Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1632

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1632
---
 or 4% of annual global revenues, whichever is greater; UK GDPR mirrors such fines under the GDPR. The GDPR also
confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial
remedies, and obtain compensation for damages resulting from violations of the GDPR. 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.

53

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