Company: INTS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001567264-25-000039
Chunk: 35

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 35
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 increased marginally by $0.1 million due to the ongoing site initiations and patient enrollment of the INVINCIBLE-03 Study. In March 2025, we paused new site activations and patient enrollments due to funding constraints, and prioritized funding for the INVINCIBLE-4 Study. Prior to this pause, the trial had enrolled 23 patients.  We will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause.  Once sufficient funding is obtained, we plan to restart site activations and patient enrollment in the INVINCIBLE-3 Study.  

•Contract manufacturing costs declined by $0.2 million, as there were no manufacturing batches of INT230-6 in the first quarter of 2025.

General and administrative expenses during the three months ended March 31, 2025 increased $0.7 million or 38%, compared to the three months ended March 31, 2024, and were primarily due to the following:

•Salaries and benefits related costs decreased $0.1 million as the Company did not accrue current year bonus accruals due to insufficient cash reserves and the current assessment that current year bonus payments are not reasonably probable to occur.  In addition, stock-based compensation was $0.3 million lower as no new equity grants were awarded in the first quarter of 2025.

•Insurance expense decreased by $0.1 million due to the favorable directors and officers insurance renewal terms obtained in June 2024 compared to the prior policy year. 

•Legal, audit and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas.   

Interest income in 2025 and 2024 related to interest earned on cash and investment balances.  

Liquidity and Capital Resources

Our financial statements have been prepared assuming we will continue as a going concern. We have incurred losses from operations and negative cash flows that raise substantial doubt about our ability to continue as a going concern.

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates. We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials for our product candidates, developing our manufacturing capabilities and building and qualifying our manufacturing facility to support clinical trials and commercialization and providing general and administrative support for our operations