Vir Biotechnology, Inc. · NASDAQ:VIR
Vir Biotechnology — Q4 2024 Earnings Presentation
45 slides from Vir Biotechnology's earnings presentation, Feb 26, 2025
Slide 1: Corporate Overview Presentation
Corporate Overview Presentation February 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 potential of Vir Biotechnology's oncology solid tu
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: 5 clinical programs across oncology and infectious disease
5 clinical programs across 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) Potential H
Slide 6: Well positioned for near-term value creation in oncology and infectious disease
We are well positioned for near-term value creation in oncology and infectious disease siRNA Antibody Masked TCE Disease Area Product Candidate Goal Pre-clinical Phase 1 Phase 2 Phase 3 Approval Accelerate and Invest Chronic tobevibart ± elebsiran Treatment Hepatitis Delta Solid Tumors VIR-5818 (HER
Slide 7: Chronic Hepatitis Delta
Chronic Hepatitis Delta Potentially Transformative Chronic Treatment 2025 Vir Biotechnology, Inc. 7
Slide 8: Hepatitis Delta dramatically increases risk of death, cirrhosis, and cancer
In infectious disease, we target Hepatitis Delta, which HDV dramatically increases risk of death, cirrhosis, and cancer >50% Liver-Related Death in 10 Years1 ~100,000 US Patients4 5 year Average Progression to Cirrhosis and Liver Failure2 ~200,000 EU Patients4 Risk of Liver Cancer 3x (HCC) vs. HBV3
Slide 9: Our ambition in HDV: chronic viral suppression 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 10: Rapid and sustained HDV RNA suppression with tobevibart + elebsiran
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 11: Tobevibart + elebsiran shows 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 12: Combination outperforms monotherapy in HBsAg reduction at Week 24
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 6 Mean HBsAg (log 10 IU/mL), 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 1
Slide 13: 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 14: ECLIPSE registrational clinical trials begin in H1 2025
We aim to establish a new standard of care in HDV, and ECLIPSE HDV registrational clinical trials begin in H1 2025 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 + elebsir
Slide 15: PRO-XTEN Dual-Masked TCE Platform
PRO-XTENTM Dual- Masked TCE Platform Potential to Overcome the Challenges of Unmasked TCEs 2025 Vir Biotechnology, Inc. 15
Slide 16: PRO-XTEN masked TCEs have potential best-in-class therapeutic index
In oncology, PRO-XTENTM masked TCEs have potential PRO-XTEN best-in-class therapeutic index and long-term durability Platform Addressing the challenges of Goal: achieve long-term, Proteases in the TME unmasked and single-masked durable responses to a broad selectively cleave linkers set of solid tum
Slide 17: PRO-XTEN masked TCEs can expand the potential of T-cell engagers
PRO-XTENTM masked TCEs can expand the potential of PRO-XTEN Platform T-cell engagers in cancer treatment PRO-XTENTM Masked TCEs VIR-5818 (HER2xCD3): The only masked HER2-targeted TCE, significant room to dose escalate including Q3W dosing • Efficacy: 33% response and 100% biomarker response in mCRC,
Slide 18: 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. 18
Slide 19: First clinical stage masked HER2 TCE in 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 20: 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 21: Preliminary safety data: VIR-5818 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 22: 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 Pt case study o Dose escalation continues shown previously in QW and Q3W regimens • 50% observed tumor shrinkage (10/20 pat
Slide 23: 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 24: Deep responses at early doses in mCRC and other HER2 tumors
Deep responses at early doses in mCRC and other VIR-5818 HER2 tumors (HER2) 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%) 1000 µg/kg CEA Case * CEA to be Response 3/3 (1
