BDTX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• In July of 2025, we completed enrollment of 43 patients in a Phase 2 trial of silevertinib in frontline NSCLC patients harboring non-classical EGFR mutations. In December of 2025, we announced initial data from these 43 frontline NSCLC patients harboring a broad spectrum of 35 distinct non-classical…

• Silevertinib has demonstrated encouraging CNS activity in multiple trials across NSCLC and GBM. In our Phase 2 in frontline patients with EGFRm NSCLC 86% of patients achieved a confirmed CNS response. The results from our Phase 1 trial of silevertinib in patients with relapsed/recurrent GBM (present…

• We are also continuing to explore potential partnership opportunities to advance silevertinib into pivotal development.

• No revenue was recorded for the three months ended March 31, 2026 compared to $70.0 million for the three months ended March 31, 2025. The decrease was a result of the upfront payment we received from Servier in the first quarter of 2025 under the Servier Agreement.

• Research and development expenses were $7.0 million for the three months ended March 31, 2026, compared to $10.5 million for the three months ended March 31, 2025. The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025:

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Enrollment in frontline patients harboring non-classical EGFR mutations (cohort 3, n=43) was completed in July 2025, and we are on track to announce initial results from this cohort in the fourth quarter of 2025. We plan to solicit U.S. Food and Drug Administration (FDA) feedback on a potential regi…

• In September 2024, we announced initial data demonstrating encouraging clinical responses and durability of silevertinib from our Phase 2 clinical trial in 27 patients with EGFRm NSCLC in the second- and third-line settings (cohorts 1 and 2). The 200 mg daily dose of silevertinib was selected for pi…

• In June 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting, we presented preliminary data from the Phase 1 trial of silevertinib in patients with relapsed/recurrent GBM, demonstrating encouraging duration of treatment and clinical activity, and a tolerability profile consistent…

• Research and development expenses were $7.4 million for the three months ended September 30, 2025, compared to $12.9 million for the three months ended September 30, 2024. The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024:

• Silevertinib research and development expenses$3,760 $6,372 $(2,612)

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Disruptions at the FDA, other government agencies or comparable foreign regulatory authorities caused by funding shortages could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or …

• Currently, federal agencies in the U.S. are operating under a federal government shutdown due to expiration of the continuing resolution on September 30, 2025. The duration of the current government shutdown is unknown. Without appropriation of additional funding to federal agencies, our business op…

• Disruptions and personnel turnover, as a result of leadership changes, staff reductions or otherwise, at the FDA, other government agencies or comparable foreign regulatory authorities may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, whi…

• Changes and cuts in FDA staffing have been reported by some in the pharmaceutical industry as creating instances of delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a time…

• Business, economic or geopolitical disruptions or global health concerns could seriously harm our development efforts and increase our costs and expenses.

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• On February 26, 2026, Elizabeth Buck, our Chief Scientific Officer, entered into a trading arrangement intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (the Buck 10b5-1 Plan). The Buck 10b5-1 Plan is scheduled to commence on May 28, 2026, and will run through May 31, 2027. Th…