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Corporate Overview Presentation August 2026 Vir Biotechnology ™ 2026 Vir Biotechnology , Inc. ™ 1
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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 CHD program, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the therapeutic and commercial potential of VIR-5500 and the other assets in Vir Biotechnology's oncology solid tumor clinical portfolio, preclinical pipeline and the PRO-XTEN® masking technology, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the potential of and Vir Biotechnology's expectations for its other pipeline programs; the potential benefits for Vir Biotechnology as a result of the collaborations with Norgine and Astellas; Vir Biotechnology's anticipated cash runway; Vir Biotechnology's plans and expectations for its clinical development programs, including protocols for and enrollment into ongoing and planned clinical studies, potential partnering opportunities, and data readouts and presentations, as well as anticipated timelines; the potential benefits, safety and efficacy of Vir Biotechnology's investigational therapies; and any assumptions underlying any of the foregoing. Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the management of Vir Biotechnology, as well as assumptions made by and information currently available to management. Such statements reflect the current views of Vir Biotechnology with respect to future events and are subject to known and unknown risks, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; the timing and amount of Vir Biotechnology's actual operating expenses, as determined in accordance with U.S. Generally Accepted Accounting Principles; difficulties in collaborating with other companies, some of whom may be competitors of Vir Biotechnology or otherwise have divergent interests, and uncertainty as to whether the benefits of Vir Biotechnology's various collaborations can ultimately be achieved; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; Vir Biotechnology's use of AI and machine learning in its efforts to engineer next-generation proteins and in other research and development efforts; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause Vir Biotechnology's actual results to differ from current expectations are discussed in Vir Biotechnology's filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which speak only as of the date of this presentation. Except as required by law, Vir Biotechnology undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Vir Biotechnology claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 for all forward-looking statements. Product candidates included in this presentation are investigational and have not been approved by the US Food and Drug Administration or other regulatory authorities. No representation is made or intended regarding their safety or efficacy or that of other investigational agents mentioned herein. Any comparative data presented are based on cross-trial comparisons and not head-to-head clinical studies; therefore, caution should be exercised in interpreting these data. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company 22026 Vir Biotechnology, Inc.
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3 POWERING THE IMMUNE SYSTEM TO TRANSFORM LIVES 2026 Vir Biotechnology, Inc.
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Our path to delivering transformational therapies to people living with devastating diseases Commercializing our chronic hepatitis delta (CHD) combination therapy will drive near-term revenue sustainability Aiming Vir Bio's discovery engine at developing a robust pipeline of cancer immunotherapies creates sustainable long-term growth 2026 Vir Biotechnology, Inc. 4 Accelerating our masked T-cell engager (TCE) immunotherapy portfolio offers key value inflection points Strategic Collaborations Selectively partner drug candidates to focus internal resources, unlock the value of our pipeline and maximize benefit to patients
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World class protein engineering, antibody discovery dAIsY AI/ML for antibody optimization Exclusive PRO-XTEN® universal masking technology We’ve developed a powerful Vir Bio discovery engine to fuel the next generation of therapeutics World class protein engineering, antibody / TCE discovery dAIsY AI/ML for antibody / TCE optimization Exclusive PRO-XTEN® universal masking technology Building on legacy of infectious disease innovation to deliver next generation of powerful medicines, including cancer immunotherapies with better therapeutic index EbangaTM (ansuvimab-zykl) for the treatment of ebola virus Xevudy® (sotrovimab) for the treatment of SARS-COVID 19 2026 Vir Biotechnology, Inc. 5 Our distinctive capabilities dAIsY : (dataAI structure and antibodY) AI engine; TCE: T-cell engager Ebanga is a trademark of Ridgeback Bio. Xevudy is a registered trademark of GSK
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Delivering a differentiated pipeline in oncology and infectious disease Driving near-term and long-term value creation 62026 Vir Biotechnology, Inc. 1 Masked TCEs licensed from Sanofi 2 In collaboration with the Gates Foundation ARPIs: androgen receptor pathway inhibitors; EGFR: epidermal growth factor receptor; HER2: human epidermal growth factor rece ptor 2; HIV: human immunodeficiency virus; PSMA: prostate-specific membrane antigen; siRNA: small interfering RNA; TCE: T-cell engager Tobevibart incorporates Xencor’s XtendTM and other Fc technologies Norgine holds exclusive license for the commercial rights to the combination of elebsiran and tobevibart in Europe, Australia and New Zealand Brii Biosciences retains rights to the combination of elebsiran and tobevibart in the Greater China Territory (People’s Republic of China, Hong Kong, Taiwan and Macau) Astellas holds co-development and co-commercialization rights for VIR-5500 for the treatment of prostate cancer Disease Area Product Candidate Goal Pre-clinical Phase 1 Phase 2 Phase 3 Approval CLINICAL PROGRAMS Chronic Hepatitis Delta elebsiran and tobevibart Treatment Solid Tumors VIR-5500 (PSMA)1 ± ARPI or ± taxane Treatment Solid Tumors VIR-5818 (HER2)1 ± pembrolizumab Treatment Solid Tumors VIR-5525 (EGFR)1 ± pembrolizumab Treatment PRE -CLINICAL PROGRAMS HIV Treatment / Cure 2 Preclinical antibody candidates Treatment Solid Tumors 7 PRO-XTEN® TCE programs in a variety of solid tumors Treatment AntibodysiRNA Masked TCE
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Upcoming clinical milestones PROGRAM DRUG CANDIDATES REGIMEN CATALYST TIMING Hepatitis Delta elebsiran (siRNA) and tobevibart (mAb) SOLSTICE: 72 & (partial) 96-week data ECLIPSE 1: topline data ECLIPSE 2: topline data ECLIPSE 3: topline data Jan’26 4Q’26 1Q’27 1Q’27 PSMA-Expressing Prostate Cancer VIR-5500 PRO-XTEN® dual-masked PSMAxCD3 TCE Phase 1 dose escalation response data Feb’26 HER2-Expressing Solid Tumors VIR-5818 PRO-XTEN® dual-masked HER2xCD3 TCE Phase 1 dose escalation response data 2H’26 EGFR-Expressing Solid Tumors VIR-5525 PRO-XTEN® dual-masked EGFRxCD3 TCE Phase 1 initial dose escalation clinical data TBA CD3: cluster of differentiation 3; EGFR, epidermal growth factor receptor; HER2: human epidermal growth factor receptor 2; PSMA: prostate-specific membrane antigen; siRNA: small interfering RNA; TBA, to be announced; TCE: T-cell engager; mAb, monoclonal antibody 2026 Vir Biotechnology, Inc. 7
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Our clinical programs address large and growing unmet needs Infectious Disease Oncology – Solid Tumors 2032 prevalence estimate for U.S., EU4 and UK EGFR VIR-5525 Phase 1 Drug-treated Patients3 431K mNSCLC 69K mHNSCC 271K mCRC HER2 VIR-5818 Phase 1 Drug-treated Patients3 27K HER2+ mUC 11K HER2+ mCRC PSMA VIR-5500 Phase 1 Drug-treated Patients3 100K mCRPC 60K mHSPC CHD Elebsiran and Tobevibart Phase 3 Active Viremic Patients 174K U.S.1 + UK + EU2 (all 27 member states) 1 U.S. sources include Wong 2024, Polaris 2024, Stockdale 2020, Gish 2024 2 EU sources include Polaris 2024, Delmas 2014, Wong 2024, Heidrich 2009, Reinheimer 2012, Stockdale 2020, Stroffolini 2020, Brancaccio 2019, Annual England Sentinel System 2020, Tseneva- Damyanova 2023, Papatheodoridis 2023, Parames 2016, Genne 2011, Hirzel 2015 3 Clarivate DRG, projected drug treated patients, 2032 CHD: chronic hepatitis delta; EGFR: epidermal growth factor receptor; EU4: France, Germany, Italy and Spain; HER2: human epidermal growth factor receptor 2; mCRC: metastatic colorectal cancer; mCRPC: metastatic castrate-resistant prostate cancer; mHNSCC: metastatic head and neck squamous cell carcinoma; mHSPC: metastatic hormone-sensitive prostate cancer; mNSCLC: metastatic non-small cell lung cancer; mUC: metastatic urothelial carcinoma; PSMA: prostate-specific membrane antigen 2026 Vir Biotechnology, Inc. 8
