Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 68

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 68
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, and any failure to adequately store our product candidates could result in significant delay to our development timelines.
Any additional or future damage or loss of raw materials or product candidates could materially impact our ability to manufacture and
supply our product candidates. Each of these risks could delay our clinical trials, the approval, if any of our product candidates by
the FDA or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenue.

In addition, 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.

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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