Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 158

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 158
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 us on commercially reasonable
terms or at all.

38

Our limited operating history makes it difficult
to evaluate our business and assess our future viability and prospects.

We are a clinical stage company
with a limited operating history. We commenced operations in 2016, and our operations to date have been limited to organizing and planning
our development efforts, raising capital, conducting discovery and research activities, filing patent applications, identifying potential
product candidates, undertaking preclinical studies, and establishing arrangements with third parties for the manufacture of initial quantities
of CER-1236 and component materials. We have not yet demonstrated our ability to successfully complete any clinical trials, obtain regulatory
approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales, marketing and
distribution activities necessary for successful product commercialization. Consequently, any predictions you make about our future success
or viability may not be as accurate as they could be if we had a longer operating history.

In addition, as a young business,
we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition
at some point from a company with a R&D focus to a company capable of supporting commercial activities. We may not be successful in
such a transition.

We expect our financial condition
and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many
of which are beyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of
future operating performance.

Our business is highly dependent on the
success of our lead product candidate. If we are unable to advance clinical development, obtain approval of and successfully commercialize
our lead product candidate for the treatment of patients in approved indications, our business would be significantly harmed.

Our business and future success
depends on our ability to advance clinical development, obtain regulatory approval of, and then successfully commercialize, CER-1236,
our lead product candidate. Because our CER-1236 product candidate will be among the first autologous T cell product candidates engineered
with cytotoxic and phagocytic potency to be evaluated in clinical trials, the failure of such product candidate, or the failure of other
autologous T cell therapies, including for reasons due to safety, efficacy or durability, may impede our ability to develop our product
candidates, and significantly influence physicians’ and regulators’ opinions with regard to the viability