Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1617

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1617
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 sales and marketing efforts of our product candidates.

There can be no assurance
that we will be able to develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaborators
to commercialize any product in the United States or overseas.

We face competition from companies that
have developed or may develop product candidates for the treatment of the diseases that we may target, including companies developing
novel therapies and platform technologies. If these companies develop platform technologies or product candidates more rapidly than we
do, if their platform technologies or product candidates are more effective or have fewer side effects, our ability to develop and successfully
commercialize product candidates may be adversely affected.

The development and commercialization
of cell and gene therapies is highly competitive. We compete with a variety of large pharmaceutical companies, multinational biopharmaceutical
companies, other biopharmaceutical companies and specialized biotechnology companies, as well as technology and/or therapeutics being
developed at universities and other research institutions. Our competitors are often larger and better funded than we are. Our competitors
have developed, are developing or will develop product candidates and processes competitive with ours. Competitive therapeutic treatments
include those that have already been approved and accepted by the medical community and any new treatments that are currently in development
or that enter the market. We believe that a significant number of product candidates are currently under development, and may become commercially
available in the future, for the treatment of conditions for which we may try to develop product candidates. There is intense and rapidly
evolving competition in the biotechnology and biopharmaceutical fields. We believe that while our T-cell based platform, its associated
intellectual property portfolio, the characteristics of our current and potential future product candidates and our scientific and technical
know-how together give us a competitive advantage in this space, competition from many sources remains.

45

Many of our competitors have
significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we do. If we successfully
obtain approval for any product candidate, we will face competition based on many different factors, including the safety and effectiveness
of our product candidates, the ease with which our product candidates can be administered, the timing and scope of regulatory approvals
for these product candidates, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage
and patent position. Competing products and product candidates could present superior treatment alternatives, including by being more
effective, safer, less expensive or marketed and sold more effectively than any products