FDA-agent-1
2週前
Insiders and management own majority of the shares and stand to gain the most if relisting back to nasdaq where min. price is $4/share if relisting on nasdaq. they own millions of shares with current structure. even if the share price was to go to $1 with 54 million shares, ceo and board of directors an management stand to make millions in stock option gains. even without FDA approval of their drug. CEO and management giving themselves free shares like 1.8 million share in stock options. they are instant millionaires if the the relist the stock back to nasdaq.
There is no retail public investors in the otc market or even institutional investors in the otc market like blackstones, vangauards, or fidelity etc. They are banned from investing in otc market stocks.
SOUTH SAN FRANCISCO, Calif., March 11, 2026
Pursuing a Strategy to List on a Major Exchange
Re-establishing our listing on a major exchange remains one of our key priorities. To that end, we have engaged with an investment bank to raise capital and pursue a strategy intended to support a potential relisting on the Nasdaq Capital Market. We believe that our new partner’s institutional relationships and sector expertise align well with our goal of raising sufficient capital in a disciplined manner while attracting longer-term, knowledgeable investors who are familiar with the clinical development landscape and strategic direction. In addition, we are considering other potential paths for relisting on a national securities exchange, including potential business combinations with listed companies, which may include a reverse merger or a business combination with a special purpose acquisition company.
Continued Funding Support
As recently disclosed, as we pursue new financing opportunities and seek to relist on Nasdaq, our lead investor continues to support CERo’s operations through investments in convertible debt. Their commitment to CERo has enabled us to sustain operations and advance our clinical programs. We believe our clinical development and focus on our financing efforts and strategy for relisting on Nasdaq will be beneficial to all CERo stockholders and are grateful for the continued confidence our loyal stockholder base.
Strategic Discussions Regarding Early Data Readouts
We continue to engage in ongoing discussions with potential strategic partners following the most recent data readouts, as is regularly seen in the biotech industry. While these conversations are encouraging, they remain at an early stage and have not resulted in formal agreements. We believe the evolution of our strategy and growing dataset may catalyze future conversations. To the extent permitted under applicable law and contractual obligations, we expect to provide further updates to stockholders should any of these discussions advance in a manner that materially impacts the Company.
Board Expansion – Appointment of Eric Francois
Finally, we recently announced that Eric Francois joined our board of directors. Eric brings decades of experience in life sciences finance, capital markets, and corporate development, including deep expertise in capital raising, M&A, and strategic partnerships. His involvement with the Company is among multiple catalysts that, we believe, will positively impact CERo in the months to come. Eric was instrumental in our discussions with our new investment bank and is already assisting with other potential funding opportunities, operational improvements, and external viewpoints on the Company’s next phase of growth.
Dedicated, Engaged Professionals Working Together to Achieve Success
It should never go without saying that CERo’s world class team – employees, partners, consultants, and advisors – all remain focused and excited about achieving the common goal of improved patient care and improving patients’ lives through innovative clinical development. Despite challenges that might have derailed other companies several times over, the CERo team has continued to perform with enthusiasm toward the achievement of bringing CER-1236 to the next inflection point and beyond.
Our take-home message is clear: CERo is operational, continuing to advance our clinical programs, and generally building momentum. We are committed to transparent communication, and we look forward to sharing the outcomes of each of our ongoing activities in the future. We thank you for your continued support and confidence in our novel approach to treatment and our leadership.
Sincerely,
Chris Ehrlich
CEO
CERo Therapeutics
About CERo Therapeutics Holdings, Inc.
CERo is an innovative immunotherapy company advancing the development of next-generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering integrates key functional attributes of both innate and adaptive immunity within a single therapeutic construct, designed to engage the body’s immune repertoire for more comprehensive tumor targeting. This novel cellular immunotherapy platform is designed to redirect patient-derived T cells toward tumor cells through both adaptive perforin/granzyme pathways and innate engulfment mechanisms, including targeting of the TIM-4 ligand. This employs phagocytic activity to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated targeting properties of CER-T cells may offer advantages compared with currently approved CAR-T therapies and could potentially extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors. CERo has initiated clinical trials for its lead product candidate, CER-1236, for hematologic malignancies.
Forward-Looking Statements
This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management.
Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Chris Ehrlich
Chief Executive Officer
chris@cero.bio
Investors:
CORE IR
investors@cero.bio
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subslover
1年前
CERo Therapeutics Holdings, Inc. Announces FDA Orphan Drug Designation Granted to CER-1236 for the Treatment of Acute Myeloid Leukemia (AML)
SOUTH SAN FRANSCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that deploy phagocytic mechanisms, announces that the U.S. Food and Drug Administration (FDA) has granted CERo’s Orphan Drug Designation (ODD) for the company's lead drug candidate CER-1236, for the treatment of acute myeloid leukemia (AML). CER-1236 is an innovative therapy that engineers a cancer patient's own T cell therapeutics that deploy phagocytic (i.e., target-cell eating) mechanisms alongside the array of built-in target cell destroying mechanisms used by T cells.
CER-1236 is currently in Phase 1 clinical trials for AML. The first-in-human, multi-center, open label, Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The two-part study has begun with dose escalation to determine highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose limited toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK).
Chris Ehrlich, CERo CEO, commented, “Orphan Drug Designation underscores the importance of developing new treatments for AML, and the potential for CER-1236 to provide a new and differentiated approach toward treatment. We believe that we are at the forefront of innovation in immuno-oncology and are grateful for the recognition from FDA. We look forward to providing updates on our trial in the near term.”
The FDA's Orphan Drug program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer US patients annually. ODD status is given to medicinal products that represent a significant benefit over existing treatments and are intended for the treatment of a disease that is life-threatening or chronically debilitating. The ODD designation qualifies CERo and CER-1236 for certain incentives, which include FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee and eligibility for seven years of marketing exclusivity.
p0
1年前
CERo Therapeutics, Inc. Announces Up to $8 Million Series D Financing
SOUTH SAN FRANCISCO, Calif, April 22, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo”), an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces that it has entered into a securities purchase agreement for the issuance and sale of securities under a new convertible preferred stock transaction.
The gross proceeds to CERo from the offering are expected to be up to $8 million, including $5 million expected to be received through the investment of securities at the first closing, and up to $3 million of cash that may be funded at one or more additional closings, at the election of the investors. CERo intends to use the net proceeds from the offering to take advantage of the two recent FDA IND allowances in liquid and solid tumors and complete the previously announced site activation at MDACC, as well as bring other sites online quickly. The proceeds will also help to address current Nasdaq deficiencies around Shareholders Equity and extend cash on hand to maintain operations and extend runway.
“On the heels of our recent announcements anticipating the imminent dosing of our first AML patient at MD Anderson Cancer Center and the IND allowance in solid tumors, we are gratified by the support we have received from investors and look forward to continued execution and progress,” said Chris Ehrlich, Chief Executive Officer.