Vir Biotechnology, Inc 8-K, filed Feb 23, 2026
Vir Biotechnology, Inc. (VIR)
8-K
2026-02-23
For: 2026-02-19
View Original
Added on
April 09, 2026
About this 8-K
Vir Biotechnology, Inc filed this 8-K on February 23, 2026, reporting on events of February 19, 2026.
Items reported
- Item 1.01: Entered into a material agreement
- Item 2.02: Financial results
- Item 3.02: Unregistered sale of equity
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 19, 2026
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(Exact name of Registrant as Specified in Its Charter)
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| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: (415 ) 906-4324
(Former Name or Former Address, if Changed Since Last Report)
________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 1.01 Entry into a Material Definitive Agreement.
On February 19, 2026, Vir Biotechnology, Inc. (Vir Bio) and Astellas US LLC (together with its subsidiaries and affiliates (including its indirect parent, Astellas Pharma Inc.), Astellas) entered into a Collaboration and License Agreement (the Agreement). Upon closing of the transaction contemplated by the Agreement (the Closing and the Transaction, respectively), Vir Bio and Astellas will enter into a global strategic collaboration to co-develop and co-commercialize VIR-5500, Vir Bio’s PRO-XTEN® dual-masked T-cell engager (TCE) targeting PSMA (prostate-specific membrane antigen), for the treatment of prostate cancer that is currently in Phase 1 development, through a sharing of expenses and revenues. Vir Bio has agreed to grant to Astellas, subject to certain intellectual property rights of Sanofi S.A. (Sanofi), an exclusive license to develop, manufacture, commercialize and otherwise exploit VIR-5500 and certain related derivative compounds throughout the world for therapeutic, prophylactic, palliative and diagnostic uses.
Under the terms of the Agreement, Vir Bio will receive $335 million in upfront and near-term milestone payments, including $240 million in cash and a $75 million equity investment pursuant to a separate Stock Purchase Agreement (the SPA, described further below), and an additional $20 million near-term milestone payment upon completion of manufacturing process technology transfer, anticipated in the second quarter or third quarter of 2027. Vir Bio will also be eligible to receive up to $1.37 billion in future development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. Global clinical development costs will be shared 40% by Vir Bio and 60% by Astellas, while costs of U.S.-specific studies will be shared equally, and Astellas will be solely responsible for costs of ex-U.S.-specific studies. In the U.S., Vir Bio will have the option to co-promote VIR-5500 and will share profits and losses from future sales of VIR-5500 equally with Astellas, should VIR-5500 receive regulatory approval. Outside of the U.S., Astellas will obtain exclusive rights to commercialize VIR-5500 and be responsible for all commercialization costs. In addition, Vir Bio has the option to opt out of development cost sharing responsibilities and U.S. profit sharing, in which case Vir Bio would be eligible to receive up to $1.37 billion (or $1.60 billion if Vir Bio has met a pre-defined limited funding threshold at the time of the opt-out) in additional future development, regulatory and sales milestones, along with tiered, double-digit royalties on global net sales.
The Closing is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
Concurrently with the execution of the Agreement, Vir Bio also entered into the SPA, pursuant to which Astellas has agreed to purchase 7,239,382 shares of Vir Bio’s common stock, par value $0.0001 per share (Common Stock), for an aggregate purchase price of approximately $75 million, subject to customary closing conditions. The purchase price per share of Common Stock of $10.36 is equal to a 50% premium of the 30-day volume weighted average price of a share of Common Stock as of February 17, 2026. The Astellas SPA includes standstill, voting and lockup provisions, with customary exceptions, that expire one year after the date of the anticipated closing of the SPA. One year after the anticipated closing of the SPA, Astellas will have, under certain circumstances, a customary right to require Vir Bio to register the resale of the shares purchased pursuant to the SPA.
Under the terms of Vir Bio’s licensing agreement with Sanofi, Vir Bio will share a portion of certain collaboration proceeds received from Astellas with Sanofi. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
The foregoing description of the terms of the Agreement and SPA does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement and SPA, copies of which the Company plans to file as exhibits to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2026.
On February 23, 2026, Vir Bio and Astellas issued a joint press release announcing the entry into the Agreement and the SPA. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
Item 2.02 Results of Operations and Financial Condition.
On February 23, 2026, Vir Bio issued a press release announcing its financial results for the quarter and full year ended December 31, 2025. A copy of the press release is furnished herewith as Exhibit 99.2 and is incorporated herein by reference.
