Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 80

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 80
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) and Phase 2 (expansion of specified cancer types). There was no control arm in the IT-01 Study and no randomization though patients were enrolled with random tumor burdens and random cancer types. Therefore, there is no formal comparator to determine the significance of any given endpoint. See Table below for the patient population.

17

Final INT230-6 monotherapy population (n=64) in the IT-01 Study

Type of CancerMonotherapyNumber of PatientsMonotherapyPercent of PopulationSarcoma 1523%10 Othera <4% each 1320%Skin (Melanoma/Merkle)69%Squamous cell carcinoma 69%Colorectal 58%Breast 46%Head and neck 46%Ovarian 46%Pancreatic 46%Cholangiocarcinoma 35%

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aOthers include: Adrenocortical carcinoma, Anal, Bladder, Cervical, Eccrine, Lung, Metastatic Cancer of Unknown Primary, Pseudomyxoma peritonei, Renal, and Thyroid.

Patients receiving a monotherapy dose of INT230-6 above 40 percent of their TTB measured in cubic centimeters had statistically significantly longer survival than patients who received treatment to less than 40% of their TTB. The subjects receiving a dose >40% of their total incoming tumor burden also lived much longer than would be expected for patients in a Phase 1/2 basket study. These data indicate a potentially active drug. Given the small size of the population, the heterogeneity of the cancers and variability of the incoming tumor burdens, the high and low dose groups may have been different in a way that we may not have been able to measure. We observed a strong overall survival signal in just sarcoma patients; however, this Phase 2 population size was also too small to properly assess effectiveness of INT230-6. Based on the analysis of strong absorption of our drug by the tumor and the ignition of the immune system, we have determined that overall survival was most appropriate for our Phase 3 study. OS is the FDA’s preferred endpoint for cancer clinical trials to prove efficacy.

The probability of survival for a given population can be plotted. Figure 11 panel A below illustrates the survival for all monotherapy INT230-6 subjects. See Table below for the patient population.

Treating only with our drug candidate, approximately 50% of patients would be expected to be alive at one year (blue curve) with a