CERo Advances Novel AML Cell Therapy in Early Clinical Trial

SOUTH SAN FRANCISCO, CA – December 17, 2025 – In the high-stakes world of cancer therapy development, early signs of safety are a crucial currency. CERo Therapeutics Holdings, Inc. announced today that it has achieved a key milestone in its Phase 1 clinical trial for a novel cell therapy, CER-1236, designed for patients with acute myeloid leukemia (AML), a notoriously difficult-to-treat blood cancer.

The company confirmed that it has successfully escalated the treatment dose for its investigational therapy after the initial patient cohort showed good tolerance. The first patient in the second cohort of the 'CertainT-1' trial received a cell dose four times higher than the initial group and has completed the subsequent safety observation period without issue. This progress, while preliminary, offers a glimmer of hope in a disease area with significant unmet needs, particularly for patients with relapsed, refractory, or high-risk genetic forms of AML.

Beyond CAR-T: A Dual-Action Attack on Cancer

CERo's approach ventures into next-generation cellular immunotherapy, aiming to build upon the successes and address the limitations of existing Chimeric Antigen Receptor T cell (CAR-T) therapies. The company's proprietary platform, called Chimeric Engulfment Receptor T cells (CER-T), engineers a patient's own T cells to execute a two-pronged attack against cancer.

Unlike conventional CAR-T therapies that primarily rely on the adaptive immune system's perforin/granzyme pathways to kill tumor cells, CER-T cells are designed to also harness the power of the innate immune system. They do this by incorporating a mechanism for phagocytosis, or cellular "engulfment," effectively enabling the T cells to eat cancer cells. CERo believes this dual-action mechanism could lead to more comprehensive tumor destruction and may extend the utility of cell therapy to solid tumors, a long-standing challenge for the field.

The key to this novel approach lies in its target: the TIM-4 ligand. Research has shown that this ligand is frequently expressed on the surface of AML cells, including in patients with high-risk mutations like TP53, who often have a poor prognosis with standard treatments. By directing its CER-T cells against TIM-4, CERo is targeting a prevalent marker on the very cancer cells that are most difficult to eradicate. This scientific rationale underpins the 'CertainT-1' trial, which is enrolling patients with relapsed/refractory AML, those in remission but with measurable residual disease (MRD), and newly diagnosed patients with TP53 mutations—precisely the groups who need new options most urgently.

Navigating Critical Early Clinical Milestones

The update from the first-in-human, multi-center 'CertainT-1' study marks important progress. Phase 1 trials are fundamentally about safety, seeking to determine the highest dose of a new drug that can be administered without causing unacceptable side effects, known as dose-limiting toxicities (DLTs).

CERo announced the completion of the DLT observation period for the first cohort, who received a dose of 1 million cells per kilogram. Following this, the first patient in the second cohort was dosed at a significantly higher level of 4 million cells per kilogram and has also successfully passed their DLT observation window. This ability to dose-escalate is a critical positive signal, suggesting the therapy is well-tolerated at initial levels and allowing researchers to explore potentially more effective, higher concentrations.

"Enrollment and dosing are ongoing in our Phase 1 clinical trial of CER-1236," said CERo CEO Chris Ehrlich in a statement. "The first patient in the second cohort has received a higher cell dose, and safety monitoring is continuing. We are focused on the careful conduct of the dose-escalation phase and the systematic collection of safety data as the trial proceeds."

Adding to the encouraging early data, the company also noted that the second patient in the initial low-dose cohort remains on the study and has received a fourth additional dose of CER-1236. While the company has not released efficacy data, the continued treatment of a patient often suggests at least disease stabilization or a perceived clinical benefit, providing a subtle hint of the therapy's potential activity.

The High-Stakes Path of a Biotech Innovator

While the clinical news is positive, it comes at a pivotal moment for CERo Therapeutics. The company faces the significant financial pressures common to many early-stage biotechnology firms. According to recent SEC filings, the company has substantial doubt about its ability to continue as a "going concern" without raising additional capital, reporting a net loss of $15.4 million for the first nine months of 2025.

The company's stock was delisted from the Nasdaq in October 2025 for failing to meet minimum stockholders' equity requirements and now trades on the OTCQB Market. This journey reflects the volatile and capital-intensive nature of drug development. For companies like CERo, positive clinical data is not just a scientific achievement; it is a vital lifeline. Each successful step in a trial, such as the dose escalation of CER-1236, serves as a crucial value-creating milestone that can attract new investors and potential pharmaceutical partners.

The company has been actively seeking funds, securing a $5 million financing round earlier in the year and establishing an equity line to sell stock. This clinical progress is exactly the kind of news needed to build confidence and secure the resources required to advance CER-1236 through the lengthy and expensive clinical trial process.

The journey for CER-1236 is still in its earliest stages, with the primary goal of the current dose-escalation phase being the determination of a safe and effective dose for a larger Phase 2 study. The trial will continue to collect data on safety, overall response rates, and other key measures of efficacy. For the AML patients and physicians watching, this careful, step-by-step progress represents the slow but essential turning of wheels in the search for better treatments against a formidable disease.