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Our path to delivering transformational therapies to people living with devastating diseases: chronic hepatitis delta (CHD) Commercializing our chronic hepatitis delta (CHD) combination therapy will drive near-term revenue sustainability Accelerating our masked T-cell engager (TCE) immunotherapy portfolio offers key value inflection points Aiming Vir Bio's discovery engine at developing a robust pipeline of cancer immunotherapies creates sustainable long-term growth 2026 Vir Biotechnology, Inc. 9 Strategic Collaborations Selectively partner drug candidates to focus internal resources, unlock the value of our pipeline and maximize benefit to patients
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CHD: devastating liver disease, significantly underserved with high mortality 102026 Vir Biotechnology, Inc. 5 years Average progression to cirrhosis and liver failure2 >50% Liver-related death in 10 years1 Risk of liver cancer (HCC) vs. HBV3 3X 1 Negro F. (2023). Hepatitis D: A Review. JAMA. 330(24):2376–2387; 2 Pan C, (2023). Diagnosis and Management of Hepatitis Delta Virus Infection. Dig Dis Sci. Aug;68(8):3237-3248; 3 Sagnelli C, et al. (2021) HBV/HDV Co-Infection: Epidemiological and Clinical Changes, Recent Knowledge and Future Challenges. Life,11(2):169. https://doi.org/10.3390/life11020169; 4 U.S. sources include Wong 2024, Polaris 2024, Stockdale 2020, Gish 2024; 5 EU sources include Polaris 2024, Delmas 2014, Wong 2024, Heidrich 2009, Reinheimer 2012, Stockdale 2020, Stroffolini 2020, Brancaccio 2019, Annual England Sentinel System 2020, Tseneva-Damyanova 2023, Papatheodoridis 2023, Parames 2016, Genne 2011, Hirzel 2015; 6 Stockdale A, et al. (2020). The global prevalence of hepatitis D virus infection: Systematic review and meta-analysis. J Hepatol, 73, 523-32 CHD: chronic hepatitis delta; HBV: hepatitis B virus; HCC: hepatocellular carcinoma ~113K ~61K Active viremic patients6 worldwide ~7M CHD Active viremic patients4 in U.S. Active viremic patients5 in total EU (27 member states) and UK
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Accelerating access to our CHD regimen to patients in Europe and ANZ through collaboration with Norgine 112026 Vir Biotechnology, Inc. • Norgine is a leading European-focused specialty pharma with market-leading products in hepatology/GI, rare disease and pediatric oncology • Exclusive commercial license in Europe, Australia, New Zealand o €55M initial reimbursement paid at closing o Up to €495M in clinical, regulatory and sales milestones o Tiered mid-teen to high-twenties percent royalties on net sales o ~25% sharing of future ECLIPSE external clinical costs • Vir Biotechnology retains all commercialization rights in the U.S. and all other markets outside of the Greater China Territory1 CHD 1 Brii Biosciences retains rights to the combination of elebsiran and tobevibart in the Greater China Territory (People’s Republic of China, Hong Kong, Taiwan and Macau) Norgine holds exclusive license for the commercial rights to the combination oftobevibart and elebsiran in Europe, Australia and New Zealand CHD: chronic hepatitis delta
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Neutralizing HDV & HBV virions Complementary mechanisms designed to maximize disruption of HDV 122026 Vir Biotechnology, Inc. cccDNA: covalently closed circular DNA; CHD: chronic hepatitis delta; HBsAg: hepatitis B virus surface antigen; HBV: hepatitis B virus; HDV: hepatitis D virus; Int: integrated; MOA: mechanism of action; NRTI: nucleoside/nucleotide reverse transcriptase inhibitor; RNP: ribonucleoprotein; SVP: subviral particle CHD (mAb) Tobevibart (siRNA) Elebsiran Inhibiting viral entry Degrading HBV RNA & reducing HBsAg production
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Well tolerated 2026 Vir Biotechnology, Inc. 13 Our dual-acting regimen aims to set a new bar for best-in-class therapy Practical administration Flexible administration setting 1 Trinity commercial and access market research, July 2024, n=18 U.S. HCPs CHD: chronic hepatitis delta; SAE: serious adverse event; TEAE: treatment-emergent adverse event Viral elimination Supporting patients and providers ease of use with monthly dosing complemented by streamlined co-packaged format Offering flexibility to patients and providers with potential option of at-home or in-office administration based individual patient needs, including the 20% of CHD patients who are not capable of self-administering at home1 Developing robust safety database to support favorable safety profile observed to date – TEAEs generally mild to moderate and transient, and no treatment-related SAEs or discontinuations Building on SOLSTICE data that achieved robust and sustained undetectable HDV RNA with the Phase 3 ECLIPSE program Characteristics of a best-in-class CHD therapy Potential of combination elebsiran and tobevibart
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Ph2 SOLSTICE trial evaluating potential best-in-class therapy for CHD Study design: elebsiran and tobevibart combination therapy Q4W and tobevibart monotherapy Q2W Primary Endpoints: • Proportion of participants with HDV RNA <LOD or ≥2 log10 IU/mL reduction (virologic response) and ALT <ULN (ALT response) at Week 24 • TEAEs and serious TEAEs Inclusion criteria: • HDV RNA ≥500 IU/mL • ALT >ULN; ALT <5 × ULN • Non-cirrhotica or cirrhotic (CTP-A)b • N = 65, randomized 1:1 a Non-cirrhotic: liver biopsy with METAVIR F0 to F3 or liver stiffness <12 kPa within 12 months of screening and platelet count >150 × 103/µL b Compensated cirrhotic participants: liver biopsy with METAVIR F4 or liver stiffness ≥12 kPa within 12 months of screening, a platelet count >90 × 103/µL, and a CTP score of 5 or 6, inclusive at screening and at the start of the study HDV RNA was measured using RoboGene 2.0 with manual RNA extraction; HDV RNA LLOQ = 63 IU/mL; HDV RNA LOD = 14 IU/mL ALT: alanine aminotransferase; CHD: chronic hepatitis delta; CTP: Child-Turcotte-Pugh; EOT: end of treatment; HDV: hepatitis D virus; LOD: limit of detection; Q2W: once every 2 weeks; Q4W: once every 4 weeks; SC: subcutaneous; TND: target not detected; TEAE: treatment-emergent adverse event; ULN: upper limit of normal SOLSTICE ClinicalTrials.gov Identifier: NCT05461170 Day 1 Week 48 AASLD 2025 New England Journal of Medicine Week 24 AASLD 2024 Week 72 Full cohort data CHD combination Q4W de novo elebsiran 200 mg and tobevibart 300 mg SC Q4W (Overall N = 32, including N = 18 cirrhotic) tobevibart Q2W tobevibart 300 mg SC Q2W (Overall N = 33, including N = 15 cirrhotic) Week 192 EOT 2026 Vir Biotechnology, Inc. 14 Key Data Presented at EASL 2026 • HDV RNA TND • Biochemical responses • TEAEs Week 96 Full cohort data
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152026 Vir Biotechnology, Inc. Ph2 SOLSTICE trial evaluating potential best-in-class therapy for CHD Patient demographic and baseline characteristics were generally balanced across the treatment groups and all participants remained on concomitant NA therapy throughout the duration of the study Elebsiran and tobevibart Q4W de novo N = 32 Tobevibart Q2W N = 33 Age, y, mean ± SD 41.5 ± 8.0 44.8 ± 9.2 Male, n (%) 18 (56.3) 16 (48.5) Race, n (%) White Black or African American Asian Other 25 (78.1) 4 (12.5) 2 (6.3) 1 (3.1) 28 (84.8) 2 (6.1) 1 (3.0) 2 (6.1) ALT, U/L, mean ± SD 83.4 ± 47.1 75.7 ± 58.8 HDV RNA, log10 IU/mL, mean ± SD 5.7 ± 1.2 5.6 ± 1.1 HDV genotype, gt (%) gt1 (97%); gt5 (3%) gt1 (97%); gt5 (3%) HBsAg, log10 IU/mL, mean ± SD 3.7 ± 0.6 3.7 ± 0.8 HBeAg positive, n (%) 3 (9.4) 8 (24.2) HBV DNA, log10 IU/mL, mean ± SD 0.74 ± 0.66 0.71 ± 0.80 Cirrhotic participantsa, n (%) 18 (56.3) 15 (45.5) Platelets, 109/L, mean ± SD 189.4 ± 58.0 200.2 ± 74.5 Liver stiffness, kPa, mean ± SD 13.5 ± 7.3 13.5 ± 8.7 FibroTest score, mean ± SD 0.48 ± 0.25 0.45 ± 0.23 a Two participants were classified as cirrhotic based on a liver biopsy; all other participants were classified by Fibroscan at screening. ALT: alanine aminotransferase; gt: genotype; HBeAg: hepatitis e antigen; HBsAg: hepatitis B surface antigen; HBV: hepatitis B virus; HDV: hepatitis D virus; LOD: limit of detection; LLOQ: lower limit of quantification; NA: nucleos(t)ide analogues; Q2W: once every 2 weeks; Q4W: once every 4 weeks; SD: standard deviation. HDV RNA was measured using RoboGene 2.0 with manual RNA extraction; HDV RNA LLOQ = 63 IU/mL; HDV RNA LOD = 14 IU/mL. 15 CHD
