Core Insights - CERo Therapeutics Holdings, Inc. is advancing its Phase 1 clinical trial of CER-1236 for treating acute myeloid leukemia (AML) at TriStar Centennial Medical Center in Nashville, Tennessee, with patient enrollment currently underway and expected dosing of the first patient in the first half of 2025 [1][2][3] 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 [4] - The company's Chimeric Engulfment Receptor T cells (CER-T) are designed to engage the body's full immune response to eliminate tumors, potentially offering greater therapeutic applications than current CAR-T therapies [4] Clinical Trial Details - The Phase 1/1b study of CER-1236 aims to evaluate safety and preliminary efficacy in patients with relapsed/refractory AML, measurable residual disease, or TP53 gene mutations, with a two-part design for dose escalation and expansion [2] - Primary outcome measures include the incidence of adverse events, dose-limited toxicities, overall response rate, complete response, composite complete response, and measurable residual disease [2]

Core Insights - CERo Therapeutics Holdings, Inc. is presenting a poster at the ASCO 2025 Annual Meeting, showcasing its innovative approach to engineered T cell therapeutics targeting cancer [1][2] - The poster details a first-in-human study of CER-1236, an autologous chimeric engulfment receptor T-cell therapy aimed at treating acute myeloid leukemia [2] - The study is a multi-center, open-label, Phase 1/1b trial focusing on safety and preliminary efficacy, with primary outcome measures including adverse events and overall response rates [2] Company Overview - CERo is focused on developing next-generation engineered T-cell therapeutics that integrate characteristics of both innate and adaptive immunity [3] - The company’s proprietary technology aims to redirect patient-derived T cells to eliminate tumors through phagocytic mechanisms, creating Chimeric Engulfment Receptor T cells (CER-T) [3] - CERo believes that CER-T cells will have broader therapeutic applications compared to current CAR-T therapies, potentially addressing both hematological malignancies and solid tumors [3]

Core Insights - CERo Therapeutics Holdings, Inc. is advancing its Phase 1 clinical trial of CER-1236 for acute myeloid leukemia (AML) at the Colorado Blood Cancer Institute, with patient enrollment currently underway and initial dosing expected by June 2025 [1][2][3] Company Overview - CERo is an innovative immunotherapy company focused on engineered T cell therapeutics that utilize phagocytic mechanisms to enhance cancer treatment [1][3] - The company’s proprietary T cell engineering approach aims to integrate characteristics of both innate and adaptive immunity, potentially offering greater therapeutic applications than current CAR-T therapies [3] 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, measurable residual disease, or TP53 gene mutations [2] - The trial will consist of a dose escalation phase to determine the highest tolerated dose, followed by an expansion phase to assess safety and efficacy [2] - Primary outcome measures include the incidence of adverse events, dose-limited toxicities, overall response rate, complete response, composite complete response, and measurable residual disease [2] Expert Commentary - Dr. Yazan Migdady from the Colorado Blood Cancer Institute highlighted the potential of chimeric engulfment receptor technology in improving treatment outcomes for AML patients [2]

Core Viewpoint - CERo Therapeutics Holdings, Inc. has announced a securities purchase agreement for a new convertible preferred stock transaction, aiming to raise up to $8 million to support its immunotherapy initiatives and address Nasdaq compliance issues [1][2]. Group 1: Financial Details - The gross proceeds from the offering are expected to be up to $8 million, with $5 million anticipated from the first closing and an additional up to $3 million from subsequent closings at the investors' discretion [2]. - The net proceeds will be utilized to leverage recent FDA IND allowances for liquid and solid tumors, activate sites at MD Anderson Cancer Center (MDACC), and improve the company's financial standing regarding Shareholders Equity [2]. Group 2: 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 [5]. - The company is advancing its Chimeric Engulfment Receptor T cells (CER-T), which are designed to enhance the therapeutic application beyond current CAR-T therapies, potentially addressing both hematological malignancies and solid tumors [5]. - Clinical trials for CERo's lead product candidate, CER-1236, are anticipated to begin in 2025 targeting hematological malignancies [5]. Group 3: Leadership Insights - Chris Ehrlich, the CEO, expressed gratitude for investor support and highlighted the company's progress towards dosing its first AML patient at MD Anderson and the recent IND allowance for solid tumors [3].

