Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 16

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 16
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    ●
    discontinue
    production or manufacturing of necessary drug substances or products.

In
the event of any of the foregoing, if we do not have an alternative supplier or manufacturer in place, we would be required to expend
substantial management time and expense to identify, qualify, and transfer processes to alternative suppliers or manufacturers. Transferring
technology to other sites may require additional processes, technologies, and validation studies, which are costly, may take considerable
amounts of time, may not be successful and, in most cases, require review and approval by the FDA. Any need to find and qualify new suppliers
or manufacturers could significantly delay production of our clinical assets, adversely impact our ability to market our clinical assets,
and adversely affect our business. Replacements may not be available to us on a timely basis, on acceptable terms, or at all. Additionally,
we and our manufacturers do not currently maintain significant inventory of drug substances and other materials. Any interruption in
the supply of a drug substance or other material or in the manufacture of our clinical assets could have a material adverse effect on
our business, financial condition, operating results, and prospects.

We
do not have direct control over the ability of our contract suppliers and manufacturers to maintain adequate capacity and capabilities
to serve our needs, including quality control, quality assurance, and qualified personnel. Although we are ultimately responsible for
ensuring compliance with regulatory requirements such as cGMPs and GACP, we are dependent on our contract suppliers and manufacturers
for day-to-day compliance with cGMPs or GACP for production of raw materials, APIs, and finished products. Facilities used by our contract
suppliers and manufacturers to produce the APIs and other substances and materials or finished products for commercial sale must pass
inspection and be approved by the FDA and other relevant regulatory authorities. Our contract suppliers and manufacturers must comply
with cGMP and GACP requirements enforced by the FDA through its facilities inspection program and review of submitted technical information.
If the safety of any product or clinical asset or component is compromised due to a failure to adhere to applicable laws or for other
reasons, we may not be able to successfully commercialize or obtain regulatory approval for the affected product or clinical asset, and
we may be held liable for injuries sustained as a result. Any of these factors could cause a delay or termination of preclinical studies,
clinical trials, or regulatory submissions or approvals of our clinical assets, and could entail higher costs or result in us being unable
to effectively