Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1616

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1616
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 to use conventional therapies, such as chemotherapy and antibody therapy, rather than participate in our clinical trials.

Delays in patient enrollment
may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these
clinical trials and adversely affect our ability to advance the development of our product candidates. In addition, many of the factors
that may lead to a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval
of our product candidates.

If the market opportunities for any of our
product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.

We are focused initially
on the development of treatments for cancers such as AML, MCL and CLL, and plan to eventually extend our treatments to other forms of
cancer. Our internal projections of addressable patient populations that have the potential to benefit from treatment with our product
candidates are based on estimates. If any of our estimates are inaccurate, the market opportunities for any of our product candidates
could be significantly diminished and have an adverse material impact on our business.

We currently have no marketing and sales
organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into
agreements with third parties to market and sell our product candidates, if licensed, we may not be able to generate product revenue.

We currently have no sales,
marketing or distribution capabilities and have no experience in marketing products. We intend to develop an in-house marketing organization
and sales force, which will require significant capital expenditures, management resources and time. We will have to compete with other
pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

If we are unable or decide
not to establish internal sales, marketing and distribution capabilities, we will pursue collaborative arrangements regarding the sales
and marketing of our product candidates following their approval. However, there can be no assurance that we will be able to establish
or maintain such collaborative arrangements, or if we are able to do so, that they will have effective sales forces. Any revenue we receive
will depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the marketing and
sales efforts of such third parties and our revenue from product sales may be lower than if we had commercialized our product candidates
ourselves. We also face competition in our search for third parties to assist us with the