Vir Biotechnology, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 23 February 2026: press release. Guidance figures: 4 new. The quarter’s numbers.

Key takeaways

Upfront paid in cash and equity: The upfront and near-term amount includes cash, an equity investment priced at a premium to the 30-day volume weighted average share price, and a near-term milestone. Source
Astellas leads U.S., holds ex-U.S.: Astellas leads U.S. commercialization, with Vir Biotechnology holding an option to co-promote. Astellas holds exclusive ex-U.S. commercialization rights. Source
Later-line data in planned update: The planned update covers VIR-5500 monotherapy in later-line mCRPC patients, including RECIST and PSA responses, durability and dose-response.
Monotherapy and combination studies: VIR-5500 is being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors for first-line mCRPC.
Phase 3 ECLIPSE trial designs: ECLIPSE 2 evaluates switching patients who have not achieved viral suppression on bulevirtide to tobevibart and elebsiran.
Norgine licensed three markets: Norgine holds exclusive commercial rights to the combination in those markets. Vir Biotechnology retained rights in the U.S. and other markets outside Greater China.
Year-end cash near $781 million: Cash, cash equivalents and investments were approximately $781 million at December 31, 2025, an unaudited figure subject to adjustment.

“We believe this collaboration reflects confidence in our PRO-XTEN ® platform, which has broad potential across multiple solid tumor indications.”
Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology

Guidance

Area	Period	Figure	Against last quarter
Collaboration upfront and near-term payments Source	Upfront and near-term	$335M	New
Collaboration milestones Source	Development, regulatory and sales milestones	up to $1.37B	New
VIR-5500 global development cost share Source	All global development costs	Astellas 60%, Vir Biotechnology 40%	New
U.S. profit and loss split Source	U.S. commercialization of VIR-5500	50/50	New
Cash runway	Into the fourth quarter of 2027	into the fourth quarter of 2027
ECLIPSE 1 topline data	Fourth quarter of 2026	fourth quarter of 2026
ECLIPSE 2 and ECLIPSE 3 topline data	First quarter of 2027	first quarter of 2027
VIR-5818 Phase 1 dose escalation response data	Second half of 2026	second half of 2026

What changed from last quarter

New: Vir Biotechnology and Astellas announced a global collaboration to co-develop and co-commercialize VIR-5500, a PSMA-targeting T-cell engager for prostate cancer. Source

Astellas collaboration terms

Upfront paid in cash and equity: The upfront and near-term amount includes cash, an equity investment priced at a premium to the 30-day volume weighted average share price, and a near-term milestone. Source
Astellas leads U.S., holds ex-U.S.: Astellas leads U.S. commercialization, with Vir Biotechnology holding an option to co-promote. Astellas holds exclusive ex-U.S. commercialization rights. Source
Tiered royalties on ex-U.S. sales: Vir Biotechnology is eligible for tiered, double-digit royalties on ex-U.S. net sales, in addition to the milestone payments. Source
Sanofi shares part of proceeds: Under Vir Biotechnology's licensing agreement with Sanofi, part of certain collaboration proceeds will be shared with Sanofi. Source

VIR-5500 development scope

Later-line data in planned update: The planned update covers VIR-5500 monotherapy in later-line mCRPC patients, including RECIST and PSA responses, durability and dose-response.
Monotherapy and combination studies: VIR-5500 is being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors for first-line mCRPC.
Described as potential best-in-class: The company describes VIR-5500 as a potential best-in-class dual-masked PSMA-targeting T-cell engager, currently in Phase 1 for advanced prostate cancer. Source

“This collaboration will enable more rapid advancement of VIR-5500 to potentially benefit more people living with prostate cancer.”
Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology

Chronic hepatitis delta program

Phase 3 ECLIPSE trial designs: ECLIPSE 2 evaluates switching patients who have not achieved viral suppression on bulevirtide to tobevibart and elebsiran.
Norgine licensed three markets: Norgine holds exclusive commercial rights to the combination in those markets. Vir Biotechnology retained rights in the U.S. and other markets outside Greater China.
Two ECLIPSE trials fully enrolled: The registrational ECLIPSE program is ongoing, with ECLIPSE 1 and ECLIPSE 3 reported as fully enrolled.

Cash position and runway

Year-end cash near $781 million: Cash, cash equivalents and investments were approximately $781 million at December 31, 2025, an unaudited figure subject to adjustment.
Runway tied to Norgine proceeds: The runway projection reflects anticipated net cash benefits from the Norgine licensing agreement and continued financial discipline.
Full-year results due late February: The year-end cash figure was preliminary. The company said it would report final fourth quarter and full-year 2025 results in late February 2026.

“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.”
Adam Pearson, Chief Strategy Officer, Astellas

PRO-XTEN masking platform

Masks keep engagers inactive: The masking technology keeps T-cell engagers inactive until they reach the tumor microenvironment, where tumor-specific proteases remove the mask.
Longer bloodstream exposure: The mask is designed to keep candidates in the bloodstream longer in inactive form, potentially allowing less frequent dosing.
Platform rights retained by Vir: Vir Biotechnology retains exclusive rights to the PRO-XTEN masking platform for oncology and infectious disease. Source

Oncology pipeline beyond VIR-5500

Two Phase 1 dose escalation trials: Dose escalation trials are enrolling patients for VIR-5818 in HER2-expressing solid tumors and VIR-5525 in EGFR-expressing solid tumors.
Preclinical PRO-XTEN programs advancing: Preclinical PRO-XTEN masked T-cell engagers target clinically validated targets with potential use in lung, colorectal and bladder tumors.

Coming up, as management said on 23 February 2026

VIR-5500 Phase 1 data at ASCO: Updated VIR-5500 Phase 1 data are scheduled to be presented at the 2026 ASCO Genitourinary Cancers Symposium on February 26. Source
Phase 1 trial handover to Astellas: Vir Biotechnology will continue the ongoing Phase 1 trial until responsibility transfers to Astellas, which will then be responsible for all development activities. Source
Complete CHD Week 96 results pending: Complete Week 96 results for the chronic hepatitis delta combination will be presented at a future medical meeting; no date is given.

Figures management reported

Figure	Reported
Undetectable HDV RNA at Week 96, combination arm (subset)	88% (21/24)
Undetectable HDV RNA at Week 96, antibody alone (subset)	46% (11/24)

Risks management discussed

Regulatory: Closing of the Astellas transaction is conditional on customary closing conditions, including clearance under the Hart-Scott-Rodino Act. Source

Earlier plans management reported on

Not stated: The company said in January it would share updated Phase 1 VIR-5500 data at the February ASCO symposium. The February release says the data is being presented on February 26.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

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%. Patients who progress to mCRPC develop therapeutic resistance and currently have limited treatment options.

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, 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 engagersacross 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:

Huo, 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

50% premium to the 30 day volume weighted average share price as of February 19, 2026

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.

Astellas Cautionary Notes

Forward-looking statements notice

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.

Vir Biotechnology Forward-Looking Statements

Forward-looking statements notice

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.

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

Contacts
Caren Scannell
Director, Communications cscannell@vir.bio
Kiki Patel, PharmD
Head of Investor Relations kpatel@vir.bio