Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 100

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 100
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 therapies, including cell therapeutic approaches. Given the incidence of AML, CER-1236 T cell therapy may qualify for an
Orphan Drug Designation by the FDA, and we have submitted an application to the FDA for an Orphan Drug Designation on March 18,
2025.

Our Phase 1 AML clinical trial is intended to evaluate the safety,
potential therapeutic utility and applicable dose of CER-1236. The approved starting dose for the clinical trial is sufficiently high
that we expect to begin to see clinical activity by the second dose level cohort. Concurrent with a trial in these hematological malignancies,
we intend to expand the clinical development of CER-1236 with an additional IND submission, which has been approved, to investigate solid
tumors such as NSCLC and ovarian cancer. We believe that CER-1236 has the potential to address unmet medical needs in the targeted indications,
and be differentiated from currently available therapeutics by its safety, tolerability and efficacy. Since no clinical trials of CER-1236
have commenced, none of the abovementioned statements regarding any of our products in development are intended to be a prediction or
conclusion of efficacy.

Our Strategy

Our intent is to become a
leading biopharmaceutical company focused on the capital-efficient advancement of innovative anti-cancer product candidates targeting
the unmet medical need associated with aggressive and difficult-to-treat hematological malignancies and solid tumors. To accomplish this
objective, the key elements of our strategy include:

●Advance the clinical development of CER-1236 for the treatment of AML patients. Based on preclinical
data generated to date related to the use of CER-1236 to treat hematological cancers, we intend to initially target relapsed and refractory
AML patients for clinical development. These are aggressive cancers with limited treatment options. Moreover, these cancers represent
a significant unmet medical need, and to date there are no approved CAR-T cell therapies for patients diagnosed with AML. There are approximately
20,800 cases of AML diagnosed annually in the U.S.

2

●Leverage past and current CAR-T product approvals to shorten the regulatory and manufacturing pathway
for CER-1236. We have designed our CER-T cells to share similar construction to currently approved CAR-T cell therapies. The processes
and protocols used to produce autologous CAR-T cells are well recognized, and we expect to benefit from the well-defined regulatory guidelines
established