Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — Investor Presentation (January 2025)
41 slides from Vir Biotechnology's investor presentation, Jan 8, 2025
Slide 1: PRO-XTEN Masked T Cell Engagers: Investor Call
PRO-XTEN Masked T Cell TM Engagers: Investor Call January 8, 2025 2025 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 therapeutic potential of Vir Biotechnology's oncology solid tu
Slide 3: Legal disclaimer (continued)
Legal disclaimer (continued) This presentation discusses product candidates that are under clinical study, and which have not yet been approved for marketing by the US Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use fo
Slide 4: Today's agenda
Today’s agenda Speaker Topic Marianne De Backer, M.Sc., Ph.D., MBA Opening Remarks Chief Executive Officer and Director Differentiated Cancer Modalities Through the PRO-XTENTM Platform Mika Derynck, M.D. Phase 1 Clinical Data: VIR-5818 (HER2 expressing tumors)1 EVP, Therapeutic Area Head Oncology PR
Slide 5: Opening Remarks
Opening Remarks Marianne De Backer, M.Sc., Ph.D., MBA 2025 Vir Biotechnology, Inc. 5
Slide 6: 2025 Vir Biotechnology, Inc.
2025 Vir Biotechnology, Inc. 6
Slide 7: Expanding the potential of T-cell engagers in cancer treatment
Expanding the potential of T-cell engagers in cancer treatment PRO-XTENTM Masked TCEs VIR-5818 (HER2xCD3): The only masked HER2-targeted TCE, early Phase 1 data show broad activity and a compelling safety profile • 50% tumor shrinkage at efficacious doses, deepening as dose increases • No Gr3 CRS, a
Slide 8: Advancing clinical programs in oncology and infectious disease
Advancing clinical programs in oncology and infectious disease Leveraging Immune-Targeted Approaches to Transform Patient Care Oncology – Solid Tumors Infectious Disease HER2 PSMA EGFR Hepatitis Delta Chronic Hepatitis B (Phase 1) (Phase 1) (Initiating Phase 1) (Initiating Phase 3) (Phase 2) Potenti
Slide 9: The Promise and the Challenge of T-Cell Engagers
The Promise and the Challenge of T-Cell Engagers TCE: T Cell Engager; CD3: cluster of differentiation 3; TAA: tumor associated antigen 2025 Vir Biotechnology, Inc. 9
Slide 10: PRO-XTEN masks could overcome the challenges of unmasked TCEs
PRO-XTENTM masks could overcome the challenges of unmasked TCEs TCE: T Cell Engager PRO-XTEN is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company 2025 Vir Biotechnology, Inc. 10
Slide 11: PRO-XTEN: potential for best-in-class therapeutic index and long-term durability
PRO-XTENTM: potential for best-in-class therapeutic index and long-term durability Goal: achieve long-term, Proteases in the TME durable responses to a broad selectively cleave linkers set of solid tumors to release mask Variable region binds Variable region binds tumor-associated antigen CD3 to act
Slide 12: Phase 1 Clinical Data: VIR-5818 (HER2)
Phase 1 Clinical Data: VIR-5818 (HER2) PRO-XTENTM Platform Proof of Concept in HER2 Expressing Tumors Mika Derynck, M.D. 2025 Vir Biotechnology, Inc. 12
Slide 13: A patient's journey: dramatic response in advanced HER2+ breast cancer
A patient’s journey: dramatic response in advanced VIR-5818 (HER2) HER2+ breast cancer Tumor pain, inflammation Day 1 Baseline Cycle 1 Day 8 Cycle 2 Day 1 VIR-5818 Case Study Compelling activity in breast cancer patient by Cycle 1 with transformative clearance of tumor 9 prior lines of therapy, Cycl
Slide 14: The first clinical stage masked HER2 TCE in ongoing Phase 1 dose escalation
The first clinical stage masked HER2 TCE in ongoing VIR-5818 (HER2) Phase 1 dose escalation Part 1: Monotherapy Dose Escalation Part 2: Pembrolizumab Combination Highest Potential Dose Eligibility: Pembrolizumab HER2 IHC2-3+, ISH+, or Continued Dose Escalation mutant Exhausted all SOC VIR-5818 QW an
Slide 15: Minimal unmasked TCE in circulation and potential for Q3W dosing
Minimal unmasked TCE in circulation and potential for VIR-5818 (HER2) Q3W Dosing Minimal unmasked TCE outside the tumor half-life of ~ 6 days unlocks potential Q3W dosing Mean PK VIR-5818 and QWuTCE PK, Dosing Stepup First Cycle* VIR-5818 PK, First Dose 1000 Plasma Concentration, nM 100 10 1 XPAT 10
Slide 16: Enrolling a heterogeneous and heavily pretreated HER2 population
