Vir Biotechnology Inc (VIR)

Vir Biotechnology Announces Appointment of Timothy Coughlin to its Board of DirectorsJune 10, 2026 4:05 PM
Business Wire Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the appointment of Timothy Coughlin to its Board of Directors and as Chair of the Audit Committee, effective June 9, 2026. “We are pleased to welcome Tim to Vir Biotechnology’s Board of Directors at a pivotal moment for the company,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “Tim brings a strong background of strategic discipline and operational insight that has helped organizations evolve into fully integrated enterprises. His extensive experience as chief financial officer and board member spanning discovery through commercialization will be highly valuable as we advance our portfolio. We look forward to his partnership as we translate scientific innovation into meaningful therapies for patients.” “I am excited to join the Board of Directors at Vir Biotechnology and contribute to the advancement of the company’s potential best-in-class treatment regimen for hepatitis delta and the progression of its robust pipeline of masked T-cell engagers for solid tumors,” said Timothy Coughlin, Board Member, Vir Biotechnology. “Vir Biotechnology is poised to make a meaningful difference for patients, and I look forward to supporting that impact.” Mr. Coughlin is the former Chief Financial Officer of Neurocrine Biosciences, Inc., where he helped lead the company’s transition from a clinical-stage biotechnology company to a fully integrated commercial pharmaceutical company, rebuilding after a key regulatory setback and bringing important therapies to patients while at the same time increasing shareholder value. Prior to joining Neurocrine, he was with Catholic Health Initiatives, a nationwide integrated healthcare delivery system, where he served as Vice President, Financial Services. Earlier in his career, Mr. Coughlin served as a Senior Manager in the Health Sciences practice of Ernst & Young LLP and its predecessors. Mr. Coughlin currently serves as chair of the board of directors of aTyr Pharma, Inc. and as a member of the boards of directors of ADC Therapeutics SA and Travere Therapeutics, Inc. He previously served on the boards of directors of Fate Therapeutics, Inc. and Peloton Therapeutics, Inc. prior to its sale to Merck in 2019. Mr. Coughlin holds a master's degree in international business from San Diego State University and a bachelor’s degree in accounting from Temple University. He is a certified public accountant in both California and Pennsylvania. 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. 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260610324261/en/ Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio Original: Vir Biotechnology Announces Appointment of Timothy Coughlin to its Board of Directors

