Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 177

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 177
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an adaptive Phase 1 trial design to evaluate patient response to CER-1236. As such, the dosing protocol will emphasize a gradual
increase in the delivered dose with the objective of achieving a clinical signal, while ensuring patient safety. We also intend our Phase 1
trial design to enable an evaluation of appropriate dosing strategies to optimize CER-T engagement and proliferation.

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We believe, subject to discussions
with the FDA and other regulatory authorities, that there may be a full development path to registration and use in the larger AML patient
populations on achieving positive safety data along with indications of therapeutic benefit in these initial trial cohorts. We believe
CER-1236 may provide significant treatment advantages over currently available therapeutics, including CAR-T therapy as a result of its
potential to enhance objective response rates and the duration of response related to the comprehensive, coordinated engagement of the
innate and adaptive immune systems and a sustained signaling environment. We believe this novel mechanism of action will enable our advance
of a single therapeutic construct to address the substantial unmet need for a safe and effective cell therapy offering an improved therapeutic
profile, despite significant competition. We subsequently anticipate initiating clinical trials for additional indications, including
the possible application of CER-1236 in the treatment of certain solid tumors such as EGFR mutation positive NSCLC and ovarian cancer.

Manufacturing Strategy

The manufacture of product
candidates derived from our autologous CER-1236 T cells involves the same type of equipment, materials and protocols already used in
the manufacture of currently FDA-approved CAR-T cell therapies, which we believe will provide us numerous benefits. We are planning for
CER-1236 cell product to be manufactured using an automated closed process, with product manufacture continuous from bulk harvested cells
through to cryopreserved drug product bags. There are multiple factors involved in the manufacturing process needed to ensure proper
CER-T cell cryopreservation both preceding and following freezing, including the thawing process and post-thaw handling prior to patient
administration. These factors are well understood and procedures have been identified to optimize yield, activity, stability and consistency.
In addition, we may be able to take advantage of the increasing regulatory familiarity with these established protocols. Our expected
manufacturing process embraces a fully automated, closed-system design intended to minimize exposure to potential contaminants and ensure
consistent successful manufacture of the product. The product will be manufactured in a contract manufacturing facility which maintains
a quality system compliant with