Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 160

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 160
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 in collaboration
with others;

●maintain a continued acceptable safety profile of the product candidates following approval;

●obtain and maintain acceptance of the product candidates, if and when approved, by patients, the medical
community and third-party payors;

●position our products to effectively compete with other therapies;

●obtain and maintain favorable coverage and adequate reimbursement by third-party payors for our product
candidates; and

●enforce and defend intellectual property rights and claims with respect to our product candidates.

Many of the factors listed
above are beyond our control and could cause us to experience significant delays or prevent us from obtaining regulatory approvals or
commercialize our product candidates. Even if we are able to commercialize our product candidates, we may not achieve profitability soon
after generating product sales, if ever. If we are unable to generate sufficient revenue through the sale of our product candidates or
any future product candidates, we will be unable to continue operations without continued funding.

Our engineered CER-T cells represent a novel
approach to cancer treatment that creates significant challenges for us.

We are developing autologous
T-cell product candidates that are engineered from healthy donor T-cells to express chimeric engulfment receptors (“CERs”)
and are intended for use in patients with certain cancers. Advancing these novel product candidates creates significant challenges for
us, including:

●manufacturing our product candidates to our regulatory specifications and in a timely manner to support
our clinical trials, and, if approved, commercialization;

●sourcing clinical and, if approved, commercial supplies for the raw materials used to manufacture our
product candidates;

●understanding and addressing variability in the quality of a donor’s T cells, which could ultimately
affect our ability to produce product in a reliable and consistent manner and treat certain patients;

●educating medical personnel regarding the potential side effect profile of our product candidates, if
approved, such as the potential adverse side effects related to CRS, neurotoxicity, prolonged cytopenia, coagulation abnormalities, thrombosis,
hypotension, aplastic anemia and neutropenic sepsis;

●using medicines to preempt or manage adverse side effects of our product candidates and such medicines
may be difficult to source or costly or may not adequately control the side effects or may have other safety risks or a detrimental impact
on the efficacy of the treatment;

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●conditioning patients with cyclophosphamide, fludarabine, or bendamustine in advance of