false 0001870404 0001870404 2024-07-26 2024-07-26 0001870404 CERO:CommonStockParValue0.0001PerShareMember 2024-07-26 2024-07-26 0001870404 CERO:WarrantsEachWholeWarrantExercisableForOneShareOfCommonStockMember 2024-07-26 2024-07-26 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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): July 26, 2024

 

CERO THERAPEUTICS HOLDINGS, INC. 

(Exact name of registrant as specified in its charter)

 

Delaware   001-40877   87-1088814
(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 Global Market
Warrants, each whole warrant exercisable for one 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 July 26, 2024, CERo Therapeutics Holdings, Inc., a Delaware corporation (the “Company”), was informed by telephone, subsequently confirmed in writing (the “FDA Communication”), that the Food and Drug Administration (the “FDA”) has placed a clinical hold on the Company’s Investigational New Drug Application (“IND”) with respect to its product candidate, CER-1236. The FDA indicated that the clinical hold has been placed as a result of insufficient data provided with regard to two issues within pharmacology and toxicology of CER-1236.

 

The FDA indicated that, within 30 calendar days, it would provide a detailed official hold letter and requested that the Company hold its response until after receipt of such letter (the “Hold Letter”).

 

The Company plans to work expeditiously to resolve this clinical hold so that CER-1236 may proceed to the clinic, including by beginning scientific experimental activities to address the two issues based upon the FDA Communication, as well as earlier discussions with the FDA. Notwithstanding the FDA Communication and pending receipt of the Hold Letter, the Company continues to believe that it will be able to initiate the planned clinical trial by the end of 2024.

 

 

 

 

 

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: July 26, 2024 CERO THERAPEUTICS HOLDINGS, INC.
   
  By: /s/ Brian G. Atwood
  Name: Brian G. Atwood
  Title: Chief Executive Officer

 

 

 

v3.24.2
Cover
Jul. 26, 2024
Document Type 8-K
Amendment Flag false
Document Period End Date Jul. 26, 2024
Entity File Number 001-40877
Entity Registrant Name CERO THERAPEUTICS HOLDINGS, INC.
Entity Central Index Key 0001870404
Entity Tax Identification Number 87-1088814
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 201 Haskins Way
Entity Address, Address Line Two Suite 230
Entity Address, City or Town South San Francisco
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94080
City Area Code (650)
Local Phone Number 407-2376
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
Common stock, par value $0.0001 per share  
Title of 12(b) Security Common stock, par value $0.0001 per share
Trading Symbol CERO
Security Exchange Name NASDAQ
Warrants, each whole warrant exercisable for one share of common stock  
Title of 12(b) Security Warrants, each whole warrant exercisable for one share of common stock
Trading Symbol CEROW
Security Exchange Name NASDAQ
Phoenix Biotech Aquisition (NASDAQ:PBAXU)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024 Haga Click aquí para más Gráficas Phoenix Biotech Aquisition.
Phoenix Biotech Aquisition (NASDAQ:PBAXU)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024 Haga Click aquí para más Gráficas Phoenix Biotech Aquisition.