Vir Biotechnology to Present Complete Week 96 Data from Phase 2 SOLSTICE Clinical Trial in Hepatitis Delta at the European Association for the Study of the Liver (EASL) Congress 2026May 18, 2026 4:05 PM
Business Wire - Oral presentation of complete Week 96 data from the Phase 2 SOLSTICE trial in chronic hepatitis delta selected for inclusion in “Best of EASL 2026” by EASL - Poster presentation of Week 48 subgroup analysis from the Phase 2 SOLSTICE trial in chronic hepatitis delta selected for poster tour by EASL Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the Company will present data from the Phase 2 SOLSTICE trial evaluating the combination of tobevibart and elebsiran for chronic hepatitis delta at the upcoming EASL Congress 2026 in Barcelona, Spain, May 27-30, 2026. Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR-2218) in participants with chronic hepatitis delta virus infection: Week 96 endpoint results from the Phase 2 SOLSTICE trial
Format: Oral presentation
Session: General Session II
Presenter: Tarik Asselah
Date: May 29, 2026
Time: 12:15 p.m. to 12:30 p.m. CEST SOLSTICE Week 48 subgroup analysis: Impact of BMI on ALT normalization after successful viral control in participants with chronic hepatitis delta virus infection treated with tobevibart plus elebsiran
Format: Poster presentation
Session: Poster Tour - Viral Hepatitis B and D: New therapies, unapproved therapies or strategies
Presenter: Alina Jucov
Date: May 29, 2026
Time: 4:15 p.m. to 5:00 p.m. CEST This poster will also be available as part of the following session:
Session: Poster - Viral Hepatitis B and D: New therapies, unapproved therapies or strategies
Date: May 27, 2026
Time: 8:30 a.m. to 5:00 p.m. CEST About Chronic Hepatitis Delta (CHD) CHD is the most severe form of chronic viral hepatitis1 and was recently classified as carcinogenic by the International Agency for Research on Cancer.2 People living with the disease rapidly progress to cirrhosis, liver failure3 and liver-related death.1 Because ongoing hepatitis delta virus (HDV) replication drives disease progression, achieving undetectable virus, as defined by HDV RNA TND (target not detected), is considered an important virologic marker associated with improved clinical outcomes in CHD.4 Individuals with CHD who have detectable HDV RNA are at a higher risk of experiencing any liver-related event, including developing compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation and mortality, compared to patients with undetectable HDV RNA.4 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally. About Tobevibart and Elebsiran Tobevibart and elebsiran are investigational agents being evaluated as a novel combination regimen administered monthly as two separate sequential subcutaneous injections for the treatment of CHD. The combination is designed to disrupt the HDV life cycle at multiple points by addressing both viral entry and the sustained presence of hepatitis B surface antigen (HBsAg) that enables ongoing HDV replication. Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting HBsAg. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to 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. 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. 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. 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. References:
1 National Institute of Diabetes and Digestive and Kidney Diseases. Hepatitis D. NIDDK. Published November 2024. Accessed September 2025. Hepatitis D - NIDDK (nih.gov).
2 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.
3 Center for Disease Control and Prevention. Hepatitis D FAQs. CDC. Published March 2020. Accessed September 2025. What is Hepatitis D - FAQ | CDC.
4 Gish R. (2024). Association of hepatitis delta virus with liver morbidity and mortality: A systematic literature review and meta-analysis. Hepatology. 79:1129-1140. View source version on businesswire.com: https://www.businesswire.com/news/home/20260518708069/en/ Media Contact
Caren Scannell
Director, Communications
cscannell@vir.bio Investor Contact
Kiki Patel, PharmD
Head of Investor Relations
kpatel@vir.bio Original: Vir Biotechnology to Present Complete Week 96 Data from Phase 2 SOLSTICE Clinical Trial in Hepatitis Delta at the European Association for the Study of the Liver (EASL) Congress 2026

Vir Biotechnology Announces Closing of Global Strategic Collaboration with Astellas for the Treatment of Prostate CancerApril 16, 2026 8:05 AM
Business Wire
- 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 obtaining exclusive rights to commercialize VIR-5500 ex-U.S.


Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its global collaboration and licensing agreement with Astellas announced on February 23, 2026 has closed following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The collaboration aims to accelerate the development of VIR-5500, a prostate-specific membrane antigen (PSMA)-targeted, PRO-XTEN® dual-masked T-cell engager (TCE) for metastatic prostate cancer.


Summary Financial Terms


Upon closing, Vir Biotechnology receives a $240 million upfront payment and a $75 million equity investment at a price of $10.36 per share. The Company will also receive a near-term $20 million milestone payment, will split U.S. profit/loss equally with Astellas (50/50), and is eligible to receive up to an additional $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.


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.


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.


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 the goal of the collaboration with Astellas to accelerate the development of VIR-5500 towards commercialization; 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 potential future financial and other obligations under the agreement and collaboration with Astellas, as well as Vir Biotechnology’s ability to realize the benefits (including future revenue sharing, milestone payments and royalties); 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.


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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260416804867/en/
Media Contact

Caren Scannell

Director, Communications

cscannell@vir.bio


Investor Contact

Kiki Patel, PharmD

Head of Investor Relations

kpatel@vir.bio


Original: Vir Biotechnology Announces Closing of Global Strategic Collaboration with Astellas for the Treatment of Prostate Cancer

Vir Biotechnology Announces First Patient Dosed in Phase 1 Dose-expansion Cohorts Evaluating PSMA-targeted, PRO-XTEN® Dual-masked T-cell Engager VIR-5500 in Patients with Metastatic Prostate CancerApril 13, 2026 8:05 AM
Business Wire

Phase 1 trial designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in both early and late-line metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC)



Dose-expansion builds on promising Phase 1 monotherapy dose-escalation data in mCRPC presented in February 2026



Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in one of three expansion cohorts in the Phase 1 trial evaluating VIR-5500, a prostate-specific membrane antigen (PSMA)-targeted, PRO-XTEN® dual-masked T-cell engager (TCE) for metastatic prostate cancer (NCT05997615). The Phase 1 trial is measuring the safety and efficacy of VIR-5500 monotherapy in late-line mCRPC, and of VIR-5500 in combination with an androgen receptor pathway inhibitor (ARPI) in early-line mCRPC and mHSPC.


