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 health care sector is experiencing a trend of oversold stocks, presenting potential investment opportunities in undervalued companies [1] Group 1: Oversold Stocks - Summit Therapeutics Inc (SMMT) has an RSI value of 22.4, with a stock price of $19.44 and a 52-week low of $15.55, having fallen approximately 31% over the past month [6] - Lunai Bioworks Inc (RENB) has an RSI value of 29.3, with a stock price of $0.19 and a 52-week low of $0.18, experiencing a decline of around 23% over the past five days [6] - CERo Therapeutics Holdings Inc (CERO) has an RSI value of 16.3, with a stock price of $4.68 and a 52-week low of $4.27, having dropped about 37% over the past five days [6]

Core Insights - CERo Therapeutics Holdings, Inc. has received a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application 19/019,111, which will provide composition of matter protection for CER-1236 and its use in cancer treatment until 2041 [1][3] - The company has also secured a patent in Japan, increasing its total to 20 granted patents and allowed applications covering CER-1236 and its platform technology internationally [2] Company Overview - CERo 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 lead product candidate, CER-1236, is currently undergoing Phase 1 clinical trials for hematological malignancies [4] Intellectual Property and Regulatory Position - The company’s intellectual property portfolio has been strengthened with the recent patent allowances, enhancing its regulatory position and exclusivity in the market [3] - CERo has also received Fast Track and Orphan Drug Designations from the FDA, further solidifying its regulatory advantages [3]

Core Insights - CERo Therapeutics Holdings, Inc. has administered a second dose in the second patient of its Phase 1 CER-1236 clinical trial for acute myeloid leukemia (AML), with the new protocol allowing for double the cell product infusion compared to the previous approach [1][3] - The study 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 [3][4] - The recent protocol modification is expected to provide valuable insights into dosing, safety, and feasibility as the study progresses [3] Company Overview - CERo 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 lead product candidate, CER-1236, is designed to redirect patient-derived T cells to eliminate tumors through phagocytic mechanisms, potentially offering advantages over existing CAR-T therapies [4] Clinical Trial Details - The Phase 1/1b study is structured in two parts: an initial dose escalation phase to determine the highest tolerated dose, followed by an expansion phase to evaluate safety and efficacy [3] - Primary outcome measures include the incidence of adverse events, dose-limited toxicities, and overall response rates, while secondary measures focus on pharmacokinetics [3]

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]

Financial Position - As of June 30, 2025, the company reported approximately $3.2 million in cash and cash equivalents, with an accumulated deficit of approximately $81.4 million [264]. - As of June 30, 2025, the company had approximately $3.2 million in cash and cash equivalents, which is insufficient to fund operations for the next 12 months [301]. - The company anticipates needing substantial additional funding for its continuing operations due to the lack of generated revenue [301]. Revenue and Sales - The company has not recognized any revenue from product sales and does not expect to generate revenue in the foreseeable future [278]. Capital Raising Activities - The company raised approximately $3.1 million from its equity line of credit and an additional $4.3 million from a public offering that closed on February 7, 2025 [276]. - On April 21, 2025, the company entered into a Securities Purchase Agreement to issue up to 10,000 shares of Series D Preferred Stock for an aggregate purchase price of up to $8 million [266]. - The company received net proceeds of approximately $4.2 million from a securities purchase agreement on February 5, 2025 [265]. - The company sold an additional 938 shares of Series D Preferred Stock for gross cash proceeds of $750,400 on June 5, 2025 [271]. - During the six months ended June 30, 2025, the company received net proceeds of approximately $4.2 million from a public offering [301]. - The company has arranged two equity lines of credit, one for the sale of up to 25,000,000 newly issued shares of common stock and another for the purchase of up to $17.5 million of common stock [301]. Stock and Compliance - The company completed a reverse stock split on January 8, 2025, converting each 100 shares of Common Stock into 1 share [269]. - The company regained compliance with Nasdaq listing requirements after raising sufficient capital and meeting the $2.5 million minimum stockholders' equity requirement [276]. - The company issued 6,250 shares of Series D Preferred Stock in exchange for 1,000,279 shares of Stella Series D Preferred Stock, valued at $500,000 [267]. Expenses - Research and development expenses for Q2 2025 were $2,754,000, an increase of $40,000 or 1.5% compared to Q2 2024 [287]. - General and administrative expenses decreased to $1,970,000 in Q2 2025, down $464,000 or 19.1% from Q2 2024 [286]. - Total operating expenses for Q2 2025 were $4,724,000, reflecting a decrease of $424,000 or 8.2% compared to Q2 2024 [286]. - Research and development expenses for the six months ended June 30, 2025 were $5,662,000, an increase of $1,279,000 or 29.2% compared to the same period in 2024 [294]. - General and administrative expenses for the six months ended June 30, 2025 were $4,013,000, a decrease of $1,305,000 or 24.5% from the same period in 2024 [296]. - The company anticipates significant increases in R&D expenses in the future due to increased headcount and contracted services for clinical development [288]. - The company expects significant increases in expenses related to ongoing research, preclinical, and clinical development to support marketing approval for its product candidates [300]. - The company recorded stock-based inducement expense of $864,000 during the six months ended June 30, 2025, compared to $0 in the same period in 2024 [305]. Losses - Net loss for Q2 2025 was $5,417,000, an increase of $2,968,000 or 121.2% from Q2 2024 [291]. - Net loss attributable to common stockholders for Q2 2025 was $30,117,000, compared to $2,449,000 in Q2 2024, representing a 1,130.0% increase [291]. - For the six months ended June 30, 2025, the net loss increased to $10,523,000, representing a 121.6% increase compared to a net loss of $4,748,000 for the same period in 2024 [298]. - The company recorded deemed dividends of $24,700,000 related to Series A, B, and C preferred stock conversions in Q2 2025 [291]. - The company recorded deemed dividends of $24,965,000 related to preferred stock conversions during the six months ended June 30, 2025 [298]. - Other expenses for Q2 2025 were $693,000, a negative change of $3,393,000 compared to other income of $2,700,000 in Q2 2024 [290]. Cash Flow - Net cash used in operating activities for the six months ended June 30, 2025 was $(9,068,702), compared to $(8,617,285) for the same period in 2024, reflecting a decrease of $451,417 [304]. - Net cash provided by financing activities for the six months ended June 30, 2025 was $9,045,000, a decrease from $9,749,000 in the same period in 2024 [307].

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].