CERo Therapeutics Holdings, Inc. Announces Progress in Initiation of Phase 1 Clinical Trial by Executing an Agreement with Contract Research Organization CellCarta to Manage Translational Assays

Rhea-AI Summary

CERo Therapeutics Holdings (Nasdaq: CERO) has made progress toward initiating its Phase 1 clinical trial for CER-1236 in Acute Myeloid Leukemia (AML) by signing an agreement with CellCarta, a contract research organization (CRO). CellCarta will manage important translational assays, including pharmacokinetics, cytokine secretion, and target detection for the upcoming trial.

The CRO will also handle sample kitting, shipment, and logistics to maintain clinical sample integrity during transport. This partnership represents a significant step as CERo prepares for patient enrollment. The company is also advancing its work in solid tumors, with updates expected in the near term.

Positive

• Progress toward Phase 1 trial initiation with CRO partnership
• Dual pipeline development in both liquid and solid tumors
• Infrastructure and logistics preparation in place for clinical trials

Negative

• Phase 1 trial not yet initiated
• No specific timeline provided for patient enrollment
• Early-stage clinical development with no efficacy data yet

Company continues toward the initiation of its Phase 1 Clinical Trial in AML for CER-1236

SOUTH SAN FRANSCISCO, Calif., March 06, 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 the execution of an agreement with contract research organization (CRO) CellCarta to manage translational assays for the Company’s upcoming Phase 1 clinical trial of CER-1236 for Acute Myeloid Leukemia (AML). This is important progress as the Company prepares to enroll patients in the trial, as CellCarta will be responsible for key data elements, including pharmacokinetics, cytokine secretion, and target detection. The CRO will also support our clinical trial sites with sample kitting, shipment, and overall logistics to ensure clinical sample integrity is maintained during transport to testing sites.    

CEO Chris Ehrlich commented, “We are diligently working toward enrolling patients in our Phase 1 clinical trial and each new milestones brings us closer to that event. The collection of samples and testing their chemistry is an essential aspect of the clinical trial process in liquid tumors, as they provide key data readouts beyond the safety data in a Phase 1 trial. Further, we are collaborating with multiple additional organizations to ensure that all aspects of the trial, down to logistics and transportation of samples, are in place and ready for execution. Combined with our ongoing work in solid tumors, which we expect to report on in the near term, and the careful management of our resources, we remain optimistic about the progress of CERo Therapeutics and look forward to continuing regular communication.”

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 financial position, business strategy and the plans and objectives of management for future operations of CERo the timing and completion of the reverse stock split, and the acceptance and implementation of its proposed 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 Ehrlich
Chief Executive Officer
chris@cero.bio

Investors:
CORE IR
investors@cero.bio

FAQ

What is the purpose of CERo Therapeutics' agreement with CellCarta for the CER-1236 trial?

CellCarta will manage translational assays, including pharmacokinetics, cytokine secretion, and target detection, plus handle sample logistics for CERo's Phase 1 AML trial.

When will CERo Therapeutics (CERO) begin patient enrollment for the CER-1236 Phase 1 trial?

While the exact enrollment date isn't specified, the company is actively preparing for patient enrollment with the recent CellCarta agreement marking progress toward trial initiation.

What type of cancer is CERo's CER-1236 drug targeting in the Phase 1 trial?

CER-1236 is targeting Acute Myeloid Leukemia (AML), a type of liquid tumor.

What additional developments is CERo Therapeutics (CERO) working on besides the AML trial?

CERo is conducting work in solid tumors, with updates expected to be reported in the near term.