The information in this Item 2.02, including the attached Exhibit 99.2, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by Vir Bio under the Securities Act of 1933, as amended (the Securities Act), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 3.02 Unregistered Sales of Equity Securities.
The information under Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference. Vir Bio offered and sold the shares of Common Stock to Astellas pursuant to the SPA in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act. Vir Bio relied on this exemption from registration based in part on Astellas’ representation that it is an accredited investor.
Item 8.01 Other Events.
On February 23, 2026, Vir Bio issued a press release announcing updated results from the Phase 1 study of VIR-5500, which will be presented in an oral presentation at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium on February 26, 2026. A copy of the press release is filed herewith as Exhibit 99.3 and is incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K (this Form 8-K) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this Form 8-K include, but are not limited to, statements regarding: the therapeutic potential of the combination of VIR-5500 to treat prostate cancer; Vir Bio’s immediate and potential future financial and other obligations under the Agreement and SPA with Astellas; Vir Bio’s ability to realize the anticipated benefits from the Agreement; the timing of the anticipated Closing, including receipt of any necessary regulatory approvals; Vir Bio’s strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, 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; difficulties in collaborating with other companies, some of whom may be competitors of Vir Bio or otherwise have divergent interests, and uncertainty as to whether the benefits of Vir Bio’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 Bio’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 Bio’s competitors, as well as changes in expected or existing competition; 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. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Bio’s available information, expectations and assumptions as of the date of this Form 8-K. Other factors that may cause Vir Bio’s actual results to differ from those expressed or implied in the forward-looking statements in this Form 8-K are discussed in Vir Bio’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Bio assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
| 99.3 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| VIR BIOTECHNOLOGY, INC. | |||||||||||
| Date: | February 23, 2026 | By: | /s/ Marianne De Backer | ||||||||
| Marianne De Backer, M.Sc., Ph.D., MBA Chief Executive Officer | |||||||||||
Exhibit 99.1
Press Release
Astellas and Vir Biotechnology Announce Global Strategic Collaboration to Advance PSMA-targeting PRO-XTEN® Dual-masked T-Cell Engager VIR-5500 for the Treatment of Prostate Cancer
- Astellas and Vir Biotechnology to co-develop and co-commercialize VIR-5500 through a sharing of expenses and revenues -
- Astellas to lead commercialization of VIR-5500 in the U.S. with Vir Biotechnology retaining option to co-promote, and Astellas will obtain exclusive rights to commercialize VIR-5500 ex-U.S. -
- Vir Biotechnology will receive $335M in upfront and near-term milestone payments, will split U.S. profit/loss equally with Astellas (50/50), and is eligible to receive up to an additional $1.37B in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales -
- Vir Biotechnology to host conference call today at 2:30 p.m. PT / 5:30 p.m. ET -
TOKYO and SAN FRANCISCO, February 23, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced they have entered into a global strategic collaboration to advance VIR-5500, an investigational PRO-XTEN® dual-masked CD3 T-cell engager (TCE) targeting PSMA for the treatment of prostate cancer. The collaboration aims to accelerate the development of VIR-5500 and further strengthen Astellas’ oncology pipeline and prostate cancer leadership.
Adam Pearson, Chief Strategy Officer, Astellas
“Astellas is proud to have helped 1.5 million patients with prostate cancer, and we are dedicated to expanding our impact as part of our R&D strategy. Our deep expertise in this disease area, combined with a growing immuno-oncology (IO) pipeline of biologics, including T-cell engagers, uniquely positions us to help advance VIR-5500, a potentially best-in-class T-cell engager for prostate cancer. This strategic collaboration allows Astellas and Vir Biotechnology to combine our expertise and reaffirms our commitment to improving the lives of people with prostate cancer.”
Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology
“Astellas is an ideal collaborator for the VIR-5500 program given the company’s successful track record advancing therapies across the treatment continuum, building blockbuster franchises and delivering value to patients through strategic development alliances with other biotech partners. This collaboration will enable more rapid advancement of VIR-5500 to potentially benefit more people living with prostate cancer. We believe this collaboration reflects confidence in our PRO-XTEN® platform, which has broad potential across multiple solid tumor indications.”
Despite recent advances in treatment, prostate cancer, especially metastatic castration-resistant prostate cancer (mCRPC), remains an aggressive and difficult cancer to treat; mCRPC has a 5-year survival rate of approximately 30%.i Patients who progress to mCRPC develop therapeutic resistance and currently have limited treatment options.