“The initiation of the VIR-5500 expansion cohorts underscores the significant momentum behind this program and the enthusiasm we are seeing across the clinical community,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “We are encouraged by the promising anti-tumor activity shown in the Phase 1 data announced earlier this year and look forward to collaborating with Astellas after closing of the transaction to explore VIR-5500’s potential to make a meaningful difference across the spectrum of metastatic prostate cancer.”


The monotherapy expansion cohort in late-line mCRPC is the first to begin enrollment based on the monotherapy dose-escalation data that showed VIR-5500 has a favorable safety profile and promising anti-tumor activity in mCRPC. These safety and efficacy data were presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February. Based on these data, the selected dose regimen to be evaluated in this monotherapy expansion cohort is Q3W 800/2000/3500 µg/kg step-up dosing. This expansion cohort will measure safety and efficacy, including Prostate-Specific Antigen (PSA) response rate and Objective Response Rate (ORR) in patients with mCRPC who are refractory following treatment with multiple prior lines of therapy including at least one second-generation ARPI and one taxane regimen in addition to standard-of-care radioligand-based therapy.


“Building on the encouraging Phase 1 dose-escalation monotherapy data, this milestone represents an important step in further evaluating VIR-5500’s best-in-class potential,” said Anthony Jarkowski, Primary Focus Lead, Immuno-oncology, Astellas. “We look forward to starting our collaboration with Vir Biotechnology to potentially benefit more people living with prostate cancer, where there remains a significant unmet medical need.”


Dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients. The Company anticipates dosing of first patients in the combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months, followed by pivotal Phase 3 trials in 2027.


About Advanced Prostate Cancer


Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.1 While diagnostic and therapeutic advances like 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. 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.


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.


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 be a best-in-class treatment for advanced mCRPC (including in early-line) and other indications across the spectrum of prostate cancer and make a meaningful difference for these patients, where there remains a significant unmet medical need; Vir Biotechnology’s clinical development plans and expectations for VIR-5500, including protocols for and enrollment into ongoing and planned clinical trials (including combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months, followed by pivotal Phase 3 trials in 2027), target endpoints and data readouts; 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; 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260413500942/en/
Media Contact

Caren Scannell

Director, Communications

cscannell@vir.bio


Investor Contact

Kiki Patel, PharmD

Head of Investor Relations

kpatel@vir.bio


Original: Vir Biotechnology Announces First Patient Dosed in Phase 1 Dose-expansion Cohorts Evaluating PSMA-targeted, PRO-XTEN® Dual-masked T-cell Engager VIR-5500 in Patients with Metastatic Prostate Cancer

Vir Biotechnology to Participate in Upcoming Investor ConferencesFebruary 26, 2026 4:05 PM
Business Wire
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that members of the management team will participate in the following investor conferences during the month of March:



TD Cowen 46th Annual Health Care Conference: Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, will participate in a fireside chat on Monday, March 2, 2026, at 3:10 p.m. ET/12:10 p.m. PT in Boston, Massachusetts.



Leerink Partners Global Healthcare Conference: Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, will participate in a fireside chat on Tuesday, March 10, 2026, at 1:40 p.m. ET/10:40 a.m. PT in Miami, Florida.



Barclays 28th Annual Global Healthcare Conference: Members of management will be available for one-on-one meetings on Thursday, March 12, 2026, in Miami, Florida.



Live webcasts of the fireside chats will be available at https://investors.vir.bio and will be archived for 30 days.


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.


