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1 January 14, 2025 J.P. Morgan 2025 Healthcare Conference Confidential © 2024 Vir Biotechnology, Inc.
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Legal disclaimer 2 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 tumor portfolio, preclinical pipeline and PRO-XTENTM masked TCE platform, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the therapeutic potential of Vir Biotechnology's CHD and CHB programs, 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; Vir Biotechnology's cash balance and anticipated cash runway; Vir Biotechnology's clinical development plans and expectations for its oncology and hepatitis programs, includingprotocols for and enrollment into ongoing and planned clinical trials, potential partnering opportunities, and data readouts and presentations, as well as anticipated timelines; the potential benefits, safety and efficacy ofVir 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 trials or in data readouts; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities; difficulties in obtaining regulatory approval; uncertainty as to whether the anticipated benefits of Vir Biotechnology's various collaborations can be achieved, including potential difficulties in collaborating with other companies that might be competitors of Vir Biotechnologyor otherwise have divergent interests; challenges in accessing manufacturing capacity; clinical site activation rates or clinical trial enrollment rates that are lower than expected;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 artificial intelligence and machine learning in its efforts to engineer next-generation proteins and in other research and development efforts; the timing and amount of actual expenses, including, without limitation, Vir Biotechnology'santicipated combined GAAP R&D and SG&A expenses;geopolitical changes or other external factors; and unexpected litigationor 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 asmall number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials 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 the Company’s actual results to differ from current expectations are discussed in the Company’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 takenas 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 arecautioned not to place undue reliance on the 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. This presentation discusses product candidates that are under clinical study, and which have not yet been approved for marketing by the US Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. Comparative Data Certain data in this presentation are based on cross-trial comparisons and are not based on any head-to-head clinical trials. Accordingly, no direct comparisons can be made. Cross-trial data interpretation should be considered with caution as it is inherently limited and may suggest similarities or differences in outcomes that may not be reflected in the actual results of any head-to-head studies, which may differ significantly from these comparisons. Differences exist between study or trial designs, patient populations, subject characteristics, and other factors, and caution should be exercised when comparing data across studies. See individual study publications for complete data and context. We have not independently verified the accuracy or completeness of the data included in publicly available study publications from other companies and make no representations as to the accuracy or completeness of such data. This presentation includes certain preliminary, estimated, and unaudited financial results as of January 1, 2025. Such preliminary estimated data constitute forward-looking statements based solely on information available to us as of the date of this presentation and may differ materially from actual results. This data should not be considered a substitute for the financial information to be filed with the SEC in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, once it becomes available. PRO-XTEN is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company 2025 Vir Biotechnology, Inc.
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32025 Vir Biotechnology, Inc. Our Vision: Powering The Immune System To Transform Lives
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We power the immune system to fight back against two related and formidable threats: cancer and viruses 2025 Vir Biotechnology, Inc. 4 Protecting us from cancer cells and viruses in normal conditions Cancer cells and viruses can evade the immune system, causing serious disease We power the immune system to fight back against cancer and infectious disease
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Leveraging Immune-Targeted Approaches to Transform Patient Care mNSCLC mCRC mHNSCC Others Potential HER2 tumors: mBC mCRC Others mCRPC Focused capital deployment: $1.1 billion cash and investments 2 (January 2025), cash runway into mid -2027 Oncology – Solid Tumors HER2 (Phase 1) PSMA (Phase 1) EGFR (Initiating Phase 1) Chronic suppressive treatment Pursuing functional cure Further HBV advancement contingent on securing a worldwide development and commercialization partner1 Infectious Disease Chronic Hepatitis B (Phase 2) Hepatitis Delta (Initiating Phase 3) 52025 Vir Biotechnology, Inc. HER2: human epidermal growth factor receptor 2; PSMA: prostate-specific membrane antigen; EGFR: epidermal growth factor receptor; mBC: metastatic breast cancer; mCRC: metastatic colorectal cancer; mCRPC: metastatic castration resistant prostrate cancer; mNSCLC: metastatic non-small cell lung cancer; mHNSCC: metastatic head and neck squamous cell carcinoma Resulting in 5 clinical programs across oncology and infectious disease 1Outside of Greater China (China, Hong Kong, Taiwan, Macau) where Brii Biosciences retains rights 2 We estimate our cash, cash equivalents, and investments to be approximately $1.1 billion as of January 1, 2025. This is a preliminary, estimated, and unaudited financial result. Actual results may differ from this estimate.