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VIR-5500 is a potential best-in-class dual-masked Prostate-Specific Membrane Antigen (PSMA)-targeting TCE and is currently in Phase 1 development for people with advanced, metastatic prostate cancer (NCT05997615). VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN® masking technology, which is designed to keep the TCEs masked (or inactive) until they reach the tumor microenvironment, reducing off-target effects and improving the therapeutic index.
Under the terms of the agreement, Vir Biotechnology will receive $335 million in upfront and near-term payments, including $240 million in cash, $75 million in equity investment at a 50% premium,ii and a near-term $20 million milestone. Global development costs for VIR-5500 will be shared, with Astellas responsible for 60% and Vir Biotechnology responsible for 40% of all costs. Vir Biotechnology will continue the ongoing Phase 1 trial, until responsibility is transitioned to Astellas, after which Astellas will be responsible for all development activities. In the U.S., Vir Biotechnology will have the option to co-promote VIR-5500 with Astellas, and profit/loss will be shared equally. Outside the U.S., Astellas will be exclusively responsible for commercialization of VIR-5500. In addition, Vir Biotechnology is eligible to receive up to $1.37 billion in development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. Under the terms of Vir Biotechnology's licensing agreement with Sanofi, a portion of certain collaboration proceeds will be shared with Sanofi.
Lazard acted as Vir Biotechnology’s exclusive financial advisor. Closing of the transaction is contingent on customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Act.
Vir Biotechnology Conference Call
Vir Biotechnology will host its fourth quarter and full year 2025 financial results conference call at 2:30 p.m. PT / 5:30 p.m. ET today, when members of the executive team and Dr. de Bono will share the updated VIR-5500 Phase 1 data that is also being presented at the 2026 ASCO Genitourinary Cancers Symposium on February 26. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days.
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagersiii across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Footnotes:
iHuo, Xingyue et al. “Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram.” Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070
ii50% premium to the 30 day volume weighted average share price as of February 19, 2026
iiiVir Biotechnology retains exclusive rights to the PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
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Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
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Vir Biotechnology Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of VIR-5500 to treat prostate cancer (including mCRPC) and Vir Biotechnology’s belief that it can be a best-in-class PSMA-targeting TCE; Vir Biotechnology’s clinical development plans and expectations for VIR-5500, including protocols for and enrollment into ongoing and planned clinical studies, target endpoints and data readouts; Vir Biotechnology’s immediate and potential future financial and other obligations under the agreement and collaboration with Astellas, as well as Vir Biotechnology’s ability to realize the benefits; Vir Biotechnology’s belief that Astellas is an ideal collaborator (given Astellas’ successful track record advancing therapies across the treatment continuum, building blockbuster franchises and delivering value through strategic development alliances) and that the agreement will enable faster and broader advancement of VIR-5500 to potentially benefit more people living with prostate cancer; the timing of the anticipated closing of the transaction with Astellas, including receipt of any necessary regulatory clearances; Vir Biotechnology’s strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, 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; 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; 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. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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Contacts for inquiries or additional information:
Astellas Pharma Inc.
Lisa Qu
R&D Communications
+1 (443) 467-0614
Lisa.qu@astellas.com
Corporate Communications
+81-3-3244-3201
Vir Biotechnology
Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio
Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio
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Exhibit 99.2
Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results
– Announces global strategic collaboration with Astellas to advance PSMA-targeted PRO-XTEN® dual-masked T-cell engager (TCE) VIR-5500 for the treatment of prostate cancer
– Reports updated VIR-5500 Phase 1 dose-escalation data supporting a favorable safety profile and promising anti-tumor activity
– Strong financial position with $781.6 million in cash and investments as of December 31, 2025
– Conference call scheduled for February 23, 2026, at 5:30 p.m. ET / 2:30 p.m. PT
SAN FRANCISCO, February 23, 2026 – Vir Biotechnology, Inc. (Nasdaq: VIR), today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2025.
“This is a seminal moment for Vir Biotechnology, marked by key high-potential partnerships on two of our programs showcasing the strength of our pipeline and technology platforms. Today, we announced a global strategic collaboration with Astellas and compelling new Phase 1 data for VIR-5500, demonstrating the potential for our PRO-XTEN® masked TCEs to play a transformative role in oncology and impact the lives of people living with hard-to-treat cancers,” said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. “Additionally, our licensing agreement with Norgine signed in December 2025, for the combination of tobevibart and elebsiran for the treatment of hepatitis delta, positions us to reach patients worldwide who face hepatitis delta, the most severe form of chronic viral hepatitis. Together, these milestones reflect how we are unlocking meaningful value in our pipeline and expanding the reach of our potential therapies.”