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0 24 48 72 96 0 20 40 60 80 100 % of participants achieving HDV RNA TND Study Week Ph2 SOLSTICE trial evaluating potential best-in-class therapy for CHD Monthly combo therapy achieved undetectable HDV RNA in 88% (28/32) of participants at Week 96 (missing = failure analysis) and 97% (31/32) of participants at Week 96 (LOCF analysis) 16 siRNA and mAb mAb alone CHD CHD: chronic hepatitis delta; HDV, hepatitis D virus; LOCF: last observation carried forward; mAb: monoclonal antibodies; Q2W: once every 2 weeks; Q4W: once every 4 weeks; siRNA: small interfering RNA; TND: target not detected HDV RNA TND = undetectable HDV RNA Data are reported for participants who completed the visit with non-missing HDV RNA and ALT or discontinued treatment before the visit By week 96, N=4 participants discontinued elebsiran and tobevibart Q4W and N=7 participants discontinued in tobevibart Q2W and are counted as failures in analysis; 1 participant receiving tobevibart Q2W is censored after week 52 due to a site protocol deviation Data as of 1/12/26 2026 Vir Biotechnology, Inc. 66% 88% 78% 49% 53%53% 41% 30% (28/32) (17/32) HDV RNA TND elebsiran and tobevibart Q4W (N =32) tobevibart Q2W (N=33) Target not detected is the most rigorous measure of virologic response in hepatitis delta. Emerging evidence suggests that achieving and maintaining TND is an important predictor of durable viral control and improved long-term liver outcomes. Tarik Asselah, M.D., Ph.D. Professor of Hepatology at the Hôpital Beaujon, APHP
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172026 Vir Biotechnology, Inc. *One participant experienced a transient ALT elevation of Grade 2; All other ALT elevations were ≤Grade 1 ALT: alanine aminotransferase; Q2W: once every 2 weeks; Q4W: once every 4 weeks; ULN: upper limit of normal ALT ULN (male) = 40 IU/mL; ALT ULN (female) = 33 IU/mL. Data are reported for participants who completed the visit with non-missing HDV RNA and ALT or discontinued treatment before the visit. By week 96, N=4 participants discontinued elebsiran and tobevibart Q4W and N=7 participants discontinued in tobevibart Q2W and are counted as failures in analysis; 1 participant receiving tobevibart Q2W is censored after week 52 due to a site protocol deviation Data as of 1/12/26 17 CHD Ph2 SOLSTICE trial evaluating potential best-in-class therapy for CHD ALT normalization was robust and similar between elebsiran and tobevibart and tobevibart monotherapy 0 24 48 72 96 0 20 40 60 80 100 % of participants achieving ALT normalization Study Week 63% 56% 53% 53% 61% 69% 47% 76% ALT Normalization elebsiran and tobevibart Q4W (N=32) tobevibart Q2W (N=33)
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High rates of viral elimination and ALT normalization for elebsiran and tobevibart combination in Phase 2 18 CHD 2026 Vir Biotechnology, Inc. 66% (21/32) 5% (1/20) 30% (6/20) 56% (18/32) 40% (8/20) 45% (9/20) 0 10 20 30 40 50 60 70 80 90 100 elebsiran 200mg and tobevibart 300mg SC Q4W n=32 brelovitug 900mg SC Q4W n=20 brelovitug 300mg SC QW n=20 HDV RNA TND SOLSTICE 48-week endpoint3 AZURE-1 24-week endpoint ALT Normalization % of participants 4 5 5 1,2 FOR ILLUSTRATIVE PURPOSES ONLY: No head -to-head trials have been conducted. Cross-trial comparisons may not be reliable due to differences in study design, patient populations, and other factors. Data from public sources have not been independently verified. See individual study publications for complete data and context. 1 Vir Biotechnology: TND defined by no HDV RNA amplification with RoboGene 2.0 assay; 2 Mirum: TND defined by HDV RNA < LLOD with VIDRL assay; 3 The only currently U.S. FDA-approved therapy was approved based on 48-week primary endpoint; 4 Vir Bio ClinicalTrials.gov Identifier: NCT05461170; 5 Mirum ClinicalTrials.gov Identifier: NCT06907290, Mirum corporate presentation dated April 27, 2026 ALT: alanine aminotransferase; CHD: chronic hepatitis delta; HDV: hepatitis delta virus; HDV RNA TND = undetectable HDV RNA; LLOD: lower limit of detection; mAb: monoclonal antibody; QD: once daily; QW: once weekly; Q4W: once every 4 weeks; siRNA: small interfering RNA; SC: subcutaneous; VIDRL: Victorian Infectious Disease Reference Laboratory
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0 24 48 72 96 0 20 40 60 80 100 Study Week % of participants with HBsAg <10 IU/mL Ph2 SOLSTICE trial evaluating potential best-in-class therapy for CHD ~90% of participants receiving elebsiran and tobevibart achieved very low HBsAg values by Week 24 and maintain suppression 192026 Vir Biotechnology, Inc. Hepatitis delta virus (HDV) requires serum HBV surface antigen (HBsAg) to replicate and complete its lifecycle; clearing HBsAg limits HDV replication CHD: chronic hepatitis delta; HBsAg: hepatitis B surface antigen; HDV: hepatitis D virus; mAb: monoclonal antibodies; Q2W: once every 2 weeks; Q4W: once every 4 weeks; siRNA: small interfering RNA Data are reported for participants who completed the visit with non-missing HBsAg measurement or discontinued treatment before the visit By week 96, N=4 participants discontinued elebsiran and tobevibart Q4W and N=7 participants discontinued in tobevibart Q2W and are counted as failures in analysis; 1 participant receiving tobevibart Q2W is censored after week 52 due to a site protocol deviation Data as of 1/12/26 CHD mAb + siRNA mAb alone Proportion with HBsAg <10 IU/mL 21% 19% 25% 91% 94% 88% 21% 88% HBsAg <1 IU/mL 47% <0.05 IU/mL 6% HBsAg <1 IU/mL 6% <0.05 IU/mL 0% elebsiran and tobevibart Q4W (N=32) tobevibart Q2W (N=33)
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202026 Vir Biotechnology, Inc. Q2W: once every 2 weeks; Q4W: once every 4 weeks; SAE: serious adverse event; TEAE: treatment-emergent adverse event. aA participant with multiple events within a category is counted only once in that category. bGrade 3 worsening of diabetes mellitus type 2 deemed unrelated to study drugs by investigator. cGrade 3 hepatocellular carcinoma (SAE) deemed unrelated to study drugs by investigator and grade 3 arterial hypertension deemed related to tobevibart by the investigator. dGrade 4 neutropenia on Week 12 and Week 16; recovered to grade 2 or 3 after Week 16 without treatment. eReason for study drug interruption: neutropenia and leukopenia (Preferred term). fReason for discontinuation: 2 cases of influenza-like illness (Preferred term) on the day of the first dose and 1 case of hepatocellular carcinoma at day 192. gOne participants with 2 concurrent SAEs of worsening nasal septum deviation and worsening nasal concha hyperplasia (both Grade 2) who underwent planned admission to the hospital for surgery; both SAEs were deemed unrelated to study drugs by investigator. hGrade 3 hepatocellular carcinoma (SAE) at day 192 deemed unrelated to study drugs by investigator. Ph2 SOLSTICE trial evaluating potential best-in-class therapy for CHD CHD Safety or tolerability measure, n (%)a Elebsiran and tobevibart Q4W de novo N = 32 Tobevibart Q2W N = 33 Any TEAE 28 (88) 32 (97) Grade 1-2 27 (84) 29 (88) Grade 3 1 (3)b 2 (6)c Grade 4 0 1 (3)d Treatment-related TEAE 23 (72) 26 (79) TEAE leading to study drug interruption 0 1 (3)e TEAE leading to study drug discontinuation 0 3 (9)f Serious TEAE 1 (3)g 1 (3)h Treatment-related serious TEAE 0 0 Combination therapy generally well-tolerated; majority of adverse events through Week 96 were grade 1 or 2 and transient
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Ph2 SOLSTICE results to-date show remarkable viral elimination, with monthly elebsiran and tobevibart administration 212026 Vir Biotechnology, Inc. CHD 88% (28/32) of elebsiran and tobevibart participants achieved undetectable HDV RNA (HDV RNA TND) ~90% of elebsiran and tobevibart participants achieved HBsAg <10 IU/mL by Week 24 and maintained through Week 96 ALT normalization was similar between combination and monotherapy cohorts through Week 96 Generally mild to moderate and transient TRAEs, no Gr3+ TRAEs ALT: alanine aminotransferase; CHD: chronic hepatitis delta; Gr3+: Grade 3 or higher; HBsAg: hepatitis B surface antigen; HDV: hepatitis D virus; TND: target not detected; TRAEs: treatment-related adverse events HDV RNA TND = undetectable HDV RNA
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*Defined as failure to achieve HDV RNA < 500 IU/mL with bulevirtide ALT: alanine aminotransferase; HDV: hepatitis D virus; TND: target not detected HDV RNA TND = undetectable HDV RNA ECLIPSE ClinicalTrials.gov Identifiers: ECLIPSE 1 NCT06903338, ECLIPSE 2 NCT07128550,ECLIPSE 3 NCT07142811 Registrational ECLIPSE program progressing ahead of schedule Initial topline data anticipated in Q4 2026 22 ECLIPSE 1 Phase 3 • HDV RNA TND + ALT normalization at Week 48 • Elebsiran and tobevibart vs. deferred treatment (n=120, 2:1) ECLIPSE 2 Phase 3 • HDV RNA TND at Week 24 • Elebsiran and tobevibart vs. bulevirtide switch* (n=150, 2:1) ECLIPSE 3 Phase 2b • HDV RNA TND at Week 48 • Elebsiran and tobevibart vs. bulevirtide naïve (n=100, 2:1) FDA breakthrough designation FDA Fast Track EMA PRIME designation EMA Orphan Drug designation Fully enrolled Fully enrolledFully enrolled CHD 2026 Vir Biotechnology, Inc.