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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260226768056/en/
Media Contact

Caren Scannell

Director, Communications

cscannell@vir.bio


Investor Contact

Kiki Patel, PharmD

Head of Investor Relations

kpatel@vir.bio


Original: Vir Biotechnology to Participate in Upcoming Investor Conferences

Vir Biotechnology Announces Proposed Public Offering of Common StockFebruary 24, 2026 4:05 PM
Business Wire
Vir Biotechnology, Inc. (Nasdaq: VIR), 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, today announced that it intends to offer $200,000,000 of shares of its common stock in an underwritten public offering. In addition, Vir Biotechnology intends to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the proposed offering will be offered by Vir Biotechnology. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.


Goldman Sachs & Co. LLC, Leerink Partners, Evercore ISI and Barclays are acting as book-running managers for the offering.


The shares described above are being offered pursuant to an automatically effective shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission, or the SEC, on November 3, 2023. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and may be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; Evercore Group L.L.C., Attn: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at Barclaysprospectus@broadridge.com; or by accessing the SEC’s website at www.sec.gov.


This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.


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.


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 anticipated size and terms of the offering, the ability to complete the offering, whether or not the underwriters ultimately purchase any additional shares; risks and uncertainties related to the market and other conditions; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation, market and other conditions, including as may be impacted by geopolitical changes and other external factors that are beyond Vir Biotechnology’s or the underwriters’ control; the ability to complete the offering; and the satisfaction of the customary closing conditions related to the offering. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on 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 the section titled “Risk Factors” of Vir Biotechnology’s Annual Report on Form 10-K, filed with the SEC on February 23, 2026, and in the preliminary prospectus supplement relating to the proposed offering. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260224282771/en/
Media

Caren Scannell

Director, Communications

cscannell@vir.bio


Investors

Kiki Patel, PharmD

Head of Investor Relations

kpatel@vir.bio


Original: Vir Biotechnology Announces Proposed Public Offering of Common Stock

they will be splitting profits if there is any

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 CancerFebruary 23, 2026 5:00 PM
PR Newswire (US)

- 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, Feb. 23, 2026 /PRNewswire/ -- 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.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.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.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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Original: 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

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 CancerFebruary 23, 2026 5:02 PM
Business Wire
– 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)


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.


“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.


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.


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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223892941/en/
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


Original: 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

Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial ResultsFebruary 23, 2026 5:14 PM
Business Wire
– 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


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 44?? 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).



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.


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.


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.


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.


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.




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






 










 




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






 







 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260222469334/en/
Media Contact

Caren Scannell

Director, Communications

cscannell@vir.bio


Investor Contact

Kiki Patel, PharmD

Head of Investor Relations

kpatel@vir.bio


Original: Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results

Vir Biotechnology to Host Conference Call for Fourth Quarter and Full Year 2025 Financial ResultsFebruary 9, 2026 4:05 PM
Business Wire
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that it will host a conference call at 5:30 p.m. ET / 2:30 p.m. PT on Monday, February 23 to provide a corporate update and discuss its financial results for the fourth quarter and full year ended December 31, 2025. The conference call may be accessed on the Events & Presentations page of the Vir Biotechnology website.


About Vir Biotechnology


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.


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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260209367749/en/
Media Contact

Caren Scannell

Director, Communications

cscannell@vir.bio


Investor Contact

Kiki Patel, PharmD

Head of Investor Relations

kpatel@vir.bio


Original: Vir Biotechnology to Host Conference Call for Fourth Quarter and Full Year 2025 Financial Results

Registration-Ready: How 2026's Clinical Leaders Are Beating Cancer BenchmarksJanuary 27, 2026 3:50 PM
PR Newswire (Canada)

Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, Jan. 27, 2026 /CNW/ -- Equity-Insider.com News Commentary – The global oncology therapy market is charging toward a massive $668 billion valuation by 2034, as a ruthless capital rotation finally rewards execution-ready platforms over the "hopes and dreams" of speculative discovery assets[1]. With the FDA's accelerated approval pathway delivering survival wins across 65% of solid tumor indications, the 2026 regulatory landscape is demanding a new breed of registration-directed study designs that prioritize raw objective response rates and durability[2]. This structural shift creates an asymmetric investment window for Oncolytics Biotech Inc. (NASDAQ: ONCY), Moderna (NASDAQ: MRNA), Merck (NYSE: MRK), Vir Biotechnology (NASDAQ: VIR), and Coherus Oncology (NASDAQ: CHRS) at the intersection of pivotal execution readiness and combination immunotherapy innovation in high-unmet-need gastrointestinal and respiratory cancer markets.