Company Classification and Reporting - The company is classified as an "emerging growth company" and a "smaller reporting company," which allows it to provide only two years of audited financial statements and reduced disclosure obligations [475]. - The company may continue to be a smaller reporting company as long as its common stock held by non-affiliates is less than $250 million or annual revenue is less than $100 million [477]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [594]. Regulatory and Compliance Risks - The company has not yet obtained regulatory approvals for any of its product candidates, making future operating results difficult to predict [478]. - The company may incur increased costs and demands upon management due to compliance with public company laws and regulations, affecting its financial condition [492]. - The company failed to timely file its Form 8-K with Form 10 information, resulting in a lapse in compliance with SEC reporting requirements since February 14, 2024 [501]. - The company is subject to increased legal and financial compliance costs due to evolving laws and regulations, which may divert management's attention from business operations [494]. - The company faces risks of litigation due to increased visibility from public disclosures, which could harm its business and financial condition [496]. Financial Performance and Fluctuations - Revenue may depend on development funding and achievement of clinical milestones under license and collaboration agreements, which can vary significantly from period to period [479]. - Operating results may fluctuate significantly due to various factors, including clinical trial outcomes and regulatory approvals [481]. - The cumulative effect of various unpredictable factors could result in large fluctuations in quarterly and annual operating results, making past results unreliable for future performance predictions [482]. - Future acquisitions or strategic partnerships may increase capital requirements and dilute stockholders, posing various risks [487]. Stock and Market Compliance - The closing bid price for the company's Common Stock has been below the minimum $1.00 per share required for continued listing on Nasdaq for 30 consecutive trading days [505]. - The company received a letter from Nasdaq indicating it did not regain compliance with the minimum market value requirement of $50,000,000 within the compliance period [506]. - The company has been granted an extension until April 22, 2025, to regain compliance with Nasdaq listing requirements, including demonstrating compliance with the Bid Price Requirement [508]. - As of April 11, 2025, there are various warrants outstanding that could result in significant dilution to existing shareholders if exercised [514]. - The company has not satisfied the $2.5 million stockholder's equity requirement as of the date of the Annual Report [510]. Internal Control and Financial Reporting - The company has identified a material weakness in its internal control over financial reporting, which could impair the accuracy and timeliness of its financial statements [497]. - Earnout Shares are classified as liabilities and their fair value is remeasured quarterly, potentially causing volatility in financial results [515]. - Changes in the estimated fair value of Earnout Shares are recorded in Other income (expense) on the consolidated statement of operations [515]. - Non-cash gains or losses on Earnout Shares are expected to be recognized each reporting period, which could materially impact financial results [515]. Insurance and Liability - The company may experience reduced coverage or increased costs for director and officer liability insurance due to being a public company [495].

Results in 17 Issued and Allowed Patent Applications Internationally with Nine Total Patent Families SOUTH SAN FRANSCISCO, Calif, April 10, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (NASDAQ:CERO) ("CERo" or the "Company") an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces the allowance of two patent applications submitted to the U.S. Patent and Trademark Office (USPTO), which materially ex ...

Results in 17 Issued and Allowed Patent Applications Internationally with Nine Total Patent Families SOUTH SAN FRANSCISCO, Calif, April 10, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces the allowance of two patent applications submitted to the U.S. Patent and Trademark Office (USPTO), which materially e ...

SOUTH SAN FRANSCISCO, Calif., April 09, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces its first clinical trial site for the Company’s Phase 1 clinical trial of CER-1236. The trial is focused on patients with acute myeloid leukemia (AML), and patient enrollment is underway, with expected dosing of the fi ...

SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) ("CERo" or the "Company") an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces that the Company has received clearance by the U.S. Food and Drug Administration (FDA) for a second Investigational New Drug (IND) application for lead compound CER-1236 for a Phase 1 clinical trial in advanced solid tu ...

Core Insights - CERo Therapeutics has received FDA approval for an amendment to its IND regarding Chemistry, Manufacturing, and Controls (CMC), allowing the company to initiate patient dosing in the first half of 2025 [1][2] - The company has also had an abstract accepted for presentation at the 2025 ASCO conference, scheduled for May 30 to June 5 in Chicago [2] - The Phase 1/1b clinical trial for CER-1236 will evaluate its safety and preliminary efficacy in patients with relapsed/refractory measurable residual disease positive acute myeloid leukemia [2][3] Company Overview - CERo Therapeutics is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a proprietary approach that combines innate and adaptive immunity [3] - The company aims to create Chimeric Engulfment Receptor T cells (CER-T) that can potentially target both hematological malignancies and solid tumors, offering a differentiated therapeutic application compared to existing CAR-T therapies [3]