Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — Q2 2024 Earnings Presentation
39 slides from Vir Biotechnology's earnings presentation, Aug 1, 2024
Slide 1: Vir Biotechnology Q2:24 Investor Conference Call
Vir Biotechnology Q2:24 Investor Conference Call August 1st 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, statements regarding the near-term financial performance of Vir Biotechnology, Inc. (the
Slide 3: Opening Remarks & Q2:24 Highlights
Opening Remarks & Q2:24 Highlights Marianne De Backer, M.Sc., Ph.D., MBA Chief Executive Officer © 2024 Vir Biotechnology, Inc. 3
Slide 4: Vir's Mission: Powering the Immune System to Transform Lives
VIR’S MISSION: POWERING THE IMMUNE SYSTEM TO TRANSFORM LIVES © 2024 Vir Biotechnology, Inc. 4
Slide 5: Today's Agenda
Today’s Agenda Speaker Topic Marianne De Backer, M.Sc., Ph.D., MBA Opening Remarks & Q2:24 highlights Chief Executive Officer Jennifer Towne, Ph.D. Platform Overview Chief Scientific Officer Mark Eisner, M.D., M.P.H. Clinical Asset Overview Chief Medical Officer Brent Sabatini Financial Overview Chi
Slide 6: Advancing Our Strategy by Entering Exclusive License Agreement with Sanofi
Today, we are Advancing 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) oppo
Slide 7: 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 8: Bringing Together Highly Synergistic Platforms and R&D Capabilities
We are Bringing 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 d
Slide 9: Focusing Resources on Near-Term, High-Value Opportunities
We will be Focusing our Resources on Near-Term, High-Value Opportunities Prioritize Impact of these actions Focusing development resources on chronic hepatitis delta, hepatitis B and licensed masked TCEs Acceleration to major value inflection points Phase Out Phasing out/partnering programs in inf
Slide 10: Platform Overview
Platform Overview Jennifer Towne, Ph.D. Chief Scientific Officer © 2024 Vir Biotechnology, Inc. 10
Slide 11: PRO-XTEN Masking Enables Preferential Immune Activation in the Tumor Microenvironment
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 12: 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 13: PRO-XTEN Masked HER2 TCEs Conditionally Activated in Tumor Microenvironment
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 14: 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 15: Expertise and Capabilities Unlock Full Potential of PRO-XTEN 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 16: PRO-XTEN Platform Offers Unique Combination of 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 17: Clinical Asset Overview
Clinical Asset Overview Mark Eisner, M.D., M.P.H. Chief Medical Officer © 2024 Vir Biotechnology, Inc. 17
Slide 18: Pursuing Multiple Clinically-Validated Solid Tumor Targets
PRO-XTENTM Portfolio Pursuing Multiple Clinically-Validated Solid Tumor Targets in Settings of High Unmet Medical Need SAR446309 (AMX-818) SAR446329 (AMX-500) SAR446368 (AMX-525) HER2 PSMA EGFR Candidate αHER2 αCD3 αPSMA αCD3 αEGFR αCD3 scFV scFV VHH scFV scFV scFV Initial HER2+ PSMA+ EGFR+ Indicati
Slide 19: Dual-Masked HER2+ TCE in Phase 1, Focus on Colorectal and Breast Cancer
SAR446309 (HER2) A Dual-Masked HER2+ TCE Currently in a Phase 1 Clinical Study, Focused Initially on Metastatic Colorectal and Metastatic Breast Cancer SAR446309 (AMX-818) SAR446329 (AMX-500) SAR446368 (AMX-525) HER2 PSMA EGFR Candidate αHER2 αCD3 αPSMA αCD3 αEGFR αCD3 scFV scFV VHH scFV scFV scFV I
Slide 20: Potential to Transform Treatment Landscape for HER2-Expressing Cancers
SAR446309 (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 21: Phase 1 Study to Generate Preliminary Safety and Efficacy Data
SAR446309 (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 SAR446309 Combo Dose Optimized Dose Secondary Goal(s
Slide 22: Only Masked TCE in Clinical Development for HER2 Overexpressing Tumors
SAR446309 (HER2) The Only Masked TCE in Clinical Development for HER2 Overexpressing Tumors; Currently in Phase 1 SAR446309 • Only masked HER2 TCE in clinical HER2 development Differentiation • Lower off-tumor toxicity Hypotheses • Allowing higher doses to increase efficacy Candidate Ph1 Ongoing – m
