CERo Therapeutics Holdings, Inc. Receives FDA Clearance of Second Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Lead Compound CER-1236 in Solid Tumors

SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces that the Company has received clearance by the U.S. Food and Drug Administration (FDA) for a second Investigational New Drug (IND) application for lead compound CER-1236 for a Phase 1 clinical trial in advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer. CERo Chief Medical Officer Robert Sikorski, M.D., Ph.D. commented, “Following the launch of our AML trial, we are now starting a second clinical study of CER-1236 to evaluate its potential in solid tumors and bring new therapeutic options to patients with ovarian and lung cancer,” said Robert Sikorski, M.D., Ph.D., Chief Medical Officer of CERo. “CER-1236 is novel: the first CAR-T cell therapy to target Tim-4L and the first with phagocytic activity programmed into a T cell. Preclinical data suggest that this dual mechanism may help overcome key resistance barriers that have hampered solid tumor CAR-T trials. The FDA’s collaborative role has been critical to maintaining development velocity and enabling us to operate two open trials in both hematologic and solid tumors. Taken together, this expansion reflects our belief in the therapeutic breadth and the commercial and partnering potential of CER-1236.” The Company recently announced data showing that CER-1236 treated ovarian cancer cells and did not generate toxicity in animal models (mice). Investigators found that following dosing, assessment of clinical and anatomic pathology after CER-1236 infusion showed T cell engraftment in lymphoid organs, but there were no in-life observations, clinical pathology, nor histopathological evaluations indicating toxicity caused by the compound. “Of note, our team has been simultaneously progressing our Phase 1 AML trial in the U.S. Their incredible efforts cannot be under-emphasized, and I wish to convey my gratitude to our extremely competent and efficient team. We are looking forward to sharing progress on each of our two Phase 1 clinical trials in the near term,” added CERo CEO Chris Ehrlich. 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 will afford them greater therapeutic application than currently approved chimeric antigen receptor (“CAR-T”) cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in 2025 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 product development and clinical potential of CER-1236, financial position, business strategy and the plans and objectives of management for future operations of CERo and the implementation of its plan of compliance with Nasdaq continued listing standards. 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, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, filed on April 2, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contact:Chris EhrlichChief Executive Officerchris@cero.bio Investors:CORE IRinvestors@cero.bio

CERo Therapeutics Holdings, Inc. Receives FDA Clearance of Second Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Lead Compound CER-1236 in Solid Tumors

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