Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — Q2 2025 Earnings Presentation
45 slides from Vir Biotechnology's earnings presentation, Aug 6, 2025
Slide 1: Corporate Overview Presentation
Corporate Overview Presentation August 2025 2025 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 therapeutic and commercial potential of Vir Biotechnology's CH
Slide 3: Our Vision: Powering The Immune System To Transform Lives
Our Vision: Powering The Immune System To Transform Lives 2025 Vir Biotechnology, Inc. 3
Slide 4: We power the immune system to fight back against cancer and viruses
We power the immune system to fight back against two related and formidable threats: cancer and viruses Protecting us from cancer cells and Cancer cells and viruses can evade the We power the immune system to fight viruses in normal conditions immune system, causing serious back against cancer and i
Slide 5: Potential best-in-class programs across oncology and infectious disease
Potential best-in-class programs across oncology and infectious disease Leveraging immune-targeted approaches to transform patient care Oncology – Solid Tumors Infectious Disease HER2 PSMA EGFR Hepatitis Delta (Phase 1) (Phase 1) (Phase 1) (Phase 3) Potential HER2 mCRPC mNSCLC Chronic suppressive tu
Slide 6: Diversified pipeline in oncology and infectious disease driving near-term and long-term value creation
Diversified pipeline in oncology and infectious disease driving near-term and long-term value creation siRNA Antibody Masked TCE Disease Area Product Candidate Goal Pre-clinical Phase 1 Phase 2 Phase 3 Approval Clinical Programs Chronic tobevibart + elebsiran Treatment Hepatitis Delta Solid Tumors V
Slide 7: We anticipate multiple important near-term program catalysts
We anticipate multiple important near-term program catalysts Program Drug Candidates/Regimen Catalyst Timing ECLIPSE 1: study start Q1’25 Hepatitis Delta tobevibart (mAb) + elebsiran (siRNA) ECLIPSE 2: study start Q3’25 ECLIPSE 3: study start Q3’25 HER2-Expressing Phase 1: initial monotherapy data Q
Slide 8: Chronic Hepatitis Delta
Chronic Hepatitis Delta Potentially Transformative Chronic Treatment 2025 Vir Biotechnology, Inc. 8
Slide 9: Hepatitis Delta dramatically increases risk of death, cirrhosis, and cancer
Hepatitis Delta dramatically increases risk of death, HDV cirrhosis, and cancer Worldwide Liver-Related >50% Death in 10 Years1 ~7M RNA+ (Active Viremic HDV) Patients4 U.S. 5 year Average Progression to Cirrhosis and Liver Failure2 ~61K RNA+ (Active Viremic HDV) Patients5,7 Total EU (27 member state
Slide 10: An estimated 61,000 patients in the U.S. have active viremic HDV infection
An estimated 61,000 patients in the U.S. have active HDV viremic HDV infection ~2M Prevalent Chronic Hepatitis B Patients 1 ~4.7% Anti-HDV proportion of HBV Patients (avg. calculated across sources)1,2,3,4 ~92K Anti-HDV Patients ~66% HDV RNA Positivity Rate (Active Viremic HDV Patients)2 ~61K HDV RN
Slide 11: Our ambition in HDV: chronic viral suppression to undetectable levels with monthly dosing
Our ambition in HDV: chronic viral suppression to HDV undetectable levels with monthly 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 MOAs: Tobevibart Degradation of HBV
Slide 12: Rapid and sustained HDV RNA suppression with tobevibart + elebsiran combination
Rapid and sustained HDV RNA suppression with tobevibart + HDV elebsiran combination Mean HDV RNA (log10 IU/mL) by Visit Mean HDV RNA (log10 IU/mL) by Visit Combo Q4W rollover Combo Q4W de novo Combo Q4W rollover Combo Q4W de novo HDV RNA levels decreased rapidly in the tobevibart + elebsiran combina
Slide 13: Tobevibart + elebsiran combo has shown transformative HDV virological responses
Tobevibart + elebsiran combo has shown transformative HDV virological responses in HDV in our ongoing P2 trial Virologic Endpoint: Tobevibart (mAb) + elebsiran (siRNA) combination therapy HDV RNA <Target Not Detected (0 IU/mL)* Key differentiators 100% P2: SOLSTICE 100% P3: MYR 301 1 Deep HDV antivi
