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Additional patent granted from the Japanese patent office now results in 20 granted patents and allowed applications covering the compound and its underlying technology SOUTH SAN FRANSCISCO, Calif., Sept. 09, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces the Company received a Notice of Allowan ...

Study investigator of Phase 1 trial presented poster at Society of Hematologic Oncology 13th annual conference highlighting original study protocol SOUTH SAN FRANSCISCO, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces it has administered a second dose in the second patient in th ...

Regulatory milestone adds to its existing Orphan Drug Designation, creating additional regulatory and financial advantages for the Company’s lead cancer immunotherapy program SOUTH SAN FRANSCISCO, Calif., Sept. 05, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces that the U.S. Food and Drug Admini ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-40877 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) | Delaware | 81-4182129 | | --- | --- | | ...

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 - CERo Therapeutics Holdings, Inc. has received Orphan Drug Designation from the FDA for its lead drug candidate CER-1236, aimed at treating acute myeloid leukemia (AML) [1][3] - CER-1236 is currently undergoing Phase 1 clinical trials to assess its safety and preliminary efficacy in AML patients [2] - The FDA's Orphan Drug program supports the development of treatments for conditions affecting fewer than 200,000 patients annually, providing various incentives to CERo [3] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a proprietary approach that combines innate and adaptive immunity [4] - The company’s innovative therapy, CER-1236, employs phagocytic mechanisms to enhance the effectiveness of T cell therapies against tumors [4] - CERo aims to differentiate its CER-T cells from existing CAR-T therapies, potentially expanding their application to both hematological malignancies and solid tumors [4]

Company Overview - CERo Therapeutics Holdings, Inc. is an innovative immunotherapy company focused on developing next-generation engineered T cell therapeutics for cancer treatment [5] - The company employs a proprietary approach to T cell engineering that integrates characteristics of both innate and adaptive immunity, aiming to enhance cancer therapy effectiveness [5] Recent Developments - CERo has issued additional shares of its Series D Preferred Stock to institutional investors, with a total purchase price of up to $8 million, including $5 million previously issued [1] - The gross proceeds from the recent closing are expected to be approximately $750,000, with potential additional funding of up to $2.25 million at the investors' discretion [3] - The net proceeds from this offering will be utilized to leverage recent FDA IND allowances in liquid and solid tumors and to expedite site activation at MDACC [3] Clinical Progress - The company has achieved a significant milestone with the completion of first-in-human dosing for its novel autologous CAR-T therapeutic candidate, CER-1236, targeting TIM 4L in acute myeloid leukemia (AML) [2] - CERo initiated clinical trials for CER-1236 in April 2025, marking its lead product candidate for hematological malignancies [5]

Core Viewpoint - CERo Therapeutics Holdings, Inc. has significantly expanded its intellectual property portfolio with the granting of multiple patents, enhancing its position in the immunotherapy market focused on engineered T cell therapeutics [1][5][6]. Patent Developments - The USPTO granted U.S. Patent No. 12,291,557 for the chimeric TIM4 receptor, which protects design aspects of the lead compound CER-1236 [2]. - The European Patent Office allowed European Patent Application No. 1882166.7, covering a chimeric engulfment receptor that further protects CER-1236's design aspects already granted in the U.S., Japan, and China [3]. - U.S. Patent No. 12,303,551 was granted for cellular immunotherapy compositions, covering combination therapies involving CER-1236, which may enhance treatment options for cancer [4]. Intellectual Property Portfolio - CERo's intellectual property now includes a total of 18 issued patents and allowed patent applications internationally, with 9 total patent families providing protection until 2042 in the United States [5][6]. Company Strategy and Future Plans - The CEO of CERo emphasized the importance of expanding the intellectual property portfolio to ensure market success and highlighted the novelty of the CER-T technology [6]. - The company anticipates updates on clinical trial progress for acute myeloid leukemia (AML) and plans to initiate human trials for ovarian and non-small cell lung cancers [6][7].