Vir Biotechnology, Inc. 8-K Filing

FAQ

Key Financial Figures

• $0.0001 — ange on which registered Common stock, $0.0001 par value VIR Nasdaq Global Select Mark

Filing Documents

• vir-20251216.htm (8-K) — 35KB
• a2025-12_halopressrelease.htm (EX-99.1) — 24KB
• image_0a.jpg (GRAPHIC) — 54KB
• 0001628280-25-057394.txt ( ) — 286KB
• vir-20251216.xsd (EX-101.SCH) — 2KB
• vir-20251216_def.xml (EX-101.DEF) — 15KB
• vir-20251216_lab.xml (EX-101.LAB) — 26KB
• vir-20251216_pre.xml (EX-101.PRE) — 16KB
• vir-20251216_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. Press Release On December 16, 2025 , Vir Bio issued a press release announcing the entry into the Agreement. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated herein by reference. SOLSTICE Clinical Trial Update Certain data from the ongoing SOLSTICE Phase 2 clinical trial were presented in an oral session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting , in Washington, D.C., in November 2025 and simultaneously published in the New England Journal of Medicine . These data focused on Week 48 endpoint analysis and included rates of virologic suppression and alanine aminotransferase (ALT) normalization, reductions in hepatitis B surface antigen (HBsAg). The data demonstrated that 66% (21/32) of participants with CHD receiving a monthly dose of the combination of tobevibart and elebsiran achieved and sustained HDV RNA target not detected (TND) at 48 weeks. Additionally, approximately 90% (29/32) of participants achieved reduction in HBsAg to values <10 IU/mL by Week 48. HBsAg reduction indicates suppression of the fundamental biologic mechanisms that HDV requires for viral replication. ALT was normalized (defined as ALT below upper limit of normal) in 56% (18/32) of participants by Week 48. The combination was well-tolerated, with no grade 3 or higher treatment-related adverse events and no treatment-related discontinuations. Most treatment-related adverse events were generally mild to moderate and transient.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K (this Form 8-K) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "should," "could," "may," "might," "will," "plan," "potential," "aim," "expect," "anticipate," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this Form 8-K include, but are not limited to, statements regarding: the therapeutic potential of the combination of tobevibart and elebsiran to treat CHD; Vir Bio's immediate and potential future financial and other obligations under the agreement with Norgine; the timing of the anticipated closing of the transaction with Norgine, including receipt of any necessary regulatory approvals; Vir Bio's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies, some of whom may be competitors of Vir 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 Biotechnolo

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release of the Company, dated December 16 , 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. VIR BIOTECHNOLOGY, INC. Date: December 16, 2025 By: /s/ Marianne De Backer Marianne De Backer, M.Sc., Ph.D., MBA Chief Executive Officer

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View this 8-K filing on SEC EDGAR