CERo Therapeutics completes $7 million financing, extends cash runway, maintains Nasdaq compliance.
PorAinvest
martes, 21 de octubre de 2025, 8:19 am ET1 min de lectura
CERO--
In a significant development, the company has authorized investigators to administer a third infusion of CER-1236 to a patient enrolled in the first cohort of its ongoing Phase 1 clinical trial. This third infusion, identical to the first two doses, is intended to gather further safety and dosing information, potentially supporting a multi-dose administration strategy as an alternative to a single, higher-dose approach [2].
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 (AML) that is either relapsed/refractory, in remission with measurable residual disease, or newly diagnosed 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 [1].
The 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) [1].
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 [2].
CERo's Chief Financial Officer, Al Kucharchuk, stated, “Our recent milestones highlight CERo’s ability to execute and advance CER-1236, even in a challenging financial climate. We are deeply grateful for the continued confidence and commitment of our shareholders, whose support enables us to move this promising program forward. The financing now underway—with the first tranche successfully completed—is expected to extend our cash runway and position us to begin the second cohort once regulatory clearance is obtained. It also reinforces our capital structure and supports ongoing efforts to maintain compliance with Nasdaq listing requirements as we continue working to build long-term value for both patients and shareholders” [1].
CERo Therapeutics has completed the first tranche of a $7 million financing to increase its cash runway and maintain Nasdaq compliance. The company is developing a novel T cell therapeutic, CER-1236, and has authorized investigators to administer a third infusion of CER-1236 to a patient in its ongoing Phase 1 clinical trial. This additional infusion aims to gather further safety and dosing information, potentially supporting a multi-dose administration strategy.
CERo Therapeutics Holdings, Inc. (Nasdaq: CERO), an innovative cellular immunotherapy company, has completed the first tranche of a $7 million financing round to extend its cash runway and maintain Nasdaq compliance. This funding, approximately $2.3 million, was completed with existing shareholders and is expected to support the company's ongoing clinical trials and regulatory requirements [1].In a significant development, the company has authorized investigators to administer a third infusion of CER-1236 to a patient enrolled in the first cohort of its ongoing Phase 1 clinical trial. This third infusion, identical to the first two doses, is intended to gather further safety and dosing information, potentially supporting a multi-dose administration strategy as an alternative to a single, higher-dose approach [2].
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 (AML) that is either relapsed/refractory, in remission with measurable residual disease, or newly diagnosed 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 [1].
The 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) [1].
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 [2].
CERo's Chief Financial Officer, Al Kucharchuk, stated, “Our recent milestones highlight CERo’s ability to execute and advance CER-1236, even in a challenging financial climate. We are deeply grateful for the continued confidence and commitment of our shareholders, whose support enables us to move this promising program forward. The financing now underway—with the first tranche successfully completed—is expected to extend our cash runway and position us to begin the second cohort once regulatory clearance is obtained. It also reinforces our capital structure and supports ongoing efforts to maintain compliance with Nasdaq listing requirements as we continue working to build long-term value for both patients and shareholders” [1].
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