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In oncology, PRO-XTENTM masked TCEs have potential best-in-class therapeutic index and long-term durability 6PRO-XTEN is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company 2025 Vir Biotechnology, Inc. TME: tumor microenvironment; TCE: T Cell Engager; CD3: cluster of differentiation 3; TAA: tumor associated antigen; CRS: cytokine release syndrome; Q3W: once every 3 weeks Variable region binds CD3 to activate T-cells Proteases in the TME selectively cleave linkers to release mask Variable region binds tumor-associated antigen (TAA) Goal: achieve long-term, durable responses to a broad set of solid tumors Addressing the challenges of unmasked and single-masked TCEs: Maximize TI Less toxicity Longer half-life and Q3W dosing Clinically validated mask Universal masking platform PRO-XTEN Platform
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VIR-5818 (HER2) Phase 1 Case Study Compelling activity in breast cancer patient by Cycle 1 (dose up to 1000 µg/kg) 9 prior lines of therapy, including Enhertu Well-tolerated 52% tumor shrinkage from baseline 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 VIR-5818 (HER2) Study identifier: NCT05356741 data cutoff: November 11, 2024 TCE: T Cell Engager; HER2: human epidermal growth factor receptor 2; mBC: metastatic breast cancer; SLD: sum of longest diameters 72025 Vir Biotechnology, Inc. We have already seen dramatic patient responses with PRO-XTENTM masked TCEs in Phase 1 trials PRO-XTEN is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company
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HER2+ Colorectal Cancer (All Patients Shown are MSS) 8 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 HER2: human epidermal growth factor receptor 2; SLD: sum of longest diameters; cPR: confirmed partial response; CEA: carcinoembryonic antigen; DCR: disease control rate; IHC: Immunohistochemistry; ISH: In situ hybridization; MSS: microsatellite stability; CRC: colorectal cancer Study identifier: NCT05356741 Data cutoff: November 11, 2024 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 Disease control rate (DCR) defined as stable disease or better Dose Levels 400 µg/kg 600 µg/kg 800 µg/kg 1000 µg/kg 100-300 µg/kg * CEA Response VIR-5818 (HER2) 2025 Vir Biotechnology, Inc. For VIR-5818, we see deep responses at early doses in mCRC and other HER2 tumors
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9 VIR-5500 (PSMA) -100 -75 -50 -25 0 25 PSA Best % Change from Baseline 200/300/400 μg/kg QW PSA50 PSA90 300/600/1000 μg/kg QW 120/180/180 μg/kg QW PSA30 -100 -75 -50 -25 0 25 PSA Best % Change from Baseline (Any timepoint) 200/300/400 μg/kg QW PSA50 PSA90 300/600/1000 μg/kg QW 120/180/180 μg/kg QW PSA30 0 1 2 3 4 5CRS Grade Early Phase 1 responses: PSA Responses (1st dose ≥ 120 µg/kg) Any decline 12/12 (100%) PSA50 7/12 (58%) PSA90 1/12 (8%) • Early response across all 12 patients • No association with CRS , no IL-6 elevations • Tolerable safety profile • Significant room to dose escalate; potential for Q3W dosing Study identifier: NCT05997615 Data cutoff: November 13th, 2024 PSA: prostate-specific antigen; CRS: cytokine release syndrome; PSMA: prostate-specific membrane antigen; QW: once weekly 2025 Vir Biotechnology, Inc. PSA Responses (1st dose ≥ 120 ug/kg) With VIR-5500, our phase 1 data show strong PSA50 responses and tolerable safety at early doses
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PRO-XTENTM masked TCEs can expand the potential of T-cell engagers in cancer treatment 102025 Vir Biotechnology, Inc. Note: detailed clinical data shared during Jan 8th investor event HER2: human epidermal growth factor receptor 2; PSMA: prostate-specific membrane antigen; EGFR: epidermal growth factor receptor; CRS: cytokine release syndrome; Gr3: Grade 3; TRAEs: treatment related adverse events; Q3W: once every 3 weeks; TCE: T Cell Engager; PSA: prostrate specific antigen; CD3: cluster of differentiation 3 PRO-XTEN is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company 