Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1642

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1642
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 timelines.

In addition, our actual and
potential future reliance on a limited number of third-party manufacturers exposes us to the following risks:

●We may be unable to identify manufacturers on acceptable terms or at all because the number of potential
manufacturers is limited and the FDA may have questions regarding any replacement contractor. This may require new testing and regulatory
interactions. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production
of our products after receipt of FDA questions, if any.

●Our third-party manufacturers might be unable to timely formulate and manufacture our product or produce
the quantity and quality required to meet our clinical and commercial needs, if any.

●Contract manufacturers may not be able to execute our manufacturing procedures appropriately.

●Manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the Drug Enforcement
Administration and corresponding state agencies to ensure strict compliance with cGMP and other government regulations and corresponding
foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards.

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●We may not own, or may have to share, the intellectual property rights to any improvements made by our
third-party manufacturers in the manufacturing process for our products.

●Our future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing
business for the time required to supply our clinical trials or to successfully produce, store and distribute our products.

●Our third-party manufacturers could breach or terminate their agreement with us.

Our contract manufacturers
would also be subject to the same risks we face in developing our own manufacturing capabilities, as described above. Our current and
potential future CDMOs may also be required to shut down in response to the spread of health epidemics or pandemics, or they may prioritize
manufacturing for therapies or vaccines for other diseases. In addition, our CDMOs have certain responsibilities for storage of raw materials
and in the past have lost or failed to adequately store our raw materials. We will also rely on third parties to store our released product
candidates, 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 or the approval of 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