Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 156

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 156
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 it could take
several years until any of our product candidates, which at present is solely CER-1236, receive regulatory and marketing approval and
are commercialized, and we may never be successful in obtaining regulatory and marketing approval and commercializing product candidates.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses will
adversely impact our stockholders’ equity and net assets and may fluctuate significantly from quarter to quarter and year to year.
We anticipate that our expenses will increase substantially as we:

●continue our ongoing and planned R&D activities for our CER-T cell therapies and product candidates;

●pursue preclinical studies and initiate clinical trials for our CER-T cell therapies and other product
candidates;

●seek to discover and develop additional product candidates and further expand our product pipeline;

●seek regulatory and marketing approvals for any product candidates that successfully complete clinical
trials;

●establish sales, marketing and distribution infrastructure to commercialize any product candidate for
which we may obtain regulatory approval;

●develop and refine the manufacturing process for our product candidates;

●change or add additional manufacturers or suppliers of biological materials or product candidates;

37

●establish or supplement relationships with CDMOs, CROs and other third-party collaborators;

●develop, maintain, expand and protect our intellectual property portfolio;

●acquire or in-license other product candidates and technologies;

●hire clinical, quality control and manufacturing personnel;

●add clinical, operational, financial and management information systems and personnel, including personnel
to support our product development and planned future commercialization efforts; and

●incur additional legal, accounting and other expenses associated with operating as a public company.

To become and remain profitable,
we must succeed in developing and eventually commercializing products that generate significant revenue. This will require us to be successful
in a range of challenging activities, including completing preclinical studies and clinical trials for our product candidates, preparing
a satisfactory filing package for regulatory authorities, obtaining regulatory approval, manufacturing, marketing and selling any products
for which we may obtain regulatory approval, as well as discovering and developing additional product candidates. We may never succeed
in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.

Because of the numerous risks
and uncertainties associated with the development, manufacturing, delivery and commercialization of complex autologous cell therapies,
we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to