SOUTH SAN FRANCISCO, Calif., March 11, 2026 — CERo Therapeutics Holdings, Inc. (OTCQB: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanism, provides an update through the letter to stockholders and stakeholders from CEO Chris Ehrlich:
To our stockholders and stakeholders:
Following our recent Form 8-K filing confirming receipt of convertible debt funding to support current operations, we believe it is an appropriate time to provide an update on CERo Therapeutics’ operational and scientific progress. Over the past six months, the Company has advanced its clinical development activities, engaged in strategic discussions, and continued to manage resources with fiscal discipline.
During this period, we have progressed the development of our lead candidate, CER-1236, including observations consistent with an acceptable safety and tolerability profile to date, across multiple treated patients. We have also observed biologic activity consistent with the mechanism of the therapy, including approximately 20–70-fold cell expansion, peaking between days 7–14 and followed by continued persistence as measured in peripheral blood. These early observations contribute to our understanding of CER-1236 and support continued clinical evaluation of the program.
Notably, in the second patient treated in our ongoing Phase I study, we observed an interval of apparent disease stability during which the patient’s disease progression and requirement for platelet transfusion support did not increase following multiple infusions of CER-1236. While this is an early observation from a single patient and Phase I studies are primarily designed to evaluate safety, we believe the clinical course of this patient is noteworthy. This patient had previously been diagnosed with myelodysplastic syndrome (MDS), a disorder of the bone marrow that can progress to acute myeloid leukemia (AML).
The emerging clinical observations provide an early signal that supports continued investigation of CER-1236. These data are helping guide the Company’s ongoing development strategy, including exploration of dosing approaches and patient selection in future cohorts.
While CER-1236 demonstrated activity across multiple tumor models during preclinical development, the observations to date in the MDS setting highlight a potentially important area for further study. We believe these early findings may also support future discussions with potential strategic partners regarding the continued development of the program.
Progress in Phase 1 Clinical Trial and Strategic Focus on MDS
We recently announced data from our ongoing CERTAIN-T Phase 1 clinical trial that reflects the Company’s current development approach for our lead compound, CER-1236. Based in part on early clinical observations in a patient with MDS, a disorder of the bone marrow that can precede AML, the Company has refined its development strategy to increase focus on enrolling patients with MDS while maintaining optionality in AML.
This strategic refinement was informed in part by observations from a patient who received four infusions of CER-1236 over approximately five months at the lowest dose level in the study.
As previously announced, prior to receiving CER-1236 the patient required frequent platelet transfusions. During the period following treatment in the study, the patient experienced an interval of platelet transfusion independence lasting more than two months, exceeding the commonly referenced ≥56-day durability benchmark used in MDS studies.
The Company is actively seeking to enroll additional patients with similar clinical characteristics to further evaluate this observation. If similar findings are observed in additional patients, these data may help inform future discussions with regulatory authorities and potential strategic partners regarding the continued development of CER-1236.
To date, the Company has initiated the second cohort of the trial, and two additional patients have recently undergone apheresis, a procedure in which blood cells are collected to manufacture CER-1236 for each individual patient. The Company plans to initiate dosing for these patients during March and April.
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
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