MTVA 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• We initiated a Phase 2a clinical trial in 2023 with the goal of establishing the mechanism of action and efficacy of vanoglipel in the treatment of MASH and to evaluate trends for T2DM. This is the first-in-human MASH clinical trial for vanoglipel. We are expecting to finalize the Clinical Study Rep…

• For additional information on vanoglipel, including an overview of the top-line 16-week results from the two-part Phase 2a clinical trial, see “Part I, Item 1. Business, Our Pipeline, vanoglipel (DA-1241) Treatment of MASH” in our 2025 Form 10-K.

• We initiated a Phase 1 clinical trial in 2024 with the goal of establishing the safety and tolerability of DA-1726 while exploring the mechanism of action and efficacy of DA-1726 in the treatment of obesity. This is the first-in-human clinical trial for DA-

• 1726. We started Part 3a and Part 3b of the Phase 1 clinical trial in April 2026. Part 3a will be a one-step titration with 16 mg for four weeks and 48 mg for 12 weeks. Part 3b will be a two-step titration with 16 mg for four weeks, 32 mg for four weeks and 64 mg for eight weeks. These titration stu…

• ●January 2026: Announced positive statistically significant results from the eight-week (extended from four weeks) non-titrated 48 mg, multiple ascending dose (MAD) cohort of the Phase 1 clinical trial for DA-1726.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• We are currently finalizing the Clinical Study Report on a Phase 2a clinical trial in the United States (“U.S.”). MASH Phase 2a is a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical trial to establish safety and an early signal of efficacy in MASH as a next-g…

• In December 2024, we announced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. Part 1 of this Phase 2a trial is exploring Vanoglipel (DA-1241), a novel GPR119 agonist compared to placebo, while Part 2 is investigating the efficacy of Vanogl…

• We are currently working to schedule an end-of-Phase 2 meeting with the Food and Drug Administration (“FDA”). For additional information on Vanoglipel (DA-1241), including an overview of the top-line 16-week results from the two-part Phase 2a clinical trial, see “Part I, Item 1. Business, Our Pipeli…

• We are currently conducting a Phase 1 trial in the U.S. The Phase 1 trial, a first-in-human trial, is a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of DA-1726 in ob…

• In September 2024, we announced positive top-line data from the single ascending dose Part 1 of our Phase 1 trial evaluating DA-1726. In April 2025, we announced positive top-line data from the multiple ascending dose (“MAD”) Part 2 study of our Phase 1 trial.

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• There have been no changes in our internal control over financial reporting during the quarter ended March 31, 2026 that have

• materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• There have been no changes in our internal control over financial reporting during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.