Current Report Filing (8-k)
January 09 2023 - 12:16PM
Edgar (US Regulatory)
0001600847
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0001600847
2023-01-09
2023-01-09
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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):
January 9, 2023
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.) |
116
Huntington Avenue, 7th Floor
Boston, MA |
|
02116 |
(Address of principal executive offices) |
|
(Zip Code) |
(617) 892-9080
(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 7.01. Regulation FD Disclosure.
On January 9, 2023, Gamida Cell Ltd.
(the “Company”) posted an updated corporate presentation on the Company’s website. To access the presentation, investors
should visit the “Investors & Media” section of the Company’s website at www.gamida-cell.com.
The information furnished under this Item
7.01 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 such information be deemed incorporated by reference in
any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such
a filing.
Item 8.01 Other Events.
In the fourth quarter of
2022, the Israeli Ministry of Health and the United States Food and Drug Administration (the “FDA”) completed physical inspections
of the Company's Kiryat Gat, Israel manufacturing facility. The Company will commercially manufacture omidubicel for sale in the United
States at such facility if omidubicel is approved for marketing by the FDA.
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.
|
GAMIDA CELL LTD. |
|
|
|
January 9, 2023 |
By: |
/s/ Josh Patterson |
|
|
Josh Patterson |
|
|
General Counsel |
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