CERo Therapeutics Stock Price, News & Analysis

CERo Therapeutics Holdings (Nasdaq: CERO) has announced its upcoming presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago from May 30-June 3, 2025. The company will present a poster titled 'First-in-human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-L in acute myeloid leukemia (CertainT-1).'

The company is launching a Phase 1/1b clinical trial to evaluate their lead program CER-1236, a novel immunotherapy treatment for acute myeloid leukemia. The study will focus on patients with relapsed/refractory disease, measurable residual disease, or TP53 gene mutations.

The two-part study includes:

• Dose escalation phase to determine highest tolerated dose
• Expansion phase evaluating safety and efficacy

CERo Therapeutics (Nasdaq: CERO) announces Sarah Cannon Research Institute at Colorado Blood Cancer Institute (CBCI) as a key clinical trial site for its Phase 1 trial of CER-1236 in acute myeloid leukemia (AML). The first-in-human, multi-center study will evaluate safety and preliminary efficacy in patients with relapsed/refractory AML, measurable residual disease, or TP53 gene mutation.

The trial consists of two parts: dose escalation to determine highest tolerated dose, followed by an expansion phase. Primary outcomes include monitoring adverse events, dose toxicities, and response rates. Patient enrollment is ongoing with initial dosing expected by June.

CBCI, serving a seven-state region, is recognized as the region's leader in blood cancer care. The trial aims to leverage chimeric engulfment receptor technology to improve treatment efficacy and reduce relapse rates in AML patients.

CERo Therapeutics (Nasdaq: CERO) has secured a Series D financing agreement for up to $8 million through a convertible preferred stock transaction. The financing includes an initial $5 million investment at first closing, with potential additional funding of up to $3 million in subsequent closings at investors' discretion.

The company plans to utilize the proceeds to leverage its recent FDA IND allowances in liquid and solid tumors, complete site activation at MD Anderson Cancer Center (MDACC), and accelerate additional site activations. The funding will also help address Nasdaq shareholders equity requirements and extend operational runway.

CERo Therapeutics Holdings (NASDAQ: CERO) announces significant expansion of its intellectual property portfolio with two new patent application allowances from the USPTO for its lead compound CER-1236.

The first patent (No. 17/040,472) covers composition and methods for combining phosphatidylserine-targeting CD4+ CER-T cells with CD8+ CAR-T or TCR-T cells for cancer treatment. The second patent (No. 17/040,317) protects design aspects of CER-1236, specifically the chimeric TIM4 receptor composition.

The company's IP portfolio now comprises 9 patent families with US protection until 2039 and 17 total issued and allowed patents internationally. These developments coincide with CERo's progress in Phase 1 trials for AML treatment and recently cleared IND for ovarian and non-small cell lung cancer trials.

CERo Therapeutics (Nasdaq: CERO) has announced its first clinical trial site for the Phase 1 study of CER-1236 in acute myeloid leukemia (AML). The trial will be conducted at The University of Texas MD Anderson Cancer Center, led by Dr. Abhishek Maiti.

The first-in-human, multi-center, open-label Phase 1/1b study will evaluate CER-1236's safety and preliminary efficacy in patients with AML that is either relapsed/refractory, has measurable residual disease, or has TP53 gene mutation. The study consists of two parts: dose escalation to determine the highest tolerated dose and an expansion phase.

Primary outcome measures include adverse events monitoring, dose- toxicities, and response rates. Patient enrollment is ongoing, with first dosing expected in H1 2025.

CERo Therapeutics (Nasdaq: CERO) has received FDA clearance for a second Investigational New Drug (IND) application for CER-1236, enabling a Phase 1 clinical trial in advanced solid tumors, specifically non-small cell lung cancer and ovarian cancer.

CER-1236 represents the first CAR-T cell therapy targeting Tim-4L and incorporating programmed phagocytic activity in T cells. Recent preclinical data demonstrated the compound's effectiveness in treating ovarian cancer cells without generating toxicity in animal models. The study showed T cell engraftment in lymphoid organs with no adverse pathological or clinical observations.

This development runs parallel to CERo's ongoing Phase 1 AML trial, showcasing the potential therapeutic breadth of CER-1236. The FDA's collaborative approach has enabled the company to maintain development momentum with two concurrent open trials in both hematologic and solid tumors.

CERo Therapeutics (NASDAQ: CERO) has received positive FDA review on Chemistry, Manufacturing and Controls (CMC) amendment to its IND for CER-1236, marking the final commitment before initiating patient dosing. This development reduces manufacturing timeline by approximately one week.

The company remains on schedule to begin dosing initial subjects in first half of 2025 for their Phase 1/1b clinical trial targeting relapsed/refractory measurable residual disease positive acute myeloid leukemia. The study will evaluate safety and preliminary efficacy through a two-part process: dose escalation followed by expansion phase.

Additionally, CERo's abstract has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) conference, scheduled for May 30-June 5 in Chicago.

CERo Therapeutics Holdings (Nasdaq: CERO) has secured a manufacturing agreement with the University of California Davis for CER-1236, advancing towards its Phase 1 clinical trial for Acute Myeloid Leukemia (AML). The agreement represents one of the final steps before patient dosing, which is anticipated in the first half of 2025.

The company emphasizes the critical importance of precision and compliance in manufacturing for successful clinical trial development and execution, highlighting UC Davis's leading reputation in this field. This development positions CERo to progress with its innovative immunotherapy program, which focuses on engineered T cell therapeutics utilizing phagocytic mechanisms.

CERo Therapeutics (Nasdaq: CERO) presented encouraging preclinical results for its lead compound CER-1236 in ovarian cancer at the 2025 SITC Spring Scientific Cellular Therapy for Solid Tumors Meeting. The study demonstrated that CER-1236 effectively treated ovarian cancer cells without generating toxicity in animal models.

Key findings showed T cell engraftment in lymphoid organs following CER-1236 infusion, with no adverse clinical pathology or histopathological evaluations indicating toxicity. The research was presented in a poster titled 'TIM-4-L Expression on Ovarian Cancer Samples can be Targeted by Engineered Chimeric Engulfment Receptor T cells without Toxicity.'

The company plans to initiate Phase 1 trials in AML and expand testing to solid tumors in 2025, noting potential broader applications across cancer types, including Non-Small Cell Lung Cancers (NSCLC).