Welcome to our dedicated page for CERo Therapeutics news (Ticker: CERO), a resource for investors and traders seeking the latest updates and insights on CERo Therapeutics stock.
CERo Therapeutics Holdings, Inc. develops cellular immunotherapy candidates for cancer using engineered T cells that employ phagocytic mechanisms. Company news centers on its CER-T platform, the lead product candidate CER-1236, and clinical updates from the CERTAIN-T Phase 1 trial in hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and myelofibrosis.
Recurring updates also address safety monitoring, pharmacokinetic and pharmacodynamic observations, dose-escalation cohorts, scientific presentations, board composition, financing activity, and trading or listing-status developments for CERO common stock and warrants.
CERo Therapeutics (OTC PINK: CERO) initiated the second cohort of its first-in-human Phase 1/1b trial of CER-1236 in acute myeloid leukemia on Nov 5, 2025. The first patient in cohort 2 received an initial dose equal to twice the cohort‑1 starting dose and a second identical dose 48 hours later. Investigators reported no dose‑limiting toxicities to date, supporting escalation. The open‑label, multi‑center study uses dose escalation to find a Phase 2 dose and an expansion phase to assess safety and preliminary efficacy with endpoints including AEs/SAEs, DLTs, ORR, CR, cCR, MRD and PK.
The company noted observed cell expansion and continues dosing while evaluating options to list the stock on a public exchange.
CERo Therapeutics (OTC PINK: CERO) will present preclinical data for lead compound CER-1236 in a poster at the Society for Immunotherapy of Cancer (SITC) conference, Nov 5–9, 2025, with the poster scheduled for Nov 8, 2025.
The poster, titled “CER-1236, an investigational T cell product targeting TIM-4 Ligand, exhibits sustained effector function and resistance to exhaustion,” reports preclinical findings of sustained cell expansion across multiple antigen stimulations and a robust cytokine response, compared with CD3/CD28 polyclonal stimulation which induced strong initial activation but led to exhaustion.
The company noted these data align broadly with observations from its ongoing Phase 1/1b first-in-human study in AML/MDS populations; the trial is a two-part dose-escalation and expansion study assessing safety, tolerability, ORR/CR/cCR and MRD, with PK as a secondary measure.
CERo Therapeutics (OTC: CERO) confirmed its shares continue trading under the OTC PINK market, effective at market open on October 31, 2025, with no action required from investors.
The company said it is evaluating up-list options to improve liquidity and accessibility while maintaining full operations and staffing. CERo highlighted progress in its Phase 1 AML program for CER-1236, announcing initiation of Cohort 2 and an FDA-approved significant dosage increase for that cohort.
CERo Therapeutics (Nasdaq: CERO) announced that a Nasdaq Hearings Panel denied its request to continue listing, and Nasdaq trading will be suspended at the open on October 31, 2025. The Panel found the company noncompliant with Nasdaq Listing Rule 5550(b)(1) regarding minimum stockholders’ equity, retroactive to April 22, 2025. The company previously reported regaining compliance after financings and asset transactions but later recorded a discounted sale of $5.0M marketable securities that prompted Nasdaq staff’s re‑determination.
CERo said it has received ~$2.25M from a Series E closing and subscriptions for ~$4.75M tied to conditions, is pursuing review by the Nasdaq Council, plans to seek trading on the OTC Markets, and intends to continue clinical trials including dosing of CER-1236, which showed early cell expansion and no observed toxicity in initial AML patients.
CERo Therapeutics (Nasdaq: CERO) reported investigators administered a third infusion of CER-1236 (1 million cells/kg) to a patient in Cohort One of its Phase 1 trial, completed about one week ago and matching the first two doses.
The third infusion precedes first dosing in Cohort Two, anticipated in coming weeks pending regulatory notifications. The company completed the first tranche (~$2.3 million) of a planned $7 million financing to extend cash runway and support Nasdaq compliance. The trial is ongoing; no CER-1236–attributable toxicities observed in the first three patients to date, and no safety or efficacy conclusions are being made yet.
CERo Therapeutics (Nasdaq: CERO) announced that CEO Chris Ehrlich will participate on a stem cell therapy panel titled “A Space That is Ready to Have its Day” at the Maxim Growth Summit on October 22, 2025 in New York City.
The Summit runs October 22–23, 2025 at the Hard Rock Hotel; the panel is scheduled for 1:30pm ET on October 22. A live webcast will be available on the company’s investor relations site, and a replay will be archived for 90 days. Mr. Ehrlich will be available for one-on-one meetings during the conference.
CERo Therapeutics (Nasdaq: CERO) announced on October 13, 2025 that it completed Cohort 1 of its first-in-human Phase 1/1b study of CER-1236 in acute myeloid leukemia (AML).
The company reported in-vivo cell expansion consistent with preclinical expectations and no dose-limiting toxicities (DLTs) in Cohort 1. The Dose Escalation Safety Committee approved initiation of Cohort 2, where three new patients will receive an increased starting dose pending regulatory approval.
CERo plans an additional infusion for the second Cohort 1 subject to explore multiple-infusion dosing versus single higher doses and said it is not currently pursuing acquisitions or partnerships while dose finding continues.
CERo Therapeutics (Nasdaq: CERO) has reached a milestone in its Phase 1 clinical trial of CER-1236 for acute myeloid leukemia (AML) with the dosing of the third patient in the initial dose cohort. The first-in-human, multi-center study aims to evaluate the safety, tolerability, and preliminary activity of CER-1236 in patients with various forms of AML.
The trial consists of two parts: dose escalation to establish a recommended Phase 2 dose, followed by an expansion phase. The protocol has been modified to allow for a second infusion in the same subject within each cohort. Initial pharmacokinetic data has shown cell expansion at the lowest dose level.
Primary outcome measures include monitoring adverse events, dose-limiting toxicities, and anti-leukemic activity through metrics such as overall response rate and complete response rates.
CERo Therapeutics (NASDAQ:CERO) has received a Notice of Allowance from the U.S. Patent and Trademark Office for its Application 19/019,111, providing composition of matter and method of use protection for CER-1236 through 2041. The patent will offer comprehensive protection for their cancer treatment compound.
The company also secured a patent in Japan for its CER platform, bringing their total intellectual property portfolio to 18 patents and 2 allowed applications internationally. This strengthens CERo's position, complementing their recent FDA Fast Track and Orphan Drug Designations, while they continue to progress with their Phase 1 clinical trial.
CERo Therapeutics (NASDAQ:CERO) has announced a significant modification to its Phase 1 clinical trial of CER-1236 for acute myeloid leukemia (AML). The company has received IRB approval to implement dose intensification, effectively doubling the cell product infusion amount following encouraging pharmacokinetic data showing cell expansion in the first two patients.
The trial, known as CertainT-1, is evaluating CER-1236, an autologous chimeric engulfment receptor T-cell therapy. The study design includes a two-part Phase 1/1b trial focusing on patients with relapsed/refractory AML, those in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML.