FDA grants Fast Track to CER-1236 for AML at CERo (NASDAQ: CERO)

Rhea-AI Filing Summary

CERo Therapeutics Holdings, Inc. reported that the U.S. Food and Drug Administration granted Fast Track Designation to its lead investigational compound, CER-1236, for the treatment of Acute Myeloid Leukemia (AML). This regulatory status is intended to facilitate the development and review of therapies for serious conditions. The company disclosed this update in a current report and attached the related press release as an exhibit.

Insights

Biopharma regulatory and pipeline analyst

FDA Fast Track status highlights regulatory engagement for CER-1236 in AML.

CERo Therapeutics states that the FDA has granted Fast Track Designation to its lead investigational compound CER-1236 for Acute Myeloid Leukemia. Fast Track is a U.S. regulatory program intended to expedite development and review of drugs addressing serious conditions with unmet medical need, often allowing more frequent FDA interaction.

This development signals that U.S. regulators recognize the potential relevance of CER-1236 in AML, but it is not an approval and does not guarantee successful development or commercialization. The company describes CER-1236 as its lead compound, so regulatory progress here is central to its pipeline story.

Future company communications and regulatory milestones related to CER-1236 in AML will further clarify clinical outcomes and next steps after this Fast Track Designation, including any subsequent trial updates or submission plans referenced in later disclosures.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or Section 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 5, 2025

CERO THERAPEUTICS HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-40877		81-4182129
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(I.R.S. Employer Identification Number)

201 Haskins Way, Suite 230, South San Francisco, CA		94080
(Address of principal executive offices)		(Zip Code)

(650) 407-2376

Registrant’s telephone number, including area code

Not applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		CERO		Nasdaq Capital Market
Warrants, each warrant exercisable for one two-thousandth of a share of Common Stock		CEROW		Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

On September 5, 2025, CERo Therapeutics Holdings, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the Company received Fast Track Designation from the U.S. Food and Drug Administration in relation to the Company’s lead investigational compound, CER-1236 for Acute Myeloid Leukemia (AML). A copy of the press release is attached herewith as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release, dated September 5, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

1

SIGNATURE

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: September 5, 2025	CERO THERAPEUTICS HOLDINGS, INC.
	By:	/s/ Chris Ehrlich
	Name:	Chris Ehrlich
	Title:	Chief Executive Officer

2

FAQ

What regulatory milestone did CERO (CERO) disclose for CER-1236?

The company disclosed that the U.S. Food and Drug Administration granted Fast Track Designation to its lead investigational compound CER-1236 for the treatment of Acute Myeloid Leukemia (AML).

Which disease area is CEROs CER-1236 targeting according to the 8-K?

CER-1236 is described as the companys lead investigational compound for Acute Myeloid Leukemia (AML), a serious blood cancer.

How did CERO formally communicate the Fast Track Designation news?

The company issued a press release announcing the Fast Track Designation and furnished it as Exhibit 99.1 to the current report.

What SEC item did CERO use to report the FDA Fast Track news?

The update about Fast Track Designation for CER-1236 was provided under Item 8.01 Other Events, which is used to report significant developments.

Who signed the CERO 8-K reporting the Fast Track Designation?

The report was signed on behalf of the company by Chris Ehrlich, who is identified as Chief Executive Officer.

What stock exchange listings are noted for CERO in this filing?

The filing lists Common Stock under the symbol CERO on the Nasdaq Capital Market and warrants under the symbol CEROW on the same market.