Company: CDT
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001246
Chunk: 5

Company: CDT Equity Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 5
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 may decline.

31

It
is difficult to predict the time and cost of development and of subsequently obtaining regulatory approval for AZD1656 as it employs
newly developed technology.

AZD1656
uses a novel mechanism to reduce inflammation in many of the immune pathways. We have concentrated our research and development efforts
of AZD1656 on a limited number of initial targeted disease indications for AZD1656. There can be no assurance that we will not experience
problems or delays in developing our current or future indications for AZD1656 and that such problems or delays will not cause unanticipated
costs, or that any such development problems can be solved. Moreover, AZD1656 would also represent a novel approach for the treatment
of uveitis as steroids are currently the most common treatment for uveitis even though there are numerous side effects associated with
the use of steroids. The clinical development of these novel technologies will require review and allowance by the FDA under an Investigational
New Drug Application.

We
may not be successful in our efforts to use and expand our development platform to build a pipeline of clinical assets.

A
key element of our strategy is to use our experienced management and scientific team to build a pipeline of clinical assets that address
a broad range of human diseases in order to treat unmet medical needs. Our current clinical assets and pipeline address the areas of
autoimmune disease and idiopathic male infertility. Although our research and development efforts to date have resulted in potential
clinical assets, we may not be able to continue to identify and develop additional clinical assets. Even if we are successful in continuing
to build our pipeline, the potential clinical assets that we identify may not be suitable for clinical development. For example, these
potential clinical assets may be shown to have harmful side effects or other characteristics that indicate that they are unlikely to
receive marketing approval and achieve market acceptance. If we do not successfully develop and commercialize clinical assets based upon
our approach, we will not be able to obtain product revenue in future periods, which likely would result in significant harm to our financial
position. There is no assurance that we will be successful in our preclinical and clinical development of our current or future clinical
assets, and the process of obtaining regulatory approvals will, in any event, require the expenditure of substantial time and financial
resources.

Clinical
drug development for our clinical assets is very expensive, time-consuming, difficult to design and implement, and uncertain. Our clinical
trials may fail to adequately demonstrate