# EDGAR Filing Document

**Accession Number:** 0001600847
**File Stem:** 0001213900-23-001594
**Filing Date:** 2023-1
**Character Count:** 4978
**Document Hash:** 8722b9b40c07ec2e4881a630957816be
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-001594.hdr.sgml**: 20230109

**ACCESSION NUMBER**: 0001213900-23-001594

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20230109

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20230109

**DATE AS OF CHANGE**: 20230109

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Gamida Cell Ltd.
- **CENTRAL INDEX KEY:** 0001600847
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** L3
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38716
- **FILM NUMBER:** 23517358

**BUSINESS ADDRESS:**
- **STREET 1:** 5 NAHUM HAFZADI STREET
- **CITY:** JERUSALEM
- **STATE:** L3
- **ZIP:** 95484
- **BUSINESS PHONE:** 97226595666

**MAIL ADDRESS:**
- **STREET 1:** 5 NAHUM HAFZADI STREET
- **CITY:** JERUSALEM
- **STATE:** L3
- **ZIP:** 95484

?xml version="1.0" encoding="utf-8"?

**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)**

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| | | |
|:---|:---|:---|
| **Israel** | **001-38716** | **Not Applicable** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

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| | |
|:---|:---|
| **116 Huntington Avenue, 7<sup>th</sup> Floor**<br> **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:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **Symbol(s)** | **Name of each exchange on which registered** |
| **Ordinary Shares, NIS 0.01 par value** | **GMDA** | **The Nasdaq Stock Market LLC** |

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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.

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| | | |
|:---|:---|:---|
|  | **GAMIDA CELL LTD.** | **GAMIDA CELL LTD.** |
| January 9, 2023 | By: | /s/ Josh Patterson |
|  |  | Josh Patterson |
|  |  | General Counsel |

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