Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 60

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 60
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 not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with
any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate
should any claim arise.

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Public opinion and scrutiny of cell-based immune-oncology therapies for treating cancer, or negative clinical trial results from our cell-based therapy competitors, or auto-immune cell therapy candidates, may impact public perception of our company and product candidates, or impair our ability to conduct our business.

Our autologous cell therapy
platforms utilizes a relatively novel technology involving the genetic modification of cells, and no CER-T cell-based immunotherapy has
been approved to date. Public perception may be influenced by claims, such as claims that cell-based immunotherapy is unsafe, unethical,
or immoral and, consequently, our approach may not gain the acceptance of the public or the medical community. Negative public reaction
to cell-based immunotherapy in general, or negative clinical trial results from our cell-based therapy competitors, or auto-immune cell
therapy candidates, could result in greater government regulation and stricter labeling requirements of cell-based immunotherapy products,
including any of our product candidates, and could cause a decrease in the demand for any products we may develop. Adverse public attitudes
may adversely impact our ability to enroll patients in clinical trials. More restrictive government regulations or negative public opinion
could have an adverse effect on our business or financial condition and may delay or impair the development and commercialization of
our product candidates or demand for any products we may develop.

For example, in November
2023, the FDA announced that it would be conducting an investigation into reports of T-cell malignancies following BCMA-directed or CD19-directed
autologous CAR-T cell immunotherapies following reports of T cell lymphoma in patients receiving these therapies. In January 2024, the
FDA determined that new safety information related to T cell malignancies should be included in the labeling with boxed warning language
on these malignancies for all BCMA- and CD-19-directed genetically modified autologous T cell immunotherapies. While CER-1236
and our engineered CER-T cells are designed to utilize a different mechanism of action, FDA’s investigation into CAR-T
therapies and other similar actions could result in increased government regulation, unfavorable public perception and publicity, potential
impacts on enrollment in our clinical trials, potential regulatory delays in the testing or approval