Pipeline Programs
Chronic Hepatitis Delta (CHD)
•To support global commercialization of the combination of tobevibart, an investigational neutralizing monoclonal antibody (mAb), and elebsiran, an investigational small interfering RNA (siRNA), for the treatment of CHD, the Company granted Norgine Pharma UK Limited (Norgine) an exclusive commercial license in Europe, Australia and New Zealand.
•Phase 2 SOLSTICE data presented at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference in January 2026 showed the combination of tobevibart and elebsiran is well tolerated and achieved undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) in 88% (21/24) of participants with CHD evaluable at Week 96 of treatment.
◦Previous positive Phase 2 SOLSTICE data at Week 48 were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 and simultaneously published in the New England Journal of Medicine.1
•Topline data from the ECLIPSE 1 trial are expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.
Solid Tumors
VIR-5500
•The Company executed a global strategic collaboration with Astellas2 to advance PSMA-targeted PRO-XTEN® dual-masked TCE VIR-5500, currently in development for metastatic castration-resistant prostate cancer (mCRPC).
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•Positive updated Phase 1 data for VIR-5500 monotherapy showed dose-dependent anti-tumor activity and a well-tolerated safety profile to date in patients with mCRPC. The data will be shared during the Company’s fourth quarter and full year conference call today and in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on February 26 (Oral Abstract #17). The oral presentation will be delivered by Dr. Johann de Bono, Principal Investigator and Director of the Drug Development Unit and Head of Prostate Cancer Targeted Therapy Group at the Institute of Cancer Research.
•Phase 1 monotherapy dose-escalation of weekly and once every three weeks dosing of VIR-5500 is complete, and the Company has defined a preliminary go-forward dose and regimen recommendation for expansion. In parallel, dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients.
•The Company anticipates initiating monotherapy dose-expansion cohorts in late-line mCRPC and combination dose-expansion cohorts in both early-line mCRPC and metastatic hormone-sensitive prostate cancer (mHSPC) in the second quarter of 2026 followed by pivotal Phase 3 trials in 2027.
VIR-5818
•Phase 1 dose-escalation of VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, in combination with pembrolizumab continues, with response data expected in the second half of 2026.
VIR-5525
•The Phase 1 study of VIR-5525, an EGFR-targeted PRO-XTEN® dual-masked TCE, continues enrollment as expected.
Preclinical Pipeline Candidates
•The Company is currently progressing a number of PRO-XTEN® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder.
Fourth Quarter and Full Year 2025 Financial Results
Cash, Cash Equivalents and Investments: As of December 31, 2025, the Company had approximately $781.6 million in cash, cash equivalents and investments, representing a decline of approximately $29.1 million during the fourth quarter of 2025. For the full year of 2025, cash, cash equivalents and investments declined approximately $313.8 million. During the fourth quarter, the Company received a $64.3 million initial cost reimbursement payment upon signing the license agreement with Norgine.
Revenue: Revenue for the fourth quarter of 2025 was $64.1 million compared to $12.4 million for the same period in 2024. Revenue for the full year of 2025 was $68.6 million compared to $74.2 million in 2024. The increase in the fourth quarter was primarily driven by the recognition of $64.3 million license revenue related to the initial cost reimbursement payment received under the license agreement with Norgine. The decrease in the full year was primarily due to lower license and collaboration revenue from GSK and lower grant revenue, partially offset by the license revenue recognized under the license agreement with Norgine.
Cost of Revenue: The change in cost of revenue for the fourth quarter and full year of 2025 compared to the same periods in 2024 was nominal.
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Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $88.3 million, which included $5.6 million of non-cash stock-based compensation expense, compared to $106.1 million for the same period in 2024, which included $8.3 million of non-cash stock-based compensation expense. R&D expenses for the full year of 2025 were $456.0 million, which included $25.1 million of non-cash stock-based compensation expense, compared to $506.5 million in 2024, which included $43.9 million of non-cash stock-based compensation expense. The decrease in both the fourth quarter and full year was primarily due to cost savings from previously announced restructuring initiatives as well as lower expenses from contingent consideration liability revaluation, partially offset by higher clinical cost due to the initiation of our Phase 3 ECLIPSE registrational program and progression of our oncology programs.