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Our path to delivering transformational therapies to people living with devastating diseases: cancer immunotherapy Commercializing our chronic hepatitis delta (CHD) combination therapy will drive near-term revenue sustainability Accelerating our masked T-cell engager (TCE) immunotherapy portfolio offers key value inflection points Aiming Vir Bio's discovery engine at developing a robust pipeline of cancer immunotherapies creates sustainable long-term growth 2026 Vir Biotechnology, Inc. 23 Strategic Collaborations Selectively partner drug candidates to focus internal resources, unlock the value of our pipeline and maximize benefit to patients
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T-cell engagers (TCEs) are a powerful modality in cancer therapy Our masked TCEs act like Trojan Horses, powered by the PRO-XTEN® platform 24 Clinically validated, used on a blockbuster drug for hemophilia A 2 2026 Vir Biotechnology, Inc. TCE Designed to reduce toxicity, enabling higher dosing and wider therapeutic window The PRO-XTEN® masking platform Our masked TCEs act like Trojan Horses, designed to maximize therapeutic index Universal, plug-and-play platform enables acceleration of next generation of drug candidates Longer drug half-life supports optimization of dosing schedules • 10 TCE breakthrough immunotherapies already on the market1 • Application in solid tumors limited due to toxicity and off- tumor activation • Masking ensures TCEs are only activated in the tumor microenvironment Non-masked TCEs hold tremendous potential, limited by toxicity 1 Glaser, A., Kochanowski, K., Oh, D., Porritt, R. A., & Kim, H. (2024). T cell engagers emerge as a compelling therapeutic strategy for solid tumors. Journal of Experimental Medicine 2 ALTUVIIIO® [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] is marketed for hemophilia A and is a registered trademark of Sanofi Q3W: once every three weeks Masks cleaved off by the proteases in the tumor microenvironment
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Our unique pipeline of TCEs is enabled by the PRO-XTEN® masking platform Allows our TCEs to overcome challenges of unmasked and single-masked TCEs 252026 Vir Biotechnology, Inc. TCE Tumor-binding domain Variable region binds tumor-associated antigen T-cell-binding domain Variable region binds CD3 to recruit T- cells PRO-XTEN® mask XTEN masks off-tumor activity of the TCE and prolongs half-life Cleavable linkers Proteases in the TME selectively cleave linkers to release masks Shields the TCE, expanding potential in cancer therapy CD3: cluster of differentiation; TCE: T-cell engager; TME: tumor microenvironment
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Presented February 2026 Phase 1 Clinical Data: VIR-5500 (PSMA) 262026 Vir Biotechnology, Inc.
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Landmark strategic collaboration with Astellas maximizes potential of VIR-5500 in prostate cancer Collaboration pairs Astellas’ world class capabilities in prostate cancer with Vir Bio’s potential best-in-class T-cell engager VIR-5500, powered by PRO-XTEN® masking technology i $1.7B in upfront payments and milestones1 50/50 profit/loss share in the U.S. Co-promote option for Vir Bio 40/60 Vir Bio / Astellas global development cost share2 Tiered, double-digit royalties on ex-U.S. net sales Positions Vir Bio to accelerate clinical development of VIR-5500 into pivotal trials in 2027 1 Amounts shown exclude payments to third parties. Sanofi is entitled to 20% of certain collaboration proceeds, including: upfront and the portion of milestones, profit share & royalties that exceed the amounts already owed to Sanofi under the terms of the existing Sanofi agreement, effective September 9, 2024. 2 R&D cost share: Global studies Vir Bio 40% & Astellas 60%; U.S.-specific studies Vir Bio 50% & Astellas 50%; ex-U.S.-specific studies Astellas 100% 272026 Vir Biotechnology, Inc. VIR-5500 (PSMA)
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Collaboration summary: accelerates development, access to expertise and delivers attractive economics1 282026 Vir Biotechnology, Inc. Scope Global development and commercialization collaboration for VIR-5500 in prostate cancer Commercial rights U.S. commercialization based on 50/50 profit share Vir Bio option to U.S. co-promote Ex-U.S. Astellas has exclusive rights to commercialize Global development cost share 40 / 60 global development cost share (Vir Bio / Astellas)4 Upfront and near-term payments2 $240M in upfront cash and $75M from equity3 $20M near-term milestone payment2 $335M combined upfront and near-term payments Additional milestones Up to $1.37B in additional development, regulatory and ex-U.S. sales milestones Royalties Tiered double-digit royalties on ex-U.S. net sales 1 Amounts shown exclude payments to third parties. Sanofi is entitled to 20% of certain collaboration proceeds, including: upfront cash payment and the portion of milestones, profit share & royalties that exceed the amounts already owed to Sanofi under the terms of the existing Sanofi agreement, effective September 9, 2024. 2 Near-term milestone represents a $20M manufacturing technology transfer payment, anticipated in the second quarter or third quarter of 2027. 3 Equity investment at $10.36 per share. 4 R&D cost share: Global studies Vir Bio 40% & Astellas 60%; U.S.-specific studies Vir Bio 50% & Astellas 50%; ex-U.S.-specific studies Astellas 100%
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VIR-5500 monotherapy study of PSMA-targeted PRO-XTEN® dual-masked TCE in prostate cancer 292026 Vir Biotechnology, Inc. All dose escalation cohorts have cleared DLT (N=58) VIR-5500 (PSMA) No requirement of prophylactic steroids or IL-6 therapy except for exploratory analysis in high dose cohort (n=3) Eligibility criteria: • Documented progressive metastatic CRPC • ≥ 1 prior taxane regimen • ≥ 1 prior ARPI • 0 to 1 ECOG status • Life expectancy >6 months 60 µg/kg (N=3) 120 180 180 µg/kg (N=4) 300 600 1000 µg/kg (N=4) 500 1000 2000 µg/kg (N=3) 30 µg/kg (N=3) 200 300 400 µg/kg (N=5) 1000 2000 3000 µg/kg (N=4) QW dose escalation (N=26) Q3W dose escalation (N=32) 300 600 1000 µg/kg (N=6) 500 1000 2000 µg/kg (N=4) 1000 2000 3000 µg/kg (N=5) 800 2000 3500 µg/kg (n=9) 1000 2000 4000 µg/kg w/ Prophylactic Steroids (N=3) 800 1500 3000 µg/kg (N=5) ARPI: androgen receptor pathway inhibitor; CRPC: castration-resistant prostate cancer; DLT; dose limiting toxicities; ECOG; Eastern Cooperative Oncology Group; PSMA: prostate-specific membrane antigen; QW: once weekly; Q3W: once every 3 weeks; TCE: T-Cell Engager VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05356741 Data as of: January 9, 2026
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Late-line mCRPC population including patients with liver metastases VIR-5500 (PSMA) 302026 Vir Biotechnology, Inc. Median age, years (range) 68 (49-81) Prior lines of therapy (Any Setting) Number, Median (Min, Max) Prior Taxane, n (%) Prior ARPI, n (%) Prior PSMA-radioligand therapy a, n (%) 4 (2, 7) 55 (94.8) 58 (100) 7 (12.1) Baseline Central PSA, ng/mL Median (min, max) 79 (4, 3708) Disease Characteristics RECIST-evaluable b, n (%) Bone metastases, n (%) Lymph node metastases, n (%) Visceral metastases c, n (%) Liver metastases, n (%) 30 (51.7) 52 (92.9) 18 (32.1) 25 (44.6) 10 (17.9) VIR-5500 baseline characteristics NCT05997615 VIR-5500 N=58 a 4 of 7 Prior PSMA-radioligand therapy treated patients received VIR-5500 doses ≤ 120 µg/kg. b RECIST-evaluable population is defined as having measurable disease documented at baseline according to RECIST v1.1 criteria and at least one follow- up tumor assessment after a full cycle of treatment c Visceral metastases include site of lesions in lung, adrenal and liver. Max: maximum; mCRPC; metastatic castration-resistant prostate cancer; Min: minimum; N: number of participants; PSA: prostate-specific antigen; PSMA: prostate-specific membrane antigen; RECIST: Response Evaluation Criteria in Solid Tumors; STEAP1: Six-transmembrane epithelial antigen of the prostate 1; TCE: T Cell Engager VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 Study & enrollment details: Heavily pre-treated participants: • Median 4 prior lines of therapy • 95% prior taxanes in any setting* • 12% prior PSMA-radioligand therapy (mostly in low dose cohorts) • 2 with prior STEAP1 TCE Significant disease burden in all cohorts: • 93% of subjects with bone metastases • 45% visceral metastases o 18% liver metastases (poor prognosis) *Participants who were deemed clinically unsuitable to be treated with a taxane regimen or have refused treatment with a taxane regimen are considered eligible.
