CERo Therapeutics Announces Completion of First Cohort of Phase 1 Clinical Trial of CER-1236 in AML

Rhea-AI Summary

CERo Therapeutics (Nasdaq: CERO) announced on October 13, 2025 that it completed Cohort 1 of its first-in-human Phase 1/1b study of CER-1236 in acute myeloid leukemia (AML).

The company reported in-vivo cell expansion consistent with preclinical expectations and no dose-limiting toxicities (DLTs) in Cohort 1. The Dose Escalation Safety Committee approved initiation of Cohort 2, where three new patients will receive an increased starting dose pending regulatory approval.

CERo plans an additional infusion for the second Cohort 1 subject to explore multiple-infusion dosing versus single higher doses and said it is not currently pursuing acquisitions or partnerships while dose finding continues.

Positive

• No dose-limiting toxicities observed in Cohort 1
• In-vivo cell expansion consistent with preclinical expectations
• Dose Escalation Safety Committee approved start of Cohort 2 with higher starting dose
• Planned additional infusion explores multiple-infusion dosing alternative

Negative

• Cohort 1 limited to three patients, restricting early evidence
• No efficacy endpoints (ORR/CR/cCR/MRD) reported yet

Insights

Clinical development strategist

Early safety and pharmacokinetic signals allow planned dose escalation; data remain preliminary for efficacy.

The study completed Cohort One with CER-1236 showing in‑vivo cell expansion and no dose‑limiting toxicities, which supports moving to a higher starting dose for Cohort Two per the Dose Escalation Safety Committee decision on October 13, 2025.

Safety and cell expansion are necessary early checkpoints for cell therapies; these findings reduce an immediate safety barrier but do not address efficacy or durability. The plan to test an additional infusion in a Cohort One subject probes an alternative dosing strategy rather than a single larger dose.

Watch for formal reporting of safety tables, incidence of AEs/SAEs, pharmacokinetic metrics, and any preliminary response assessments (ORR, CR, cCR, MRD) across the next 1–3 dosing cohorts; those readouts will materially affect interpretation.

Clinical program policy and risk analyst

Progress is operationally constructive; corporate statements confirm focus on dose finding, not partnerships.

The company emphasizes continued dose‑escalation and clarifies it is not pursuing transactions while it completes clinical dose finding for CER-1236. That narrows near‑term strategic variability and signals priority on generating a robust clinical package before exploring options.

Risks remain: early safety signals do not equate to efficacy, and the protocol‑defined escalation and expansion endpoints (AEs, SAEs, DLTs, ORR, CR, cCR, MRD, PK) must still mature. Regulatory approval to increase dose and any external reviewer findings will influence next steps.

Monitor the next safety review decisions, any detailed AE/PK tables, and objective response data across the coming cohorts over the next several months to a year to assess whether the program advances beyond early tolerability into meaningful clinical benefit.

Study’s Dose Escalation Safety Committee approves initiation of Cohort 2 with fourth patient to receive increase in initial dose pending regulatory approval

Company issues correction of recently published article, asserts it is not for sale and is not currently actively seeking partnerships as it continues dose finding clinical activities for CER-1236

SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) --  CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanisms, announces it has concluded the first cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML). The conclusion of the first cohort follows observation of cell expansion consistent with preclinical expectations, with no dose-limiting toxicities observed. The initial dose chosen for Cohort One was identical to the standard dose administered in CAR T therapy to B-cell lymphoma patients, where toxicity is commonly observed and treated in hospital. Additional dose infusions were administered to the second and third patients as the company continues forward with dose-finding investigations.

The conclusion of the first cohort follows observations of cell expansion with no dose-limiting toxicities. Following approval of the Dose Escalation Safety Committee, the investigators have agreed to initiate the second cohort of the study in which three new patients will receive an increase in the starting dosage from the previous cohort.

As the second cohort begins, the Company also plans to provide an additional infusion of CER-1236 to the second subject of Cohort One based on encouraging pharmacokinetic data and interest from the patient and treating physician. This approach explores whether multiple infusions may provide an alternative to dose intensification through a single larger initial dose.

Robert Sikorski, M.D., Ph.D., CERo’s Chief Medical Officer, noted, “Completion of the first cohort without any dose-limiting toxicities and in-vivo cell expansion of CER-1236 therapeutic cells represent important early steps in this study. The data collected to date support moving to the next planned dose level in accordance with the trial protocol. As we advance, we will continue close safety monitoring and systematic evaluation of pharmacokinetic and clinical data to inform subsequent stages of development.”

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).

CERo CEO Chris Ehrlich added, “The completion of the first cohort represents important progress in the ongoing Phase 1 trial of CER-1236.  We remain focused on advancing the current clinical trial and wish to clarify that the Company is not currently pursuing acquisition or partnership discussions. At this time, we are dedicated to completing our current dose escalating Phase 1 trial.  Once we have further advanced the trial and have achieved the clinical data package we are seeking, we will explore all potential options that would best achieve optimal shareholder value.”

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
chris@cero.bio

Investors:
CORE IR
investors@cero.bio

FAQ

What did CERo announce about its Phase 1 CER-1236 trial on October 13, 2025?

CERo said Cohort 1 completed with in-vivo cell expansion and no dose-limiting toxicities, and the Dose Escalation Safety Committee approved initiation of Cohort 2.

How many patients were in Cohort 1 of CERo's CER-1236 study (CERO)?

Cohort 1 enrolled three patients, with additional infusions given to the second and third subjects.

What will change in Cohort 2 of the CER-1236 trial (CERO)?

Cohort 2 will enroll three new patients who will receive an increased starting dose versus Cohort 1, pending regulatory approval.

Did CERo report any efficacy results for CER-1236 (CERO)?

No efficacy outcomes (ORR, CR, cCR, MRD) were disclosed in the announcement; the study remains in dose-finding stage.

Why is CERo considering an additional infusion for a Cohort 1 patient (CERO)?

The company plans an extra infusion for the second Cohort 1 subject based on encouraging pharmacokinetic data and clinician/patient interest to explore multiple-infusion dosing.

Is CERo (CERO) pursuing a sale or partnership following the Cohort 1 update?

CERo stated it is not currently pursuing acquisition or partnership discussions and is focused on completing dose escalation.