South San Francisco, Calif. — January 7, 2026 — Leads & Copy — CERo Therapeutics Holdings, Inc., (OTCQB: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company, has announced a key clinical update from its ongoing CertainT-1 trial, which focuses on patients with acute myeloid leukemia (AML).
Following the completion of the dose-limiting toxicity (DLT) observation period for the first cohort, investigators observed cell expansion without any reports of CRS, ICANS, or treatment-related adverse events. The expansion was noted both with and without lymphodepletion.
The second patient enrolled, who had myelodysplastic syndrome (MDS) that progressed to AML with an inv3 chromosome translocation, received four rounds of CER-1236 cells. After treatment with CER-1236, a 61-day platelet transfusion-free interval was observed, exceeding the commonly referenced 8-week benchmark cited in clinical studies for platelet transfusion independence. This independence ended after a subsequent round of lymphodepleting chemotherapy plus CER-1236 treatment.
CERo has filed an amendment to CertainT-1 with the U.S. Food and Drug Administration (FDA) to include advanced MDS and myelofibrosis (MF) as additional cohorts for the study.
The company will host a conference call today, January 7, 2026, at 5:00PM ET, to discuss the progress and its strategy moving forward.
CERo’s Chief Scientific Officer, Robert Sikorski, M.D.,Ph.D., said that the patient’s clinical course, including a platelet transfusion–free interval despite advanced MDS/AML, is encouraging and supports continued evaluation of CER-1236 in diseases of the bone marrow. Sikorski added that the CertainT-1 trial has been amended to expand the focus to include MDS and MF patients.
The first-in-human, multi-center, open label, Phase 1/1b study was designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML 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 the incidence of adverse events (AEs) and serious adverse events (SAEs), the incidence of dose-limited toxicities, and the 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 stated that the evolution of this trial to MDS and MF is an important milestone as the company continues to dose escalate, both in terms of volume and frequency. He also stated that the company is looking forward to sharing additional details in the conference call, and communicating with all stakeholders, including regulatory authorities, toward the continuing of its development.
Ehrlich added that the company remains grateful to its trial patients for their participation as well as the shareholders who ensure that the company is able to conduct this work. He stated that the company remains focused on the conduct of the dose-escalation phase and the systematic collection of safety data as the trial proceeds and the company seeks to expand its initial focus.
The conference call will take place today, January 7, 2026 at 5:00PM ET. Interested parties within the U.S. can dial 1-844-763-8274 (domestic) or 1-412-717-9224 (international). Callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the CERo Therapeutics conference call. The conference call will also be available through a live webcast.
CERo Therapeutics is an immunotherapy company focused on advancing the development of next-generation engineered T-cell therapeutics for cancer treatment. CERo’s approach to T-cell engineering integrates functional attributes of both innate and adaptive immunity within a single therapeutic construct, designed to engage the body’s immune repertoire for tumor targeting. The cellular immunotherapy platform is designed to redirect patient-derived T-cells toward tumor cells through adaptive perforin/granzyme pathways and innate engulfment mechanisms, including targeting of the TIM-4 ligand. This employs phagocytic activity to destroy cancer cells, creating Chimeric Engulfment Receptor T cells (“CER-T”).
CERo believes the 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 CER-1236 for hematologic malignancies.
Chris Ehrlich
Chief Executive Officer
chris@cero.bio
Investors:
CORE IR
investors@cero.bio
Source: CERo Therapeutics Holdings, Inc.
