Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1610

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1610
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●conditioning patients with cyclophosphamide, fludarabine, or bendamustine in advance of administering
our product candidates, which may be difficult to source, costly or increase the risk of infections and other adverse side effects;

●obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with
development of CER T cell therapies for cancer;

●establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance
of a novel therapy; and

●obtaining acceptance and approval by physicians, patients, hospitals, cancer treatment centers and others
in the medical community.

Our current product candidates are in early
clinical or preclinical development and have never been tested in humans. One or all of our current product candidates may fail in clinical
development or suffer delays that materially and adversely affect their commercial viability.

Our current product candidates are in early clinical and preclinical
development and we are subject to the risks of failure inherent in the development of product candidates based on novel approaches, targets
and mechanisms of action. Although we received IND clearance for CER-1236 from the FDA in November 2024 and for additional indications
in March 2025, and we anticipate beginning clinical trials in the first half of 2025, there is no guarantee that we will be able to proceed
with clinical development of CER-1236 or any of our other product candidates or that any product candidate will demonstrate a clinical
benefit once we advance these candidates to testing in patients. Accordingly, you should consider our prospects in light of the costs,
uncertainties, delays and difficulties frequently encountered by early clinical stage biotechnology companies such as ours.

Success in preclinical studies or clinical
trials may not be indicative of results in future clinical trials.

Results from preclinical
studies are not necessarily predictive of future clinical trial results, and interim results of a clinical trial are not necessarily indicative
of final results. Our product candidates may ultimately fail to show the desired safety and efficacy in clinical settings despite positive
results in preclinical studies or having successfully advanced through initial clinical trials. This failure to establish sufficient efficacy
and safety could cause us to abandon clinical development of our product candidates.

Manufacturing genetically engineered products
is complex and we, or our third-party manufacturers, may encounter difficulties in production. If we or any of our third-party manufacturers
encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients,
if