The full year of 2025 R&D expenses include a $75.0 million milestone payment made upon VIR-5525 achieving first-in-human dosing, the $30.0 million expense in connection with amending the Company’s license agreement with Alnylam Pharmaceuticals, Inc., and milestone payments due upon initiation of the ECLIPSE Phase 3 registrational program. These 2025 license-related expenses were substantially offset by the $102.8 million upfront license payment made to Sanofi in 2024.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2025 were $23.6 million, which included $5.6 million of non-cash stock-based compensation expense, compared to $26.7 million for the same period in 2024, which included $7.5 million of non-cash stock-based compensation expense. SG&A expenses for the full year of 2025 were $92.1 million, which included $24.0 million of non-cash stock-based compensation expense, compared to $119.0 million in 2024, which included $34.5 million of non-cash stock-based compensation expense. The decrease in both the fourth quarter and the full year was primarily due to efficiencies and cost savings from previously announced restructuring initiatives.
Restructuring, Long-Lived Assets Impairment and Related Charges: The decrease in restructuring, long-lived assets impairment and related charges for the fourth quarter and full year of 2025 was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.
Other Income: The decrease in other income for the fourth quarter and full year of 2025 was primarily driven by lower interest income. Additionally, the decrease in the full year was partially offset by lower unrealized loss from the Company’s equity investment.
Benefit from (Provision for) Income Taxes: The change in benefit from (provision for) income taxes for the fourth quarter and the full year of 2025 was nominal.
Net Loss: Net loss attributable to Vir Biotechnology for the fourth quarter of 2025 was $(42.9) million, or $(0.31) per share, basic and diluted, compared to a net loss of $(104.6) million, or $(0.76) per share, basic and diluted, for the same period in 2024. Net loss attributable to Vir Biotechnology for the year of 2025 was $(438.0) million, or $(3.16) per share, basic and diluted, compared to a net loss of $(522.0) million, or $(3.83) per share, basic and diluted, in 2024.
2026 Financial Guidance
Based on current operating plans, including the expected net effects of the Astellas global collaboration and the Astellas equity investment,2 the Company expects its cash, cash equivalents and investments to fund operations into the second quarter of 2028.
Conference Call
Vir Biotechnology will host its fourth quarter and full year 2025 financial results conference call at 5:30 p.m. ET / 2:30 p.m. PT today, when members of the executive team and Dr. de Bono will share the updated VIR-5500 Phase 1 data that is also being presented at the 2026 ASCO Genitourinary Cancers Symposium on February 26. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days.
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About the ECLIPSE Registrational Program
ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and is designed to provide important supportive data to help establish access and reimbursement in key markets.
About Tobevibart and Elebsiran
Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously and is currently in clinical development for the treatment of patients with chronic hepatitis delta (CHD).
Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously and is currently in clinical development for the treatment of patients with CHD.
About Chronic Hepatitis Delta (CHD)
CHD is the most severe form of chronic viral hepatitis3 and was recently classified as carcinogenic by the International Agency for Research on Cancer.4 People living with the disease rapidly progress to cirrhosis, liver failure5 and liver-related death.3 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally.
About VIR-5500, VIR-5818 and VIR-5525
VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN® masking technology and target PSMA, HER2 and EGFR, respectively.
TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal PRO-XTEN® masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.
4
About Advanced Prostate Cancer
Prostate cancer remains a significant global health burden, representing the most common cancer diagnosis in men and the second leading cause of cancer-related mortality in men behind lung cancer.6 Despite diagnostic and therapeutic advances, patients with prostate cancer continue to face substantial unmet medical need. While androgen directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).7 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. While androgen-directed therapies have improved outcomes in mHSPC settings, the majority of these patients still eventually progress to metastatic castration-resistant prostate cancer (mCRPC).8 This stage is associated with poor clinical outcomes, including limited durability of existing therapies,with a 5-year survival rate of approximately 30%.9 There is a critical need for safer, more effective and precisely targeted therapies capable of improving long-term disease control and quality of life across the prostate cancer continuum.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Footnotes and references:
1 Asselah T, Chattergoon MA, Jucov A, et al. “A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D” N Engl J Med. vol. 394, no. 4 (2026), 343-353, doi:10.1056/NEJMoa2508827.
2 Closing of the Astellas global collaboration and Astellas equity investment is contingent on customary closing conditions, including clearance under the Hart-Scott-Rodino (HSR) Act. Under the terms of Vir Biotechnology's licensing agreement with Sanofi, we will share with Sanofi 20% of certain future collaboration proceeds from the Astellas collaboration agreement.
3 National Institute of Diabetes and Digestive and Kidney Diseases. Hepatitis D. NIDDK. Published November 2024. Accessed September 2025. Hepatitis D - NIDDK (nih.gov).
