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SHELTON, Conn. - Intensity Therapeutics, Inc. (NASDAQ:INTS), a small-cap biotech company with a market capitalization of $9.25 million, reported that the first few patients receiving its experimental cancer drug INT230-6 achieved high levels of tumor necrosis after eight days in its Phase 2 INVINCIBLE-4 study, before they began standard-of-care treatment. The company’s stock has experienced significant volatility, falling nearly 90% over the past year according to InvestingPro data.
The ongoing randomized trial is evaluating INT230-6 in patients with early-stage, operable triple-negative breast cancer (TNBC). Patients are randomized to receive either two doses of INT230-6 followed by standard immunochemotherapy, or standard treatment alone. The primary endpoint is pathological complete response, defined as the absence of live cancer in the primary tumor and affected lymph nodes. While the company maintains a favorable debt-to-equity ratio of 0.39, InvestingPro analysis indicates current short-term obligations exceed liquid assets, with a current ratio of 0.63.
"We are encouraged to see high levels of tumor necrosis from the MRI scans and evidence of tumor inflammation after two INT230-6 injections and before initiation of the standard of care in our first patients," said Dr. Ursina Zürrer, Coordinating Investigator for the study.
The trial is currently recruiting patients in Switzerland and France with an expected enrollment of 54 participants.
INT230-6 is designed for direct injection into tumors and contains two anti-cancer agents, cisplatin and vinblastine sulfate, along with a diffusion enhancer molecule. According to the company, the drug remains in the tumor and causes the release of neoantigens that engage the immune system.
Triple-negative breast cancer affects approximately 56,000 new patients annually in the U.S. and 420,000 worldwide. It is considered more aggressive than other breast cancer types, with fewer targeted treatment options available.
The information in this article is based on a press release statement from Intensity Therapeutics.
In other recent news, Intensity Therapeutics disclosed its financial results for the first quarter of 2025, reporting a quarterly loss of $3.3 million, or $0.19 per share. This represents an improvement from the previous year’s loss of $4.6 million, or $0.34 per share, during the same period. The company is actively engaged in clinical trials, including a significant Phase 3 trial for INT230-6 as a monotherapy for advanced soft tissue sarcoma. Brookline Capital Markets downgraded Intensity Therapeutics from a Buy to a Hold rating, citing concerns over the company’s financial runway, which is expected to last until the end of the second quarter, and the need for additional funding.
Intensity Therapeutics recently announced a public offering to raise approximately $2.35 million, with proceeds earmarked for ongoing clinical studies and other corporate purposes. The offering includes over 3 million shares of common stock and accompanying warrants, with a combined purchase price of $0.75 per share and warrant. Benchmark maintained its Speculative Buy rating on the company, emphasizing the progress in clinical studies, including the INVINCIBLE-4 study, which has received authorization from the European Medicines Agency to enroll patients in France. The company’s focus on research and development, particularly in its INT230-6 program, remains a key aspect of its corporate strategy.
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