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Company completes first tranche of a $7 million financing to increase cash runway and maintain Nasdaq compliance
SOUTH SAN FRANCISCO, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (NASDAQ:CERO) ("CERo" or the "Company"), an innovative cellular immunotherapy company developing novel T cell therapeutics that incorporate phagocytic mechanisms, today announced that investigators have been authorized under the study protocol to administer a third infusion of CER-1236 to a patient enrolled in the first cohort of its ongoing Phase 1 clinical trial. This additional infusion of 1 million CER-1236 cells per kilogram of body weight of the patient -- completed approximately one week ago and identical to the first two doses -- is intended to generate further safety and dosing information that may help assess the feasibility of a multi-dose administration strategy as an alternative to a single, higher-dose approach. The initial dose level for Cohort One was selected based on dose ranges commonly used in other adoptive T-cell therapy studies.
The third infusion in this patient occurs prior to the first dosing of the first patient in the previously announced second cohort of the study, which is anticipated in the coming weeks, pending completion of study-related regulatory notifications and approvals. It also takes place as the Company has completed the first tranche of a planned $7 million financing (approximately $2.3 million) with existing shareholders. This additional financing is expected to extend its cash runway and support efforts to maintain compliance with Nasdaq listing requirements.
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). While there has been no observation of toxicities attributable to CER-1236 observed in the first three patients treated to date, the clinical trial is in progress, and no representations or conclusions should be made at this stage regarding the safety, tolerability, or efficacy of CER-1236.
Posted In: CERO
