UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On June 26, 2024, Vir Biotechnology, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has cleared its investigational new drug application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection (the “Fast Track Designation”). A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
Forward-Looking Statements
This disclosure, including the press release filed herewith as Exhibit 99.1, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “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. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this Current Report on Form 8-K. Forward-looking statements contained herein include, but are not limited to, statements regarding the Company’s strategy and plans, the potential clinical effects, benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from the Company’s multiple ongoing trials evaluating tobevibart and elebsiran, including the previously announced Phase 2 SOLSTICE data, the timing of any further releases of data or of any presentations or investor conference calls, the Company’s plans and expectations for its chronic hepatitis delta and chronic hepatitis B programs, the Company’s ability to realize the benefits from receiving the Fast Track Designation from the FDA, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including that the Fast Track Designation might not result in a more expedited development or regulatory review process, and such a designation does not increase the likelihood that the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection will receive marketing approval in the United States; the Fast Track Designation does not change the standards for regulatory approval; the FDA may later decide that the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection no longer meets the conditions for qualification or that the time period for FDA review or approval will not be shortened; unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by the Company’s competitors; changes in expected or existing competition; delays in or disruptions to the Company’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. 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 trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements herein are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press Release of the Company, dated June 26, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| VIR BIOTECHNOLOGY, INC. | ||||||
| Date: June 26, 2024 | By: | /s/ Marianne De Backer | ||||
| Marianne De Backer, M.Sc., Ph.D., MBA | ||||||
| Chief Executive Officer | ||||||