CERo Therapeutics Stock Price, News & Analysis

CERo Therapeutics (NASDAQ: CERO) has received FDA Orphan Drug Designation (ODD) for CER-1236, its lead drug candidate targeting acute myeloid leukemia (AML). CER-1236 is an innovative T cell therapy that engineers patients' own immune cells to deploy phagocytic mechanisms alongside traditional T cell destroying mechanisms. The drug is currently in a Phase 1/1b clinical trial evaluating safety and preliminary efficacy in various AML patient groups. The study includes dose escalation and expansion phases, measuring outcomes such as adverse events, toxicities, and response rates. The ODD status grants CERo significant benefits, including FDA trial design assistance, grant eligibility, fee exemptions, and 7 years of marketing exclusivity upon approval.

CERo Therapeutics Holdings (NASDAQ: CERO), an immunotherapy company, has announced a 1-for-20 reverse stock split effective June 13, 2025. The split will reduce outstanding common shares from approximately 10.3 million to 516,092. Trading on Nasdaq will begin on a split-adjusted basis on June 13, with a new CUSIP number 71902K402. The company will make proportional adjustments to equity incentive plans, stock options, preferred stock conversion terms, and outstanding warrants. Stockholders will receive rounded-up fractional shares, and those with book-entry holdings need not take action. This reverse split ratio was approved within the range authorized by stockholders at the May 29, 2025 Annual Meeting.

CERo Therapeutics (NASDAQ: CERO) has secured additional Series D financing through the issuance of Series D Preferred Stock to institutional investors. This follows an April 2025 agreement for up to $8 million, with $5 million previously issued and $3 million available at investors' option. The current closing brings approximately $750,000 in gross proceeds, with potential for up to $2.25 million in additional funding. The company plans to use the proceeds to advance their clinical programs, particularly following two FDA IND allowances for liquid and solid tumors, and to expand site activation including at MDACC. CERo's lead candidate, CER-1236, is a novel autologous CAR-T therapeutic targeting TIM 4L for AML treatment, which has recently achieved first-in-human dosing.

CERo Therapeutics (NASDAQ: CERO) has strengthened its intellectual property portfolio with three significant patent developments for its lead compound CER-1236. The USPTO granted two patents: US Patent No. 12,291,557 covering chimeric TIM4 receptor design aspects, and US Patent No. 12,303,551 for combination cellular immunotherapy compositions. Additionally, the European Patent Office allowed Patent Application No. 1882166.7 for chimeric engulfment receptor technology. The company now holds 18 issued patents and allowed applications across 9 patent families, with US protection extending to 2042. CERo's technology focuses on engineered T cell therapeutics using phagocytic mechanisms. The company expects upcoming updates on clinical trials for AML treatment and plans to initiate human trials for ovarian and non-small cell lung cancers.

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.