CERo Therapeutics Stock Price, News & Analysis

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.

CERo Therapeutics (NASDAQ:CERO) has received Fast Track Designation from the FDA for its lead compound CER-1236 in treating Acute Myeloid Leukemia (AML). This designation, complementing its existing Orphan Drug Designation, aims to accelerate development and review of the therapy.

The company is currently conducting a Phase 1/1b first-in-human study evaluating CER-1236's safety and preliminary efficacy in multiple AML patient groups. The trial includes dose escalation to determine optimal dosing, followed by an expansion phase focusing on safety and efficacy measures including response rates and pharmacokinetics.

CERo Therapeutics (NASDAQ:CERO) has announced the dosing of the second patient in its Phase 1 clinical trial of CER-1236, a novel CAR-T therapy targeting TIM 4L for acute myeloid leukemia (AML). The treatment was administered at the Sarah Cannon Research Institute at Colorado Blood Cancer Institute.

The company reported promising data from the first patient, who showed no dose-limiting toxicities during the 28-day observation period. Notably, the therapy demonstrated a 20.8-fold expansion of infused cells, peaking at 14 days post-infusion.

The Phase 1/1b study aims to evaluate CER-1236's safety and efficacy in patients with relapsed/refractory AML, AML in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML.

CERo Therapeutics (NASDAQ: CERO) announced significant progress in its Phase 1 clinical trial of CER-1236, with the first patient completing the dose-limiting toxicity observation period without any reported toxicities. The trial evaluates CER-1236, a novel T cell therapeutic targeting TIM4L, in patients with Acute Myeloid Leukemia (AML). The Phase 1/1b CertainT-1 study is designed to assess safety and preliminary efficacy in various AML patient populations, including relapsed/refractory cases and newly diagnosed patients with specific mutations. The company plans to dose a second AML patient soon and is preparing to initiate a second trial in solid tumors later in 2025. The study includes dose escalation to determine optimal dosing followed by an expansion phase, with primary endpoints focusing on safety metrics and response rates.

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.