Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 139

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 139
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•We have limited experience conducting cancer clinical trials, and we are subject to risks and challenges that may prevent or delay the completion of our up-coming or on-going clinical trials.

•Our prospects for obtaining additional financing are uncertain.

•We have yet to obtain regulatory approval from the FDA, and therefore we are not currently permitted to market products made using our technology in the United States.

•Delays in FDA approval could be costly to us and prevent us from commercializing our product candidates effectively.

•Even if product candidates using our technology obtain approval, we will be subject to additional ongoing regulatory obligations and oversight.

•The FDA approval process is long, expensive and uncertain.

•Our ability to market a product may be limited by the uses that are approved for that product.

•We may be unable to export or sell products in foreign markets, which will limit our sales opportunities.

•We will rely on third parties to conduct preclinical research and any clinical trials.

•Third-party payors may not reimburse for the use of our product candidates, or such reimbursement may be inadequate.

•We are dependent on third parties to manufacture components of the final drug products made using our technology.

•We purchase components for our product candidates from third parties, some of which may be sole-source suppliers.

•We have not entered into long term manufacturing and supply agreements with any producers.

•We have limited experience and may not be successful in commercializing products that use our technology.

•Our plan to use collaborative arrangements with third parties to help finance and to market and sell products using our technology may not be successful.

•We will be dependent on healthcare professionals’ efforts to learn about our product candidates.

•We may need to establish clinical training and centers of excellence to educate and train physicians and healthcare payors, but the key opinion thought leadership required for initial market acceptance within the healthcare arena may take time to develop.

•Rapid technological developments in treatment methods for cancer and competition with other forms of cancer treatments could affect our ability to achieve meaningful revenues or profit.

•Our success depends in part on our ability to obtain patents, maintain trade secret protection, operate without infringing on the proprietary rights of third parties, and commercialize our technology prior to the expiration of our patent protection.

•We may be unable to protect our intellectual property rights because of our limited resources.

•We may be the subject of product liability claims or product recalls.

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Risks Related to Our Business, Financial, and Investment Conditions

The market price of our Common Stock may be highly