Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1641

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1641
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 successfully carry
out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the
clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other
reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory
approval of or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for
our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Switching or adding third
parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. In addition, changes
in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies
between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating
the comparability of clinical supplies which could require the conduct of additional clinical trials. Additionally, there is a natural
transition period when a new third party commences work. As a result, delays occur, which can materially impact our ability to meet our
desired clinical development timelines.

We rely on third parties to manufacture
and store our clinical product supplies, and we may have to rely on third parties to produce and process our product candidates, if approved.
There can be no assurance that we will be able to establish or maintain relationships with such third parties. We may in the future establish
our own manufacturing facility and infrastructure in addition to or in lieu of relying on third parties for the manufacture of our product
candidates, which would be costly, time-consuming and which may not be successful.

Our product candidates are
manufactured in the United States by third parties, and we manage all other aspects of the supply, including planning, oversight, disposition
and distribution logistics. There can be no assurance that we will not experience supply or manufacturing issues in the future.

We have a long-term agreement
in place with a CDMO for the manufacture of CER-1236. However, we have not yet caused our product candidates to be manufactured or processed
on a commercial scale and may not be able to achieve manufacturing and processing and may be unable to create an inventory of mass-produced
product to satisfy demands for any of our product candidates. Our clinical supply will also be limited to small quantities and any latent
defects discovered in our supply could significantly delay our development