Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — Q3 2024 Earnings Presentation
50 slides from Vir Biotechnology's earnings presentation, Oct 31, 2024
Slide 1: Corporate Overview
Corporate Overview November 2024 © 2024 Vir Biotechnology, Inc. 1
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, the Company's cash balance; the Company's future financial and operating results and its
Slide 3: Vir's Mission: Powering the Immune System to Transform Lives
V IR’S M ISS ION : POWERING THE IMMUNE SYSTEM TO TRANSFORM LIVES © 2024 Vir Biotechnology, Inc. 3
Slide 4: Exclusive License Agreement with Sanofi Advances Our Strategy
We Advanced our Strategy of Powering the Immune System by Entering into an Exclusive License Agreement with Sanofi Enhanced Clinical Pipeline 3 potentially best-in-class clinical- • Bolsters Vir’s clinical pipeline and adds near-term value creation stage masked T-cell engagers (TCE) opportunities VI
Slide 5: Highly Synergistic Platforms and R&D Capabilities
We Have Brought Together Highly Synergistic Platforms and R&D Capabilities Augmenting core Vir capabilities… …bringing complementary expertise World-class immunology PRO-XTENTM protease-cleavable masking & virology expertise platform for TCEs, cytokines and other molecules Key leadership Uniquely di
Slide 6: We Anticipate Multiple Near-Term Catalysts
We Anticipate Multiple Near-Term Catalysts Program Drug Candidates/Regimen Catalyst Timing Chronic Hepatitis Delta tobevibart (mAb) +/- elebsiran (siRNA) SOLSTICE Phase 2: additional clinical data Q4’24 Chronic MARCH-B Phase 2: 48-week end of treatment Hepatitis B tobevibart (mAb) + elebsiran (siRNA
Slide 7: Our Development Priorities are Poised to Accelerate Near-Term Value
siRNA Antibody Masked TCE Our Development Priorities are Poised to Accelerate Near-Term Value T re a t me n t / D i se a s e A re a Pr o d u ct C a n d i d a t e Pr e cl i n i ca l Ph a s e 1 Ph a s e 2 Ph a s e 3 Au t h o ri z e d C o l l a b o ra t o r Pr e ve n t i o n Chronic tobevibart ± elebsi
Slide 8: Potentially Transformative Treatment for Chronic Hepatitis Delta
Potentially Transformative Treatment for Chronic Hepatitis Delta © 2024 Vir Biotechnology, Inc. 8
Slide 9: Hepatitis Delta: Most Severe Form of Viral Hepatitis
Hepatitis Delta: HDV Occurs Exclusively in Patients with HBV Infection and is the Most Severe Form of Viral Hepatitis Severe unmet need Irreversible progression to cirrhosis1 ~12M living with hepatitis delta globally1-5 300K patients across U.S. (~100k) and Europe (~200k)6 • No approved therapy in U
Slide 10: Our Ambition: Transformative Viral Suppression with 1X/Month Dosing
Our Ambition: Transformative Viral Suppression with 1X/Month Dosing HBsAg is the key viral protein responsible for recognition, binding, and entry of HBV and Inhibition of viral entry HDV virions to hepatocytes (tobevibart) Complementary mechanisms of action in combination: Degradation of HBV Tobevi
Slide 11: Preliminary Data from Three Cohorts in 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 12: SOLSTICE Trial Endpoints
SOLSTICE Trial Endpoints Include Virologic Response and ALT Normalization at Week 24 Primary Endpoints Key Secondary Endpoints ► Combined Endpoint (CE) = virologic response and ALT normalization Proportion of participants with at Week 24 undetectable HDV RNA: • Virologic response = Undetectable HDV
Slide 13: 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 14: Sustained HDV RNA Virologic Suppression in 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 1 13) Rollover cohort
Slide 15: 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 16: De Novo Combination: 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 17: Tobevibart Monotherapy: HDV RNA 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=26 4 n=11 4 8 Virologic 19/26 6/11 tobevibart 90 tobevibart Response2 (73%) (55%)
Slide 18: HBsAg Response: All Three Cohorts
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 19: Summary of Preliminary Safety and Tolerability
Summary of Preliminary Safety and Tolerability Presented at EASL 2024 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 A
