Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 89

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 89
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 manufacturing sources. This would require substantial capital on our part,
which we may not be able to obtain on commercially acceptable terms or at all. Additionally, we would likely experience months of manufacturing
delays as we build facilities or locate alternative suppliers and seek and obtain necessary regulatory approvals. If this occurs, we will
be unable to satisfy manufacturing needs on a timely basis, if at all. If changes to CMOs occur, then there also may be changes to manufacturing
processes inherent in the setup of new operations for our product candidates and any products that may obtain approval in the future.
Any such changes could require the conduct of bridging studies and regulatory approval before we can use any materials produced at new
facilities or under new processes in clinical trials or, for any products reaching approval, in our commercial supply. Further, business
interruption insurance may not adequately compensate us for any losses that may occur and we would have to bear the additional cost of
any disruption. For these reasons, a significant disruptive event of any CMOs could have drastic consequences, including placing our financial
stability at risk.

Our product candidates and
any drugs that we may develop may compete with other product candidates and drugs for access to manufacturing facilities. There are no
assurances we would be able to enter into similar arrangements, on acceptable terms, with other manufacturers that operate under cGMP
regulations and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future manufacturers
could delay clinical development or marketing approval.

If we were to experience an
unexpected loss of supply of or if any supplier were unable to meet our clinical or commercial demand for any of our product candidates,
we could experience delays in our planned clinical studies or commercialization. We could be unable to find alternative suppliers of acceptable
quality and experience that can produce and supply appropriate volumes at an acceptable cost or on favorable terms. Moreover, our suppliers
are often subject to strict manufacturing requirements and rigorous testing requirements, which could limit or delay production. The long
transition periods necessary to switch manufacturers and suppliers, if necessary, would significantly delay our clinical trials and, for
any product candidates that reach approval, the commercialization of our products, which would materially adversely affect our business,
financial condition and results of operation.

We are dependent on third party suppliers, and if we experience problems with any of these third parties, the manufacturing of our product candidates could be delayed, which could harm our results of operations.

We are dependent upon certain