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CERo Therapeutics Holdings, Inc. (NASDAQ: CERO) is a pioneering company in the field of immunotherapy, focused on developing next-generation engineered T-cell therapeutics for cancer treatment. Leveraging cutting-edge technology, CERo integrates key characteristics of innate and adaptive immunity into their T-cell engineering approach. This innovative method aims to engage the body's complete immune system to optimize cancer therapies.
The company's flagship product, CER-1236, targets TIM-4-L and is designed to treat hematological malignancies, such as Acute Myeloid Leukemia (AML). Recent preclinical data showcased that CER-1236 effectively eliminates adverse-risk p53-mutated AML cell lines in vivo, with a low risk of off-tumor toxicity to hematopoietic progenitor stem cells.
CERo's proprietary platform, known as Chimeric Engulfment Receptor T cells (CER-T), integrates phagocytic mechanisms, creating a unique pathway for T cells to destroy cancer cells. This novel approach is anticipated to provide broader therapeutic applications compared to traditional chimeric antigen receptor (CAR-T) cell therapy, potentially addressing both hematological malignancies and solid tumors.
In a significant corporate milestone, CERo completed its merger with Phoenix Biotech Acquisition Corporation in February 2024, transitioning from a private entity to a publicly traded company on Nasdaq. This strategic move is expected to enhance the company's operational capabilities and shareholder value.
According to CEO Brian G. Atwood, CERo is diligently working toward submitting an Investigational New Drug (IND) application for CER-1236 to the FDA. The company has made considerable progress in preclinical studies, including toxicology and manufacturing runs fulfilling cGMP standards, which are essential for IND approval. Clinical trials for CER-1236 are anticipated to commence in 2024.
To stay updated on CERo's latest developments and to gain a deeper understanding of their innovative therapies, visit their official website and review recent publications and corporate announcements.
CERo Therapeutics Holdings (Nasdaq: CERO), an immunotherapy company, announced a one-for-one hundred reverse stock split of its common stock. This split will be effective at 12:01 a.m. Eastern Time on January 8, 2025, and the company's stock will start trading on a split-adjusted basis on Nasdaq from the opening of trading on the same day. The CUSIP number 71902K303 will be assigned to the common stock post-split.
The reverse stock split will reduce the number of outstanding shares from approximately 260 million to 2.6 million. Proportional adjustments will be made to shares awarded under equity incentive plans and the exercise prices of stock options and other equity securities. Additionally, adjustments will be made to preferred stock and warrants.
No fractional shares will be issued; stockholders will receive an additional fraction to round up to the next whole share. Stockholders with shares in book-entry form or through brokers do not need to take any action as the split will be automatically reflected in their accounts.
The reverse stock split ratio is within the range authorized by stockholders at the Autumn 2024 Special Meeting on November 11, 2024. The split aims to increase the market price of CERo's common stock to meet Nasdaq's minimum bid price requirement of $1.00 per share, following a delisting notice due to the stock trading below $0.10 for ten consecutive days.
CERo Therapeutics (Nasdaq: CERO) has appointed Chris Ehrlich as permanent CEO, following his previous role as Interim CEO. The company, focused on engineered T cell therapeutics with phagocytic mechanisms, plans to advance its CER-1236 program with an anticipated IND filing for solid tumors, including ovarian and non-small cell lung cancers, in H1 2025.
Ehrlich brings extensive experience in biotechnology, business development, venture capital, and investment banking. He currently serves as CEO of Launch One Acquisition and has previously led successful mergers including Phoenix Biotech Acquisition with CERo, and Locust Walk Acquisition with eFFECTOR Therapeutics.
CERo Therapeutics (Nasdaq: CERO) has received FDA clearance for its Investigational New Drug Application to begin Phase 1 clinical trials of CER-1236 in acute myelogenous leukemia (AML). The company, focused on developing engineered T cell therapeutics with phagocytic mechanisms, plans to initiate its first-in-human trial in Q1 2025. The treatment represents a novel approach to treating AML, one of the deadliest forms of cancer.
CERo Therapeutics (Nasdaq: CERO) presented preclinical data showing its lead compound CER-1236 effectively kills ovarian cancer cells without toxicity in animal models. The data, presented at the SITC 2024 Conference, demonstrated that CER-1236 targets the immune receptor TIM-4-L in ovarian cancer cell lines. The study revealed that after introducing CER-1236, TIM-4-L expression increased, leading to cancer cell death while sparing healthy cells. The compound's specificity to TIM-L-4 and absence of clinical toxicity suggest potential applications in ovarian cancer treatment. The company plans to pursue Orphan designation during clinical development.
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.
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