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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): April 26, 2022

 

 

 

Gamida Cell Ltd.

(Exact name of registrant as specified in its Charter)

 

 

 

Israel   001-38716   Not Applicable

(State or other jurisdiction
of incorporation)

  (Commission File Number)  

(IRS Employer
Identification No.)

 

5 Nahum Heftsadie Street

Givaat Shaul, Jerusalem, Israel

  91340
(Address of principal executive offices)   (Zip Code)

 

+972 (2) 659-5666

(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 (see General Instruction A.2. below):

 

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
Ordinary Shares, NIS 0.01 par value   GMDA   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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 April 26, 2022, Gamida Cell Ltd. issued a press release entitled “Gamida Cell Announces FDA Clearance of IND and Removal of Clinical Hold for NK Cell Therapy Candidate GDA-201”. The full text of the press release is attached 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 April 26, 2022.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Gamida Cell Ltd.
   
Dated: April 26, 2022 By: /s/ Shai Lankry
    Shai Lankry
    Chief Financial Officer

 

 

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