CERo Therapeutics Stock Price, News & Analysis

CERo Therapeutics (NASDAQ: CERO) has announced the dosing of its first patient in a Phase 1 clinical trial for CER-1236, targeting acute myeloid leukemia (AML). The first-in-human, multi-center study is evaluating the safety and preliminary efficacy of CER-1236 in patients with various forms of AML. The trial, led by Dr. Abhishek Maiti from MD Anderson Cancer Center, includes a dose escalation phase followed by an expansion phase. The patient has completed seven days post-infusion with ongoing monitoring. The study's details will be presented at the 2025 ASCO Annual Meeting. The trial focuses on primary outcomes including adverse events, toxicities, and response rates, with secondary measures including pharmacokinetics. CER-1236 is a novel autologous CAR-T therapeutic candidate targeting TIM 4L, supported by previously published preclinical data in Clinical Cancer Research.

CERo Therapeutics Holdings (NASDAQ: CERO) has successfully regained compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million. The compliance was achieved through multiple financial moves including a private placement of Series D Preferred Stock, a partial drawdown from the Company's Equity Line of Credit, and a public offering completed in February 2025.

The Nasdaq Hearings Panel confirmed the company's compliance on May 7, 2025. CEO Chris Ehrlich highlighted that the company can now focus on advancing its lead program, CER-1236, an immunotherapy treatment for cancer. CERo expects to initiate the first dose of its Phase 1 clinical trial soon and plans to provide regular updates on its progress.

CERo Therapeutics announces TriStar Centennial Medical Center as a clinical trial site for its Phase 1 study of CER-1236 in treating acute myeloid leukemia (AML). The trial, conducted through Sarah Cannon Research Institute in Nashville, Tennessee, is currently enrolling patients with expected first dosing in H1 2025.

The first-in-human, multi-center study will evaluate CER-1236's safety and efficacy in patients with AML that is either relapsed/refractory, has measurable residual disease, or has TP53 gene mutation. The two-part study includes dose escalation and expansion phases, focusing on safety metrics and response rates.

Dr. Stephen Strickland, Director of Leukemia Research at SCRI, highlighted CER-1236's promising preclinical results showing cancer cell targeting while preserving healthy cells. CEO Chris Ehrlich emphasized the significance of securing TriStar Centennial as a trial site, indicating strong confidence in CER-1236's potential.

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

Primary outcomes will measure adverse events, toxicities, overall response rate, complete response, and measurable residual disease, with secondary focus on pharmacokinetics.

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.