4 Karagas, Margaret R et al., "Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus" The Lancet Oncology, vol. 26, no. 8 (2025): 994 – 995. doi: 10.1016/S1470-2045(25)00403-6.
5 Center for Disease Control and Prevention. Hepatitis D FAQs. CDC. Published March 2020. Accessed September 2025. What is Hepatitis D - FAQ | CDC.
6 Kratzer TB, et. al. “Prostate cancer statistics, 2025.” CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028.
7 Bernard-Terrier A & Beltran H. “Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine.” J Clin Invest. vol. 136 no. 3 (2026):e200920. doi: 10.1172/JCI200920.
8 Leith A, et. al. “Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (France, Germany, Italy, Spain, and the United Kingdom) and Japan.” Adv Ther. vol. 39 (2022): 2236-2255. doi: 10.1007/s12325-022-02073-w.
9 Huo, X et al. “Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram.” Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070.
5
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: Vir Biotechnology’s cash balance and anticipated runway; Vir Biotechnology’s collaboration with Astellas, including potential payments to be made to Vir Biotechnology under such collaboration; Vir Biotechnology's future financial and operating results and its expectations related thereto, including Vir Biotechnology’s financial guidance; the therapeutic and commercial potential of Vir Biotechnology's chronic hepatitis delta 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 portfolio, preclinical pipeline and 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; 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. Many factors may cause differences between current expectations and actual results, 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 in the amounts and on the timeline Vir Biotechnology expects, including risks affecting the anticipated closing of the transaction with Astellas, including delays and the satisfaction of closing conditions that are outside Vir Biotechnology's control; 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. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
6
VIR BIOTECHNOLOGY, INC.
Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
| December 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| ASSETS | |||||||||||
| CURRENT ASSETS: | |||||||||||
| Cash and cash equivalents | $ | 232,185 | $ | 222,947 | |||||||
| Short-term investments | 228,753 | 678,051 | |||||||||
| Restricted cash and cash equivalents, current | 1,922 | 89,385 | |||||||||
| Equity investments | 6,077 | 4,350 | |||||||||
| Prepaid expenses and other current assets | 45,143 | 47,725 | |||||||||
| Total current assets | 514,080 | 1,042,458 | |||||||||
| Intangible assets, net | 7,850 | 8,120 | |||||||||
| Goodwill | 16,937 | 16,937 | |||||||||
| Property and equipment, net | 55,620 | 63,183 | |||||||||
| Operating right-of-use assets | 62,099 | 59,680 | |||||||||
| Restricted cash and cash equivalents, noncurrent | 6,963 | 6,363 | |||||||||
| Long-term investments | 314,575 | 190,015 | |||||||||
| Other assets | 24,699 | 12,057 | |||||||||
| TOTAL ASSETS | $ | 1,002,823 | $ | 1,398,813 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| CURRENT LIABILITIES: | |||||||||||
| Accounts payable | $ | 9,803 | $ | 5,081 | |||||||
| Accrued and other liabilities | 83,012 | 98,521 | |||||||||
| Contingent consideration obligation, current | — | 16,060 | |||||||||
| Total current liabilities | 92,815 | 119,662 | |||||||||
| Operating lease liabilities, noncurrent | 89,054 | 90,139 | |||||||||
| Contingent consideration obligation, noncurrent | 34,100 | 24,050 | |||||||||
| Other long-term liabilities | 21,578 | 14,577 | |||||||||
| TOTAL LIABILITIES | 237,547 | 248,428 | |||||||||
| Commitments and contingencies | |||||||||||
| STOCKHOLDERS’ EQUITY: | |||||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2025 and 2024, respectively; no shares issued and outstanding as of December 31, 2025 and 2024 | — | — | |||||||||
Common stock, $0.0001 par value; 300,000,000 shares authorized as of December 31, 2025 and 2024, respectively; 139,474,954 and 136,959,446 shares issued and outstanding as of December 31, 2025 and 2024, respectively | 14 | 14 | |||||||||
| Additional paid-in capital | 1,965,090 | 1,911,872 | |||||||||
| Accumulated other comprehensive loss | (2,057) | (1,717) | |||||||||
| Accumulated deficit | (1,197,771) | (759,784) | |||||||||
| TOTAL STOCKHOLDERS’ EQUITY | 765,276 | 1,150,385 | |||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 1,002,823 | $ | 1,398,813 | |||||||
7