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, 50% tumor shrinkage in other HER2 tumors at early doses • Safety: no Gr3 CRS, and very low levels of ≥Gr3 TRAEs VIR-5500 (PSMAxCD3): The only dual-masked PSMA-targeted TCE, significant room to dose escalate including Q3W dosing • Efficacy: 100% PSA decline, 58% PSA50 responses at early doses • Safety: no Gr3 CRS, and very low levels of ≥Gr3 TRAEs PRO-XTENTM Masked TCEs Pipeline and Platform VIR-5525 (EGFRxCD3): Potential to unlock multiple high-value indications • Planned Phase 1 start in H1 2025 Universal masks are designed to be applied to new targets without the need for tailoring • Potential for rapid dose escalation, utilizing learnings from clinical assets PRO-XTEN Platform
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In infectious disease, we target Hepatitis Delta, which dramatically increases risk of death, cirrhosis, and cancer 112025 Vir Biotechnology, Inc. >50% 5 year 3x Average Progression to Cirrhosis and Liver Failure2 Risk of Liver Cancer (HCC) vs. HBV3 Liver-Related Death in 10 Years1 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. Stockdale A, et al. (2020). The global prevalence of hepatitis D virus infection: Systematic review and meta-analysis. J Hepatol, 73, 523-32. ~100,000 ~200,000 ~12M US Patients4 EU Patients4 Patients WW4 HDV
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122025 Vir Biotechnology, Inc. HDV Tobevibart + elebsiran combo has shown transformative virological responses in HDV in our ongoing P2 trial Tobevibart (mAb) + elebsiran (siRNA) combination therapy Key differentiators Similar efficacy in cirrhotic patients 4 Deep HDV antiviral responses 1 Continued deepening of response over time2 Lowers HBsAg levels, limiting HDV replication 3 Virologic Endpoint: HDV RNA <Target Not Detected (0 IU/mL)* 41% 64% 0% 20% 40% 60% 80% 100% Tobevibart + Elebsiran (24w) Tobevibart + Elebsiran (36w) 14/22 14/22 Participants (%) 13/32 12% 0% 20% 40% 60% 80% 100% Bulevirtide 2MG (48w) 6/49 P2: SOLSTICE P3: MYR 301 Bulevirtide QD (Gilead)Tobevibart + elebsiran Q4W de novo HDV: hepatitis delta virus; LLOQ: lower limit of quantification; Q4W: once every 4 weeks; QD: once daily; TND: target not detected. Data are reported for participants who completed the visit and had an HDV RNA measurement / ALT measurement or who discontinued treatment before the visit. HDV RNA TND = no detectable HDV RNA (0 IU/mL). Source: Wedemeyer, Heiner, et al. "A phase 3, randomized trial of bulevirtide in chronic hepatitis D." New England Journal of Medicine 389.1 (2023): 22-32. *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. See individual study publications for complete data and context.
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✓ FDA breakthrough designation ✓ FDA Fast Track We aim to establish a new standard of care in HDV, and ECLIPSE registrational clinical trials begin in H1 2025 132025 Vir Biotechnology, Inc. ECLIPSE 1 – Phase 3 HDV RNA LLOQ, TND + ALT normalization at week 48 tobevibart + elebsiran vs. deferred treatment (n=120, 2:1) ECLIPSE 2 – Phase 3 HDV RNA LLOQ, TND at week 24 tobevibart + elebsiran vs. bulevirtide switch* (n=150, 2:1) ECLIPSE 3 – Phase 2b HDV RNA LLOQ, TND at week 48 tobevibart + elebsiran vs. bulevirtide naïve (n=100, 2:1) Pivotal studies supporting marketing application in the U.S. and Europe Study supporting ex -U.S. pricing, reimbursement, and label expansion HDV *Defined as failure to achieve HDV RNA < 500 IU/mL with bulevirtide HDV: hepatitis D virus; ODD: orphan drug designation; LLOQ: lower limit of quantification; TND: target not detected; ALT: alanine aminotransferase; HDV RNA TND = no detectable HDV RNA (0 IU/mL) Supported by: ✓ EMA PRIME designation ✓ EMA ODD
