Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 87

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 87
---
and monitor our third-party providers. To the extent we are unable to identify and successfully manage the performance of third-party
service providers in the future, our business may be adversely affected. Though we carefully manage our relationships with our CROs, there
can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not
have a material adverse impact on our business, financial condition and prospects.

We rely on third parties to manufacture our product candidates, and we expect to continue to rely on third parties for the clinical as well as any future commercial supply of our product candidates and other future product candidates. The development of our current and future product candidates, and the commercialization of any approved products, could be stopped, delayed or made less profitable if any such third party fails to provide us with sufficient clinical or commercial quantities of such product candidates or products, fails to do so at acceptable quality levels or prices or fails to achieve or maintain satisfactory regulatory compliance.

We do not currently have,
and we do not plan to build, the infrastructure or capability internally to manufacture current product candidates or any future product
candidates for use in the conduct of our clinical trials or, if approved, for commercial supply. We rely on, and expect to continue to
rely on, contract manufacturing organizations, or CMOs. Reliance on third-party contractors may expose us to more risk than if we were
to manufacture our product candidates ourselves. Although our agreements with CMOs require them to perform according to certain cGMP requirements
such as those relating to quality control, quality assurance, maintenance of production and testing records, and qualified personnel,
we do not control the manufacturing processes of our CMOs, and we are dependent on such CMOs for the production of our product candidates
in accordance with cGMP and other relevant applicable regulations.

In complying with the manufacturing
regulations of the FDA and other comparable foreign regulatory authorities, we and our third-party manufacturers must spend significant
time, money and effort in the areas of design and development, testing, production, record-keeping and quality control to assure that
the product candidates meet applicable specifications and other regulatory requirements. If either we or our CMOs fail to comply with
these requirements, we may be subject to regulatory enforcement action, including the seizure of product candidates and shutting down
of production.

Even if we are able to establish
and maintain agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

| •