Cero Therapeutics Holdings, Inc 8-K, filed Jan 7, 2026
Cero Therapeutics Holdings, Inc. (CERO)
About this 8-K
Cero Therapeutics Holdings, Inc filed this 8-K on January 7, 2026.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
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Item 7.01 Regulation FD Disclosure.
On January 7, 2026, CERo Therapeutics Holdings, Inc., a Delaware corporation (the “Company”), published a presentation, which it plans to use in meetings with investors, analysts and others. A copy of this presentation is furnished hereto as Exhibit 99.1.
The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On January 7, 2026, the Company issued a press release titled “CERo Therapeutics Provides Clinical Update on Phase 1 Trial of CER-1236 in AML (CertainT-1) Highlighting Key Safety Data and Platelet Transfusion-Free Interval Observed in a Patient with Myelodysplastic Syndrome/AML.” A copy of the press release is attached herewith as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit No. |
Description | |
| 99.1 | Presentation (January 2026) | |
| 99.2 | Press release dated January 7, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: January 7, 2026 | CERO THERAPEUTICS HOLDINGS, INC. | |
| By: | /s/ Chris Ehrlich | |
| Name: | Chris Ehrlich | |
| Title: | Chief Executive Officer | |
2
Exhibit 99.1
January 7. 2026 CERTAINT - 1 Trial Update
CERO This presentation (this “Presentation”) is provided for informational purposes only and for no other purpose and has been prepared to assist interested parties in making their own evaluation with respect to a potential investment in CERo The information contained herein is preliminary in nature and is subject to change, and such changes may be material . CERo’s business is subject to a number of risks that are not described in this presentation, including those set forth in the statements below and in the Summary of Risk Factors at the end of this presentation . By reviewing or reading this Presentation, you will be deemed to have agreed to the obligations and restrictions set out below . This Presentation supersedes and written communications between the parties hereto relating to the subject matter hereof . No representations or warranties, express or implied are given in, or in respect of, this Presentation . To the fullest extent permitted by law, in no circumstances will CERo or any of their respective subsidiaries, stockholders, affiliates, representatives, officers, employees, advisers or agents be responsible or liable for any direct, indirect or consequential loss or loss of profit arising from the use of this Presentation, its contents (including internal economic models), its omissions, reliance on the it, or opinions communicated in relation thereto or otherwise arising in connection therewith . Industry and market data used in this Presentation have been obtained from third - party industry publications and sources as well as from research reports purposes . CERo has not independently verified the data obtained from these sources and cannot assure you of the data’s accuracy or completeness . This data is subject to change . Recipients of this Presentation are not to construe its contents, or communication from or with CERo or their respective representatives as investment, legal or tax advice . In addition, this Presentation does not purpose to be all - inclusive or contain all of the information that may be required to make a full analysis Presentation should each make their own evaluation of Cero and of the relevance and adequacy of the information and should make such other investigations as they deem necessary . No Offer or Solicitation This Presentation and any oral statements made in connection with this Presentation do not constitute an offer to sell, or a solicitation of an offer to buy, or a recommendation to purchase, any securities in any jurisdiction . This Presentation does not a recommendation regarding any securities . Any offer to sell securities will be made only pursuant to a definitive subscription agreement and will be made in reliance on an exemption from registration under the Securities Act of 1933 , as amended, securities that do not involve a public offering . CERo reserves the right to withdraw or amend for any reason any offering and to reject any subscription agreement for any reason . The communication of this Presentation is restricted by law ; it is not or use by any person in, any jurisdiction where such distribution or use would be contrary to local law or regulation . Investors should consult with their counsel as to the applicable requirements for a purchaser to avail itself of any exemption under the Securities Act . The transfer of the securities may also be subject to conditions set forth in an agreement under Investors should be aware that they might be required to bear the final risk of their investment for an indefinite period of time . Cero is not making an offer of the securities in any jurisdiction where the offer is not permitted . This presentation shall not “solicitation” as defined in Section 14 of the Securities Exchange Act of 1934 , as amended . Forward - Looking Statements Certain statements included in this Presentation are not historical facts but are forward - looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995 . Forward - looking accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events that are not statements of historical matters . These forward - looking statements include, but are not limited to, statements regarding our financial performance ; the accuracy of our estimates regarding expenses, future