=3 of 21) HBsAg seroclearance HBsAg seroclearance HBsAg seroclearanc
Slide 24: Chronic Hepatitis B: MARCH Part B Trial Design
Chronic Hepatitis B: MARCH Part B Trial Design A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing tobevibart (VIR-3434), elebsiran (VIR-2218) and/or PEG-IFN-α in Participants With Chronic Hepatitis B Virus Infection Primary Endpoints: Dual Combination Regimen C
Slide 25: CHB: MARCH Phase 2 Data Readouts Expected in 2024/5
CHB: MARCH Phase 2 Data Readouts Expected in 2024/5 ‘25 24w Off Treatment Data (Post-48w Tx) • ~50 tobevibart + elebsiran participants • ~30 tobevibart + elebsiran + PEG-IFN- participants Q4 2024 Q2 2025 ‘24 48w End of Treatment Data • ~50 tobevibart + elebsiran participants • ~30 tobevibart + eleb
Slide 26: Next-Generation Research & Development
GROWTH BEYOND HEPATITIS: Next-Generation Research & Development © 2024 Vir Biotechnology, Inc. 26
Slide 27: Vir's Proprietary mAb Platform
Vir’s Proprietary mAb Platform: Our Goal: Best-in-Class mAbs via Discovery and Protein Engineering Discovery Protein Engineering Optimized mAb Platform enables mAb identification with unique features, combined with multi-parameter optimization mAb: monoclonal antibody; AI: artificial intelligence; H
Slide 28: Next-Gen Protein Engineering: Leveraging Proprietary AI/ML Tools
Next-Gen Protein Engineering: Leveraging Proprietary AI/ML Tools and High Throughput Wet Lab Selection Proprietary process for holistic optimization of mAb properties that reduces time to clinic AI: artificial intelligence; HT: high throughput; ML: machine learning; IgG: immunoglobulin G mAb: monocl
Slide 29: Example: Using an AI-Powered Approach to Develop a Next-Gen COVID mAb
Example: Using an AI-Powered Approach to Develop a Next-Gen COVID mAb Sotrovimab VIR-7229 >2M doses delivered since 2020, Broad, potent, and more resistant to authorized in multiple markets ex- viral evolution in preclinical testing US OUR GOAL • Tolerates high diversity in the target • Tolerates di
Slide 30: Antibody Candidates: Expected to Enter the Clinic in the Next 12-24 Months
Antibody Candidates: Expected to Enter the Clinic in the Next 12- 24 Months Influenza A and B: Prevention RSV +/- MPV: Prevention VIR-2981 (neuraminidase- VIR-8190 (& other investigational targeting mAb) AI-engineered mAbs) • Potent preclinical activity against major • Ability to potently neutralize
Slide 31: T Cell-Based Viral Vector Platform: Clinical Proof-of-Concept in 2024
T Cell-Based Viral Vector Platform: Clinical Proof-of-Concept in 2024 T Cell-Based Viral Vector HIV: Prevention D I F F E R E N T I AT O R S VIR-1388 HIV T cell vaccine candidate • Designed to elicit abundant T cells that recognize viral proteins to ✓ Generates unique, abort primary infection potent
Slide 32: Poised to Achieve Our Near- and Long-term Goals
FINANCIAL STRENGTH: Poised to Achieve Our Near- and Long-term Goals © 2024 Vir Biotechnology, Inc. 32
Slide 33: Strong Balance Sheet Enables Execution of Strategic Priorities
Strong Balance Sheet Enables Execution of Strategic Priorities Financial Highlights 2024 Capital Allocation Priorities Phase 2 pipeline advancement • Chronic Hepatitis Delta $1.51 billion • Chronic Hepatitis B cash and investments* Antibody platform generating multiple • Well capitalized potential n
Slide 34: GAAP 2024 Financial Guidance
GAAP 2024 Financial Guidance Vir reiterates its full year 2024 guidance, originally provided in February 2024 (in millions) 2024 guidance 2023 actual (Provided on May 2, 2024)** GAAP combined R&D and SG&A expense range: $650 to $680 $768 The following expenses are included in the GAAP combined R&D &
Slide 35: Q1 2024: Financial Results
Q1 2024: Financial Results Three Months Ended March 31, Investor Relations – NASDAQ GS : VIR $ in millions 2024 2023 Change Analyst Coverage: Total revenues Bank of America: Geoff Meacham, Ph.D $56.4 $63.0 $(6.6) Barclays: Gena Wang, Ph.D., CFA Operating expenses: Cost of revenue 0.1 1.9 (1.8) Cowen
Slide 36: Thank You
Thank You © 2024 Vir Biotechnology, Inc. 36
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