Company: CERO
Filing Date: 2025-09-05
Form Type: 424B3
Source: 0001213900-25-085127
Chunk: 4

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-09-05
Form: 424B3
Chunk 4
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 on an as-approved basis under pre-specified
conditions.

The first-in-human, multi-center, open label, Phase 1/1b study, currently
underway, is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either
relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The
two-part study has begun with dose escalation to determine the highest tolerated dose and recommended dose for Phase 2, followed by an
expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious
adverse events (SAEs), incidence of dose limited toxicities and estimation of overall response rate (ORR), complete response (CR), composite
complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK).

About CERo Therapeutics Holdings, Inc.

CERo is an innovative immunotherapy company advancing the development
of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables
it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed
to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected
to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy
cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated
activity of CER-T cells may offer advantages compared with currently approved CAR-T therapies and could potentially extend the reach of
cellular immunotherapy to both hematologic malignancies and solid tumors. CERo has commenced clinical trials for its lead product candidate
CER-1236 for hematological malignancies.

Forward-Looking Statements

This communication contains statements that are forward-looking and
as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and
the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking
statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical
or current facts. When used in this communication,