SOUTH SAN FRANCISCO, Calif., Oct. 15, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company, announces that Chris Ehrlich, Chief Executive Officer will participate in a stem cell therapy panel titled, “A Space That is Ready to Have its Day,” at the Maxim Growth Summit presented by Maxim Group LLC. The Summit is being held on October 22 – 23, 2025 at the Hard Rock Hotel in New York City. The panel will be moderated by ...

Study’s Dose Escalation Safety Committee approves initiation of Cohort 2 with fourth patient to receive increase in initial dose pending regulatory approval Company issues correction of recently published article, asserts it is not for sale and is not currently actively seeking partnerships as it continues dose finding clinical activities for CER-1236 SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”), an innovative cellu ...

Third patient in the first cohort is now advancing through protocol-defined evaluations as Company anticipates additional results from second dosing of second patient in the cohort SOUTH SAN FRANCISCO, Calif, Sept. 22, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company, today announced that it has dosed the third patient in the starting dose cohort of its Phase 1 clinical trial evaluating CER-1236 in acute myeloid ...

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]

Core Insights - CERo Therapeutics has initiated dosing of the second patient in its Phase 1 clinical trial for CER-1236, targeting acute myeloid leukemia (AML) [1][2] - The first patient showed no dose-limiting toxicities during the observation period, with a significant 20.8-fold expansion of infused cells observed at 14 days post-infusion [2][3] - The trial aims to evaluate the safety and preliminary efficacy of CER-1236, with primary outcomes including adverse events and overall response rates [3][4] Company Overview - CERo Therapeutics is focused on developing next-generation engineered T cell therapeutics, specifically targeting cancer through a novel approach that integrates innate and adaptive immunity [5] - The company’s lead product candidate, CER-1236, is designed to utilize phagocytic mechanisms to enhance the elimination of tumors, potentially offering broader therapeutic applications than current CAR-T therapies [5]

Core Viewpoint - CERo Therapeutics Holdings, Inc. has completed the initial evaluation of the first patient in its Phase 1 clinical trial for CER-1236, showing no dose-limiting toxicity, indicating a positive start for the trial [1][2]. Company Overview - CERo is an innovative immunotherapy company 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 [3]. - The company’s lead product candidate, CER-1236, targets TIM4L and is designed to redirect patient-derived T cells to eliminate tumors through phagocytic mechanisms, which may offer greater therapeutic applications compared to existing CAR-T therapies [3]. Clinical Trial Details - The Phase 1/1b study, titled "Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia (CertainT-1)," aims to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia [2]. - The trial includes a dose escalation phase to determine the highest tolerated dose and a subsequent expansion phase to assess safety and efficacy, with primary outcome measures focusing on adverse events, dose-limiting toxicities, and overall response rates [2]. Future Plans - The company plans to initiate a second trial of CER-1236 in solid tumors later in the year, indicating a commitment to advancing its clinical programs [2].

Core Insights - CytoMed Therapeutics Limited is focused on developing affordable donor-derived, cell-based allogeneic immunotherapies, targeting the ASEAN region and North Asia with a population exceeding two billion [2][22] - The company reported a reduced net loss of US$1.85 million for the year ended December 31, 2024, a 39% improvement from US$3.03 million in 2023, primarily due to lower operational costs [4][3] - CytoMed is advancing its clinical trials, including the ANGELICA trial, which is the first-in-human CAR T trial using donor-derived gamma delta T cells [9][10] Financial Performance - Topline income for 2024 was US$624,771, an increase from US$588,423 in 2023 [3] - Cash and bank balances decreased to US$3.64 million as of December 31, 2024, down from US$6.58 million in 2023, but are expected to fund operations through at least 2026 [5] - Research expenses rose to US$1.40 million in 2024 from US$1.16 million in 2023, driven by higher clinical trial costs [6] Clinical Developments - The ANGELICA trial, approved in Singapore, began dosing patients in November 2024, focusing on the use of gamma delta T cells for various cancers [9][10] - A Phase II Investigator Initiated Trial in India is set to commence patient recruitment in the second half of 2025, utilizing CytoMed's manufactured cells [11] - The company is also developing iPSC-derived hybrid immune cells for cancer treatment and has received trial approvals for other conditions [14] Corporate Strategy - CytoMed is exploring a joint venture in China to enhance low-cost cell manufacturing and expand its market reach [16] - The acquisition of a licensed cord blood bank in Malaysia aims to support the development of cord blood-derived therapeutics for autoimmune diseases and cancers [17] - The company plans to establish a liaison office in New York to strengthen its presence in the U.S. market and explore strategic partnerships [19] Future Outlook - An important milestone for 2025 includes the initial clinical readout of the ANGELICA trial and the submission of a U.S. FDA IND application for gamma delta T cells [18] - The company aims to implement alternative revenue-generating methods to assist late-stage patients and capitalize on the growing medical tourism market in Asia [20] - Financial prudence is emphasized, with plans to strengthen financials and prepare for potential mergers and acquisitions in 2025 [21]