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VIR-5500 Phase 1 study shows favorable safety profile with meaningful anti-tumor activity VIR-5500 (PSMA) 312026 Vir Biotechnology, Inc. Well tolerated with no dose limiting toxicities Dose-dependent and meaningful anti-tumor activity CRS All Grades 59% (13/22) Grade 1 50% (11/22) Grade 2 9% (2/22) Grade 3 0 PSA Response PSA50 82% (14/17) PSA90 53% (9/17) PSA99 29% (5/17) • Emerging evidence of durable PSA50, PSA90 and RECIST responses Early signs of PSA and radiographic durability ≥3,000 µg/kg Q3W • 12% Grade ≥ 3 TRAEs • Limited CRS 50% (29/58) primarily seen in first cycle and mostly Grade 1 (Fever Only) • No DLTs • Clear dose-response relationship with deeper PSA declines observed with higher doses • 45% (5/11) ORR of RECIST-evaluable* patients (Q3W ≥3,000 µg/kg) • 4 patients confirmed up to Week 27 • 1 patient pending confirmation Safety evaluable population is defined as all enrolled participants who have received at least one dose of VIR-5500. PSA evaluable population is defined as participants who received ≥1 cycle of VIR-5500 and must have at least one pre- treatment and at least one post-treatment PSA measurement. PSA 50, PSA decline of 50%-100% from baseline; PSA90, PSA decline of 90%-100% from baseline; PSA99, PSA decline of 99%-100% from baseline *RECIST-evaluable population is defined as having measurable disease documented at baseline according to RECIST v1.1 criteria and at least one follow-up tumor assessment after a full cycle of treatment CRS: cytokine release syndrome; DLT: dose limiting toxicities;G3+: Grade ≥ 3; ORR; objective response rate; PSA: prostate-specific antigen;Q3W; once every 3 weeks; RECIST: Response Evaluation Criteria in Solid Tumors; TRAE: treatment related adverse event VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9,2026
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Case Study 1: complete resolution of multiple (>14) liver lesions at Week 9; PSA99 322026 Vir Biotechnology, Inc. Case study detail • 63-year-old male • High disease burden: liver and bone lesions • 5 Prior Lines of Treatment: Docetaxel, Olaparib, Cabazitaxel, Abiaterone, MOMA-313-001 • uPR, 63% decrease in tumor diameter • Metabolic response of PSMA-avid bone and hepatic lesions • Patient bone pain resolved • Continues on treatment (Cycle 6) Q3W Cohort 800/1500/3000 µg/kg Baseline PSA 99 ng/mL Week 9 PSA 0.4 ng/mL PSMA-PET PSMA-PET Whole Body MRI Whole Body MRI 99% PSA Decline VIR-5500 (PSMA) PSA: prostate-specific antigen; PSMA: prostate-specific membrane antigen; Q3W: once every 3 weeks; uPR; unconfirmed partial response VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026
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Case Study 2: significant RECIST response in large liver lesions 332026 Vir Biotechnology, Inc. Case study detail • 75-year-old male • High disease burden; liver and lymph- nodes (no bone lesions) • 6 Prior Lines of Treatment: Enzalutamide, Docetaxel, Cabazitaxel, and NX-1607 • Confirmed PR, 46% decrease in tumor diameter • Disappearance of majority of PSMA-avid hepatic lesions • Continues on study (Cycle 10) PR: partial response; PSA: prostate-specific antigen; PSMA: prostate-specific membrane antigen; Q3W: once every 3 weeks; RECIST: Response Evaluation Criteria in Solid Tumors; VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 Q3W cohort 800/2000/3500 µg/kg Week 9 PSA 44 ng/mL Baseline PSA 403 ng/mL 2 lymph-node lesions, SLD changes: A) 2.1 to 2.0 cm; B) 2.7 to 1.7 cm 2 Liver Lesions SLD Changes: •6.3 to 3.1 cm •3.2 to 1.2 cm 94% Best PSA Decline VIR-5500 (PSMA)
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Case Study 3: durable RECIST, PSMA-PET and deep PSA response up to 8 months 342026 Vir Biotechnology, Inc. Case study detail • 70-year-old male with peritoneal and abdominal wall lesions • 3 Prior lines of Treatment: Enzalutamide, Docetaxel, Cabazitaxel • Confirmed PR, complete resolution of small lesions • Ongoing sustained PSA90 response at 8 months • Complete PSMA-PET response • Excellent Quality of life • Continues on study (Cycle 10) Week 9Baseline Week 18 Baseline Week 27 PSMA-PET CT/MRI Week 9 PET: positron emission tomography; PR: partial response; uPR: unconfirmed partial response; PSA: prostate-specific antigen; PSMA: prostate-specific membrane antigen; Q3W: once every 3 weeks; RECIST: Response Evaluation Criteria in Solid Tumors VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 Q3W cohort 800/2000/3500 µg/kg Week 9Baseline Week 18 CT/MRI PSA 15 ng/mL PSA 0.3 ng/mL PSA 0.1 ng/mL VIR-5500 (PSMA)
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Case Study 4: complete response in diffuse lesions with prior radioligand therapy 352026 Vir Biotechnology, Inc. LN, 40x mag PSMA membrane H-score 1401 100% tumor PSMA+ T cell abundance 0 PSMA H-score 0 No malignancy identified T cell abundance 4 Baseline Week 5 LN, 40x mag LN 10x mag LN, 10x mag Complete Response in Lymph Node Brown = PSMA+ tumor cells Pink = CD3 T cells Lymph Node Biopsy PSMA/CD3 Duplex IHC LN, 40x mag Week 9 PSA 0.05 ng/mL Baseline PSA 81 ng/mL Q3W Cohort 1000/2000/4000 µg/kg with Prophylactic Steroids Case Study Detail • 63-year-old male with lymph-node and bone lesions • 5 prior lines of Treatment including Enzalutamide, Docetaxel, TAS3681 AR antagonist, and RLT ( 225Ac-pelgifatama) • CR for target lesions and non-CR/non-PD for non-target bone lesions; PSA99 at Cycle 2 Day 1 (Week 4) • Excellent quality of life, with significant reduction in pain • Patient withdrew from the study on Cycle 5, while in remission since deriving significant benefit 99% PSA Decline PSMA PET PSMA PET AR: androgen receptor; CD3: cluster of differentiation 3; CR: complete response H-score: histo-score; IHC: immunohistochemistry; PD: progressive disease; PSA: prostate-specific antigen; PSMA: prostate-specific membrane antigen; Q3W: once every 3 weeks; RLT: radioligand therapy VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026
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Case Study 5: complete response with ~12 months of durability VIR-5500 (PSMA) 362026 Vir Biotechnology, Inc. 14-Jan-2025 3-Jun-2025 21-Oct-2025 0 20 40 60Local PSA (ng/mL) C1D1 C3D1 C5D1 C7D1 C9D1 C11D1 C13D1 C15D1 C17D1 9 Week Scans SD Baseline Scans 18 Week Scans SD 27 Week Scans CR (NTL) 39 Week Scans CR (NTL) Baseline Week 9 Baseline Week 9 Baseline Week 9 Week 18 Week 27 Case study detail • 77-year-old male • Significant disease burden including >20 bone lesions and positive lymph nodes • 4 prior lines of Treatment: • Darolutamide, Abiraterone, Olaparib, and Docetaxel • Complete Response per PCWG3 at Cycle 9/Week 27 • Significant PSA responder with PSA90 response starting at Cycle 3 Day 1 and PSA currently undetectable • Continues on treatment (Cycle 17) PSA 42 ng/mL PSA 0.6 ng/mL CR: complete response; NTL: non-target lesion; PCWG3: prostate cancer working group 3; PSA: prostate-specific antigen; Q3W: once every 3 weeks; SD: stable disease VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 Q3W cohort 300/600/1000 µg/kg
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Well-tolerated with favorable safety profile 12% grade ≥ 3 TRAEs, limited CRS, mostly grade 1 (Fever Only), and no DLTs 372026 Vir Biotechnology, Inc. TEAEs in any Participant n (%) (N=58) Any TEAE 58 (100) Related TEAE 50 (86.2) Serious Related TEAE 17 (29.3) Related Grade ≥ 3 TEAE# 7 (12.1) TEAE Leading to Treatment Discontinuation^ 2 (3.4) Treatment Related AEs (Most Frequent) in Doses ≥3,000 µg/kg Q3W (N=22) Preferred Term Grade 1 Grade 2 Grade ≥ 3 Participant with at least 1 TRAE 9 (41) 9 (41) 3(14)1 Cytokine Release Syndrome 11 (50) 2 (9) 0 Back Pain 3 (14) 2 (9) 0 Fatigue 3 (14) 2 (9) 0 Infusion Related Reaction 4 (18) 1 (5) 0 Anemia 1 (5) 3 (14) 0 Asthenia 4 (18) 0 0 Nausea 4 (18) 0 0 Blurred Vision 1 (5) 0 2 (9) 0 1 2 3 4 5 6 7 8 9 800/1500/3000 µg/kg (n=5) 1000/2000/3000 µg/kg (n=5) 800/2000/3500 µg/kg (n=9) 1000/2000/4000 µg/kg with C1 Steroid Prophylaxis^ (n=3) Grade 1 Grade 2 Grade ≥ 3 1 G3 Neutropenia (2), G3 Tumor Flare, G3 Bone Pain (2), G3 Lymphocyte Decrease; G3 Vision Blurred, G4 Vision Blurred Limited High-Grade Events and Tx Discontinuations Low Grade CRS in Doses ≥3,000 µg/kg Q3W (N=22) Limited transaminase elevation Very Low incidence of hypoacusis, xerostomia, dry eye, stomatitis or dysgeusia; Grade 1 only1 No DLTs* No ICANS * Two blurred vision events at the 4,000 ug/kg dose were reviewed and incorporated into dose-escalation considerations and ongoing study conduct ^ 4-8 mg of Dexamethasone premedication in cycle 1 evaluated in 1000-2000-4000 ug/kg Q3W cohort. 1 Grade 1 events: Dry Mouth/Xerostomia (4), Dry Eye (2), Hypoacusis (5), Stomatitis (1), Dysgeusia (1), Renal toxicities (2); as well as 3 unrelated SAEs of Acute Kidney Injury and Hematuria AE: adverse event; C1: cycle one; CRS: cytokine release syndrome; DLT: dose limiting toxicities; ICANS: immune effector cell- associated neurotoxicity syndrome; Q3W: once every 3 weeks; TEAE: treatment emergent adverse event VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 No requirement of prophylactic steroids or IL-6 therapy except for exploratory analysis in high dose cohort (n=3) Participants with CRS (n) No Prophylactic Steroids or Anti-IL-6 # Related Grade ≥ 3 TEAE: AST increased, neutrophil count decreased, WBC count decreased, cytokine release syndrome (in participant at 200-300-400 ug/kg undergoing intraparticipant dose escalation), tumor flare/arthralgia, neutropenia, blurred vision, lymphocyte count decreased, bone pain ^ One unrelated spinal cord compression requiring radiation therapy and one Grade 4 treatment- related blurred vision event that improved, with unclear pathophysiology & non-specific MRI findings.