Slide 20: 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 21: 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 22: 2024: Clinical Development in Hepatitis Delta
2024: 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 8 th June • Explore appropriate regimen at 24 weeks will • Latest SOLSTICE data accelerated development pa
Slide 23: Pursuit of a Functional Cure in Chronic Hepatitis B
PHASE 2 CATALYST: Pursuit of a Functional Cure in Chronic Hepatitis B (CHB) © 2024 Vir Biotechnology, Inc. 23
Slide 24: 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 N EE D FOR FUNCTI ONAL CURE tobevibart + elebsiran + PEG-IFN-⍺ Investigational neutralizing mAb Investigational Immunomodulator to engineered for immune engagement HBV-targeted siRNA augment immune response
Slide 25: CHB: Two Approaches for Functional Cure, Data Expected
CHB: Two Approaches with Potential for Achieving a Functional Cure V I R - 2 2 1 8 - 1 0 0 1 T R IA L MAR CH 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 seroclearanc
Slide 26: 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 27: 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 28: PRO-XTEN Platform Overview
PRO-XTENTM Platform Overview © 2024 Vir Biotechnology, Inc. 28 PRO-XTEN is a trade ma rk of Amunix Ph armaceuticals, Inc., a Sanofi co mp any
Slide 29: Unique Opportunity to Address High Unmet Need in Cancer
We Have a Unique Opportunity to Address the Persistent High Unmet Need in Cancer Through Transformative Technological Innovation Worldwide burden of cancer T-cell Engagers: Much progress has been made… Have shown promising potential to date, but have been limited by >14,000 cancer clinical trials cu
Slide 30: PRO-XTEN Masking Enables Preferential Immune Activation in Tumor
PRO-XTENTM Masking Enables Preferential Immune Activation in the Tumor Microenvironment, Leading to Potential Higher Efficacy PRO-XTENTM Technology (Protease-releasable XTEN mask) PRO-XTENTM masked TCEs PRO-XTENTM masked Cytokines • XTEN Mask can be universally applied to protein therapeutic modalit
Slide 31: PRO-XTEN Masked TCEs Overcome Limitations of Traditional TCEs
PRO-XTENTM Masked TCEs have the Potential to Overcome the Limitations of Traditional TCEs, Unlocking New Opportunities PRO-XTENTM molecules preferentially unmask and become active in the tumor as compared to healthy tissues, mitigating off-tumor toxicity Blood circulation Healthy tissue Tumor microe
Slide 32: PRO-XTEN Masked HER2 TCEs Conditionally Activated in Tumor
PRO-XTENTM Masked HER2 TCEs are Conditionally Activated in the Tumor Microenvironment, Leading to Robust Preclinical Efficacy Outside Tumor: masking is In Tumor: similar anti-tumor Substantial unmasking of maintained, leading to ~10,000- activity with PRO-XTENTM masked PRO-XTENTM HER2 TCE occurs fol
Slide 33: PRO-XTEN Increases Masked HER2 TCE Therapeutic Index Over 100-Fold
PRO-XTENTM Increases Masked HER2 TCE Therapeutic Index by Over 100-Fold in Non-Clinical Studies Short half life of Masking prevents CRS in >100x Therapeutic Index unmasked HER2 TCE non-human primates improvement IL-6 Maximum tolerated dose* 43 mpk 0.2 mpk Masked Unmasked HER2-TCE HER2-TCE Lethal CRS
Slide 34: Expertise and Capabilities to Unlock PRO-XTEN Masking Platform
Our Expertise and Capabilities Allow us to Unlock the Full Potential of the PRO-XTENTM Masking Platform, and Enable Broad Application T-cell Biology mAb platform Next-gen protein engineering Vir Optimizing responses for ID Rapid generation of novel Leveraging proprietary AI/ML tools and high experti
Slide 35: PRO-XTEN Platform Differentiating Characteristics
PRO-XTENTM Masking Platform Offers a Unique Combination of Differentiating Characteristics, to Deliver Potential Best-in-Class TCEs Dual masking Rapid clearance Plug & play Masking both TAA and CD3 Short half-life of active drug Universal tunable masks can mask binding domains to maximize TI provide
Slide 36: Solid Tumor Masked TCE Clinical Portfolio
Solid Tumor Masked TCE Clinical Portfolio © 2024 Vir Biotechnology, Inc. 36
Slide 37: Multiple Clinically-Validated Solid Tumor Targets
PRO-XTENTM Portfolio Pursuing Multiple Clinically-Validated Solid Tumor Targets in Settings of High Unmet Medical Need VIR-5818 VIR-5500 VIR-5525 HER2 PSMA EGFR Candidate αHER2 αCD3 αPSMA αCD3 αEGFR αCD3 scFV scFV VHH scFV scFV scFV Initial HER2+ PSMA+ EGFR+ Indications • 3L+ metastatic • 3L+ metast