revenue, capital financing ; the scope, progress, results and costs of developing CER - 1236 or any other product candidates we may develop, and conducting preclinical studies and clinical trials ; the timing and costs involved in obtaining and maintaining regulatory other product candidates we may develop, and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations or accelerated approvals for our drug candidates for various indications ; our ability to into and successfully complete clinical trials ; the ability of our clinical trials to demonstrate the safety and efficacy of CER - 1236 and any other product candidates we may develop, and other positive results ; the size and growth potential of the candidates, and our ability to serve those markets ; our expectations regarding our ability to obtain, maintain, protect and enforce intellectual property protection for CER - 1236 and for any other product candidate ; our ability to realize the anticipated transactions ; and the ability to obtain or maintain the listing of our common stock, and our public warrants on Nasdaq ; and other matters . These statements are based on various assumptions, whether or not identified in this Presentation, and on the CERo and are not predictions of actual performance . These forward - looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by, any investor as, a guarantee, an assurance, a of fact or probability . Actual events and circumstances are difficult or impossible to predict and will differ from assumptions . Many actual events and circumstances are beyond the control of CERo . These forward - looking statements are subject to a number of risks and uncertainties including the risks and uncertainties described under the heading “Risk Factors” in CERo’s most recent Annual Report on Form 10 - K filed with the SEC and any may be additional risks that CERo does not presently know or that CERo currently believes are immaterial that could also cause actual results to differ from those contained in the forward - looking statements . In addition, forward - looking statements plans or forecasts of future events as of the date of this Presentation . CERo anticipates that subsequent events and developments will cause CERo’s assessments to change . However, while CERo may elect to update these forward - looking future, CERo specifically disclaims any obligation to do so . These forward - looking statements should not be relied upon as representing CERo assessments as of any date subsequent to the date of this Presentation . Accordingly, undue reliance forward - looking statements . This presentation discusses product candidates that are under preclinical or clinical study and which have not yet been approved for marketing by the U . S . Food and Drug Administration . No representation is made as to the safety or effectiveness for the uses for which they are being studied . Trademarks This Presentation contains trademarks, service marks, trade names, and copyrights of CERo and third parties, which are the property of their respective owners . The use or display of third parties’ trademarks, service marks, trade names or intended to, and does not imply, a relationship with CERo, or an endorsement or sponsorship by or of CERo . Solely for convenience, the trademarks, service marks, trade names and copyrights referred to in this Presentation may appear without the but such references are not intended to indicate, in any way, that CERo will not assert, to the fullest extent under applicable law, their rights or the rights of the applicable licensor to these trademarks, service marks, trade names and copyrights 2 Disclaimers and Other Important Information
CERO 3 What is a CER - T Cell? himeric ngulfment eceptor C E R Uses TIM - 4 Phagocytic Receptor to Engage Tumor Targets via the Cell of Damaged Receptor TIM - 4 Ligand Tumor Cell TIM 4 Ligand T umor Cell CER - T Cell Multifunctional Construct Transmembrane Extracellular Domain Tumor binding and phagocytosis Intracellular Domain T cell activation and enhancement of phagocytosis TIM - 4 Ligand Binding triggers the capture of tumor cell fragments by the CER - T cell and activates cytotoxicity TIM - 4 Phagocytic Receptor Binds to TIM 4 Ligand CER - T Cell
CERO Cohort 1.1 1 x 10 6 cells/kg CER - 1236 Cohort 1.3s 5 x 10 6 cells/kg x 2 CER - 1236 START Cohort 1.2s 2.0 x 10 6 cells/kg x 2 CER - 1236 Cohort 2.1 – R/R AML 7 + 11 patients in each cohort Cohort 1.0 0.3 x 10 6 CER - 1236 Part 1 (Dose Escalation) Part 2 (Dose Expansion) Cohort 2.2 – cCR MRD+ AML Cohort 2.3 – TP53 - Mutated AML CERTAINT - 1 Trial Design (Pre Amendment) 4
CERO Three Key Findings in Current Program 1. Robust cell expansion with no CRS, ICANS, or treatment - related adverse events reported to date. 2. Repeat dosing is feasible without LD. 3. Platelet recovery observed in patient 2 with MDS/AML. 5
CERO 1. Robust Cell Expansion With No CRS, ICANS, Or Treatment - related Adverse Events Reported To Date • No CRS reported to date in all 4 patients • No ICANS reported to date in all 4 patients 6
CERO 2. Repeat dosing is feasible without LD • Several fold cell expansion observed after reinfusion without lymphodepletion. 7
CERO Patient 2 – MDS/AML • 74 year old man with MDS progressing to AML • Karyotype 46,XY,inv(3)(q21q26.2)x2[18]/44~46,idem[cp2] • FISH positive for MECOM (EVI1) rearrangement consistent with inv(3) • Never achieved marrow CR with standard or experimental treatments Response # Cycles Therapy No objective response 1 Cladribine + Cytarabine + Venetoclax No objective response 1 Azacitidine + Venetoclax No objective response 1 Clinical trial A No objective response 2 Clinical trial B 8
