Company Description
CERo Therapeutics Holdings, Inc. (OTCQB: CERO) is a biotechnology company in the healthcare sector focused on cellular immunotherapy for the treatment of cancer. According to the company’s public disclosures, CERo is advancing the development of next generation engineered T cell therapeutics that are designed to integrate functional attributes of both innate and adaptive immunity within a single therapeutic construct. The company is incorporated in Delaware and maintains its principal executive offices in South San Francisco, California.
Business focus and therapeutic platform
CERo describes itself as an innovative immunotherapy company developing engineered T cell therapies intended for oncology applications. Its proprietary T cell engineering approach is designed to engage the body’s immune repertoire for more comprehensive tumor targeting. Public descriptions state that this cellular immunotherapy platform redirects patient-derived T cells toward tumor cells through adaptive perforin/granzyme pathways and innate engulfment mechanisms.
A central element of CERo’s platform is the use of phagocytic activity to destroy cancer cells. The company refers to its engineered cells as Chimeric Engulfment Receptor T cells (CER-T). These CER-T cells are designed to target ligands such as TIM-4 ligand and to employ engulfment pathways as part of their anti-tumor mechanism. CERo has stated that it believes the differentiated targeting properties and activity of CER-T cells may offer advantages compared with currently approved chimeric antigen receptor T cell (CAR-T) therapies and may potentially extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors.
Lead product candidate CER-1236
CERo has initiated clinical development of its lead product candidate, CER-1236, which it describes as an investigational T cell product targeting the TIM-4 ligand. CER-1236 is being evaluated for hematologic malignancies, with a particular focus on acute myeloid leukemia (AML) and related bone marrow diseases. Company communications describe CER-1236 as exhibiting sustained effector function and resistance to exhaustion in preclinical studies, with sustained cell expansion across multiple rounds of antigen stimulation accompanied by a cytokine response.
The company is conducting a first-in-human, multi-center, open-label Phase 1/1b clinical trial of CER-1236, known as CertainT-1. This trial is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML that is relapsed or refractory, in remission with measurable residual disease, or newly diagnosed with TP53-mutated myelodysplastic syndrome/AML or AML. The study uses a two-part design, beginning with dose escalation to determine the highest tolerated dose and the recommended dose for Phase 2, followed by an expansion phase to further evaluate safety and efficacy.
Clinical trial design and disease focus
In its public updates, CERo reports that the CertainT-1 trial includes multiple cohorts and a dose-limiting toxicity (DLT) observation period. The Phase 1/1b protocol includes primary outcome measures such as:
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
- Incidence of dose-limiting toxicities
- Estimation of overall response rate (ORR)
- Complete response (CR) and composite complete response (cCR)
- Measurable residual disease (MRD)
Secondary outcome measures include pharmacokinetics (PK). Company updates have described observations of in vivo cell expansion of CER-1236 and the absence of dose-limiting toxicities in early cohorts at initial dose levels. In at least one patient with myelodysplastic syndrome (MDS) that progressed to AML, CERo reported a platelet transfusion–free interval following CER-1236 treatment within the context of the trial.
CERo has also disclosed that it filed an amendment to the CertainT-1 trial with the U.S. Food and Drug Administration (FDA) to include advanced MDS and myelofibrosis (MF) as additional cohorts. This reflects a focus on diseases of the bone marrow where CER-1236’s mechanism of action is being explored.
Corporate status and trading market
CERo Therapeutics Holdings, Inc. is identified in SEC filings as an emerging growth company and a smaller reporting company under U.S. securities laws. The company’s common stock has traded under the symbol CERO. In October 2025, a Nasdaq Hearings Panel determined to deny the company’s request for continued listing on the Nasdaq Capital Market based on stockholders’ equity requirements, and trading of CERO common stock on Nasdaq was suspended at the open of trading on October 31, 2025. CERo disclosed that it commenced the process of seeking to trade its shares on the OTC Markets, and subsequent company announcements state that its shares were listed on OTC PINK and then available to trade on the OTCQB market, continuing under the ticker CERO.
Public filings and press releases indicate that CERo has used various financing arrangements, including convertible preferred stock (such as Series C, Series D and Series E preferred stock) and equity line of credit structures with institutional investors, to fund operations and clinical development. The company has also filed registration statements on Form S-1 related to potential resales of common stock issued under these financing arrangements.
Regulatory and corporate governance context
CERo’s SEC filings describe typical corporate governance and capital structure matters for a clinical-stage biotechnology issuer. These include a Second Amended and Restated Certificate of Incorporation, amendments to its 2024 Equity Incentive Plan, and proposals for a potential reverse stock split to combine outstanding shares of common stock into a lesser number of shares at a ratio to be determined by the board of directors. The company has also designated Series E convertible preferred stock through a Certificate of Designation that sets out ranking, conversion rights, dividend rights, and other preferences relative to its common stock and other preferred stock series.
As of the dates referenced in its filings, CERo continues to describe itself as conducting clinical trials of CER-1236 and reviewing financing alternatives to support its operations. The company’s disclosures emphasize the early-stage nature of its clinical data and note that no conclusions regarding safety, tolerability, or efficacy should be drawn beyond what is stated in its trial updates.
Research and development orientation
CERo’s public statements highlight its focus on research and development in cellular immunotherapy. The company has presented preclinical data for CER-1236 at scientific venues such as the Society for Immunotherapy of Cancer (SITC) conference, where it reported sustained cell expansion and cytokine responses in preclinical models. The company positions its CER-T platform as an approach that builds engulfment pathways and phagocytic mechanisms into T cells to eliminate tumors, with the goal of applying this modality across hematologic malignancies and potentially solid tumors.
Overall, CERo Therapeutics Holdings, Inc. represents a clinical-stage biotechnology company focused on engineered T cell immunotherapies, with its lead candidate CER-1236 in Phase 1/1b development for AML and related bone marrow disorders, and with corporate and regulatory disclosures centered on capital formation, listing status, and progression of its early-stage clinical program.