VIR BIOTECHNOLOGY, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| License and collaboration revenue | $ | 63,760 | $ | 10,589 | $ | 63,130 | $ | 61,370 | |||||||||||||||
| Grant revenue | 310 | 1,096 | 2,036 | 10,493 | |||||||||||||||||||
| Other revenue | — | 689 | 3,390 | 2,342 | |||||||||||||||||||
| Total revenues | 64,070 | 12,374 | 68,556 | 74,205 | |||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Cost of revenue | 26 | 684 | 26 | 845 | |||||||||||||||||||
| Research and development | 88,349 | 106,083 | 455,966 | 506,499 | |||||||||||||||||||
| Selling, general and administrative | 23,616 | 26,701 | 92,074 | 119,031 | |||||||||||||||||||
| Restructuring, long-lived assets impairment and related charges, net | — | (3,944) | (182) | 34,995 | |||||||||||||||||||
| Total operating expenses | 111,991 | 129,524 | 547,884 | 661,370 | |||||||||||||||||||
| Loss from operations | (47,921) | (117,150) | (479,328) | (587,165) | |||||||||||||||||||
| Other income: | |||||||||||||||||||||||
| Change in fair value of equity investments | (2,606) | (1,172) | 1,729 | (5,528) | |||||||||||||||||||
| Interest income | 7,802 | 14,153 | 40,238 | 71,809 | |||||||||||||||||||
| Other expense, net | (335) | (506) | (409) | (2,221) | |||||||||||||||||||
| Total other income | 4,861 | 12,475 | 41,558 | 64,060 | |||||||||||||||||||
| Loss before benefit from (provision for) income taxes | (43,060) | (104,675) | (437,770) | (523,105) | |||||||||||||||||||
| Benefit from (Provision for) income taxes | 137 | 86 | (217) | 1,145 | |||||||||||||||||||
| Net loss | $ | (42,923) | $ | (104,589) | $ | (437,987) | $ | (521,960) | |||||||||||||||
| Net loss per share, basic and diluted | $ | (0.31) | $ | (0.76) | $ | (3.16) | $ | (3.83) | |||||||||||||||
| Weighted-average shares outstanding, basic and diluted | 139,232,143 | 136,808,690 | 138,520,419 | 136,246,865 | |||||||||||||||||||
Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio
Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio
8
Exhibit 99.3
Vir Biotechnology Reports Positive Updated Phase 1 Results for PSMA-targeting, PRO-XTEN® Dual-masked T-Cell Engager VIR-5500 in Patients with Metastatic Prostate Cancer
–Updated Phase 1 dose-escalation data (n=58) show VIR-5500 monotherapy has a favorable safety profile and was well tolerated with no dose-limiting toxicities observed to date
–Dose-dependent anti-tumor activity was observed, with 82% PSA50 and 53% PSA90 declines and RECIST-evaluable objective responses (45% ORR in 5/11 patients) in ≥3,000 µg/kg Q3W dosing cohorts
–Vir Biotechnology to host conference call today at 5:30 p.m. ET / 2:30 p.m. PT
–Data will be presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on February 26 (Oral Abstract #17)
SAN FRANCISCO, February 23, 2026 – Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new data from the ongoing Phase 1 clinical trial of VIR-5500, a prostate-specific membrane antigen (PSMA)-targeting, PRO-XTEN® dual-masked T-cell engager (TCE) being evaluated in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who have progressed after multiple lines of therapy (NCT05997615). These data suggest that VIR-5500 monotherapy is well tolerated and exhibits promising anti-tumor activity. Data will be presented in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on February 26 in San Francisco, CA (Oral Abstract #17).
"We are encouraged by VIR-5500's safety and tolerability profile and the early signals of durable anti-tumor activity in a heavily pre-treated population, which validate our PRO-XTEN® masking strategy aimed at achieving a differentiated therapeutic index," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "Based on these data, we are advancing dose-expansion cohorts and plan to initiate our registrational trial in 2027. We want to thank the patients in our Phase 1 program and their families for participating in the development of VIR-5500.”
Data across all patients receiving VIR-5500 monotherapy in the Phase 1 trial (n=58) show that VIR‑5500 was generally well tolerated with no dose‑limiting toxicities (DLTs) observed to date. Grade ≥3 treatment‑related adverse events occurred in 12% (7/58) of patients and were manageable. Limited cytokine release syndrome (CRS) was observed in 50% (29/58) of patients, with events generally restricted to Grade 1 (fever only). Prophylactic steroids were not required and were only explored in a small cohort of three patients. Enrolled patients were heavily pre-treated (median of four prior lines) and a substantial proportion presented with high tumor burden, including nearly one half with visceral metastases.
