Company: INTS
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001567264-25-000103
Chunk: 46

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 1
Chunk 46
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 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, and once sufficient funding is obtained, we plan to restart site activations and patient enrollment. The final costs for the IT-01 and INVINCIBLE-2 studies were also incurred during the nine months ended September 30, 2024, contributing to the decrease in clinical trial expenses compared to the nine months ended September 30, 2025.  

•Contract manufacturing costs declined by $0.6 million, as there were no manufacturing batches of INT230-6 in 2025.

General and administrative expenses during the nine months ended September 30, 2025 decreased $1.3 million or 27%, compared to the nine months ended September 30, 2024, and were primarily due to the following:

•Salaries and benefits related costs decreased $0.3 million as we 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 during the current year period.

•Insurance expense decreased by $0.2 million due to the favorable directors and officers insurance renewal terms obtained in June 2024 compared to the prior policy year. 

•Legal, consulting and other expenses decreased as a result of cost saving from the integration of new systems and other cost-efficient activities 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, including the cost associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from