Intensity Therapeutics Q2 2024 Financial Results and Corporate Update

Intensity Therapeutics, Inc., a biotechnology company developing immune-based intratumoral cancer therapies, has announced significant updates for the second quarter of 2024. The company, listed on Nasdaq as INTS, detailed the progress of its clinical trials, financial performance, and recent corporate developments.

In July 2024, Intensity Therapeutics initiated a Phase 3 open-label, randomized study named the INVINCIBLE-3 Study. This study tests their lead drug candidate, INT230-6, as a monotherapy for certain soft tissue sarcoma subtypes, compared to standard of care (SOC) drugs. The trial aims to enroll 333 patients to measure overall survival rates. Over 50 sites have been screened and qualified, with contract negotiations expected to take up to six months per site for activation.

Furthermore, in May 2024, the company entered a collaboration with the Swiss Group for Clinical Cancer Research (SAKK) to conduct a Phase 2 randomized controlled study, the INVINCIBLE-4 Study. This trial will evaluate the clinical and biological effects of INT230-6 followed by SOC versus SOC alone in early-stage triple-negative breast cancer. The study plans to enroll 54 to 60 patients in Europe and aims to measure changes in the pathological complete response rate. The data gathered is expected to inform the size of a subsequent Phase 3 study. Site screening and qualifying for the INVINCIBLE-4 Study are ongoing, with the study planned to start in the third quarter of 2024.

Intensity Therapeutics has also bolstered its leadership by appointing Thomas Dubin, J.D., MPH, to its board of directors in May 2024. Dubin brings extensive experience in pharmaceutical business development, regulatory affairs, and commercialization, expanding the board to five members.

CEO Lewis H. Bender commented on these developments, highlighting the importance of the first patient being dosed in their randomized controlled Phase 3 sarcoma trial as a critical milestone. He emphasized the company's progress in site qualification and contract negotiations for their Phase 3 study and the promising collaboration with SAKK. Bender also expressed enthusiasm about Dubin's addition to the board, noting his valuable insights and expertise.

From a financial perspective, Intensity Therapeutics reported increased research and development expenses totaling $3.6 million for the three months ending June 30, 2024, compared to $0.9 million in the same period in 2023. This increase is mainly attributed to preliminary work related to the INVINCIBLE-3 Study and manufacturing a new batch of INT230-6, as well as higher salary, benefits, and stock-based compensation costs.

General and administrative expenses also rose to $1.5 million for the second quarter of 2024, up from $0.4 million in the same period in 2023, driven by higher salary, benefits, stock-based compensation, and legal, audit, and consulting fees, alongside increased insurance costs for directors and officers. The net loss for the second quarter of 2024 was $5.0 million, compared to $3.7 million in the same period in 2023.

As of June 30, 2024, the company's cash, cash equivalents, and marketable debt securities totaled $6.3 million, expected to fund operations into the first quarter of 2025.

INT230-6, Intensity Therapeutics' lead investigational product, is designed for direct intratumoral injection, comprising cisplatin, vinblastine, and a penetration enhancer molecule (SHAO). This combination helps the drugs diffuse into cancer cells within tumors, leading to both local disease control and systemic anti-tumor effects without the immunosuppression often seen with systemic chemotherapy.

Intensity Therapeutics' approach of using engineered chemistry to saturate the tumor environment has shown promising results in clinical trials, demonstrating the potential to turn many deadly cancers into manageable chronic diseases. Over 200 patients have been enrolled in earlier studies, and the company continues to advance its clinical programs, including the ongoing Phase 3 trial in soft tissue sarcoma and the upcoming Phase 2/3 program in presurgical triple-negative breast cancer.