Completion of DLT observation period for Cohort 1; first patient in Cohort 2 dosed at higher cell level; additional dosing in Cohort 1 SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (OTCQB: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanisms, announces recent advances to the CertainT-1 trial that is focused on patients with acute myeloid leukemia (AML). Following completion of the ...

Core Insights - CERo Therapeutics Holdings, Inc. has initiated the second cohort of its Phase 1 clinical trial for CER-1236, targeting patients with acute myeloid leukemia (AML) [1][2] - The first patient in this cohort received an initial dose of CER-1236 at twice the initial dose given to patients in the first cohort, with a follow-up dose 48 hours later [1][2] - The trial aims to evaluate the safety and preliminary efficacy of CER-1236 in various AML patient populations, including those who are relapsed/refractory or newly diagnosed with TP53 mutated MDS/AML [2] Clinical Trial Details - The Phase 1/1b study is designed to assess safety and preliminary efficacy, with primary outcome measures including adverse events, dose-limiting toxicities, and overall response rates [2] - The study consists of a dose escalation phase to determine the highest tolerated dose, followed by an expansion phase to further evaluate safety and efficacy [2] - Secondary outcome measures include pharmacokinetics [2] Company Strategy and Future Outlook - The CEO of CERo expressed optimism regarding the trial's progress, highlighting the safety data and cell expansion observed so far [3] - The company is focused on the development of CER-1236 and is considering options for listing on a public exchange while continuing the clinical study [3] - CERo's innovative approach integrates innate and adaptive immunity in T cell engineering, potentially offering advantages over existing CAR-T therapies [4]

Core Insights - CERo Therapeutics Holdings, Inc. is presenting data on its lead compound CER-1236 at the Society for Immunotherapy of Cancer (SITC) conference from November 5-9, 2025 [1] - The poster presentation highlights preclinical data demonstrating the sustained effector function and resistance to exhaustion of CER-1236, showing durability of activity compared to traditional stimulation methods [2] - The CEO of CERo expressed confidence in the data supporting the ongoing Phase 1 trial, which aims to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia [3] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, integrating both innate and adaptive immunity in its approach [4] - The company’s proprietary platform, which includes Chimeric Engulfment Receptor T cells (CER-T), aims to enhance tumor targeting capabilities compared to existing CAR-T therapies [4] - CERo has initiated clinical trials for CER-1236 specifically targeting hematologic malignancies [4]

Core Insights - CERo Therapeutics Holdings, Inc. continues to trade under the ticker symbol CERO on the OTC Markets, with no action required from investors [1] - The company is exploring options for an up-list to enhance liquidity and investor accessibility [1] - CEO Chris Ehrlich emphasized the company's commitment to maximizing shareholder value and advancing its clinical trials, particularly for CER-1236 in AML [2] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, integrating both innate and adaptive immunity [3] - The company's proprietary platform aims to redirect patient-derived T cells towards tumor cells using both adaptive and innate mechanisms, creating Chimeric Engulfment Receptor T cells (CER-T) [3] - CERo believes that CER-T cells may provide advantages over existing CAR-T therapies and could be effective for both hematologic malignancies and solid tumors [3] - Clinical trials for CER-1236, the lead product candidate, have been initiated for hematologic malignancies [3]

Core Points - CERo Therapeutics Holdings, Inc. will have its shares suspended from trading on Nasdaq starting October 31, 2025, following a determination by the Nasdaq Hearings Panel to deny the company's request for continued listing [1] - The company plans to appeal the Panel's decision and is seeking to trade its shares on the OTC Markets while continuing its clinical operations [1][5] Financial Compliance - CERo has struggled to comply with Nasdaq Listing Rule 5550(b)(1), which requires a minimum stockholders' equity of $2.5 million [2] - In April 2025, the company believed it had regained compliance after a financing round that included the issuance of Series D Convertible Preferred Stock valued at $5 million [2] - However, due to difficulties in valuing Marketable Securities, the company sold them at a substantial discount, leading to a determination of non-compliance with the Equity Rule [3][4] Panel Decision - The Nasdaq Panel's decision was based on a retroactive assessment of non-compliance as of April 22, 2025, disregarding the company's plans for future compliance [4] - The company has executed parts of its compliance plan, including receiving approximately $2.25 million from the sale of Series E Convertible Preferred Stock and subscriptions for an additional $4.75 million [4] Future Plans - CERo has submitted a request for review of the Panel's decision and is exploring trading on the OTC Markets, although this market is less liquid than Nasdaq [5] - The company intends to continue its clinical trials, specifically for its lead product candidate, CER-1236, which has shown promising early-stage results in patients with AML [6][7] - CERo is reviewing its cash resources and potential financing alternatives to support ongoing operations [7] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a unique approach that combines innate and adaptive immunity [8] - The company's proprietary technology aims to enhance tumor targeting through Chimeric Engulfment Receptor T cells (CER-T), which may offer advantages over existing CAR-T therapies [8]

