SMMT 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-07-23

• In July 2026, an updated analysis was conducted with a data cutoff date of June 2026 which analyzed OS when most western patients had discontinued treatment or completed two years of treatment. This analysis showed a consistent OS trend amongst western and Asian patients as western patients were fol…

• Enrollment in the non-squamous cohort of the global HARMONi-3 study was completed in the second quarter of 2026. For this cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027.

• In July 2026, the Company entered into a clinical trial collaboration with Arcus Biosciences, Inc (“Arcus”) to evaluate ivonescimab in combination with Arcus’ novel inhibitor of hypoxia-inducible factor 2-alpha, casdatifan, in clear cell renal cell carcinoma (the “Arcus Collaboration”). Both Arcus a…

• The dual primary endpoints were allocated separate alpha levels and tested individually. The alpha was recycled from the PFS to the OS analysis upon the successful achievement of the PFS endpoint.

• In September 2025, an additional ad hoc OS analysis was performed for the HARMONi study whereby the western patients were followed for a longer period of time (Asian patients were locked at the time of the primary analysis). In this analysis that included longer-term follow-up of western patients (m…

相对上期删除的文字 · 来源:10-Q · 2026-04-30

• The dual primary endpoints were allocated separate alpha levels and tested individually. The alpha was recycled from the PFS to the OS analysis upon the successful achievement of the PFS endpoint.

• Enrollment in the non-squamous cohort of HARMONi-3 is expected to complete by the end of the second quarter of 2026. The Company expects to perform the PFS analysis for this cohort in the first half of 2027. Interim analyses for OS are planned to be conducted, based upon reaching prespecified number…

• In September 2025, an additional ad hoc OS analysis was performed for the HARMONi study whereby the Western patients were followed for a longer period of time (Asian patients were locked at the time of the primary analysis). In this analysis that included longer-term follow-up of Western patients (m…

• The dual primary endpoints were allocated separate alpha levels and tested individually. The alpha was recycled from the PFS to the OS analysis upon the successful achievement of the PFS endpoint.

• Enrollment in the non-squamous cohort of HARMONi-3 is expected to complete by the end of the second quarter of 2026. The Company expects to perform the PFS analysis for this cohort in the first half of 2027. Interim analyses for OS are planned to be conducted, based upon reaching prespecified number…

相对上期删除的文字 · 来源:10-Q · 2026-04-30

• rate risk. Exposures are generally managed through natural hedging via the currency denomination of cash balances and any impact currently is not material to us.

相对上期新增的文字 · 来源:10-Q · 2026-07-23

• We have carried out an evaluation of the effectiveness of our disclosure controls and procedures under the supervision and the participation of the Company’s management, including our Co-Chief Executive Officers (our Principal Executive Officers) and our Chief Operating Officer and Chief Financial O…

• controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded…

• There were no changes in our internal control over financial reporting (as defined in Rules 13a‑15(f) and 15d‑15(f) under the Exchange Act) during the quarter ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial report…

相对上期删除的文字 · 来源:10-Q · 2026-04-30

• We have carried out an evaluation of the effectiveness of our disclosure controls and procedures under the supervision and the participation of the Company’s management, including our Co-Chief Executive Officers (our Principal Executive Officers) and our Chief Operating Officer and Chief Financial O…

• There were no changes in our internal control over financial reporting (as defined in Rules 13a‑15(f) and 15d‑15(f) under the Exchange Act) during the quarter ended March 31, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial repor…