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Dose response relationship: deeper PSA declines and confirmed PSA responses at higher doses VIR-5500 (PSMA) 382026 Vir Biotechnology, Inc. 1 Prior Radioligand therapy 2 Prior STEAP1 TCE # PCWG3 (Prostate Cancer Working Group 3) measured PSA rise or fall at ≥C2D1. Y-axis truncated at 100. All Best PSA %Changes occurred prior to intra-patient dose escalation ^ CRS event grade at dose indicated, prior to any intra-patient dose escalation C1: cycle one; PSA: prostate-specific antigen VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 0 1 2^CRS Grade Confirmed PSA Response at ≥ 3 weeks * -100 -50 0 50 100PSA Best % Change from Baseline (PCWG3)# 30 μg/kg QW 60 μg/kg QW 200/300/400 μg/kg QW PSA50 PSA90 300/600/1000 μg/kg QW 120/180/180 μg/kg QW 500/1000/2000 μg/kg QW 500/1000/2000 μg/kg Q3W 1000/2000/3000 μg/kg QW 300/600/1000 μg/kg Q3W 1000/2000/3000 μg/kg Q3W 800/2000/3500 μg/kg Q3W 1000/2000/4000 μg/kg Q3W (+C1 Steroid Prophylaxis) 800/1500/3000 μg/kg Q3W * * * * * * * * * * * * * * * ** * * * * * * 1 22 1 11
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Deep PSA declines observed as early as Cycle 1 Day 8, evidence of concordant RECIST responses in evaluable patients Doses ≥ 3000 ug/kg Q3W VIR-5500 (PSMA) -100 -75 -50 -25 0 25 50 75 100 PSA Best % Change from Baseline (PCWG3)^ PSA50 PSA90 1000/2000/3000 μg/kg Q3W 1000/2000/4000 μg/kg Q3W (+C1 Steroid Prophylaxis) 800/2000/3500 μg/kg Q3W 800/1500/3000 μg/kg Q3W * *** *** * * * ** * 392026 Vir Biotechnology, Inc. Significant Anti-tumor Responses: • Rapid and deep responses as soon as Cycle 1 Day 8 • Participants with the deepest PSA responses (PSA 90 & PSA99) often had confirmed RECIST responses Any PSA Decline 15/17 (88%) PSA50 14/17 (82%) PSA90 9/17 (53%) PSA99 5/17 (29%) ≥ 3000 µg/kg Q3W PSA50, PSA decline of 50%-100% from baseline; PSA90, PSA decline of 90%-100% from baseline; PSA99, PSA decline of 99%-100% from baseline Evaluable participants who received ≥1 cycle of VIR-5500 PCWG3 measured PSA at ≥C2D1. Y-axis truncated at 100 VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 0 1 2CRS Grade Visceral Mets2 RECIST Response CRS GradePD PD SD PD SD PD NM NM NM cPR cPR NM NM NM cPR uPR1 cCR + + + - - + - - - + + - - - + + - Confirmed PSA Response at ≥ 3 weeks * 1 Week 18 visit pending for RECIST confirmation 2 Visceral metastases include site of lesions in lung, adrenal and liver 3 Prior Radioligand therapy C1: cycle one; cCR: confirmed complete response; cPR: confirmed partial response; CRS: cytokine release syndrome; NM: non-measurable disease; PD: progressive disease; PR: partial response; PSA: prostate-specific antigen; Q3W: once every 3 weeks; RECIST: Response Evaluation Criteria in Solid Tumors; SD: stable disease; uPR: unconfirmed partial response 3
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Reduction in PSMA total tumor volume by central PSMA PET analysis, RECIP responses associated with deep PSA declines and RECIST responses Doses ≥ 3000 ug/kg Q3W 402026 Vir Biotechnology, Inc. Complete Response Partial Response Stable Disease Progressive Disease RECIP 1.0 Classification PSA99 PSA90 PSA50 PSA 0-50% decrease PSA Increase Best PSA Response RECIP Response PSA Response RECIST ResponsePD PD NM cPR PD NM NM cPR SD cPR uPR* cCR NM Imaging performed at baseline and at 9 weeks, or EOT, whichever comes first. PSMA-Total Tumor Volume is the sum of all PSMA-avid lesions (bone and soft tissue) in cubic centimeters. https://pubmed.ncbi.nlm.nih.gov/40473460/ Y-axis truncated at 100% C1: cycle one; cCR: confirmed complete response; cPR: confirmed partial response; EOT: end of treatment; NM: non-measurable disease; PD: progressive disease; PET: positron emission tomography; PSA: prostate-specific antigen; PSMA; prostate-specific membrane antigen; Q3W: once every 3 weeks; RECIP: Response Evaluation Criteria in PSMA; RECIST: Response Evaluation Criteria in Solid Tumors; SD: stable disease; uPR: unconfirmed partial response -100 -50 0 50 100 % Change in PSMA Total Tumor Volume (PSMA-PET) 800/2000/3500 μg/kg Q3W 1000/2000/3000 μg/kg Q3W 1000/2000/4000 μg/kg Q3W (+C1 Steroid Prophylaxis) 800/1500/3000 μg/kg Q3W -30 1 Prior Radioligand therapy 1
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Robust RECIST responses with VIR-5500 monotherapy in RECIST-evaluable participants Doses ≥ 3000 ug/kg Q3W VIR-5500 (PSMA) -80 -60 -40 -20 0 20 40 60 80 100 -62.80-62.50-59.70 -48.70-46.00 -16.40 -11.36-10.90 0.00 26.70 71.43 Best Change from Baseline in RECIST SLD (%) 1000/2000/3000 μg/kg Q3W PSA50 PSA90 800/2000/3500 μg/kg Q3W 1000/2000/4000 μg/kg Q3W (+C1 Steroid Prophylaxis) 800/1500/3000 μg/kg Q3W Measurable Lesion Site Liver Liver, Adrenal Adrenal gland Liver, Abdom wall Lymph nodes Lymph node Liver, LN Lymph Nodes Peritoneal implants Lymph node Liver Best Overall Response PD PD PD (new lesions) SD SD PD (new lesions) cPR cPR cPR cCR uPR (Wk 18 pending) PSMA PET Response (SUVmax) Not available -79.6% 8.3 -78% -64.1% -22.6% -89.7% -95% -81% -88.2% -97.3% 412026 Vir Biotechnology, Inc. ORR 45% (5/11)* DCR 64% (7/11) * 4 patients with confirmed responses and 1 patient pending confirmation Imaging performed every 9 weeks Baseline Assessment: patient must have measurable disease per RECIST criteria at baseline Post-Baseline Assessment: at least one follow-up tumor assessment after starting treatment is required to determine response (CR, PR, SD, PD) C1: cycle one; cCR: confirmed complete response; cPR: confirmed partial response; DCR: Disease Control Rate (includes SD+PR+CR); NM: non- measurable disease; ORR: objective response rate; PD: progressive disease; PET: positron emission tomography; PR: partial response; PSA: prostate- specific antigen; PSMA: prostate-specific membrane antigen; Q3W: once every 3 weeks; RECIST: Response Evaluation Criteria in Solid Tumors; SD: stable disease; SLD: sum of longest diameters; QW: once weekly; PD: progressive disease; uPR: unconfirmed partial response 1 Prior Radioligand therapy 1
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RECIST responses concordant with deep PSA responses Doses ≥ 3000 ug/kg Q3W VIR-5500 (PSMA) -80 -60 -40 -20 0 20 40 60 80 Months since first treatment % Change from Baseline (RECIST SLD) 800/1500/3000 μg/kg Q3W 800/2000/3500 μg/kg Q3W 1000/2000/3000 μg/kg Q3W 1000/2000/4000 μg/kg Q3W (+ C1 Steroid Prophylaxis) 1 2 3 4 5 60 422026 Vir Biotechnology, Inc. cPR, PSA90 cCR, PSA90 cPR,PSA90cPR, PSA90 uPR*, PSA90 Initial Stable Disease followed by disease progression due to metastases to the liver and new bone metastases resulting in spinal fracture Progressive Disease with metastasis to liver and lungs leading to discontinuation; only received 3 cycles of treatment Progressive Disease with PSMA-negative lesions in the liver; only received 2 cycles of treatment PSA50 PSA50 PSA50 Ongoing Imaging performed every 9 weeks * Week18 visit pending C1: cycle one; cCR: confirmed complete response; cPR: confirmed partial response; ORR: objective response rate; PSA: prostate- specific antigen; PSMA: prostate-specific membrane antigen; Q3W: once every 3 weeks; RECIST: Response Evaluation Criteria in Solid Tumors; SLD: sum of longest diameters; uPR: unconfirmed partial response VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 Radiographic responses at efficacious Q3W dose levels • 45% (5/11) ORR in RECIST-evaluable patients • All evaluable responders achieved confirmed responses; 1 patient pending confirmation • Tumor shrinkage across multiple lesions and patients, providing evidence of effective T-cell engagement
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Emerging evidence of PSA and radiographic durability Doses ≥ 3000 ug/kg Q3W, CRS Restricted to Early Cycles VIR-5500 (PSMA) 432026 Vir Biotechnology, Inc. *101-1007: PSMA-positive brain lesions, early progressor, received 3 cycles of VIR-5500 ^101-1006: PSMA-negative liver lesions, early progressor, received 2 cycles of VIR-5500 cCR: confirmed complete response; cPR: confirmed partial response; CRS: cytokine release syndrome; G1: Grade 1; G2: Grade 2; PSA: prostate-specific antigen; Q3W: once every 3 weeks; uPR: unconfirmed partial response VIR-5500-V101 ClinicalTrials.gov Identifier: NCT05997615. Data as of: January 9, 2026 0 2 4 6 8 10 Months * ^ Time on Treatment Ongoing PSA50 PSA90 uPR cPR cCR G1 CRS G2 CRS 800 / 1500 / 3000 µg/kg 1000 / 2000 / 3000 µg/kg 800 / 2000 / 3500 µg/kg 1000 / 2000 / 4000 µg/kg
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Next steps for VIR-5500: rapid advancement into earlier treatment setting in prostate cancer 442026 Vir Biotechnology, Inc. QW: once weekly; Q3W: once every 3 weeks; mCRPC: metastatic castration-resistant prostate cancer; mHSPC: metastatic hormone-sensitive prostate cancer; RLT: radioligand therapy VIR-5500 (PSMA) Plans to initiate Phase 3 program in 2027 Monotherapy VIR-5500 Expansion Cohorts Q3W 800/2000/3500 µg/kg Taxane naïve mCRPC RLT-exposed mCRPC RLT-naïve mCRPC Currently enrolling Combination Therapy VIR-5500 + enzalutamide in taxane naïve mCRPC VIR-5500 + darolutamide in mHSPC VIR-5500 + docetaxel in taxane naïve mCRPC Currently enrolling Currently enrolling Currently enrolling
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Our clinical pipeline of masked TCEs demonstrates promise of the PRO-XTEN® platform 452026 Vir Biotechnology, Inc. PRO-XTEN® universal masking platform allows us to rapidly expand into other solid tumors with high unmet need 7 preclinical programs across solid tumors, including lung, colorectal and bladder cancers Progressing to development candidate selection by early 2027 The most advanced dual- masked TCE in clinical development for prostate cancer Well-tolerated with favorable safety profile Potent anti-tumor activity Potential to move into earlier treatment settings and initiate pivotal trials in 2027 The only dual-masked TCE in clinical development for HER2 tumors PD-1 combination dose escalation ongoing Phase 1 dose escalation data in 2H’26 PRO-XTEN® dual-masked TCE in clinical development for EGFR tumors (NSCLC, CRC, HNSCC and cSCC) Phase 1 evaluating monotherapy and in combination with pembrolizumab ongoing Phase 1 initial dose escalation data TBD VIR-5500 (PSMA) VIR-5818 (HER2) VIR-5525 (EGFR) 7 Preclinical Programs CRC: colorectal cancer; EGFR: epidermal growth factor receptor; HER2: human epidermal growth factor receptor 2; HNSCC: head and neck squamous cell carcinoma; NSCLC: non-small cell lung cancer; cSCC: cutaneous squamous cell carcinoma; PSMA: prostate-specific membrane antigen; TCE: T-cell engager TCE
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Financials and Closing 462026 Vir Biotechnology, Inc.
