VIR 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• •We completed enrollment in the Phase 3 ECLIPSE 2 trial, and the entire ECLIPSE registrational program is now fully enrolled. ECLIPSE 2 evaluates the efficacy and safety of switching from bulevirtide to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirt…

• ◦Topline data from the Phase 3 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.

• •We presented complete Week 96 Phase 2 SOLSTICE data at the European Association for the Study of the Liver (EASL) Congress in May 2026.

• ◦In the intent-to-treat (ITT) analysis, the data showed 88% (28/32) of participants treated with the combination of elebsiran and tobevibart achieved undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) compared to 53% (17/32) of participants on antibody monotherapy.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• •We will present additional data from the Phase 2 SOLSTICE trial evaluating the combination of tobevibart and elebsiran for CHD at the European Association for the Study of the Liver (EASL) Congress taking place May 27-30, 2026.

• •In January 2026, we reported Phase 2 SOLSTICE data showing that the monthly combination of tobevibart and elebsiran was highly efficacious and well-tolerated. Undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) was achieved and maintained by 77% (24/31) of participants receivi…

• •Topline data from the Phase 3 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.

• •On April 15, 2026, we closed our global strategic collaboration with Astellas US LLC (together with its subsidiaries and affiliates (including its indirect parent, Astellas Pharma Inc.), Astellas) to advance PSMA-targeted PRO-XTEN® dual-masked TCE VIR-5500 for the treatment of prostate cancer.

• •The first patient was dosed in the Phase 1 dose-expansion cohorts evaluating the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in prostate cancer. The first expansion cohort will evaluate VIR-5500 monotherapy in Q3W 800/2000/3500 µg/kg step-up dosing in late-line mCRPC. We anticipat…

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• •certain strategic collaborations may require us to fund a portion of future development or commercialization costs to maintain our participation in any profit-sharing or other economic arrangements for a product candidate, and if we are unable to satisfy those funding obligations, or determine that…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• For example, on February 19, 2026, we and Astellas entered into a Collaboration and License Agreement (the Astellas Agreement). On April 15, 2026, this global strategic collaboration to co-develop and co-commercialize VIR-5500 for the treatment of prostate cancer became effective, and we will receiv…

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• On April 27, 2026, Mark Eisner, M.D., M.P.H., our former Executive Vice President and Chief Medical Officer, terminated a trading arrangement intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (the Eisner Trading Plan). The Eisner Trading Plan was originally adopted on May 19, …

• On May 26, 2026, for estate and financial planning purposes, Vanina de Verneuil, J.D., our Executive Vice President, General Counsel and Corporate Secretary, adopted a Rule 10b5-1 trading plan for the sale of our common stock that is intended to satisfy the affirmative defense conditions of Exchange…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• On February 22, 2026, the Company issued restricted stock units (RSUs) subject to mandatory sell-to-cover tax withholding arrangements intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c) to the following officers of the Company:

• •Marianne De Backer, M.Sc., Ph.D., MBA, our President and Chief Executive Officer;

• •Vanina de Verneuil, J.D., our Executive Vice President, General Counsel and Corporate Secretary;

• •Mark Eisner, M.D., M.P.H., our then-serving Executive Vice President and Chief Medical Officer;

• •Jason O’Byrne, MBA, our Executive Vice President and Chief Financial Officer; and