Dose‑dependent activity was observed across the entire treatment group as measured by both prostate-specific antigen (PSA) declines and radiographic responses. Efficacy data were reported in the highest dose cohorts (≥3,000 µg/kg Q3W; n=22/58) as of the January 9, 2026 data cut-off. In these cohorts, PSA50 declines occurred in 82% (14/17) and PSA90 declines in 53% (9/17) of PSA-evaluable patients. Among RECIST (Response Evaluation Criteria in Solid Tumors)‑evaluable patients, objective responses were seen in 45% (5/11). Of the five responders, four achieved confirmed responses with one patient pending confirmation. Reductions on PSMA‑PET (positron emission tomography) affirm PSA declines and radiographic responses, with tumor shrinkage observed across multiple lesions, including visceral metastases. These findings support proof‑of‑concept and further evaluation in expansion cohorts.
1
“It is remarkable to see these early signs of profound anti-tumor activity in heavily pre-treated mCRPC patients, and the favorable tolerability with minimal CRS to date means VIR-5500 could play a role in treating earlier disease,” said Dr. Johann de Bono, Principal Investigator and Director of the Drug Development Unit and Head of Prostate Cancer Targeted Therapy Group at the Institute of Cancer Research. “For patients with metastatic prostate cancer who have long faced limited treatment choices, VIR-5500 may offer a renewed sense of hope and a potential path to better outcomes.”
Vir Biotechnology has concluded QW and Q3W monotherapy dose-escalation in late-line mCRPC and has defined a preliminary go-forward dose and regimen recommendation for expansion. In parallel, dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients. The Company anticipates initiating monotherapy dose-expansion cohorts in late-line mCRPC and combination dose-expansion cohorts in both early-line mCRPC and metastatic hormone-sensitive prostate cancer (mHSPC) in the second quarter of 2026 followed by pivotal Phase 3 trials in 2027.
Conference Call
Vir Biotechnology will host its fourth quarter and full year 2025 financial results conference call at 5:30 p.m. ET / 2:30 p.m. PT today, when members of the executive team and Dr. de Bono will share the updated VIR-5500 Phase 1 data that is also being presented at the 2026 ASCO Genitourinary Cancers Symposium on February 26. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days.
About Advanced Prostate Cancer
Prostate cancer remains a significant global health burden, representing the most common cancer diagnosis in men and the second leading cause of cancer-related mortality in men behind lung cancer.1 Despite diagnostic and therapeutic advances, patients with prostate cancer continue to face substantial unmet medical need. While androgen directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).2 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. While androgen-directed therapies have improved outcomes in mHSPC settings, the majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).3 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.4 There is a critical need for safer, more effective, and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.
About VIR-5500
T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 is an investigational PRO-XTEN® dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, pharmacokinetics and preliminary efficacy in participants with metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is the only dual-masked PSMA-targeting TCE in clinical evaluation.
VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN® masking technology. The PRO-XTEN® masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens.
2
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Footnotes and references:
1 Kratzer TB, et. al. “Prostate cancer statistics, 2025.” CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028.
2 Bernard-Terrier A & Beltran H. “Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine.” J Clin Invest. vol. 136 no. 3 (2026):e200920. doi: 10.1172/JCI200920.
3 Leith A, et. al. “Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (France, Germany, Italy, Spain, and the United Kingdom) and Japan.” Adv Ther. vol. 39 (2022): 2236-2255. doi: 10.1007/s12325-022-02073-w.
4 Huo, X et al. “Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram.” Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070.
3
Vir Biotechnology Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of VIR-5500, both as a monotherapy and in combination with enzalutamide, to treat advanced mCRPC and other forms of prostate cancer (including in earlier disease) and offer patients a path to better outcomes; Vir Biotechnology’s clinical development plans and expectations for VIR-5500, including protocols for and enrollment into ongoing and planned clinical trials (including monotherapy dose-expansion cohorts in late-line mCRPC and combination dose-expansion cohorts in both early-line mCRPC and mHSPC in the second quarter of 2026, followed by pivotal Phase 3 trials in 2027), target endpoints and data readouts; Vir Biotechnology’s strategy and plans (including its PRO-XTEN® masking strategy aimed at achieving a differentiated therapeutic index); and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, 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; 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; 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. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Vir Biotechnology retains exclusive rights to the PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
Contacts for inquiries or additional information:
Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio
Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio
4