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Q2 2026 Financial Results 472026 Vir Biotechnology, Inc. Three Months Ended June 30, $ in millions 2026 2025 Change % Total revenues $238.9 $1.2 $237.7 19808% Operating expenses: Research and development (1) 135.3 97.5 37.8 39% Selling, general and administrative (1) 30.2 22.3 7.9 35% Restructuring, long-lived assets impairment and related charges, net — (0.2) 0.2 (100%) Total operating expenses 165.5 119.6 45.9 38% Income (loss) from operations 73.5 (118.4) 191.9 162% Total other income 6.8 7.6 (0.8) (11%) Provision for income taxes (0.2) (0.2) — —% Net income (loss) $80.1 $(111.0) $191.1 172% (1) Amount includes stock-based compensation expenses as follows: Research and development $5.5 $6.9 $(1.4) (20%) Selling, general and administrative 6.9 5.5 1.4 25% Total stock-based compensation expense $12.4 $12.5 $(0.1) (1%) Ending headcount (full-time & part-time) 362 381 (19) (5%) Note: Numbers may not add due to rounding.
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Our strategic approach creates short and long-term value drivers chronic hepatitis delta ECLIPSE 1 topline data in 4Q’26 ECLIPSE 2 & 3 topline data in 1Q’27 universal masked TCEs VIR-5500 PSMA pivotal trials to initiate in 2027 VIR-5818 HER2 data update 2H’26 discovery engine 7 preclinical PRO-XTEN® TCE targets identified Progressing to development candidate selection by early 2027 Strategic Collaborations Selectively partner drug candidates to focus internal resources, unlock the value of our pipeline and maximize benefit to patients 2026 Vir Biotechnology, Inc. 48 Financial Highlights $1.01B cash and investments1 with cash runway into 2H 20282 1 Vir Bio reported cash, cash equivalents and investments of $1.01 billion as of June 30, 2026. Amount includes $315 million combined upfront and equity investment from Astellas collaboration received in the second quarter of 2026. 2 Cash runway projection based on the current operating plan and incorporating the effects of the Astellas collaboration agreement.
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PATIENTS ARE WAITING 2026 Vir Biotechnology, Inc. 2026 Vir Biotechnology, Inc. 49
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Presented January 2025 Phase 1 Clinical Data: VIR-5818 (HER2) 502026 Vir Biotechnology, Inc.
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The first clinical stage masked HER2 TCE in ongoing Phase 1 512026 Vir Biotechnology, Inc. VIR-5818 (HER2) Part 1: Monotherapy Dose Escalation - Completed Part 2: Pembrolizumab Combination 200 µg/kg 100 200 400 µg/kg 100 300 800 µg/kg1 100 300 1000 µg/kg 1 µg/kg 100 250 600 µg/kg Recommended expansion dose and schedule Eligibility: HER2 IHC2-3+, ISH+, or mutant Exhausted all SOC 79 patients enrolled Evaluating QW and Q3W Demonstrates wide safety margin Cleared DLT Currently Evaluating VIR-5818 QW and Q3W Currently enrolling Analysis ongoing Pembrolizumab Q3W 200 mg + 1 Evaluating 800 µg/kg Q3W maintenance dose (cycle ≥ 2) in parallel HER2: human epidermal growth factor receptor 2; IHC: immunohistochemistry; ISH: in situ hybridization;QW: once weekly; Q3W: once every 3 weeks; SOC: standard of care; TCE: T-cell engager VIR-5818 ClinicalTrials.gov Identifier: NCT05356741; Data cutoff: November 11, 2024
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Minimal unmasked TCE in circulation and potential for Q3W dosing 522026 Vir Biotechnology, Inc. VIR-5818 (HER2) 0 7 14 21 0.01 0.1 1 10 100 1000 Nominal Time, Days Plasma Concentration, nM VIR-5818 PK, First DoseVIR-5818 and uTCE PK, First Cycle* Minimal unmasked TCE outside the tumor Low levels of uTCE in circulation, consistent with minimal CRS Linear and dose proportional PK * All patients with PK data in step-up cohorts with 100 µg/kg starting dose CRS: cytokine release syndrome; PK: pharmacokinetic; Q3W: once every 3 weeks; QW: once weekly; TCE: T-cell engager; uTCE: unmasked T cell engager Half-life of ~ 6 days unlocks potential Q3W dosing
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Preliminary safety data indicates VIR-5818 is not dose-limited by CRS 532026 Vir Biotechnology, Inc. VIR-5818 (HER2) Highly Tolerable Safety VIR-5818 N = 79 Grade 1 N (%) Grade 2 N (%) Grade ≥ 3 N (%) Any TRAE 15 (19.0) 35 (44.3) 13 (16.5) Pneumonitis* 16 (20.3) 9 (11.4) 2 (2.5)* CRS 16 (20.3) 8 (10.1) 0 Nausea 12 (15.2) 8 (10.1) 0 Asthenia 12 (15.2) 6 (7.6) 1 (1.3) Diarrhoea 14 (17.7) 5 (6.3) 0 Pruritus 13 (16.5) 1 (1.3) 0 Vomiting 8 (10.1) 6 (7.6) 0 TRAE (max grade) in >15% of pts Low Cytokine Levels, Even at Higher Doses Peaks of IL-6 Secretion Post VIR-5818 Dosing IL-6 release significantly lower than for unmasked TCEs, despite higher VIR-5818 dose 100 μg/kg IL-6 peaks for unmasked TCE 400 μg/kg 600 μg/kg 800 μg/kg 1000 μg/kg Third Dose (final step-up)First Dose Peak IL-6 with GBR1302 (unmasked HER2 TCE)1 1 Wermke et al., ASCO-SITC 2018 *Two cases of G3 pneumonitis include one event reversible with treatment and one confounded by rapid progression of pulmonary disease CRS: cytokine release syndrome; IL-6: interleukin-6; TCE: T-cell engager; TRAE, treatment-related adverse event VIR-5818 ClinicalTrials.gov Identifier: NCT05356741; Data cutoff: November 11, 2024
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Notable tumor shrinkage observed during dose escalation 542026 Vir Biotechnology, Inc. VIR-5818 (HER2) *Includes cPR, uPR, and mixed responses Note: HER2+ defined as IHC3+ or ISH+ BC: breast cancer; CCA: cholangiocarcinoma; cPR: confirmed partial response; CRC: colorectal cancer; DCR: disease control rate; GEJ: gastroesophageal junction; HER2: human epidermal growth factor receptor 2; IHC: immunohistochemistry; ISH: in situ hybridization; OC: ovarian cancer; PAAD: pancreatic adenocarcinoma; QW: once weekly; Q3W: once every 3 weeks; RECIST: Response evaluation criteria in solid tumors; SCCAC: squamous cell carcinoma of the anal canal; SLD: sum of longest diameters; uPR: unconfirmed partial response VIR-5818 ClinicalTrials.gov Identifier: NCT05356741; Data cutoff: November 11, 2024 HER2+ Solid Tumors (Doses ≥ 400 µg/kg) Breast cancer patient case study 7 No of prior lines 3 7 3 4 4 4 2 3 6 5 1 3 3 1 1 4 1 4 6 9 Liver metastases Efficacy detail: • ≥ 400 µg/kg drive significant RECIST responses o Dose escalation continues in QW and Q3W regimens • 50% observed tumor shrinkage (10/20 patients), with a DCR of 65% o 4/20 responses to date* o Responses in patients with up to 9 prior lines o 14/20 with prior HER2 treatment
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A patient’s journey: dramatic response in advanced HER2+ breast cancer 552026 Vir Biotechnology, Inc. VIR-5818 (HER2) VIR-5818 Case Study Cycle 2 Day 8 Cycle 3 Day 8 Cycle 4 Day 1 Day 1 Baseline Cycle 1 Day 8 Cycle 2 Day 1 Tumor pain, inflammation HER2: human epidermal growth factor receptor 2 VIR-5818 ClinicalTrials.gov Identifier:NCT05356741; Data cutoff: November 11, 2024 Compelling activity in breast cancer patient by Cycle 1 with transformative clearance of tumor 9 prior lines of therapy, including Enhertu Dose: 100/300/1000 µg/kg Well-tolerated 52% tumor shrinkage from baseline
