Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 22

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 22
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 inability
    of our contract suppliers and manufacturers to efficiently and cost-effectively increase and maintain high yields and batch quality,
    consistency, and stability;

    ●
    our
    inability to develop an FDA-approved bioassay for release of any future product;

    ●
    difficulty
    in establishing optimal drug delivery substances and techniques, production, and storage methods and packaging and shipment processes;

    ●
    transportation
    and import/export risk, particularly given the global nature of our supply chain;

    ●
    delays
    in analytical results or failure of analytical techniques that we depend on for quality control and release of any future product;

    ●
    natural
    disasters, pandemics, labor disputes, financial distress, lack of raw material supply, issues with facilities and equipment, or other
    forms of disruption to business operations of our contract manufacturers and suppliers; and

    ●
    latent
    defects that may become apparent after the product has been released and which may result in recall and destruction of product.

Any
of these factors could result in delays or higher costs in connection with our clinical trials, regulatory submissions, required approvals,
or commercialization of our clinical assets, which could harm our business, financial condition, operating results, and prospects.

Our
operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating
results to fall below expectations.

The
operations of the Company since the Business Combination and of Old Conduit prior to the Business Combination have been primarily limited
to researching and developing our clinical assets and undertaking preclinical studies and clinical trials of our clinical assets. We
have not yet obtained regulatory approvals for any of our clinical assets. Consequently, any predictions investors make about our future
success or viability may not be as accurate as they could be if we had a longer operating history or approved products on the market.
Furthermore, our operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may
be difficult to predict, including the following:

    ●
    delays
    in the commencement, enrollment, and the timing of clinical testing for our clinical assets;

    ●
    the
    timing and success or failure of clinical trials for our clinical assets or competing clinical assets, or any other change in the
    competitive landscape of our industry, including consolidation among our competitors or partners;

    ●
    any
    delays in regulatory review and approval of clinical assets in clinical development;

    ●