As pharmaceutical giants face a staggering patent cliff, they are aggressively hunting for late-stage assets with clear, high-signal registration pathways[3]. In 2026, the market isn't buying "promise"—it's buying the disciplined execution of pivotal trials and the mechanistic clarity that determines valuation floors[4].Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers.The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications.The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat patient population.The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months.Second-line or later results were equally compelling, with pelareorep achieving a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options.Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas.CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/In other recent industry developments and happenings in the market include:Moderna (NASDAQ: MRNA) and Merck (NYSE: MRK) announced median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, demonstrating that adjuvant treatment with intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% compared to KEYTRUDA alone in patients with high-risk stage III/IV melanoma following complete resection."Now with five years of follow-up data, today's results highlight the potential of a prolonged benefit of the intismeran autogene and KEYTRUDA combination in patients with resected high-risk melanoma," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Oncology and Therapeutics. "We continue to invest in our platform in oncology because of encouraging outcomes like these, which illustrate mRNA's potential in cancer care."The companies have eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types, including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. Moderna and Merck plan to present further data from follow-up analyses of the study's primary and secondary endpoints at an upcoming medical meeting, with the Phase 3 INTerpath-001 trial for adjuvant melanoma fully enrolled.Vir Biotechnology (NASDAQ: VIR) provided updates on its oncology solid tumor portfolio, including new Phase 1 data from its PSMA-targeted PRO-XTEN dual-masked T-cell engager VIR-5500 in prostate cancer to be presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium in February. VIR-5500 is currently being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors for the first-line treatment of metastatic castration-resistant prostate cancer, with the Phase 1 trial successfully clearing the second dose cohort.The Company is also currently enrolling patients in its Phase 1 dose escalation trials for VIR-5818 in HER2-expressing solid tumors and VIR-5525 in EGFR-expressing solid tumors, with Phase 1 dose escalation response data for VIR-5818 expected in the second half of 2026. Vir Biotechnology is progressing additional PRO-XTEN masked T-cell engagers in preclinical studies directed at clinically validated targets with potential applications across lung, colorectal and bladder cancers, all discovered using the Company's proprietary antibody and T-cell engager discovery platform including dAIsY, a proprietary artificial intelligence engine, and the universal PRO-XTEN masking technology.Coherus Oncology (NASDAQ: CHRS) announced publication in Molecular Cancer Therapeutics highlighting the strong pharmacology of investigational CCR8 antibody tagmokitug, demonstrating picomolar binding affinity with no off-target binding. The publication provides important scientific evidence showing tagmokitug selectively eliminates CCR8+ T regulatory cells without affecting other immune cells, with proof-of-mechanism established in first-in-human clinical studies showing selective reductions in CCR8+ Tregs."This publication presents the robust pharmacology of tagmokitug in preclinical and clinical studies, and with a selectivity profile and potent binding and killing of CCR8+ T regulatory cells and not other immune cells. These data provide evidence that tagmokitug has the potential for a differentiated profile," said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer at Coherus. "The data show a high abundance of CCR8 target expression in a broad range of solid tumors suggesting the promise of the tagmokitug program."Coherus Oncology is currently evaluating tagmokitug in Phase 1b/2a clinical trials in patients with solid tumors, including head and neck, colorectal, gastric, and esophageal cancer. The company's immunotherapy pipeline focuses on enhancing innate and adaptive immune responses to enable robust antitumor activity in combination with the approved PD-1 inhibitor LOQTORZI.Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:Equity Insider
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Original: Registration-Ready: How 2026's Clinical Leaders Are Beating Cancer Benchmarks

