Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 1

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 1
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 just one of our clinical assets or any future clinical assets that we may in-license, acquire, or develop. The
preclinical, clinical and commercial success of our clinical assets will depend on a number of factors, including the following:

    ●
    the
    ability to raise additional capital to fund our current pre-clinical and clinical plans on acceptable terms, or at all;

    ●
    the
    timely completion of our clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend
    substantially upon the performance of third-party contractors;

    ●
    whether
    we are required by the FDA or similar foreign regulatory agencies to conduct additional preclinical or clinical trials beyond those
    planned to support the approval and commercialization of our clinical assets or any future clinical assets;

    ●
    the
    acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our clinical assets
    by the FDA or similar foreign regulatory authorities;

    ●
    our
    ability to demonstrate the safety and efficacy of our clinical assets or any future clinical assets to the satisfaction of the FDA
    and similar foreign regulatory authorities;

    ●
    the
    prevalence, duration, and severity of potential side effects experienced in connection with our clinical assets or future approved
    products, if any;

30

    ●
    the
    timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;

    ●
    achieving
    and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain, compliance with our contractual
    obligations and with all regulatory requirements applicable to our clinical assets or any future clinical assets or approved products,
    if any;

    ●
    the
    ability of third parties with whom we contract to manufacture clinical trial and commercial supplies of our clinical assets or any
    future clinical assets, remain in good standing with regulatory agencies, and develop, validate, and maintain commercially viable
    manufacturing processes that are compliant with cGMP;

    ●
    a
    continued acceptable safety profile during preclinical and clinical development and following approval of our clinical assets or
    any future clinical assets;

    ●
    our
    ability to successfully commercialize our clinical assets or any future clinical assets in the U.S. and internationally, if approved
    for marketing, sale, and distribution in such countries and territories, whether alone or in collaboration with others;

    ●
    the
    acceptance by physicians, patients