Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 48

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 48
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 candidates, and we or our licensing partners may experience difficulties recruiting
a diverse population of patients in attempting to fulfill the requirements of any approved diversity action plan.

Inability to enroll a sufficient
number of patients for clinical trials would result in significant delays and could require us to abandon one or more clinical trials
altogether. Enrollment delays in these clinical trials may result in increased development costs for our product candidates, which would
cause the value of our company to decline and limit our ability to obtain additional financing. Furthermore, we expect to rely on CROs
and clinical trial sites to ensure the proper and timely conduct of our clinical trials and we will have limited influence over their
performance.

We are exposed to political, regulatory, social and economic risk relating to the United Kingdom’s exit from the European Union.

Following the result of a
referendum in 2016, the United Kingdom left the European Union on January 31, 2020, commonly referred to as Brexit. Pursuant to the formal
withdrawal arrangements agreed between the United Kingdom and the European Union, the United Kingdom was subject to a transition period
until December 31, 2020, during which European Union rules continued to apply. The Trade and Cooperation Agreement between the United
Kingdom and the European Union, which outlines the future trading relationship between the United Kingdom and the European Union, was
agreed in December 2020. The impact of the new trade agreement on the general and economic conditions in the United Kingdom remains uncertain.
There may be, for example, additional costs in materials and equipment sourced from the European Union and/or delays that could have a
material adverse effect on our business, financial condition and results of operations.

From a regulatory perspective,
the United Kingdom’s withdrawal from the European Union could bear significant complexity and risks. A basic requirement of
European Union law relating to the grant of a marketing authorization for a medicinal product in the European Union is that the applicant
is established in the European Union. Following the withdrawal of the United Kingdom from the European Union, marketing authorizations
previously granted to applicants established in the United Kingdom may no longer be valid. Moreover, the scope of a marketing authorization
for a medicinal product granted by the European Commission pursuant to the centralized procedure might not, in the future, include the
United Kingdom. In these circumstances, an authorization granted by competent United Kingdom authorities would be required to place medicinal
products on the United Kingdom market.

Any of these factors could
significantly increase the complexity of our activities in the