VIR under $8

VIR reports 3Q24 results—9/30/24 cash=$1.19B:

https://www.businesswire.com/news/home/20241031806056/en

VIR under $10

$VIR PR during News Halt on Aug. 01 2024

Vir Biotechnology Acts on Expanded Strategy of Powering the Immune System Through Exclusive Worldwide License Agreement with Sanofi for Multiple Potential Best-in-Class Clinical-Stage T-cell Engagers— NuntioBot (@NuntioBot) August 1, 2024

https://finviz.com/quote.ashx?t=VIR&p=d#google_vignette

Message in reply to:
VIR pares pipeline—reduces workforce 25%:

https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Reports-Second-Quarter-2024-Financial-Results-and-Announces-Strategic-Restructuring-to-Prioritize-Clinical-Stage-Pipeline-Opportunities/default.aspx

VIR has terminated its programs in flu, COVID, and T cell-based viral vectors.

VIR also announced a collaboration with SNY to develop T-cell engagers (https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Acts-on-Expanded-Strategy-of-Powering-the-Immune-System-Through-Exclusive-Worldwide-License-Agreement-with-Sanofi-for-Multiple-Potential-Best-in-Class-Clinical-Stage-T-cell-Engagers/default.aspx ), but financial terms of the collaboration were not disclosed.


2Q24 CC slides:
https://s203.q4cdn.com/628578897/files/doc_presentations/2024/Jul/Vir-Corporate-Presentation_Q2-2024.pdf

VIR pares pipeline—reduces workforce 25%:

https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Reports-Second-Quarter-2024-Financial-Results-and-Announces-Strategic-Restructuring-to-Prioritize-Clinical-Stage-Pipeline-Opportunities/default.aspx

VIR has terminated its programs in flu, COVID, and T cell-based viral vectors.

VIR also announced a collaboration with SNY to develop T-cell engagers (https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Acts-on-Expanded-Strategy-of-Powering-the-Immune-System-Through-Exclusive-Worldwide-License-Agreement-with-Sanofi-for-Multiple-Potential-Best-in-Class-Clinical-Stage-T-cell-Engagers/default.aspx ), but financial terms of the collaboration were not disclosed.


2Q24 CC slides:
https://s203.q4cdn.com/628578897/files/doc_presentations/2024/Jul/Vir-Corporate-Presentation_Q2-2024.pdf

VIR under $11

VIR under $10

VIR +18% on phase-2 HDV data at EASL:

https://finance.yahoo.com/news/tobevibart-monotherapy-combination-therapy-elebsiran-093000369.html

Note: HDV is a subset of HBV insofar as HDV resides within HBV’s capsid.

VIR 1Q24 CC transcript:

https://finance.yahoo.com/news/vir-biotechnology-inc-nasdaq-vir-170535096.html

VIR still reversing off the recent 52 week low

VIR reports 1Q24 results—3/31/24 cash=$1.51B(!):

https://www.businesswire.com/news/home/20240502260564/en

VIR re-iterated guidance for 2024 operating expenses of $650-680M.

CC slides:
https://investors.vir.bio/files/doc_financials/2024/q1/Vir-Corporate-Presentation_Q1-2024.pdf

VIR under $10

VIR adds two luminaries to BoD:

https://www.businesswire.com/news/home/20240418098064/en

The capsule bios in the PR speak for themselves.

VIR 4Q23 CC transcript:

https://finance.yahoo.com/news/q4-2023-vir-biotechnology-inc-185403667.html

VIR 4Q23 CC slides:

https://investors.vir.bio/files/doc_presentations/2024/02/22/Vir-Corporate-Presentation_Q4-2023.pdf

VIR reports 4Q23 results—issues 2024 expense guidance:

https://www.businesswire.com/news/home/20240222740501/en

12/31/23 cash was $1.63B, after burning $108M during 4Q23.

2024 guidance for SG&A + R&D GAAP expenses is $650-680M.

At the current share price, VIR has an enterprise value of roughly negative $200M.

