Company: CERO
Filing Date: 2025-09-05
Form Type: 424B3
Source: 0001213900-25-085121
Chunk: 3

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-09-05
Form: 424B3
Chunk 3
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<div align='center'>CERo Therapeutics Receives FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia (AML)

Regulatory milestone adds to its existing Orphan Drug Designation, creating additional regulatory and financial advantages for the Company’s lead cancer immunotherapy program</div>

SOUTH SAN FRANSCISCO, Calif., Sept. 05, 2025 (GLOBE NEWSWIRE) -- CERo
Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company
seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces that the U.S. Food
and Drug Administration (FDA) has granted Fast Track Designation to the Company’s lead investigational compound, CER-1236 for Acute
Myeloid Leukemia (AML). This designation is in addition to the existing .

“These FDA designations are important additional validation with
regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitted. Further, these
designations help to decrease the potential time to market and provide additional benefits across the FDA process that are expected to
prove both medically and financially valuable. We continue to believe that CER-1236 represents a truly novel approach to cancer immunotherapy
and are gratified by this regulatory milestone,” said CERo Therapeutics CEO Chris Ehrlich.

FDA’s Fast Track Designation is designed to accelerate the development
and review of therapies for serious or life-threatening conditions with unmet medical need. The designation provides CERo with the opportunity
for increased FDA interactions, potential eligibility for priority review, and the ability to submit data on a rolling basis. Further,
it also requires the Company to potentially provide expanded access to the investigational drug 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