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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). |
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 |