VIR’s CMO left the company, which explains the exercise-and-hold transaction from January in the post I'm replying to:

https://finance.yahoo.com/news/vir-biotechnology-announces-dr-phil-213000676.html

Note: The above was issued on 2/20/24.

GSK, VIR terminate flu collaboration inked in 2021:

https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/0001706431/000162828024006346/vir-20240221.htm

This outcome is not surprising outcome insofar as the phase-2 trial of VIR-2484, the lead compound of the collaboration, was a failure ( #msg-172395320).

VIR’s CMO exercised and held ~$800K of stock yesterday:

https://www.sec.gov/Archives/edgar/data/1706431/000162828024000169/xslF345X05/wk-form4_1704311270.xml

The options in question did not expire until 2027-2028.

VIR cuts workforce 12%:

https://www.businesswire.com/news/home/20231213396441/en

It’s bizarre to see belt-tightening by a company with $1.7B of net cash (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001706431/000162828023036702/vir-20230930.htm#i4ba948c416a6412b946073491455ca74_19 ), but it’s probably the right thing to do inasmuch as the stock’s EV is deeply negative.

Nice move today

VIR -45% on phase-2 failure in influenza:

https://finance.yahoo.com/news/vir-biotechnology-announces-topline-data-120000102.html Vir Biotechnology…today announced that the Phase 2 PENINSULA trial evaluating VIR-2482 for the prevention of symptomatic influenza A illness did not meet primary or secondary efficacy endpoints. Why such a steep selloff? One reason is that VIR has tended to present itself to investors as all-powerful and all-knowing, which is perhaps a consequence of having George Scangos as (ex)CEO and having raised a huge amount of capital based on management’s reputation.

VIR starts 4-drug phase-2 HBV trial:

https://www.globenewswire.com/news-release/2023/05/11/2666740/0/en/Vir-Biotechnology-Announces-First-Patient-Dosed-in-New-Phase-2-Chronic-Hepatitis-B-Virus-Trial-Evaluating-Combinations-of-VIR-2218-VIR-3434-PEG-IFN%CE%B1-and-an-NRTI.html

The four drugs are: VIR-2218, a siRNA; VIR-3434, a mAb; PEG-IFN; and a (generic) nucleoside.

A separate phase-2 trial (VIR calls it a “subprotocol”) will test VIR-3434 and a nuke, with and without VIR-2218, in patients who are chronic inactive carriers of the HBV virus. I'm unclear as to whether this second trial is for research purposes or for an addressable commercial market.

48w VIR-2219 +peg-IFN—>31% HBs seroconverion:

https://www.globenewswire.com/news-release/2022/11/06/2549180/0/en/Vir-Biotechnology-Presents-New-Data-Evaluating-the-Potential-for-VIR-2218-and-VIR-3434-to-Achieve-a-Functional-Cure-for-Chronic-Hepatitis-B-Virus-HBV-Infection.html

The 31% figure is impressive insofar as peg-IFN by itself has a 48w seroconversion rate of only 5-10%. Of course, a 48w regimen of VIR-2219 + peg-IFN won’t be any easier to tolerate than 48w of peg-IFN monotherapy, so this regimen is still far from the ultimate answer for treating chronic HBV.

VIR has started testing the triple combination of VIR-2219 (siRNA) + VIR-3434 (mAb) + peg-IFN; initial data are expected in 2H23.

VIR EASL presentations:

https://www.globenewswire.com/news-release/2022/06/25/2469082/0/en/Vir-Biotechnology-Announces-New-Clinical-Data-From-its-Broad-Hepatitis-B-Program.html

No CC.

VIR HBV webcast slides:

https://investors.vir.bio/static-files/7ece44c3-0585-47af-81b4-2199889d6934

VIR -14% on amended Sotrovimab EUA due to Omicron BA.2 variant:

https://finance.yahoo.com/news/us-food-drug-administration-revises-200400156.html GlaxoSmithKline plc and Vir Biotechnology…today announced that the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody. The FDA has determined that, based on the totality of available evidence, including new live virus data generated by Vir, it is unlikely that the sotrovimab 500 mg dose will be effective against the Omicron BA.2 variant.

