Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 92

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 92
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 failures can result in significant clinical or commercial supply interruptions which could materially hamper our ability to conduct
clinical trials or to supply adequate commercial supplies (if any of our product candidates receive marketing authorization), and efforts
to qualify new suppliers can be costly and time consuming. Further, any action taken by a third party that is detrimental to our reputation
could have a negative impact on our ability to register our trademarks and/or market and sell our products, if any.

For some of these raw materials,
components, devices and manufacturing equipment, we rely and may in the future rely on sole source vendors or a limited number of vendors.
The supply of the reagents and other specialty materials and equipment that are necessary to produce our product candidates could be reduced
or interrupted at any time. In such case, identifying and engaging an alternative supplier or manufacturer could result in delay, and
we may not be able to find other acceptable suppliers or manufacturers on acceptable terms, or at all. Switching suppliers or manufacturers
may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines. If any of our product
candidates receive marketing authorization and we change suppliers or manufacturers for commercial production, applicable regulatory agencies
must approve such changes and may require us to conduct additional studies or trials. If key suppliers or manufacturers are lost, or if
the supply of the materials is diminished or discontinued, we may not be able to develop, manufacture and market our product candidates
in a timely and competitive manner, or at all. An inability to continue to source product from any of these suppliers, which could be
due to a number of issues, including regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments
experienced by a supplier, labor disputes or shortages, unexpected demands or quality issues, could adversely affect our ability to satisfy
demand for our product candidates, which could adversely and materially affect our product approval or commercialization plans and operating
results or our ability to conduct clinical trials, either of which could significantly harm our business.

As we continue to develop
our product candidates and manufacturing processes, we expect that we will need to obtain rights to and supplies of certain materials
and equipment to be used as part of that process. We may not be able to obtain rights to such materials on commercially reasonable terms,
or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of such materials or find a suitable
substitute, it would have a material adverse effect on our business. Even