Intensity Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Intensity Therapeutics, Inc. reported its third quarter 2025 financial results and provided updates on its clinical studies, particularly focusing on its lead product candidate INT230-6, which is designed for intratumoral cancer therapy [1][4]. Corporate Update - The INVINCIBLE-4 Study, a Phase 2 trial for early-stage triple-negative breast cancer, has paused new patient enrollment due to localized skin irritation in some patients. The company plans to amend the protocol and resume enrollment in Q1 2026 [2][8]. - The INVINCIBLE-3 Study, a Phase 3 trial for specific soft tissue sarcoma subtypes, has also paused new site activations and patient enrollments due to funding constraints, with 21 patients enrolled prior to the pause. The company continues to treat existing patients and plans to restart the study once funding is secured [3][8]. - A manuscript detailing the Phase 1/2 IT-01 study results was published in eBioMedicine, highlighting the safety and efficacy of INT230-6 in treating advanced solid tumors [4][5]. Financial Results - Research and development expenses for Q3 2025 were $1.6 million, down from $2.2 million in Q3 2024, primarily due to reduced costs associated with the INVINCIBLE-3 Study [6]. - General and administrative expenses decreased to $1.2 million in Q3 2025 from $1.4 million in Q3 2024, attributed to lower consulting expenses [6]. - The net loss for Q3 2025 was $2.7 million, an improvement from a net loss of $3.5 million in the same period last year [7]. Capital Raises and Cash Runway - The company raised a total of $13.6 million since the beginning of Q3 2025, extending its cash runway until the end of Q1 2027 [5][8]. - Recent fundraising included $7.5 million raised in Q3 2025 and an additional $4 million in a registered direct offering in October 2025 [9]. Clinical Efficacy of INT230-6 - In heavily pretreated patients with advanced disease, INT230-6 achieved a disease control rate of 75% and a median overall survival of 11.9 months, significantly better than historical data [9]. - In a subset of metastatic sarcoma patients, the median overall survival was reported at 21.3 months [9]. - The treatment demonstrated a qualitative decrease in proliferating cancer cells and an increase in activated T-cells in the tumor microenvironment, with no dose-limiting toxicities reported [9][10].