GSK and Vir are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and will be sharing these data with regulatory and health authorities around the world for discussion. This PR was issued after the close, but the market apparently got wind of the FDA decision about 3:45pm ET.

VIR 4Q21 results:

https://www.globenewswire.com/news-release/2022/02/24/2391890/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html As of December 31, 2021, excluding restricted cash, the Company had approximately $909.5 million in cash, cash equivalents, and investments. Excluding restricted cash and its equity investment in Brii Biosciences, the Company had approximately $766.4 million in cash, cash equivalents and investments.

VIR’s 2022 HBV newsflow:

https://www.globenewswire.com/news-release/2022/02/24/2391890/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html In 2022, the Company expects data readouts from multiple trials evaluating VIR-2218 and VIR-3434:

• Initial data from the first cohorts of Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial of VIR-2218 in combination with VIR-3434, are expected in the first half of 2022.

• Additional data from the Phase 2 trial of VIR-2218 in combination with PEG-IFN-alpha are expected in the first half of 2022.

• Additional data from the Phase 1 monotherapy trial of VIR-3434 are expected in the first half of 2022.

• The Company’s collaborator, Brii Biosciences, continues to lead the Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the potential treatment of chronic HBV infection. Initial data are expected in the second half of 2022. Evidently, there will not be a 2022 readout from the phase-2 trial testing combinations of VIR-2218, GILD’s GS-9688, Vemlidy (TAF), and Opdivo (#msg-167061759, #msg-160854272, #msg-167063133).

Up so far on another Biotech down day
Seems like a good omen.

VIR slide set from JPM:

https://investors.vir.bio/static-files/7ecf45fb-6918-4cf8-9a02-b8c12183ca4f

VIR/GILD start phase-2 trial testing quadruple regimen of VIR-2218; GS-9688; Opdivo; and Vemlidy (TAF) in (both nuc-suppressed and viremic) HBV patients:

https://finance.yahoo.com/news/vir-biotechnology-announces-initiation-phase-133000267.html

I’m not sure why it took almost a year for this trial to begin enrolling patients—the PR announcing the collaboration was issued on 1/12/21.

Please see #msg-160854272 for background.

Loaded again. After omicron news all weekend this will be the next MRNA biotech. $75+ by years end for starters imo.

In $46, omicron play.

VIR starts HBV_combination_trial_of_ VIR-2218 and VIR-3434:

https://finance.yahoo.com/news/vir-biotechnology-initiates-phase-2-123000780.html The multi-center, open-label Phase 2 trial is designed to evaluate the safety, tolerability and efficacy of the combination of VIR-2218 and VIR-3434 in approximately 90 adult patients (ages 18 to 65) with chronic HBV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Both VIR-2218 and VIR-3434 will be administered via subcutaneous injection at varying dose levels over the course of the trial for a treatment period ranging from four to 20 weeks, and a follow-up period of up to 116 weeks, depending on the dosing cohort.

…VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 “vaccinal mutation,” allowing it to potentially function as a therapeutic T cell vaccine against HBV. See #msg-164593550, #msg-161217289, and #msg-164599741 for related info.

VIR -6% on VIR-2218 and VIR-3434 monotherapy data presented at EASL:

https://finance.yahoo.com/news/vir-biotechnology-presents-clinical-data-125000851.html

CC to discuss these data with investment community at 11am ET.

"profound efficacy." Vir Biotechnology and GSK plan to seek emergency use authorization for their experimental COVID-19 antibody therapy after interim data from a study showed 85% reduction in hospitalization and deaths among patients.


Based on these positive results, Vir and GlaxoSmithKline intend to request Emergency Use Authorization (EUA) for VIR-7831 from the U.S. Food and Drug Administration (FDA) and other international regulators.

"We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients," GlaxoSmithKline chief scientific officer Dr. Hal Barron said. "We look forward to the possibility of making VIR-7831 available to patients as soon as possible."

Too high too fast. Very typical price movement. I you think your gonna ride a rocket to the moon you better be ready when the booster fuel runs out.