Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 185

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 185
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regulatory approval. Unknown binding-reactivity of the CER-T cell binding domain to related proteins could also occur. Any non-specific
binding interactions that impacts patient safety could materially impact our ability to advance our product candidates into clinical trials
or to proceed to marketing approval and commercialization.

If product liability lawsuits are brought
against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We face an inherent risk
of product liability as a result of the planned clinical testing of our product candidates and will face an even greater risk if we commercialize
any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise
unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects
in manufacturing, defects in design, packaging, a failure to warn of dangers inherent in the product, negligence, strict liability or
a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves
against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates.
Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability
claims may result in:

●decreased demand for our product candidates or products that we may develop;

●injury to our reputation;

●withdrawal of clinical trial participants;

●initiation of investigations by regulators;

●costs to defend the related litigation;

●a diversion of management’s time and our resources;

●substantial monetary awards to trial participants or patients;

●product recalls, withdrawals or labeling, marketing or promotional restrictions;

●loss of revenue;

●exhaustion of any available insurance and our capital resources;

●the inability to commercialize any product candidate; and

●a decline in our stock price.

Failure to obtain or retain
sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit
the commercialization of products we develop, alone or with corporate collaborators. Although we plan on purchasing clinical trial insurance,
such insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage.
We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered
by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such