Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1643

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1643
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, we will rely
on third parties to perform release tests on our product candidates prior to delivery to patients. If these tests are not appropriately
done and test data are not reliable, patients could be put at risk of serious harm.

We maintain single supply relationships
for certain key components, and our business and operating results could be harmed if supply is restricted or ends or the price of raw
materials used in our suppliers’ manufacturing process increases.

We are dependent on sole
suppliers or a limited number of suppliers for certain components that are integral to our product candidates, including CER-1236. If
these or other suppliers encounter financial, operating or other difficulties or if our relationship with them changes, we may be unable
to quickly establish or qualify replacement sources of supply and could face production interruptions, delays and inefficiencies. In addition,
technology changes by our vendors could disrupt access to required manufacturing capacity or require expensive, time-consuming development
efforts to adapt and integrate new equipment or processes. Our growth may exceed the capacity of one or more of these suppliers to produce
the needed equipment and materials in sufficient quantities to support our growth. Any one of these factors could harm our business and
growth prospects.

Our product candidates rely on the availability
of specialty raw materials, which may not be available to us on acceptable terms or at all.

Our product candidates, including
CER-1236, require many specialty raw materials, some of which are manufactured by small companies with limited resources and experience
to support a commercial product. In addition, those suppliers normally support blood-based hospital businesses and generally do not have
the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms. The suppliers may be ill-equipped to support
our needs, especially in non-routine circumstances like an FDA inspection or medical crisis, such as widespread contamination. We also
do not have contracts with many of these suppliers and may not be able to contract with them on acceptable terms or at all. Accordingly,
we may experience delays in receiving key raw materials to support clinical or commercial manufacturing.

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In addition, some of our
raw materials are currently available from a single supplier, or a small number of suppliers. For example, the type of cell culture media
and cryopreservation buffer that we currently use in our manufacturing process for the CER-T cells are available from multiple suppliers,
but each version may perform differently, requiring us to characterize them and modify our protocols if we change suppliers. Disruption
of our cell manufacturing process may