Slide 14: Combination markedly outperforms monoclonal antibody monotherapy in HBsAg reduction
Combination of tobevibart + elebsiran markedly outperforms monoclonal HDV antibody monotherapy in HBsAg reduction at Week 24 HBsAg Level HBsAg (IU/mL) Category at Week 24 Mean HBsAg (log10 IU/mL), 6 100 3 11 4 22 Mean ± SD 80 2 <0.05 60 38 0.05 to <10 0 78 84 10 to <100 40 ≥100 Missing Day 1 Week 12
Slide 15: Majority of adverse events were Grade 1-2 and transient
Majority of adverse events were Grade 1-2 & transient, no Grade 2 or HDV higher ALT elevations have occurred to date Combo Q4W Tobevibart Q2W Combo Q4W rollover de novo N = 33 N = 13 Safety or tolerability measure, n (%)a N = 32 Any TEAE 29 (87.9) 25 (78.1) 5 (38.5) Grade 1-2 28 (84.9) 25 (78.1) 5 (
Slide 16: We aim to establish a new standard of care in HDV; ECLIPSE trials enrolling
We aim to establish a new standard of care in HDV, and all HDV ECLIPSE registrational clinical trials are actively enrolling Supported by: ✓ FDA breakthrough designation ✓ FDA Fast Track ✓ EMA PRIME designation ✓ EMA ODD ECLIPSE 1 – Phase 3 HDV RNA LLOQ, TND + ALT normalization at week 48 tobevibart
Slide 17: PRO-XTEN Dual-Masked TCE Platform
PRO-XTENTM Dual- Masked TCE Platform Potential to Overcome the Challenges of TCEs 2025 Vir Biotechnology, Inc. 17
Slide 18: PRO-XTEN masked TCEs have potential best-in-class therapeutic index and durability
PRO-XTENTM masked TCEs have potential best-in-class PRO-XTEN therapeutic index and long-term durability Platform CD3: cluster of differentiation 3; TME: tumor microenvironment; TCE: T-cell engager; TI: therapeutic index; Q3W: once every 3 weeks PRO-XTEN is a trademark of Amunix Pharmaceuticals, Inc.
Slide 19: PRO-XTEN masked TCEs can expand the potential of T-cell engagers in cancer treatment
PRO-XTENTM masked TCEs can expand the potential of PRO-XTEN Platform T-cell engagers in cancer treatment PRO-XTENTM Dual-Masked TCEs VIR-5818 (HER2xCD3)1: The only masked HER2-targeted TCE, significant room to dose escalate including Q3W dosing • Efficacy: 33% response and 100% biomarker response in
Slide 20: Phase 1 Clinical Data: VIR-5818 (HER2)
Phase 1 Clinical Data: VIR-5818 (HER2) PRO-XTENTM Platform Proof of Concept in HER2 Expressing Tumors 2025 Vir Biotechnology, Inc. 20
Slide 21: The first clinical stage masked HER2 TCE in ongoing Phase 1
The first clinical stage masked HER2 TCE in ongoing VIR-5818 (HER2) Phase 1 Part 1: Monotherapy Dose Escalation - Completed Part 2: Pembrolizumab Combination Recommended expansion Eligibility: + dose and schedule Pembrolizumab HER2 IHC2-3+, ISH+, or VIR-5818 100 → 300 → 1000 µg/kg mutant Q3W QW and
Slide 22: 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 23: 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 24: 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 Breast cancer o Dose escalation continues patient case study in QW and Q3W regimens • 50% observed tumor shrinkage (10/20 p
Slide 25: A patient's journey: dramatic response in advanced HER2+ breast cancer
A patient’s journey: dramatic response in advanced VIR-5818 HER2+ breast cancer (HER2) 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 26: Deep responses at early doses in MSS colorectal cancer
Deep responses at early doses in MSS colorectal cancer, VIR-5818 (HER2) a tumor type traditionally resistant to immunotherapy HER2+ Colorectal Cancer Dose Levels (All Patients Shown are MSS) Early Phase 1 efficacy: 100-300 µg/kg 400 µg/kg 600 µg/kg Activity HER2+ CRC ≥400 µg/kg 800 µg/kg cPR 2/6 (33
Slide 27: Patient Case Study: 2 years on treatment, exceptional durability
Patient Case Study: 2 years on treatment, exceptional VIR-5818 (HER2) durability Rapid and Sustained Decrease Over time Dose-Dependent Tumor Shrinkage 900 CEA 899 ng/mL Change in Target Tumors Size from Baseline Dose Levels 0 Change in SLD from Baseline (%) 800 60 µg/kg Dose Levels 120 µg/kg Plasma
