Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 14

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 14
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GLP, or GACP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other regulatory
authority may require us to perform additional clinical trials before approving our or our partners’ marketing applications. We
cannot assure investors that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our
clinical or preclinical trials complies with applicable GCP and GLP requirements. In addition, our clinical trials must generally be
conducted with product produced under cGMP regulations. Our failure to comply with these regulations and policies may require us to repeat
clinical trials, which would delay the regulatory approval process.

Our
CROs are not our employees, and we do not control whether or not they devote sufficient time and resources to our clinical trials. Our
CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical
trials, or other drug development activities, which could harm our competitive position. We face the risk of potential unauthorized disclosure
or misappropriation of our intellectual property by CROs, which may reduce our trade secret protection and allow potential competitors
to access and exploit our proprietary technology. If our CROs do not successfully carry out their contractual duties or obligations,
fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to
adhere to our clinical trial protocols or regulatory requirements or for any other reason, our clinical trials may be extended, delayed,
or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize any clinical asset that we develop.
As a result, our financial results and the commercial prospects for any clinical asset that we develop would be harmed, our costs could
increase, and our ability to generate revenue could be delayed.

If
any of our CROs or clinical trial sites terminate their involvement in one of our clinical trials for any reason, we may not be able
to enter into arrangements with alternative CROs or clinical trial sites or do so on commercially reasonable terms. In addition, if our
relationship with clinical trial sites is terminated, we may experience the loss of follow-up information on patients enrolled in our
ongoing clinical trials unless we are able to transfer the care of those patients to another qualified clinical trial site. In addition,
principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and could receive
cash or equity compensation in