CERo Therapeutics Stock Price, News & Analysis

CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has provided a corporate update to stockholders. Key points include:

• Submission of a Complete Response Letter to the FDA addressing the clinical hold on CERO-1236
• Adjustment of potential clinical trial entry from 2024 to early 2025
• Appointment of Al Kucharchuk as new Chief Financial Officer
• Promotion of Kristen Pierce to Chief Development Officer
• Changes to the Board of Directors to enhance business plan execution
• Disclosure of a $3.2 million cash balance as of September 30, 2024

The company remains optimistic about its future and anticipates providing updates on the FDA's determination regarding the clinical hold in the coming weeks.

CERo Therapeutics has announced key appointments to its management team. Andrew Albert 'Al' Kucharchuk has been named Chief Financial Officer and Kristen Pierce, Ph.D., has been appointed Chief Development Officer. These appointments support interim CEO Chris Ehrlich in advancing CERo's mission to develop next-generation T cell therapeutics. Mr. Kucharchuk brings extensive experience from roles at Nukkelous, Chain Bridge I, Theralink, Adhera Therapeutics, and OncBioMune. Dr. Pierce has over 20 years of oncology experience, previously holding leadership roles at Pionyr Therapeutics and Pfizer Therapeutics. The team aims to drive CERo's lead compound, CER-1236, through ongoing in vitro studies towards a successful Type A meeting with the FDA.

CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has announced a $1.25 million financing from existing investors to address the clinical hold on CER-1236. The company has requested a Type A Meeting with the FDA to discuss its plans and data collected to date. CERo is implementing significant management changes, with Chris Ehrlich becoming Chairman and Interim CEO, while Brian Atwood steps down to a consulting role. The CFO and CTO have also stepped down.

The company is focusing on resolving the remaining IND issues for CER-1236, which relate to two pharmacology and toxicology questions. CERo has initiated pre-clinical in vitro studies and experiments, with interim data submitted in the Type A Meeting Request. The company is implementing cost reductions to minimize capital needs and is working on identifying replacements for key positions.

CERo Therapeutics (Nasdaq: CERO) presented data on their lead compound, CER-1236, at the Global Cell & Gene Therapy Summit 2024. The data reveals that TIM-4-L, a target for engineered T cell therapy, is prevalent in acute myeloid leukemia (AML) but absent in healthy tissue. CER-1236 demonstrated strong cytotoxicity against TP53 mutant AML in both in vitro and in vivo studies without causing adverse effects in healthy tissues, even at high doses. The company anticipates the start of initial human trials focused on AML pending IND clearance.

CERo Therapeutics has completed the necessary IND-enabling activities for its lead compound, CER-1236. The successful manufacturing runs meet the required safety and efficacy standards for drug administration in clinical trials. This accomplishment marks the final technical step needed before submitting the Investigational New Drug (IND) Application to the FDA. The company anticipates a near-term filing of the IND to enable the commencement of Phase 1 human trials. Chairman and CEO Brian G. Atwood emphasized this milestone as important for advancing CERo's therapeutic pipeline and acknowledged the team's efforts. Further updates on the IND filing are expected soon.

CERo Therapeutics has successfully completed toxicology studies for its lead compound, CER-1236, an important step toward submitting an Investigational New Drug (IND) application to the FDA. The South San Francisco-based company focuses on innovative immunotherapy, specifically engineered T cell therapeutics. According to CERo's Chairman and CEO, Brian G. Atwood, the company is now nearing readiness for FDA submission to begin Phase 1 human trials. The next steps include completing compliant manufacturing procedures and other final IND-enabling studies. The company expects to finalize its IND package in the coming weeks and will keep shareholders updated on progress.

CERo Therapeutics, a South San Francisco-based immunotherapy company listed on Nasdaq under the ticker CERO, has provided a corporate update. After merging with SPAC Phoenix Biotech Acquisition in June 2023 and completing the de-SPAC process in February 2024, CERo is now positioned as an operating Nasdaq-traded entity. Key activities include completion of preclinical milestones and preparation for clinical trials with their lead candidate CER-1236, aimed at treating Acute Myeloid Leukemia (AML). March 2024 saw the publication of a paper in Clinical Cancer Research detailing CER-1236's efficacy. The company is finalizing Investigational New Drug (IND) application requirements for the FDA and plans to update shareholders via investor conferences and additional publications.

CERo Therapeutics, Inc. presents encouraging preclinical data for AML on CER-1236 at Stanford Drug Discovery Symposium, highlighting tumor elimination and manufacturing attributes. The poster outlines the successful elimination of adverse-risk AML cell lines by CER-1236 engineered T cells with low off-tumor toxicity to HSPCs. Additionally, the company demonstrates high yields of CER-1236 drug product with favorable memory and immunophenotypic profiles.