Enrolling a heterogeneous and heavily VIR-5818 (HER2) pretreated HER2 population VIR-5818 Study Disposition VIR-5818 (N = 79) NCT05356741 Male, n (%) 40 (50.6) Study & Enrollment detail: Median age, years (range) 60 (35-78) • Heavily pre-treated patients: Prior lines of therapy, n (%) 1-2 29 (36.7)
Slide 17: Preliminary safety data indicates VIR-5818 is not dose-limited by CRS
Preliminary safety data indicates VIR-5818 is not dose- VIR-5818 (HER2) limited by CRS Highly Tolerable Safety Low Cytokine Levels, Even at Higher Doses TRAE (max grade) in >15% of pts Peaks of IL-6 Secretion Post VIR-5818 Dosing VIR-5818 Grade 1 Grade 2 Grade ≥ 3 N = 79 N (%) N (%) N (%) Peak IL-6
Slide 18: Notable tumor shrinkage observed during dose escalation
VIR-5818 Notable tumor shrinkage observed during dose escalation (HER2) HER2+ Solid Tumors (Doses ≥ 400 µg/kg) Efficacy detail: • ≥ 400 µg/kg drive significant RECIST responses o Dose escalation continues Pt case study shown previously in QW and Q3W regimens • 50% observed tumor shrinkage (10/20 pat
Slide 19: Deep responses observed in HER2+ mCRC at early doses
VIR-5818 Deep responses observed in HER2+ mCRC at early doses (HER2) HER2+ Colorectal Cancer (All Patients Shown are MSS) Dose Levels 100-300 µg/kg Efficacy detail: 400 µg/kg 600 µg/kg Activity HER2+ CRC ≥400 µg/kg1 800 µg/kg 1000 µg/kg cPR 2/6 (33%) Case * CEA to be Response discussed by CEA Respon
Slide 20: Molecular evidence of anti-tumor activity across multiple cancer types
Molecular evidence of anti-tumor activity across VIR-5818 (HER2) multiple cancer types Molecular Responses: ctDNA (Step-up doses only) Detail: 100 • High value of biomarkers for Percent Change from Baseline (%) immunologics 50 • RECIST responses may be Best % cfBL confounded by tumor 0 inflammation
Slide 21: A potential first-in-class HER2 TCE designed to clinically validate the PRO-XTEN platform
A potential first-in-class HER2 TCE designed to VIR-5818 (HER2) clinically validate the PRO-XTENTM platform Clear activity based on early Phase 1 data with Dose escalation continuing potential for long-term durable responses Part 1 Single Agent Emerging activity: wide TI in heavily pretreated popula
Slide 22: KOL Perspectives
KOL Perspectives On VIR-5818 Data and Masked TCEs in HER2 Josep Tabernero, M.D., Ph.D. 2025 Vir Biotechnology, Inc. 22
Slide 23: Patient Case Study: 2 years on treatment, exceptional durability
VIR-5818 Patient Case Study: 2 years on treatment, exceptional (HER2) durability Rapid and Sustained Decrease Over time Dose-Dependent Tumor Shrinkage Change in Target Tumors Size from Baseline CEA Levels Over Time 0 Change in SLD from Baseline (%) Dose Levels -10 60 µg/kg 120 µg/kg 200 µg/kg -20 30
Slide 24: Phase 1 Clinical Data: VIR-5500 (PSMA)
Phase 1 Clinical Data: VIR-5500 (PSMA) Potential Best-in-Class Profile in Prostate Cancer Mika Derynck, M.D. 2025 Vir Biotechnology, Inc. 24
Slide 25: Ongoing dose escalation of first dual-masked TCE in prostate cancer
Ongoing dose escalation of first dual-masked TCE in VIR-5500 (PSMA) prostate cancer QW Dose Escalation Q3W Dose Escalation QW Highest Potential Dose Eligibility: Q3W Highest Potential Dose Documented progressive Continued Dose Escalation metastatic CRPC Continued Dose Escalation ≥ 1 prior taxane reg
Slide 26: Enrolling a heavily pretreated mCRPC population
Enrolling a heavily pretreated mCRPC population VIR-5500 (PSMA) VIR-5500 Study Disposition VIR-5500 NCT05997615 N = 18 Study & Enrollment detail: Median age, years (range) 69 (57-79) Heavily pre-treated patients: • 4 median prior lines of therapy Prior lines of therapy Number, Median (Min, Max) 4 (3
Slide 27: Minimal systemic unmasking and potential for Q3W dosing
10 Plasma XPAT Plasma XP 10 Minimal systemic1 unmasking and potential for Q3W 1 VIR-5500 (PSMA) dosing 0.1 0.1 0.01 Minimal Participantunmasked X PK TCE outside 0.01 the tumor 8-10 Day Half-Life: 0 Supportive 1 2 of Q3W 3 Dosing 4 5 0 1 2 3 4 5 6 7 Nominal Time, Day ticipant200/300/400 X PK μg/kg QW
Slide 28: Well tolerated without prophylactic corticosteroids or anti-IL-6 premedication
Well tolerated without prophylactic corticosteroids or VIR-5500 (PSMA) anti-IL-6 premedication in early Phase 1 testing Potential Best-in-Class Safety No Anti-IL-6, No Corticosteroids, No Gr ≥3 CRS CRS by VIR-5500 Dose Regimen* Grade 1 Grade 2 Grade ≥ 3 5 Vir-5500 (n=18) N (%) N (%) N (%) Participan
