Intensity Therapeutics Q1 2024 Financial Results and Corporate Update

Intensity Therapeutics, Inc., a clinical biotechnology company, is progressing with its lead drug candidate, INT230-6. This candidate is moving forward into advanced clinical programs for sarcoma and breast cancer. The company's financial resources, including $10.5 million in cash and investments, are expected to sustain operations until the end of the first quarter of 2025.

In mid-2024, Intensity plans to start the INVINCIBLE-3 Study, a Phase 3 trial comparing INT230-6 as a monotherapy against standard care drugs for certain types of soft tissue sarcoma. The study aims to enroll 333 patients, focusing on overall survival as the main endpoint. Over 30 sites have been screened and qualified for this study, with ongoing contract negotiations. The site approval process is anticipated to take between two to six months.

Simultaneously, the company will also begin the INVINCIBLE-4 Study, a Phase 2/3 program testing INT230-6 in combination with standard chemotherapy or immunotherapy against standard care alone for women with triple-negative breast cancer. The initial Phase 2 portion will evaluate the change in pathological complete response rates for the combination treatment compared to standard care. This study is also set to begin in mid-2024, with sites being screened and qualified.

Lewis H. Bender, Founder, President, and CEO of Intensity Therapeutics, highlighted the progress in both INVINCIBLE-3 and INVINCIBLE-4 studies. In the first quarter of 2024, the company successfully released and shipped INT230-6 Phase 3 clinical supplies to their main depot, labeled a portion of vials for United States sites, and evaluated numerous trial sites. Contract and budget discussions with over 30 sarcoma centers are ongoing, and new sarcoma specialty hospitals in the US and internationally are being qualified. Centers from previous metastatic studies are also showing interest in participating in the INVINCIBLE-3 trial.

Regarding financial performance, research and development expenses amounted to $2.8 million for the quarter ending March 31, 2024, up from $0.8 million during the same period in 2023. This rise is mainly attributed to preliminary work for the INVINCIBLE-3 Study, manufacturing a new batch of INT230-6, and increased expenses related to salaries, benefits, and stock-based compensation. General and administrative expenses also rose to $1.9 million from $0.5 million in the same timeframe, driven by higher costs in salaries, benefits, stock-based compensation, legal, audit, and consulting fees, and directors and officers insurance. The net loss for the first quarter of 2024 was $4.6 million, compared to $1.3 million for the first quarter of 2023.

Intensity Therapeutics' INT230-6 is an investigational product designed for direct intratumoral injection, discovered through the company's DfuseRx technology platform. Comprising cisplatin, vinblastine, and a penetration enhancer (SHAO), INT230-6 facilitates the dispersion of cytotoxic drugs throughout tumors, resulting in a favorable safety profile and local disease control. It also triggers systemic anti-tumor effects by releasing neoantigens after tumor cell death.

The company's novel approach aims to turn "cold" tumors "hot," enabling INT230-6 to penetrate and saturate tumors effectively. Clinical trials have shown that INT230-6 can kill tumors and elicit an immune response within days of injection, offering a potential new paradigm in cancer treatment. The drug has already completed over 200 patient enrollments in Phase 1/2 trials and is advancing towards new studies in soft tissue sarcoma and triple-negative breast cancer.