Announcement • Jun 15
CERo Therapeutics Holdings Announces Clinical Update From CERTAIN-T Phase 1 CER-1236 Trial CERo Therapeutics Holdings announced a clinical update from investigators participating in the ongoing Phase 1 CERTAIN-T clinical trial evaluating CER-1236 in hematologic malignancies. Patient five in the trial had multiple refractory acute myeloid leukemia and, according to the treating investigator, had not previously achieved disease control sufficient to enable allogeneic stem cell transplantation prior to enrollment in the study. Following treatment with CER-1236 at a total dose of 4 million cells/kg, bone marrow blast counts were reported at 14% on Days 14 and 28 and 7% on Day 42. The patient subsequently underwent allogeneic stem cell transplantation on Day 71 following infusion. The patient’s transplant course and longer-term clinical outcome remain under evaluation. These observations are preliminary, based on a limited number of patients, and no definitive conclusions regarding safety or efficacy can be made at this stage of the trial. The observed safety profile across all treated patients remains consistent with clinical data previously presented at the Tandem Meetings in February, which reported no cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, DLTs, or treatment-related severe adverse events during the DLT assessment window. The Company has now treated six patients in the ongoing Phase 1 trial. In the most recent cohort of three patients, CER-1236 was administered at an increased dose level, with no dose-limiting toxicities observed during the DLT assessment period. As previously reported, CERo has also observed expansion of infused CER-1236 cells following administration, and the Company continues to evaluate the pharmacokinetic and pharmacodynamic profile of CER-1236 as the study advances through dose escalation. The Company has initiated the third planned cohort of the CERTAIN-T study, which is expected to evaluate the planned one billion cells/patient protocol and is currently screening patients for enrollment. The cohort is also expected to include patients with myelodysplastic syndromes and myelofibrosis, reflecting the Company’s strategy to further evaluate CER-1236 in additional myeloid disease settings. The first-in-human, multicenter, open-label Phase 1/1b CERTAIN-T study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of CER-1236 in patients with hematologic malignancies. The study initially enrolled patients with acute myeloid leukemia, including relapsed/refractory AML, measurable residual disease AML, and newly diagnosed TP53-mutated AML, and has since expanded to include transfusion-dependent myelodysplastic syndromes, high-risk myelodysplastic syndromes, and post-JAK inhibitor myelofibrosis. Primary endpoints include safety and tolerability. Secondary endpoints include pharmacokinetics and measures of clinical response, including overall response rate, complete response, composite complete response, and measurable residual disease. Announcement • May 30
CERo Therapeutics Holdings, Inc. announced that it has received $0.75 million in funding from SRx Health Solutions Inc. CERo Therapeutics Holdings, Inc. announced that it has issued and sold a convertible promissory note in the principal amount of $937,500 at an original issue discount of 20% ($187,500) for gross proceeds of $750,000 on May 28, 2026. the transaction included participation from SRX Health Solutions, Inc. Pursuant to the Note, the Company may borrow, from time to time thereunder, up to a maximum aggregate amount not to exceed a sum of $750,000. The Note bears interest at a rate of 10% per annum, matures on May 28, 2027, and is convertible into shares of the Company’s common stock, par value $0.0001 per share. The issuance of the Note was made in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Rule 506(b) promulgated thereunder, the offer and sale of securities not involving a public offering. Announcement • May 11
Cero Therapeutics Holdings, Inc. Completes Second Ascending Dose Cohort of Phase 1 Cer-1236 Trial CERo Therapeutics Holdings, Inc. announced that it has completed dosing and the 28-day dose-limiting toxicity assessment period for all three patients in the second cohort of its Phase 1 CERTAIN-T clinical trial of CER-1236 in hematologic malignancies. In the second cohort, patients received CER-1236 at a total dose of 4 × 106 cells/kg, administered as a split dose on Day 0 and Day 2. No dose-limiting toxicities were observed through the dose-limiting toxicity assessment window, supporting continued dose escalation in accordance with the clinical protocol. The observed safety profile remains consistent with clinical data presented at the Tandem Meetings in February, which reported no cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, dose-limiting toxicities, or treatment-related severe adverse events during the dose-limiting toxicity assessment window. CERo is now escalating to the planned 1 × 107 cells/kg split-dose cohort and is screening patients for enrollment. This next cohort is expected to include patients with myelodysplastic syndrome and myelofibrosis, reflecting the Company’s strategy to evaluate CER-1236 in myeloid disease settings characterized by inflammatory bone marrow microenvironments and impaired hematopoiesis. The Company has now treated six patients in its Phase 1 trial. In the most recent cohort of three patients, CER-1236 was administered at an increased dose level, with no dose-limiting toxicities observed during the dose-limiting toxicity assessment period. As previously reported, CERo has also observed expansion of infused CER-1236 cells following administration, supporting continued evaluation of CER-1236’s pharmacokinetic and pharmacodynamic profile as the study advances through dose escalation. The first-in-human, multicenter, open-label Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236. The trial was initially focused on AML patients, including those with relapsed/refractory disease, measurable residual disease, or newly diagnosed TP53-mutated AML, and has since expanded to include transfusion-dependent MDS, high-risk MDS, and post-JAK inhibitor MF. Primary endpoints include safety and tolerability, while secondary endpoints include pharmacokinetics and measures of clinical response, including overall response rate, complete response, composite complete response, and measurable residual disease. 
