(RTTNews) - Intensity Therapeutics, Inc. (INTS), a late-stage clinical biotechnology company developing intratumoral cancer therapies using its proprietary DfuseRx technology, is up over 8% in premarket trading on Monday. The company has significant catalysts to watch during the upcoming months.
A key focus for 2026 is the INVINCIBLE-4 Phase 2 study evaluating INT230-6 in combination with standard of care (SOC) in early-stage, operable triple-negative breast cancer. Following localized skin irritation observed in some patients in 2025, Intensity plans to file a protocol amendment in the first quarter of 2026 to adjust dosing volumes.
The company expects to reinitiate enrollment for the now 61-patient study in Q1 2026, adding seven additional patients to Cohort A. Early data presented in December 2025 showed a favorable safety profile, with 50% fewer Grade 3 or higher adverse events compared to standard neoadjuvant chemotherapy.
The INVINCIBLE-3 Phase 3 trial, an open-label randomized study evaluating INT230-6 as monotherapy against standard-of-care drugs in second- and third-line soft tissue sarcoma subtypes, remains on enrolment pause due to prior funding constraints. Intensity plans to restart patient enrolment and site activations during 2026, contingent on securing sufficient capital. Before the pause, 21 patients had been enrolled.
The company is also evaluating the potential initiation of a new Phase 3 breast cancer study combining INT230-6 with standard of care. This program may advance in 2026 if safety and efficacy trends from INVINCIBLE-4 continue and additional funding is obtained.
Intensity plans to continue an aggressive peer-review publication strategy in 2026, building on its October 2025 eBioMedicine publication that reported a 75% disease control rate and evidence of abscopal effects in metastatic cancer patients treated with INT230-6.
The company strengthened its financial position in 2025 by raising over $20 million, extending its operating runway into the second quarter of 2027. Intensity intends to maintain disciplined spending while opportunistically raising additional capital in 2026 to support its Phase 3 programs.
INTS has traded between $0.18 and $2.52 over the past year. The stock closed Friday's (February 6, 2026), trading at $0.34, up 3.01% and rose further in the overnight trading to $0.37, up 8.42%%.
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