Company: INTS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001567264-25-000039
Chunk: 70

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 2
Chunk 70
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 our third-party contract research organizations to reduce ongoing costs during this pause.  Once sufficient funding is obtained, we plan to restart site activations and patient enrollment in the INVINCIBLE-3 Study. 

In October 2024, in collaboration with the Swiss Group for Clinical Cancer Research SAKK (“SAKK”), we initiated and dosed our first patient in a Phase 2 study (the “INVINCIBLE-4 Study”) to treat patients with localized triple-negative breast cancer (“TNBC”). We plan to enroll 54 patients and expect to complete enrollment by the end of the first quarter of 2026 provided that we are able to obtain sufficient additional funding, and the endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. In the event we are unable to obtain sufficient additional funding, we may have to defer completion of the study until such funding is obtained. 

We have also successfully developed Phase 3 quality analytical methods for the three INT230-6 components and successfully manufactured multiple large-scale batches of INT230-6. In a meeting with the FDA in the fourth quarter of 2023, we agreed on a chemical manufacture and control (“CMC”) plan for Phase 3 and product registration for our three key ingredients and INT230-6. If we successfully execute the agreed-upon plan, we expect that the CMC portion of a New Drug Application (“NDA”) should be acceptable to the FDA for product approval and registration (subject to final NDA review). We also anticipate publishing a series of manuscripts on completed studies beginning in the second half of 2025.

Since our inception in 2012, our operations have included business planning, hiring personnel, raising capital, building our intellectual property portfolio, and performing both research and development on our product candidates. We have incurred net losses since inception and expect to incur net losses in the future as we continue our research and development activities. To date, we have funded our operations primarily through net proceeds received from issuances of our Common Stock, preferred stock and convertible notes. As of March 31, 2025, we had approximately $0.9 million of cash and cash equivalents. Since our inception, we have incurred significant operating losses. We incurred net losses of $3.3 million and $4.6 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $70.1 million. 

We expect