Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 4

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 4
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or may result in our being unable to expand our operations or otherwise capitalize on our business opportunities. As a result, our business,
financial condition and results of operations could be materially affected.

As
a result of our limited operating history, we may not be able to correctly estimate, operating expenses, need for investment capital,
or stability of operations, which could lead to cash shortfalls.

We
have a limited operating history from which to evaluate our business. As a result, our historical financial data is of limited value
in estimating future operating expenses. We have not obtained regulatory approvals for any of our clinical assets. Therefore, our budgeted
operating expense levels are based in part on our expectations concerning the FDA approval process and expenses related to development
of other clinical assets. Failing to reach our short-term developmental milestones within anticipated timelines due to serious adverse or unacceptable side effects caused by our clinical assets, or other events, many of which
may be beyond our control, may cause our financial condition and operating results to continue to fluctuate significantly from quarter
to quarter and year to year.

Preclinical
drug development for our clinical assets (AZD1656 and AZD5904) is expensive, time-consuming, and uncertain. Our preclinical trials may
fail to adequately demonstrate pharmacologic activity in therapeutic areas of interest; cause unintended short- or long-term effects
in other bodily systems; or produce unexpected toxicity that may alter or risk benefit assessment.

The
scientific discoveries that form the basis for our efforts to generate and develop our clinical assets are relatively recent. AZD1656
is a glucokinase activator that is in a number of Phase II ready autoimmune disorders including uveitis, Hashimoto’s thyroiditis,
preterm labor, and renal transplant, and the successful development of AZD1656 may require additional studies and efforts to optimize
its therapeutic potential. In addition, our development pipeline includes what we believe to be a potent irreversible inhibitor of human
Myeloperoxidase (MPO) that has the potential to treat idiopathic male infertility, which we refer to as AZD5904. AZD5904 may not demonstrate
in patients the therapeutic properties ascribed to it in the laboratory or preclinical studies, and may interact with human biological
systems in unforeseen, ineffective, or even harmful ways. If we are not able to successfully develop and commercialize our clinical assets,
including AZD1656 and AZD5904, we may never become profitable and the value of our capital stock