Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1644

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1644
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 affect product health, fitness, and potentially anti-tumor activity and clinical responses. In addition,
the cell processing equipment and tubing that we use in our current manufacturing process is only available from a single supplier. We
also use certain biologic materials, including certain activating antibodies, that are available from multiple suppliers, but each version
may perform differently, requiring us to characterize them and potentially modify some of our protocols if we change suppliers. We cannot
be sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company
that is not interested in continuing to produce these materials for our intended purpose. If we are required to change suppliers, the
materials may only be available from another supplier on terms that are less favorable to us than the terms under which we currently obtain
the materials. Accordingly, if we no longer have access to these suppliers, we may experience delays in our clinical or commercial manufacturing
which could harm our business or results of operations.

If we or our third-party suppliers use hazardous,
non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our R&D activities involve
the controlled use of potentially hazardous substances, including chemical and biological materials. We and our suppliers are subject
to federal, state and local laws and regulations in the United States governing the use, manufacture, storage, handling and disposal of
medical and hazardous materials. Although we believe that we and our suppliers’ procedures for using, handling, storing and disposing
of these materials comply with legally prescribed standards, we and our suppliers cannot completely eliminate the risk of contamination
or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, we may incur liability or local,
city, state or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident,
we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not have any insurance
for liabilities arising from medical or hazardous materials. In addition, any violation in the use, manufacture, storage, handling and
disposal under foreign law may subject us to additional liability.

Compliance with applicable
environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development
and production efforts, which could harm our business, prospects, financial condition or results of operations.

Risks Related to Government and Regulation

Clinical development and the