CERo Therapeutics Holdings, Inc. has begun the second cohort of its Phase 1/1b study of the CAR‑T‑derived candidate CER‑1236 in patients with acute myeloid leukemia (AML). The first patient in the new cohort received an initial infusion that is twice the cell dose used in the first cohort, followed by a second identical infusion 48 hours later. The company reported that no dose‑limiting toxicities (DLTs) were observed in that patient, a key safety milestone that supports the decision to increase the dose level and informs the recommended phase 2 dose.
The absence of DLTs in the first patient is significant because it validates the safety profile of the higher cell dose and allows the trial to continue escalating doses in subsequent patients. In a dose‑escalation study, early safety signals determine whether the trial can progress to the next cohort; the data from this patient therefore keep the study on track and provide the first indication that the higher dose may be tolerable in a broader patient population.
CERo is a pre‑revenue, high‑risk biotechnology company that recently moved its shares to the OTC Pink market after a Nasdaq panel determination on October 29, 2025. The company’s financial statements show zero revenue and substantial operating losses, with a Q2 2025 loss of $61.71 million versus an estimated $124.26 million. These financial realities underscore the importance of clinical milestones, as the company’s future depends on the success of CER‑1236 and the ability to secure additional funding or a partnership.
CEO Chris Ehrlich said, “We remain encouraged by the progress and results of our ongoing Phase 1 trial of CER‑1236 given the safety data and cell expansion seen to date. The safety results observed thus far in the trial, which have included those recorded from subsequent dosing following the initial doses, have guided the strategy to significantly increase the dosing in this cohort, which we believe will be very instructive as we continue to determine a Phase 2 dose.” The statement highlights the company’s focus on safety data to drive dose‑escalation decisions and signals confidence that the trial can reach a phase 2 dose recommendation.
CER‑1236 has received Fast Track and Orphan Drug designations from the FDA for AML, and the company has also cleared a Phase 1 trial in advanced solid tumors, including non‑small cell lung cancer and ovarian cancer. These regulatory designations provide potential pathways for accelerated development and market access, which are critical for a company that has no commercial products yet.
The trial’s progress is a positive development for CERo’s pipeline, but the company’s financial fragility and recent listing changes mean that investors and partners will closely monitor subsequent safety and efficacy data. The dose‑escalation milestone keeps the study on schedule and may improve the company’s attractiveness to future collaborators, but the lack of revenue and ongoing operating losses remain significant headwinds that will shape the company’s strategic options in the coming months.
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