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HER2+ Colorectal Cancer (All Patients Shown are MSS) Deep responses at early doses in MSS colorectal cancer, a tumor type traditionally resistant to immunotherapy 562026 Vir Biotechnology, Inc. VIR-5818 (HER2) Early Phase 1 efficacy No. of Prior Lines 1 3 4 6 3 4 6 4 6 Case to be discussed by Dr.Tabernero Activity HER2+ CRC ≥400 µg/kg cPR 2/6 (33%) CEA Response* 3/3 (100%) DCR1 5/6 (83%) • 33% response and 100% biomarker response in mCRC • Up to 18.1 months duration of response (pt remains on study) • Significant room to dose escalate; potential for Q3W dosing Note: HER2+ defined as IHC3+ or ISH+ * CEA response defined as >50% decrease in CEA post-treatment. Denominator includes all pts with longitudinal data 1 DCR defined as stable disease or better CEA: carcinoembryonic antigen; cPR: confirmed partial response; CRC: colorectal cancer; DCR: disease control rate; HER2: human epidermal growth factor receptor 2; IHC: immunohistochemistry; ISH: in situ hybridization; MSS: microsatellite stability; SLD: sum of longest diameters VIR-5818 ClinicalTrials.gov Identifier:NCT05356741; Data cutoff: November 11, 2024 Dose Levels 400 µg/kg 600 µg/kg 800 µg/kg 1000 µg/kg 100-300 µg/kg * CEA Response CRC patient case study
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Patient Case Study: 2 years on treatment, exceptional durability 572026 Vir Biotechnology, Inc. VIR-5818 (HER2) Rapid and Sustained Decrease Over Time Rapid and sustained CEA decrease with deeper tumor shrinkage when dose escalates CEA: carcinoembryonic antigen; cPR: confirmed partial response; IHC: immunohistochemistry; MSS: microsatellite stability; QW: weekly; SLD: sum of longest diameters; TMB: tumor mutational burden VIR-5818 ClinicalTrials.gov Identifier: NCT05356741; Data cutoff: November 11, 2024 -50 0 -20 -30 -40 -10 0 100 200 500 600 700300 400 Time from first dose (day) Change in SLD from Baseline (%) Dose Levels 200 µg/kg 300 µg/kg 600 µg/kg 60 µg/kg 120 µg/kg Change in Target Tumors Size from Baseline 0 100 200 600 700 800400300 500 Time from first dose (day) 100 200 300 400 500 600 700 800 900 0 Plasma CEA (ng/mL) 400 µg/kg 600 µg/kg 300 µg/kg 200 µg/kg 120 µg/kg 60 µg/kg Dose LevelsCEA 899 ng/mL CEA 112 ng/mL Rapid tumor marker decrease; tumor shrinkage seen 6-12 wks later cPR wk 64 @ 600 µg/kg Dose-Dependent Tumor Shrinkage • 57-Year-old male w/ colorectal cancer (MSS/TMB Low) • Status: remains on study (current dose: 600 µg/kg QW) • HER2 status: IHC 3+ • 6 prior lines including trastuzumab / tucatinib • Significant improvement on quality of life • 114 doses as of data cutoff, patient remains on study
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Molecular evidence of anti-tumor activity across multiple cancer types 582026 Vir Biotechnology, Inc. VIR-5818 (HER2) Molecular Responses: ctDNA (Step-up doses only)Percent Change from Baseline (%) CRC NSCLC BC Salivary CRC Rectum BC CRC BC CRC GEJ NSCLC GEJ -100 -50 0 50 100 Dose (µg/kg) 100 60 100 100 60 60 100 100 100 100 60 60 100 200 120 250 300 120 120 300 300 250 200 120 120 300 400 120 600 1000 300 200 800 1000 600 400 200 200 800 Detail: • High value of biomarkers for immunologics • RECIST responses may be confounded by tumor inflammation • With on-treatment ctDNA collection, VIR-5818 has molecular response for 54% subjects 1 • Now universally collecting ctDNA 1 Molecular response defined as >50% decline in overall ctDNA BC: breast cancer; CRC: colorectal cancer; ctDNA: circulating tumor DNA; GEJ: gastroesophageal junction; NSCLC: non-small-cell lung cancer; RECIST: Response evaluation criteria in solid tumors VIR-5818 ClinicalTrials.gov Identifier: NCT05356741; ctDNA data cutoff: November 19th, 2024; EDC data cutoff: November 11, 2024
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A potential first-in-class HER2 TCE designed to clinically validate the PRO-XTEN® platform 592026 Vir Biotechnology, Inc. VIR-5818 (HER2) 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, 16% all Gr3+ TRAEs • 33% response in heavily pre-treated CRC patients (≥400 µg/kg) • ctDNA Molecular response in 54% of subjects Proof of concept for PRO-XTEN® platform • Clear evidence of unmasking with antitumor activity Universal masks: mechanism designed to apply across platform • Potential rapid dose escalation for VIR-5500 (PSMA) and other targets CRC: colorectal cancer; CRS: cytokine release syndrome; ctDNA: circulating tumor DNA;Gr3: Grade 3; HER2: human epidermal growth factor receptor 2; PSMA: prostate-specific membrane antigen; TCE: T-cell engager; TI: therapeutic index; TRAE: treatment-related adverse event VIR-5818 ClinicalTrials.gov Identifier: NCT05356741; Data cutoff: November 11, 2024
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Phase 1 Clinical Program: VIR-5525 (EGFR) 602026 Vir Biotechnology, Inc.
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VIR-5525 Phase 1 study design: dose escalation and expansion 612026 Vir Biotechnology, Inc. VIR-5525 (EGFR) Part 1 & 2: Monotherapy Dose Escalation & Expansion Part 3 & 4: Pembrolizumab Combination Dose Escalation & Expansion Dose Escalation Continued Dose Escalation Continued Dose Escalation 3 µg/kg Continued Dose Escalation Highest Potential Dose Indications: NSCLC (nonsquamous or squamous histology), CRC, HNSCC, cSCC or have a solid tumor with EGFR amplification Eligibility Criteria: • ≥18 years old • Histological, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic • Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type • At least 1 measurable lesion per RECIST 1.1 • ECOG 0-1 Objectives: Primary: safety, tolerability, RP2D Secondary: • PK, PD, ADA • Radiographic response Cleared DLT Currently Evaluating VIR-5525 Planned Pembrolizumab+ ADA: anti-drug antibody; CRC: colorectal cancer; cSCC: cutaneous squamous cell carcinoma; ECOG: Eastern Cooperative Oncology Group; EGFR: epidermal growth factor receptor; HNSCC: head and neck squamous cell carcinoma; NSCLC: non-small cell lung cancer; PD: pharmacodynamics; PK: pharmacokinetics; Rp2D: recommended phase 2 dose; RECIST: Response Evaluation Criteria In Solid Tumors; TCE: T- cell engager Note: Step up dosing and additional schedules may be evaluated based on emerging clinical and PK data
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Preclinical data demonstrate potent activity and substantial safety margin with PRO-XTEN® masking 622026 Vir Biotechnology, Inc. Anti-tumor activity in vitro1 Tumor growth inhibition in vivo1 1 Cattaruzza, F., Nazeer, A., To, M. et al. Precision-activated T-cell engagers targeting HER2 or EGFR and CD3 mitigate on-target, off-tumor toxicity for immunotherapy in solid tumors. Nat Cancer 4, 485– 501 (2023). https://doi.org/10.1038/s43018-023-00536-9. ~250-fold safety margin data from IND filing analysis (>200-fold reported in Nature paper). 2 Adapted from Cattaruzza, F., Nazeer, A., Lange, Z., Hammond, M., Koski, C., Henkensiefken, A., & Schellenberger, V. (2020). HER2-XPAT and EGFR-XPAT: Pro-drug T-cell engagers (TCEs) engineered to address on-target, off-tumor toxicity with potent efficacy in vitro and in vivo and large safety margins in NHP. Cancer Research, 80(16_Supplement), 3376-3376. EGFR: epidermal growth factor receptor; EGFR uTCE: EGFR-targeted unmasked T-cell engager; mpk: milligrams per kilogram; NHP: non-human primate; TCE: T-cell engager Outside Tumor: masking is maintained, leading to ~10,000-fold shift in cytotoxicity In Tumor: similar anti-tumor activity in PRO-XTEN® masked vs. unmasked EGFR TCE PRO-XTEN® masked EGFR TCE enabled ~250-fold higher tolerated exposure in NHPs vs. unmasked TCE2 EGFR uTCE EGFR Masked TCE EGFR Masked TCE 1 mpk EGFR Masked TCE 2.5 mpk VIR-5525 (EGFR)