Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 57

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 57
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 Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business
or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties,
litigation, and reputational harm in connection with European activities. This and other future developments regarding the flow of data
across borders could increase the cost and complexity of delivering our product candidates, if approved, in some markets and may lead
to governmental enforcement actions, litigation, fines and penalties or adverse publicity, which could have an adverse effect on our
reputation and business.

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Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.

Future undesirable or unacceptable
side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and
could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory
authorities. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected
characteristics. Approved autologous T cell therapies and those under development by other companies have shown frequent rates of CRS,
neurotoxicity, serious infections, prolonged cytopenia and hypogammaglobulinemia, and adverse events have resulted in the death of patients.
Similar adverse events may occur for our T cell product candidates.

In addition, we utilize
a lymphodepletion regimen, which generally includes fludarabine, cyclophosphamide or bendamustine, that may cause serious adverse events.
For instance, because the regimen will cause a transient and sometimes prolonged immune suppression, patients will have an increased
risk of infection, such as to COVID-19, that may be unable to be cleared by the patient and ultimately lead to other serious adverse
events or death. Our lymphodepletion regimen has caused and may also cause prolonged cytopenia and aplastic anemia.

We may also combine the
use of our product candidates with other investigational or approved therapies that may cause separate adverse events or events related
to the combination or potentiate side effects of approved drugs.

If unacceptable toxicities
arise in the development of our product candidates, we could suspend or terminate our trials or the FDA, the EMA or comparable foreign
regulatory authorities could order us to cease clinical trials