Item 8.01. Other Events.
On September 10, 2025, Intensity Therapeutics, Inc. (the "Company") announced an update on it's INVINCIBLE-4 study. The update reported that a pathological complete response ("pCR") was observed in the first patient evaluated in Cohort A, where each patient received two doses of INT230-6 eight days apart, followed by the standard of care immunochemotherapy, and that to date, the safety profile looks favorable in Cohort A. However, some patients in Cohort A experienced localized skin irritation near the tumor site and therefore, new patient enrollment has been paused to evaluate the data collected and to implement necessary adjustments prior to reopening patient enrollment.