Intensity moves to resume INVINCIBLE-3 sites, restarts TNBC treatment, reports $9.5M cash

Intensity Therapeutics reported second quarter 2026 results on August 11, 2026, and provided updates on its two active clinical programs. For the Phase 3 "INVINCIBLE-3" study in soft tissue sarcoma, the company initiated activities in April 2026 to resume enrollment in a limited number of U.S. sites using an FDA-reviewed amended protocol based on learnings from patients previously enrolled¹. That trial had been paused in March 2025 due to funding constraints, at which point 21 patients had enrolled, with the company continuing to treat all patients and maintain the database during the pause¹. The company said the FDA has reviewed the amended protocol, which will be implemented for new patient enrollment¹, and that submission of documentation necessary for restarting in the EU is in progress¹. Site activation is expected to speed up as sufficient funding is obtained¹.

In the Phase 2 "INVINCIBLE-4" study in presurgical triple negative breast cancer, patient treatment restarted in July 2026, with the company targeting complete enrollment by the end of 2027¹. The trial had paused new enrollment in September 2025 to revise the dosing regimen after some patients experienced localized skin irritation near the tumor site¹. A protocol change lowering drug-to-tumor volume ratio was approved in Switzerland in March 2026, and in August 2026 the company opened its first site in France for accrual following EU submission of the modified protocol¹. Preliminary data from the first 14 patients showed a 71% pathological complete response in the INT230-6 cohort versus 42% in the standard-of-care cohort, along with a 44% reduction in grade 3 adverse events¹.

The company reported a net loss of $3.0 million for the quarter and cash and cash equivalents of $9.5 million as of June 30, 2026¹. It also disclosed a $60 million at-the-market facility established in March 2026, under which it raised net proceeds of $1.6 million during the second quarter and an additional $1.3 million after quarter-end¹.