Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 7

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 7
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, fatigue with the clinical trial process, or for any other reason;

    ●
    difficulty
    in obtaining IRB approval for studies to be conducted at each clinical trial site;

    ●
    delays
    in manufacturing or obtaining, or inability to manufacture or obtain, sufficient quantities of materials for use in clinical trials;

    ●
    inadequacy
    of or changes in our manufacturing process or the product formulation or method of delivery;

    ●
    changes
    in applicable laws, regulations, and regulatory policies;

    ●
    delays
    or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective CROs, clinical trial sites, and other third-party contractors;

    ●
    inability
    to add a sufficient number of clinical trial sites;

    ●
    uncertainty
    regarding proper formulation and dosing;

    ●
    failure
    by us, our employees, our CROs or their employees, or other third-party contractors to comply with contractual and applicable regulatory
    requirements or to perform their services in a timely or acceptable manner;

    ●
    failure
    by us, our employees, our CROs or their employees, or any partner with which we may collaborate or their employees to comply with
    applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security, and
    recordkeeping for drug and biologic products;

    ●
    scheduling
    conflicts with participating clinicians and clinical institutions;

    ●
    failure
    to design appropriate clinical trial protocols;

    ●
    insufficient
    data to support regulatory approval;

    ●
    inability
    or unwillingness of medical investigators to follow our clinical trial protocols; or

    ●
    difficulty
    in maintaining contact with subjects during or after treatment, which may result in incomplete data.

33

We
or any partner with which we may collaborate may suffer significant setbacks in their clinical trials similar to the experience of a
number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials.
In the event that we or our potential partners abandon or are delayed in the clinical development efforts related to our clinical assets,
we may not be able to execute on our business plan effectively and our business, financial condition, operating results, and prospects
would be harmed.

We
may be unable to obtain regulatory approval for our early-stage clinical assets under applicable regulatory requirements. The FDA and
foreign regulatory bodies have substantial