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Financial Highlights Accelerate and Invest Partnership Programs Cash runway into mid-2027 ~$1.1 billion cash and investments 1 Hepatitis Delta Phase 3 starts H1’25 Masked TCEs VIR-5818 (HER2) VIR-5500 (PSMA) VIR-5525 (EGFR) Hepatitis B Functional cure data Q2’25 Further advancement is contingent on securing a worldwide development and commercialization partner 2 2025 Vir Biotechnology, Inc. HER2: human epidermal growth factor receptor 2; PSMA: prostate-specific membrane antigen; EGFR: epidermal growth factor receptor 14 1 We estimate our cash, cash equivalents, and investments to be approximately $1.1 billion as of January 1, 2025. This is a preliminary, estimated, and unaudited financial result. Actual results may differ from this estimate; 2 Outside of Greater China (China, Hong Kong, Taiwan, Macau) where Brii Biosciences retains rights. Clinical development is underpinned by strict financial discipline, enabling runway into mid-2027
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152025 Vir Biotechnology, Inc. Disease Area Product Candidate Goal Pre-clinical Phase 1 Phase 2 Phase 3 Approval Partner Accelerate and Invest Chronic Hepatitis Delta tobevibart ± elebsiran Treatment Alnylam (elebsiran only) Solid Tumors VIR-5818 (HER2)1 ± pembrolizumab Treatment Solid Tumors VIR-5500 (PSMA)1 Treatment Solid Tumors VIR-5525 (EGFR)1 Treatment Partnership Programs Chronic Hepatitis B tobevibart + elebsiran ± PEG-IFN-⍺2 Functional Cure Alnylam (elebsiran only) HIV Cure Preclinical antibody candidates Treatment Bill & Melinda Gates Foundation Solid Tumors Undisclosed PRO-XTENTM TCE targets Treatment AntibodysiRNA Masked TCE HIV: Human Immunodeficiency Virus; PEG-IFN-α: peg-interferon alfa-2a; mAb: monoclonal antibody; siRNA: small interfering RNA; HER2: human epidermal growth factor receptor 2; PSMA: prostate-specific membrane antigen; EGFR: epidermal growth factor receptor. Tobevibart incorporates Xencor’s XtendTM and other Fc technologies. PRO-XTEN is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company 1: Masked TCEs licensed from Sanofi 2: MARCH study (Part B) With multiple assets in oncology and infectious disease, we are well positioned for near-term value creation
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We anticipate multiple important near-term program catalysts 162025 Vir Biotechnology, Inc. Program Drug Candidates/Regimen Catalyst Timing Solid Tumors VIR-5818: dual-masked HER2xCD3 TCE VIR-5500: dual-masked PSMAxCD3 TCE Phase 1: initial monotherapy data Jan. 8th Hepatitis Delta tobevibart (mAb) + elebsiran (siRNA) ECLIPSE: registrational study start H1’25 Solid Tumors VIR-5525: dual-masked EGFRxCD3 TCE Phase 1: study start and first-in-human dose H1’25 Chronic Hepatitis B tobevibart (mAb) + elebsiran (siRNA) +/- PEG-IFN-⍺ MARCH-B Phase 2: 24-week post- treatment (functional cure) clinical data Q2’25 Solid Tumors VIR-5818: dual-masked HER2xCD3 TCE VIR-5500: dual-masked PSMAxCD3 TCE Phase 1: additional clinical data TBA PEG-IFN-α: peg-interferon alfa-2a; mAb: monoclonal antibody; siRNA: small interfering RNA; HER2: human epidermal growth factor receptor 2; PSMA: prostate-specific membrane antigen; EGFR: epidermal growth factor receptor; TCE: T-cell engager; CD3: cluster of differentiation 3; H1: First half; TBC: to be confirmed; Tobevibart incorporates Xencor’s XtendTM and other Fc technologies.
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Vir Biotechnology: powering the immune system to transform lives 172025 Vir Biotechnology, Inc. Delivering on promise of universal dual -masked TCEs in cancer treatment Clinical proof of concept for PRO-XTEN platform 1 We estimate our cash, cash equivalents, and investments to be approximately $1.1 billion as of January 1, 2025. This is a preliminary, estimated, and unaudited financial result. Actual results may differ from this estimate. PRO-XTEN is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company Transformative virological responses in HDV Phase 3 start in H1 2025 $1.1 billion cash and investments 1 (January 2025) Cash runway into mid-2027
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© 2023 PROPERTY OF VIR BIOTECHNOLOGY, INC. 18 PATIENTS ARE WAITING 182025 Vir Biotechnology, Inc.