Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1608

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1608
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, may impede our ability to develop our product
candidates, and significantly influence physicians’ and regulators’ opinions with regard to the viability of our entire pipeline
of autologous T cell therapies.

All of our product candidates,
including our lead product candidate, will require additional preclinical, clinical and non-clinical development, regulatory review and
approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing
efforts before we can generate any revenue from product sales. In addition, because our other product candidates are based on similar
technology as our lead product candidate, if the lead product candidate encounters additional safety issues, efficacy problems, manufacturing
problems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed.

We have not generated any revenue and may
never be profitable.

Our ability to become profitable
depends upon our ability to generate revenue. To date, we have not generated any revenue. We do not expect to generate significant revenue
unless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize,
our product candidates. We do not know when, or if, we will generate any revenue. We received clearance of our IND for our first product
candidate, CER-1236, and the rest of our product candidates are in the preclinical stages of development. Our product candidates will
require additional preclinical studies, clinical development regulatory review and approval, substantial investment, access to sufficient
commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales. Our ability
to generate revenue depends on a number of factors, including, but not limited to, our ability to:

●successfully complete preclinical studies and clinical trials for our CER-T cell product candidates;

●timely file and receive acceptance of INDs, and amendments thereto, as applicable, in order to commence
our planned and future clinical trials;

●successfully enroll subjects in, and complete, clinical trials for our CER-T cell product candidates;

●hire additional staff, including clinical, scientific and management personnel;

●timely file BLAs and receive regulatory approvals for our product candidates from the FDA and other regulatory
authorities;

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●initiate and successfully complete clinical trials and safety studies required to obtain U.S. and applicable
foreign marketing approval for our product candidates;

●establish commercial manufacturing capabilities through third-party manufacturers and CDMOs for clinical
supply and commercial manufacturing of our product candidates;

●obtain and maintain patent and trade secret