Slide 23: Dual-Masked PSMA-Directed TCE in Phase 1 for mCRPC
SAR446329 (PSMA) A Dual-Masked PSMA-Directed TCE in a Phase 1 Clinical Study, Focused on Metastatic Castration-Resistant Prostate Cancer SAR446309 (AMX-818) SAR446329 (AMX-500) SAR446368 (AMX-525) HER2 PSMA EGFR Candidate αHER2 αCD3 αPSMA αCD3 αEGFR αCD3 scFV scFV VHH scFV scFV scFV Initial HER2+ PS
Slide 24: Potential to Improve Survival in Metastatic Castration-Resistant Prostate Cancer
SAR446329 (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, Japan
Slide 25: Only Dual-Masked TCE in Clinical Development for Prostate Cancer
SAR446329 (PSMA) The Only Dual-Masked TCE in Clinical Development for Prostate Cancer; Currently in Phase 1 SAR446329 PSMA • Only dual-masked PSMA TCE in development Differentiation • Lower off-tumor toxicity Hypotheses • Allowing higher doses to increase efficacy Candidate Ph1 Monotherapy Ongoing •
Slide 26: Dual-Masked EGFR-Directed TCE with IND Clearance
SAR446368 (EGFR) A Dual-Masked EGFR-Directed TCE with IND Clearance, Focused Initially on Metastatic Colorectal, NSCLC, and Head & Neck Cancers SAR446309 (AMX-818) SAR446329 (AMX-500) SAR446368 (AMX-525) HER2 PSMA EGFR Candidate αHER2 αCD3 αPSMA αCD3 αEGFR αCD3 scFV scFV VHH scFV scFV scFV Initial H
Slide 27: Potential to Improve Survival in EGFR-Expressing Solid Tumors
SAR446368 (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 3%-38% Initial indicat
Slide 28: Preclinical Studies Demonstrate Activity in Tumor Microenvironment
SAR446368 (EGFR) Preclinical Studies Demonstrate Compelling Activity in the Tumor Microenvironment and Minimal Off-Target Cytotoxicity Outside Tumor: masking is maintained, leading to In Tumor: similar anti-tumor activity in ~10,000-fold shift in cytotoxicity PRO-XTENTM masked vs. unmasked EGFR TCE
Slide 29: Phase 1 Clinical Study Targeted to Start in Q1 2025
SAR446368 (EGFR) Phase 1 Clinical Study Targeted to Start in the First Quarter of 2025 SAR446368 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 • Ra
Slide 30: Financial Overview
Financial Overview Brent Sabatini, CPA Chief Accounting Officer, Interim CFO © 2024 Vir Biotechnology, Inc. 30
Slide 31: Value Creation Potential from Exclusive License Agreement with Sanofi
Transformative Value Creation Potential from Our Exclusive License Agreement with Sanofi Exclusive worldwide license agreement for 3 clinical-stage dual-masked T-cell engagers* Exclusive use of the PRO-XTENTM protease-cleavable masking platform for oncology and infectious diseases After HSR clearanc
Slide 32: Strategic Restructuring and Prioritization of Resources
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, chronic hepatitis B and li
Slide 33: Q2 2024: Financial Results
Q2 2024: Financial Results Three Months Ended June 30, $ in millions 2024 2023 Change Total revenues $3.1 $3.8 $(0.7) Operating expenses: Cost of revenue 0.1 ― 0.1 Research and development 105.1 168.1 (63.0) Selling, general and administrative 30.3 45.5 (15.2) Restructuring, long-lived assets Impair
Slide 34: Lowering 2024 Operating Expense Guidance Range by $70 Million
Lowering 2024 Operating Expense Guidance Range by $70 million, Driven by Increased Pipeline Prioritization and Strategic Restructure Previous 2024 guidance Revised 2024 guidance (Provided on May 2, 2024) (Provided on August 1, 2024)** GAAP operating expense range: $650 to $680 $580 to $610 The follo
Slide 35: Closing Remarks
Closing Remarks Marianne De Backer, M.Sc., Ph.D., MBA Chief Executive Officer © 2024 Vir Biotechnology, Inc. 35
Slide 36: Development Priorities Poised to Accelerate Near-Term Value
siRNA Antibody Masked TCE Our Development Priorities are Poised to Accelerate Near-Term Value 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 Prevention Chronic tobevibart ± elebsiran Treatment Alnylam Hepatitis Delta Chronic tobe
Slide 37: Value Driving Catalysts in the Next 4 to 18 Months
We Anticipate Important Value Driving Catalysts in the Next 4 to 18 Months 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 tob
Slide 38: Patients Are Waiting
PATIENTS ARE WAITING © 2023 PROPERTY OF VIR BIOTECHNOLOGY, INC. 38 © 2024 Vir Biotechnology, Inc. 38
Slide 39: Q&A
Q&A © 2024 Vir Biotechnology, Inc. 39