Core Insights - CERo Therapeutics Holdings, Inc. has completed the first tranche of a $7 million financing, amounting to approximately $2.3 million, to extend its cash runway and maintain compliance with Nasdaq listing requirements [2][4] - The company is advancing its Phase 1 clinical trial for CER-1236, with a third infusion administered to a patient to gather more safety and dosing information [1][3] - The ongoing clinical trial aims to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia, focusing on various patient conditions [3] Financing and Compliance - The financing is expected to support the company's efforts to maintain Nasdaq compliance and extend its operational cash runway [2][4] - The successful completion of the first tranche reinforces the company's capital structure and positions it to begin the second cohort of the clinical trial once regulatory approvals are obtained [4] Clinical Trial Details - The Phase 1/1b study is designed to assess the safety and efficacy of CER-1236 in patients with acute myeloid leukemia, including those who are relapsed/refractory or newly diagnosed with TP53 mutated MDS/AML [3] - Primary outcome measures include the incidence of adverse events, dose-limited toxicities, and overall response rates, while secondary measures focus on pharmacokinetics [3] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a unique approach that combines innate and adaptive immunity [5] - The company's proprietary technology aims to enhance tumor targeting through Chimeric Engulfment Receptor T cells (CER-T), potentially offering advantages over existing CAR-T therapies [5]

Core Insights - CERo Therapeutics Holdings, Inc. is participating in a stem cell therapy panel at the Maxim Growth Summit on October 22-23, 2025, in New York City [1][2] - The panel will be moderated by Jason McCarthy, Ph.D., Senior Managing Director at Maxim Group [2] - Chris Ehrlich, CEO of CERo, will be available for one-on-one meetings during the conference [3] Company Overview - CERo is an innovative immunotherapy company focused on developing next-generation engineered T cell therapeutics for cancer treatment [4] - The company’s proprietary T cell engineering approach integrates characteristics of both innate and adaptive immunity, aiming to optimize cancer therapy [4] - CERo's Chimeric Engulfment Receptor T cells (CER-T) are designed to redirect patient-derived T cells to eliminate tumors using phagocytic mechanisms, potentially allowing broader therapeutic applications than current CAR-T therapies [4] - Clinical trials for CERo's lead product candidate, CER-1236, targeting hematological malignancies have commenced [4]

Core Insights - CERo Therapeutics has completed the first cohort of its Phase 1 clinical trial for CER-1236, targeting acute myeloid leukemia (AML), with no dose-limiting toxicities observed and cell expansion consistent with preclinical expectations [1][2][4] - The Dose Escalation Safety Committee has approved the initiation of the second cohort, where three new patients will receive an increased starting dosage [2][4] - The company is not currently seeking partnerships or acquisitions, focusing instead on advancing its clinical trial [5] Company Overview - CERo Therapeutics is an innovative immunotherapy company developing next-generation engineered T cell therapeutics for cancer treatment, integrating innate and adaptive immunity [6] - The company’s lead product candidate, CER-1236, is designed to target both hematologic malignancies and solid tumors, utilizing a novel cellular immunotherapy platform [6][7] Clinical Trial Details - The Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory AML or newly diagnosed patients with TP53 mutated MDS/AML [4] - Primary outcome measures include the incidence of adverse events, dose-limiting toxicities, and overall response rates, while secondary measures focus on pharmacokinetics [4]

Core Insights - CERo Therapeutics has initiated dosing for the third patient in the starting dose cohort of its Phase 1 clinical trial for CER-1236 targeting acute myeloid leukemia (AML) [1][2] - The trial aims to evaluate the safety, tolerability, and preliminary activity of CER-1236 in various AML patient populations, including those with relapsed/refractory disease and newly diagnosed cases with TP53 mutations [2][4] - The company has observed pharmacokinetic data indicating cell expansion at the lowest dose level and has modified the protocol to allow for a second infusion in the same subject to gather more data [3] Company Overview - CERo Therapeutics is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a proprietary approach that integrates characteristics of both innate and adaptive immunity [4] - The company's novel cellular immunotherapy platform aims to redirect patient-derived T cells to eliminate tumors through mechanisms that enhance the therapeutic potential beyond current CAR-T therapies [4]

Core Insights - The U.S. FDA has granted Fast Track Designation to CERo Therapeutics' investigational compound CER-1236 for Acute Myeloid Leukemia (AML), in addition to its existing Orphan Drug Designation, providing regulatory and financial advantages for the company's lead cancer immunotherapy program [1][2][3] Regulatory Designations - The Fast Track Designation aims to accelerate the development and review of therapies for serious conditions with unmet medical needs, allowing for increased FDA interactions, potential priority review eligibility, and rolling data submissions [3] - The designations are seen as validation of the urgency of AML and the potential of the submitted data, which may decrease time to market and provide additional benefits throughout the FDA process [2] Clinical Trials - A Phase 1/1b study is currently underway to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML, focusing on various patient groups including those with relapsed/refractory disease and newly diagnosed patients with TP53 mutated MDS/AML [4] - The study includes dose escalation to determine the highest tolerated dose and will assess primary outcomes such as adverse events, overall response rate, and complete response [4] Company Overview - CERo Therapeutics is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a proprietary approach that integrates characteristics of both innate and adaptive immunity [5] - The company's Chimeric Engulfment Receptor T cells (CER-T) are designed to enhance the immune response against tumors, potentially offering advantages over existing CAR-T therapies and extending the application of cellular immunotherapy to both hematologic malignancies and solid tumors [5]