Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 91

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 91
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 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
qualified suppliers, of which there are a limited number, for the supply of raw materials, components, devices and manufacturing equipment,
some of which are manufactured or supplied by small companies with limited resources and experience to support commercial pharmaceutical
and biologics production. Additionally, these suppliers may also have upstream suppliers who supply materials, components, devices and
manufacturing equipment, which may indirectly impact our business operations. Thus, the success of our business may be adversely affected
by the underperformance of third parties, exploitation by third parties of our commercial dependence and by unforeseen interruptions to
third parties’ businesses. Although the existence of several alternative suppliers for each function mitigates the risks associated
with this dependence, as does the availability of commercial insurance in respect of the impact of accidental events, the failure of a
third party to properly to carry out their contractual duties or regulatory obligations could be highly disruptive to our business. Supply
chain