Slide 28: 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 29: 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 potential for long-term durable responses Emerging activity: wide TI in heavily pretreated population • Unprecedented tolerability: no Gr3+ CRS,
Slide 30: Phase 1 Clinical Data: VIR-5500 (PSMA)
Phase 1 Clinical Data: VIR-5500 (PSMA) Potential Best-in-Class Profile in Prostate Cancer 2025 Vir Biotechnology, Inc. 30
Slide 31: 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 500 → 1000 → 2000 µg
Slide 32: Minimal systemic unmasking and potential for Q3W dosing
10 Plasma XPAT Plasma XP 10 Minimal systemic 1unmasking and potential 1 for VIR-5500 (PSMA) Q3W dosing 0.1 0.1 0.01 Minimal 0.01 0 1 2 of Q3W 3 4 5 Participantunmasked X PK TCE outside the tumor 0 1 2 3 4 5 6 7 8-10 Day Half-Life: Supportive Dosing ticipant200/300/400 X PK μg/kg QW Nominal Time, Day
Slide 33: 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 (%) Grade 1 Gr
Slide 34: Strong PSA50 responses and tolerable safety at early doses
Strong PSA50 responses and tolerable safety at early VIR-5500 (PSMA) doses in Phase 1 testing PSA Responses (1st dose ≥ 120 ug/kg) 120/180/180 μg/kg QW Early Phase 1 responses: 25 120/180/180 μg/kg QW 25 200/300/400 μg/kg QW from Baseline 200/300/400 μg/kg QW PSA Best % Change from Baseline 300/600/
Slide 35: 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 36: 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 37: Potential for best-in-class therapeutic index and positioning in early and late lines
Potential for best-in-class therapeutic index and VIR-5500 (PSMA) positioning in both 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 Targete
Slide 38: Phase 1 Clinical Program: VIR-5525 (EGFR)
Phase 1 Clinical Program: VIR-5525 (EGFR) Potential for Effective and Differentiated Targeting of EGFR Expressing Tumors 2025 Vir Biotechnology, Inc. 38
Slide 39: VIR-5525 Phase 1 study design: dose escalation and expansion
VIR-5525 Phase 1 study design: dose escalation and VIR-5525 (EGFR) expansion Part 3 & 4: Pembrolizumab Combination Part 1 & 2: Monotherapy Dose Escalation & Expansion Dose Escalation & Expansion Highest Potential Dose Indications: Continued Dose Escalation NSCLC (nonsquamous or squamous histology),
Slide 40: Potential to revolutionize treatment in EGFR-expressing cancers
Potential to revolutionize treatment in EGFR-expressing VIR-5525 (EGFR) cancers High annual incidence and EGFR expression in key solid tumors Poor survival in advanced EGFR-expressing tumors Initial indications No currently approved antibodies directly engage T-cell killing in their mechanism of act
Slide 41: Preclinical data demonstrate potent activity and substantial safety margin
Preclinical data demonstrate potent activity and VIR-5525 (EGFR) substantial safety margin with PRO-XTEN masking 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 Anti-tumor activity in
Slide 42: Financials and closing
Financials and closing 2025 Vir Biotechnology, Inc. 42
Slide 43: Q2 2025 Financial Results
Q2 2025 Financial Results Three Months Ended June 30, $ in millions 2025 2024 Change % Total revenues $1.2 $3.1 $(1.9) (61%) Operating expenses: Cost of revenue — 0.1 (0.1) (100%) Research and development (1) 97.5 105.1 (7.6) (7%) Selling, general and administrative (1) 22.3 30.3 (8.0) (26%) Restruc
Slide 44: Clinical execution underpinned by strict financial discipline, enabling runway into mid-2027
Clinical execution underpinned by strict financial discipline, enabling runway into mid-2027 & through multiple catalysts Financial Highlights Clinical Programs Pre-clinical Programs Cash runway into Hepatitis Delta HIV Cure mid-2027 ECLIPSE studies all enrolling Undisclosed PRO-XTENTM TCE targets D
Slide 45: Patients Are Waiting
PATIENTS ARE WAITING 2025 Vir Biotechnology, Inc. 45