Company: CERO
Filing Date: 2025-12-05
Form Type: S-1
Source: 0001213900-25-118817
Chunk: 179

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-12-05
Form: S-1
Chunk 179
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 emphasize a gradual increase in the delivered dose with the objective of achieving a clinical signal, while ensuring patient safety. Our Phase 1 trial is also designed to enable an evaluation of appropriate dosing strategies to optimize CER-T engagement and proliferation. Two patient products have been successfully manufactured and dosed. The initial patient did not experience any dose-limiting toxicities during the 28-day observation window, and the second patient was still under observation 7 days after treatment. Pharmacokinetic data from the first patient indicates that the CER-1236 T cells successfully expanded upon infusion, and began to contract after 2 weeks. We dosed a third patient in September 2025, which will be followed by a meeting of the dose escalation safety committee to determine if we can advance to the next dose. The fourth patient is anticipated to be treated in October 2025. We believe, subject to discussions with the FDA and other regulatory authorities, that there may be a full development path to registration and use in the larger AML patient populations on achieving positive safety data along with indications of therapeutic benefit in these initial trial cohorts. We believe CER-1236 may provide significant treatment advantages over currently available therapeutics, including CAR-T therapy as a result of its potential to enhance objective response rates and the duration of response related to the comprehensive, coordinated engagement of the innate and adaptive immune systems and a sustained signaling environment. We believe this novel mechanism of action will enable our advance of a single therapeutic construct to address the substantial unmet need for a safe and effective cell therapy offering an improved therapeutic profile, despite significant competition. We subsequently anticipate initiating clinical trials for additional indications, including the possible application of CER-1236 in the treatment of certain solid tumors such as NSCLC and ovarian cancer. Ongoing Phase 1 trial of CER-1236 in patients with AML In May 2025, we initiated our Phase 1 clinical trial designed to evaluate the safety, potential therapeutic utility and applicable dose of CER-1236 in patients with acute myeloid leukemia (“AML”). 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 has begun with dose escalation to determine highest tolerated dose and recommended dose for