Slide 29: Strong PSA50 response with limited and low-grade CRS at early doses
Strong PSA50 response with limited and low-grade CRS VIR-5500 (PSMA) at early doses in Phase 1 testing PSA Responses (1st dose ≥ 120 µg/kg) 120/180/180 μg/kg QW 120/180/180 μg/kg QW Early Responses: 25 200/300/400 μg/kg QW from Baseline 25 200/300/400 μg/kg QW PSA Best % Change from Baseline 300/600
Slide 30: Meaningful responses and evidence of durability at early dose cohorts
Meaningful responses and evidence of durability at VIR-5500 (PSMA) early dose cohorts Longitudinal Responses *Note: Participant had dose 120/180/180 μg/kg QW 200/300/400 μg/kg QW 300/600/1000 μg/kg QW interruption at Day 20 due to 120/180/180 μg/kg QW 200/300/400 μg/kg QW 300/600/1000 μg/kg QW 0 * u
Slide 31: VIR-5500 TI provides significant room for dose escalation
VIR-5500 TI provides significant room for dose VIR-5500 (PSMA) escalation based on early Phase 1 data CRS Incidence and ≥Gr3 TRAEs Progression of prostate cancer TCE development Gr1/2 CRS ≥Gr3 TRAEs Unmasked TCE Single masked TCE Dual masked TCE 100% 6% 90% 80% Percentage of Participants 70% 9% 60%
Slide 32: Potential for deeper PSA responses at higher doses
VIR-5500 Potential for deeper PSA responses at higher doses (PSMA) Initial Dose Cohorts Higher Dose Cohorts PSA50 56% PSA50 83% PSA50 100% Janux Janux Janux Feb’241 Feb’241 Dec’242 PSA90 6% PSA90 17% PSA90 63% (≥0.1mg (≥0.2mg (≥0.2mg n=18) CRS 94% n=6) CRS 100% n=16) CRS 100% (6% Gr3) PSA50 58% Vir
Slide 33: Potential for best-in-class TI and positioning in early and late lines
Potential for best-in-class TI and positioning in both VIR-5500 (PSMA) early and late lines Late-line mCRPC Early-line mCRPC Expansion Opportunities 3L+ 1L-2L nmCRPC, HSPC 12,000 patients 90,000 patients 80,000 patients Chemo Anti-Androgen Therapies Radioligand Therapies Other Targeted Therapies • C
Slide 34: KOL Perspectives
KOL Perspectives On VIR-5500 and Masked TCEs in mCRPC Johann de Bono, MD, MSc, PhD, FRCP, FMedSci 2025 Vir Biotechnology, Inc. 34
Slide 35: Patient case study: whole-body MRI and PSMA-PET show widespread changes
Patient case study: whole-body MRI and PSMA-PET show VIR-5500 (PSMA) widespread and homogeneous changes indicative of tumor cell death Individual case subject 200/300/400 µg/kg Baseline Week 9 (PSA 959) (PSA 31) Case Study Detail: • Prior treatment: Cabazitaxel, Docetaxel and Darolutamide • Related
Slide 36: Closing Remarks
Closing Remarks: Advancing Immune-Powered Therapies to Transform Patient Care Marianne De Backer, M.Sc., Ph.D., MBA 2025 Vir Biotechnology, Inc. 36
Slide 37: PRO-XTEN masked TCEs: expanding the potential for T-cell engagers
PRO-XTENTM masked TCEs: expanding the potential for T-cell engagers in cancer treatment Universal dual-masking designed to apply across platform Potential best-in-class therapeutic index tied to MOA Early Phase 1 data show clear efficacy signals in HER2 and PSMA with room for further dose escalation
Slide 38: Executing toward multiple important near-term catalysts
Executing toward multiple important near-term catalysts Program Drug Candidates/Regimen Catalyst Timing HER2 solid tumors VIR-5818: Dual-masked HER2xCD3 TCE Phase 1: initial monotherapy data Jan. 8th PSMA solid tumors VIR-5500: Dual-masked PSMAxCD3 TCE Phase 1: initial monotherapy data Jan. 8th Hepa
Slide 39: Financial discipline and portfolio prioritization enable runway into mid-2027
Financial discipline and portfolio prioritization enable runway into mid-2027 Financial Highlights Accelerate and Invest Partnership Program Cash runway into Hepatitis Delta Hepatitis B mid-2027 Phase 3 starts H1’25 Functional cure data Q2’25 Masked TCEs VIR-5818 (HER2) Further advancement is ~$1.1
Slide 40: Vir Biotechnology: poised to deliver in '25 and beyond
Vir Biotechnology: poised to deliver in ’25 and beyond Our Mission Powering the immune system to transform lives Core AI-driven antibody discovery, protein engineering Capabilities and PRO-XTENTM masking Advancing HDV Focused capital Delivering on promise Strategic registrational deployment, cost of
Slide 41: Patients are waiting
PATIENTS ARE WAITING © 2023 PROPERTY OF VIR BIOTECHNOLOGY, INC. 41 © 2024 Vir Biotechnology, Inc. 41
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