Slide 38: VIR-5818 (HER2): Potential to Transform Treatment of HER2-Expressing Cancers
VIR-5818 (HER2) Potential to Transform the Treatment Landscape for Patients with HER2-Expressing Cancers with T-Cell Directed Therapy Disease Burden Unmet Need Drug Treated Metastatic HER2+ Patients Immune-based therapies (e.g., anti-PD1, anti-CTLA4) not approved for Yearly (2023), US, EU-5, Japan1
Slide 39: VIR-5818 Phase 1 Study Design
VIR-5818 (HER2) Phase 1 Study to Generate Preliminary Safety and Efficacy Data to Support Optimal Treatment for Patients with HER2 Tumors Part 1: Single Agent Dose Escalation Part 2: Pembrolizumab Combo Dose Escalation Primary Goal: Optimize Dose VIR-5818 Combo Dose Optimized Dose Secondary Goal(s):
Slide 40: Only Masked TCE in Clinical Development for HER2 Tumors
VIR-5818 (HER2) The Only Masked TCE in Clinical Development for HER2 Overexpressing Tumors; Currently in Phase 1 VIR-5818 • Only masked HER2 TCE in clinical HER2 development Differentiation • Lower off-tumor toxicity Hypotheses • Allowing higher doses to increase efficacy Candidate Ph1 Ongoing – mon
Slide 41: VIR-5500 (PSMA): Metastatic Castration-Resistant Prostate Cancer
VIR-5500 (PSMA) Potential to Improve Survival and Prevent Metastatic Recurrence in Patients with Metastatic Castration-Resistant Prostate Cancer Disease Burden Unmet Need Drug-Treated Metastatic Patients and Outcomes Immune-based therapies (e.g., anti-PD1, anti-CTLA4) Yearly (2023), US, EU-5, Japan1
Slide 42: Only Dual-Masked TCE in Clinical Development for Prostate Cancer
VIR-5500 (PSMA) The Only Dual-Masked TCE in Clinical Development for Prostate Cancer; Currently in Phase 1 VIR-5500 PSMA • Only dual-masked PSMA TCE in development Differentiation • Lower off-tumor toxicity Hypotheses • Allowing higher doses to increase efficacy Candidate Ph1 Monotherapy Ongoing • S
Slide 43: VIR-5525 (EGFR): Potential to Improve Survival in EGFR-Expressing Tumors
VIR-5525 (EGFR) Potential to Improve Survival in Patients with EGFR-Expressing Solid Tumors Disease Burden Unmet Need Drug-Treated Metastatic Patients, No currently approved antibodies directly engage T-cell Yearly (2023), US, EU-5, Japan1 killing in their mechanism of action 2 HNSCC Initial indicat
Slide 44: VIR-5525 Phase 1 Study Targeted to Start Q1 2025
VIR-5525 (EGFR) Phase 1 Clinical Study Targeted to Start in the First Quarter of 2025 VIR-5525 EGFR • EGFR is expressed across several solid tumors, and in healthy tissue Candidate • Potential therapeutics therefore must limit off-tumor toxicity Differentiation αEGFR scFV αCD3 scFV Hypotheses • Rapi
Slide 45: Financial Overview
Financial Overview © 2024 Vir Biotechnology, Inc. 45
Slide 46: Strategic Restructuring and Prioritization of Resources
Previously Announced Strategic Restructuring and Prioritization of Resources Allows Us to Focus on Near-Term Value Maximization Strategic decisions Financial impact Prioritize Investing in programs with most Focusing development resources on hepatitis significant potential for near-term delta, chron
Slide 47: Q3 2024: Financial Results
Q3 2024: Financial Results Three Months Ended September 30, $ in millions 2024 2023 Change Total revenues $2.4 $2.6 $(0.2) Operating expenses: Cost of revenue 0.1 ― 0.1 Research and development 195.2 145.0 50.2 Selling, general and administrative 25.7 40.9 (15.2) Restructuring, long-lived assets Imp
Slide 48: Updated 2024 Operating Expense Guidance Range
Updated 2024 Operating Expense Guidance Range, incorporating upfront R&D expense related to our license agreement with Sanofi $ in millions Prior 2024 guidance Updated 2024 guidance (Previously provided on August 1, 2024) (As of October 31, 2024)* GAAP operating expense range $580 to $610 $660 to $6
Slide 49: 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 $1.19 billion • Chronic Hepatitis B cash and investments* Masked TCE clinical portfolio • Multiple masked TCEs in phase 1 deve
Slide 50: Patients Are Waiting
PATIENTS ARE WAITING © 2023 PROPERTY OF VIR BIOTECHNOLOGY, INC. 50 © 2024 Vir Biotechnology, Inc. 50