VIR 最新10-Q变化

相对上期新增的文字 · 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…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• •The ECLIPSE 1 Phase 3 trial has completed enrollment approximately two months ahead of our internal projections. Primary completion is expected in the fourth quarter of 2026, with topline data expected in the first quarter of 2027. ECLIPSE 1 evaluates the combination of tobevibart and elebsiran com…

• •The ECLIPSE 2 Phase 3 trial continues enrolling well, and topline data are expected in the first quarter of 2027. ECLIPSE 2 evaluates the switch to the combination of tobevibart and elebsiran in participants who have not achieved undetectable hepatitis delta virus RNA with bulevirtide treatment.

• •The ECLIPSE 3 Phase 2b trial is progressing ahead of schedule with strong enrollment momentum, and topline data are expected in the first quarter of 2027. ECLIPSE 3 evaluates the combination of tobevibart and elebsiran compared to bulevirtide monotherapy in bulevirtide treatment-naïve participants.

• •Following positive data presented at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2024, we will present Week 48 endpoint results from its SOLSTICE Phase 2 clinical study in patients with CHD at AASLD The Liver Meeting® 2025. The oral presentation will take place o…

• •VIR-5500, a PRO-XTEN® dual-masked TCE targeting prostate-specific membrane antigen (PSMA), continues to advance through Phase 1 dose escalation as a monotherapy in heavily pre-treated patients with mCRPC and has demonstrated promising early anti-tumor activity and a favorable safety profile.

相对上期新增的文字 · 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…

• •while we have assumed regulatory sponsorship for all current TCE trial programs, we may in the future, and in certain cases expect to, rely on licensors to continue serving as regulatory sponsors for clinical trial programs until a complete transition of sponsorship can be made, or alternatively tr…

• •any milestones that would trigger payments pursuant to our strategic collaborations may not occur on the anticipated timelines, or at all;

• In order for our products to be eligible for coverage under certain government health care programs, we will be required to enter into agreements with the government and provide complex pricing calculations that, in turn, may influence government reimbursement rates. For instance, reimbursement for …

• Healthcare legislative, administrative and other reform measures may have a negative impact on our business, financial condition, results of operations and prospects.

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• We do not expect meaningful future revenue from the sale of sotrovimab for the treatment of COVID-19, even if it were reauthorized by the FDA.

• In December 2024, the FDA revoked the EUA that we and GSK had received in May 2021 for the sale of sotrovimab to treat COVID-19. Even prior to the FDA’s revocation of our EUA, sotrovimab had not been authorized for use in any U.S. region for the treatment of COVID-19 since the FDA’s exclusionary rev…

• While sotrovimab still maintains emergency authorization, temporary authorization or marketing approval (under the brand name Xevudy®) for early treatment of COVID-19 in certain territories outside of the United States, we did not earn meaningful revenue from sales of sotrovimab during the most rece…

• For these reasons, we do not currently expect meaningful future revenue from sotrovimab for the treatment of COVID-19.

• •while we have assumed regulatory sponsorship for all current TCE trial programs, we may, during any transition period with respect to future in-licensed clinical programs, be reliant on licensors to continue serving as regulatory sponsors (and executing all appropriate sponsorship responsibilities …

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• A portion of the compensation of the Company’s directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) is in the form of equity awards and, from time to time, directors and officers may engage in open-market transactions with respect to the securities acquired pursuant to such eq…

• Transactions in Company securities by directors and officers are required to be made in accordance with the Company’s insider trading policy, which requires that the transactions be in accordance with applicable U.S. federal securities laws that prohibit trading while in possession of material non-p…

• During the quarterly period covered by this report, none of our directors or officers entered into or terminated a Rule 10b5-1 trading arrangement or adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) except as follows:

• 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;

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• During the quarterly period covered by this report, none of our directors or officers entered into or terminated a Rule 10b5-1 trading arrangement or adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).