Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 6

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 6
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 the safety and efficacy of our clinical assets, which could prevent or delay regulatory approval
and commercialization.

Clinical
drug development for our clinical assets is very expensive, time-consuming, difficult to design and implement, and its outcome is inherently
uncertain. Before obtaining regulatory approval for the commercial sale of a clinical asset, we must demonstrate through clinical trials
that a clinical asset is both safe and effective for use in the target indication, which is impossible to predict. Most clinical assets
that commence clinical trials are never approved by regulatory authorities for commercialization. Our clinical assets are in various
stages of development and a failure of one more clinical trial can occur at any stage of testing or at any time during the trial process.
We expect that clinical trials for these clinical assets will continue for several years but may take significantly longer than expected
to complete. Not all of our clinical assets have been tested in humans and the first use in humans may reveal unexpected effects. We
have not completed all clinical trials for the approval of any of our clinical assets.

32

We
may experience delays in ongoing and future clinical trials for our clinical assets and we do not know if future clinical trials, if
any, will begin on time, need to be redesigned, enroll adequate number of patients on time or be completed on schedule, if at all. In
addition, the Company, any partner with which we currently or may in the future collaborate, the FDA, an IRB or other regulatory authorities, including state and local agencies and counterpart agencies in foreign countries, may suspend,
delay, require modifications to, or terminate our clinical trials at any time, for various reasons, including:

    ●
    discovery
    of safety or tolerability concerns, such as serious or unexpected toxicities or side effects or exposure to otherwise unacceptable
    health risks, experienced by study participants or other safety issues;

    ●
    lack
    of effectiveness of any clinical asset during clinical trials or the failure of our clinical assets to meet specified endpoints;

    ●
    slower
    than expected rates of subject recruitment and enrollment rates or inability to enroll a sufficient number of patients in clinical
    trials resulting from numerous factors, including the prevalence of other companies’ clinical trials for their clinical assets
    for the same indication, or clinical trials for indications for which patients do not as commonly seek treatment;

    ●
    difficulty
    in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy,
    insufficient efficacy