Slide 25: 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 26: 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 27: Potential first-in-class HER2 TCE to 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 28: 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. 28
Slide 29: 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 30: Minimal systemic unmasking and potential for Q3W dosing
10 Plasma XPAT Plasma XP 10 VIR-5500 Minimal systemic1 unmasking and potential for Q3W 1 (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 31: Well tolerated without prophylactic corticosteroids or anti-IL-6
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 32: Strong PSA50 responses and tolerable safety at early doses
Strong PSA50 responses and tolerable safety at early VIR-5500 doses in Phase 1 testing (PSMA) PSA Responses (1st dose ≥ 120 ug/kg) 120/180/180 μg/kg QW Early Phase 1 responses: 25 120/180/180 μg/kg QW 200/300/400 μg/kg QW from Baseline 25 200/300/400 μg/kg QW PSA Best % Change from Baseline 300/600/
Slide 33: 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 34: Patient case study: whole-body MRI and PSMA-PET
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 35: Potential for best-in-class TI 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 36: Chronic Hepatitis B (CHB)
Chronic Hepatitis B (CHB) Pursuit of a Functional Cure 2025 Vir Biotechnology, Inc. 36
Slide 37: Our ambition in HBV: functional cure following finite treatment
Our ambition in HBV: functional cure following finite CHB treatment regimen HBsAg is the key viral protein responsible for recognition, Inhibition of viral entry binding, and entry of HBV virions (tobevibart) to hepatocytes Complementary mechanisms of action: Degradation of HBV Tobevibart RNA & redu
Slide 38: CHB: HBsAg loss of up to 45% at EOT with Vir regimens
CHB CHB: HBsAg loss of up to 45% at EOT with Vir regimens Baseline HBsAg Loss by Baseline HBsAg Categorya 50 45* 45 Participants (%) 39 40 30 25 22 20 16 10 0/20 0/12 0/6 0 8/51 6/27 0 8/32 5/11* 0 7/18 5/11 0 Total Population Baseline HBsAg <3,000 IU/mL Baseline HBsAg <1,000 IU/mL Tobevibart (N = 2
Slide 39: CHB: MARCH phase 2 functional cure data in Q2 2025
CHB: MARCH phase 2 functional cure data in Q2 2025 CHB ‘25 Completion of Enrollment 24w Off Treatment Data (48w Post-Treatment) • ~50 tobevibart + elebsiran participants • ~50 tobevibart + elebsiran participants • ~30 tobevibart + elebsiran + • ~30 tobevibart + elebsiran + PEG-IFN- participants PE
Slide 40: Financials and closing
Financials and closing 2025 Vir Biotechnology, Inc. 40
Slide 41: 2024 Financial Results
2024 Financial Results Years Ended December 31, $ in millions 2024 2023 Change % Total revenues $74.2 $86.2 $(12.0) (14%) Operating expenses: Cost of revenue 0.8 2.8 (1.9) (68%) Research and development 506.5 A 579.7 (73.2) (13%) Selling, general and administrative 119.0 174.4 (55.4) (32%) Restructu
Slide 42: 2024 cash consumption of $354M; runway into mid-2027
2024 cash consumption of $354M, excluding Sanofi transaction cash items; runway into mid-2027 $532M $179M $354M cash consumed in 2024, excluding $354M Sanofi transaction-related cash items 2024 Cash Consumed Sanofi transaction-related cash items1 Change in cash & investments, excluding the Sanofi tr
Slide 43: Clinical development underpinned by strict financial discipline
Clinical development is underpinned by strict financial discipline, enabling runway into mid-2027 Financial Highlights Accelerate and Invest Partnership Programs Cash runway into Hepatitis Delta Hepatitis B mid-2027 Functional cure data Q2’25 Phase 3 ECLIPSE starts H1’25 Masked TCEs Further advancem
Slide 44: Multiple important near-term program catalysts
We anticipate multiple important near-term program catalysts Program Drug Candidates/Regimen Catalyst Timing VIR-5818: dual-masked HER2xCD3 TCE Solid Tumors VIR-5500: dual-masked PSMAxCD3 TCE Phase 1: initial monotherapy data Jan. 8th Hepatitis Delta tobevibart (mAb) + elebsiran (siRNA) ECLIPSE: reg
Slide 45: Patients are waiting
PATIENTS ARE WAITING © 2023 PROPERTY OF VIR BIOTECHNOLOGY, INC. 2025 Vir Biotechnology, Inc. 45 45