Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 164

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 164
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 to pay out-of-pocket in the absence of coverage and adequate reimbursement
by third-party payors and government authorities;

●relative convenience and ease of administration, including as compared to alternative treatments and competitive
therapies; and

●the effectiveness of our sales and marketing efforts.

If our product candidates
are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical
community, we will not be able to generate significant revenue. Even if our products achieve market acceptance, we may not be able to
maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products,
are more cost effective or render our products obsolete.

Data from our preclinical studies is limited
and may change as patient data become available or may not be validated in any future or advanced clinical trial.

Data from preclinical studies
and any clinical trials that we may complete is subject to the risk that one or more of the clinical outcomes may materially change as
patient enrollment continues and more patient data becomes available. For example, preclinical and Phase 1 results are preliminary in
nature and should not be viewed as predictive of ultimate success. It is possible that such results will not continue or may not be repeated
in any clinical trial of our product candidates. For instance, our preclinical studies provide limited data and any clinical trials may
not validate such results. Additionally, manufacturing can impact clinical outcomes and we have not yet completed manufacturing runs with
a CDMO. We may also fail to develop and transfer to a CDMO any optimized manufacturing processes for any of our programs. Ultimately,
if we cannot manufacture our product candidates with consistent and reproducible product characteristics, our ability to develop and commercialize
any product candidate would be significantly impacted.

Preliminary data also remains
subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we
previously published. As a result, initial, interim and preliminary data should be viewed with caution until the final data are available.
Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

We may not be able to file INDs or IND amendments
to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.

The IND for CER-1236 was filed on June 28, 2024 and on November 15,
2024, the FDA cleared us to