CERo Therapeutics Announces Third Dose for Patient in Phase 1 Clinical Trial of CER-1236 in AML
Company completes first tranche of a $7 million financing to increase cash runway and maintain Nasdaq compliance
SOUTH SAN FRANCISCO, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (NASDAQ:CERO) ("CERo" or the "Company"), an innovative cellular immunotherapy company developing novel T cell therapeutics that incorporate phagocytic mechanisms, today announced that investigators have been authorized under the study protocol to administer a third infusion of CER-1236 to a patient enrolled in the first cohort of its ongoing Phase 1 clinical trial. This additional infusion of 1 million CER-1236 cells per kilogram of body weight of the patient -- completed approximately one week ago and identical to the first two doses -- is intended to generate further safety and dosing information that may help assess the feasibility of a multi-dose administration strategy as an alternative to a single, higher-dose approach. The initial dose level for Cohort One was selected based on dose ranges commonly used in other adoptive T-cell therapy studies.
The third infusion in this patient occurs prior to the first dosing of the first patient in the previously announced second cohort of the study, which is anticipated in the coming weeks, pending completion of study-related regulatory notifications and approvals. It also takes place as the Company has completed the first tranche of a planned $7 million financing (approximately $2.3 million) with existing shareholders. This additional financing is expected to extend its cash runway and support efforts to maintain compliance with Nasdaq listing requirements.
The first-in-human, multi-center, open-label, Phase 1/1b study 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 initiated 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). While there has been no observation of toxicities attributable to CER-1236 observed in the first three patients treated to date, the clinical trial is in progress, and no representations or conclusions should be made at this stage regarding the safety, tolerability, or efficacy of CER-1236.
CERo Chief Financial Officer Al Kucharchuk stated, "Our recent milestones highlight CERo's ability to execute and advance CER-1236, even in a challenging financial climate. We are deeply grateful for the continued confidence and commitment of our shareholders, whose support enables us to move this promising program forward. The financing now underway—with the first tranche successfully completed—is expected to extend our cash runway and position us to begin the second cohort once regulatory clearance is obtained. It also reinforces our capital structure and supports ongoing efforts to maintain compliance with Nasdaq listing requirements as we continue working to build long-term value for both patients and shareholders."
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 integrates key functional attributes of both innate and adaptive immunity within a single therapeutic construct, designed to engage the body's immune repertoire for more comprehensive tumor targeting. This novel cellular immunotherapy platform is designed to redirect patient-derived T cells toward tumor cells through both adaptive perforin/granzyme pathways and innate engulfment mechanisms. The latter employ phagocytic activity to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ("CER-T"). CERo believes the differentiated targeting properties 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 initiated clinical trials for its lead product candidate, CER-1236, for hematologic 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, 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 most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, 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 Ehrlich
Chief Executive Officer
[email protected]
Investors:
CORE IR
[email protected]