CERO Patient 2 – Multidose Treatment Course Infusions of 1e6 cells/kg 1 2 3 4 9
CERO LD + CER - 1236 CER - 1236 CER - 1236 Platelet Tx Platelet Tx LD + CER - 1236 61 days 3. Platelet recovery observed in patient 2 with MDS/AML • Platelet and RBC transfusion dependent prior to CER - 1236 • A 61 - day platelet transfusion - free interval - exceeding the commonly used 8 - week threshold for durable platelet transfusion independence - was observed after CER - 1236 treatment • TI ended following a subsequent LD + CER - 1236 treatment 10
CERO Patient 2 - Hematological Indices -50 0 50 100 150 20 40 60 80 100 Platelets Day x 1 0 ^ 3 / μ l -50 0 50 100 150 6 7 8 9 10 Hemoglobin Day g / d L 11
CERO 12 Planned Next Steps x Protocol amended in December to include additional indications x Completed source data verification of foundational datasets x Engaged in exploratory discussions with potential partners at ASH □ Evaluating submission of data for scientific publication
CERO Opportunities in Myelodysplastic Syndrome (MDS) • HMAs (azacitidine/decitabine) remain the only approved disease - modifying therapies in higher - risk MDS • The VERONA trial did not demonstrate an overall survival benefit for venetoclax added to HMAs • Observed transfusion independence (e.g., patient #2) represents an early, clinically meaningful signal that supports further evaluation in MDS 13
CERO Cohort 1.1 1 x 10 6 cells/kg CER - 1236 Cohort 1.3s 5 x 10 6 cells/kg x 2 CER - 1236 START Cohort 1.2s 2.0 x 10 6 cells/kg x 2 CER - 1236 Cohort 2.1 – R/R AML Cohort 1.0 0.3 x 10 6 CER - 1236 Part 1 (Dose Escalation) Part 2 (Dose Expansion) Cohort 2.2 – cCR MRD+ AML Cohort 2.3 – TP53 - Mutated AML Cohort 2.4 – TD - MDS (Transfusion - Dependent) Cohort 2.5 – HR - MDS (High - Risk) Cohort 2.6 – MF (Post - JAK Failure) Current Trial Amendment
Exhibit 99.2
CERo Therapeutics Provides Clinical Update on Phase 1 Trial of CER-1236 in AML (CertainT-1) Highlighting Key Safety Data and Platelet Transfusion–Free Interval Observed in a Patient with Myelodysplastic Syndrome/AML
Company to host analyst call at 5:00pm ET today to discuss progress to date and expansion of clinical trial
SOUTH SAN FRANCISCO, Calif., January 7, 2026 (GLOBE NEWSWIRE) — CERo Therapeutics Holdings, Inc., (OTCQB: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanisms, announces a key clinical update from the Company’s ongoing CertainT-1 trial focused on patients with acute myeloid leukemia (AML). Following completion of the dose-limiting toxicity (DLT) observation period for the first cohort, investigators observed cell expansion with no CRS, ICANS, or treatment-related adverse events reported to date. Expansion was seen with or without lymphodepletion. Investigators gave four rounds of CER-1236 cells to the second patient enrolled, with myelodysplastic syndrome (MDS) that progressed to AML with an inv3 chromosome translocation. A 61-day platelet transfusion-free interval was observed after CER-1236 treatment, exceeding a commonly referenced 8-week benchmark cited in clinical studies in the context of platelet transfusion independence. Transfusion independence ended following a subsequent round of lymphodepleting chemotherapy plus CER-1236 treatment.
The Company has filed an amendment of CertainT-1 with the U.S. Food and Drug Administration (FDA) to include advanced MDS and myelofibrosis (MF) as additional cohorts for the study. CERo will be conducting a conference call this afternoon, January 7, 2026, at 5:00PM ET to discuss progress and the Company’s go-forward strategy.
Robert Sikorski, M.D.,Ph.D., CERo’s Chief Scientific Officer, stated, “The patient’s clinical course, including a platelet transfusion–free interval despite having advanced MDS/AML, is encouraging and supports continued evaluation of CER-1236 in diseases of the bone marrow. We have amended the CertainT-1 trial to expand the focus to include MDS and MF patients going forward.”
The first-in-human, multi-center, open label, Phase 1/1b study was initially designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML 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 initiated with dose escalation to determine the 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).
“The evolution of this trial to MDS and MF is an important milestone as we continue to dose escalate, both in terms of volume and frequency. We are looking forward to sharing additional details in our call this afternoon, and to communicating with all stakeholders – including regulatory authorities – toward the continuing of its development. We also remain grateful to our trial patients for their participation as well as the loyal and long-time shareholders who continue to ensure that the Company is able to conduct this work. We remain focused on the careful and deliberate conduct of the dose-escalation phase and the systematic collection of safety data as the trial proceeds and we seek to expand its initial focus,” said CERo CEO Chris Ehrlich.
Conference Call on January 7, 2026 at 5:00PM ET
The Company will conduct a conference call today, January 7, 2026 at 5:00PM ET. Following formal remarks, there will be a question-and-answer session.
To listen to the conference call, interested parties within the U.S. should dial 1-844-763-8274 (domestic) or 1-412-717-9224 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the CERo Therapeutics conference call. The conference call will also be available through a live webcast that can be accessed here. A replay of the call will be available until March 7, 2026 and can be accessed here.
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