0000000000-18-031744.txt : 20181127 0000000000-18-031744.hdr.sgml : 20181127 20181010101236 ACCESSION NUMBER: 0000000000-18-031744 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20181010 FILED FOR: 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: UPLOAD 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 PUBLIC REFERENCE ACCESSION NUMBER: 0001140361-18-039574 LETTER 1 filename1.pdf begin 644 filename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MKL_Z_KIYVY_?WL"GJ>?'5^TW5WCNM=^NNTU_N=>QVJPO\MY< M70?3+H?NICE87]X.>1?KT>W-#QS!Y>I8DLSE[O@[S?^5I.__UI2PGJ!K/5C_ MH:Z?/_L%VE]8=0T*96YD)PU MT3E2 F$0AN$>%!B$85%4%I%%!424?=7B" H&) 8N59[!1(HS$!%P%<[ A0C& MWWZA@WZJJ[H[^41,N:YE>DSDGQFL%6NCA!:*,U+"5>5YJKS8L%7&*V7RJ[S^ MB'C,L[CT80!#Z,%NY=$.(!#\((/_&!# (X@""%P( P1B$(,CN$$ MXG *9W ."4A""M)P 5FXA SDX GR4( KN(82%.$&RG +%;B#*MS# ]2@#@UH M0@O:T(&NR>']6_/[:"B?I/DU%_D#5F0:>PT*96YDF4@.#$O4F]O=" Q(# @4B]) M;F9O(#')E9@T*,C4V-3$-"B4E14]�IXF4@.#$O4F]O=" Q(# @4B]);F9O(# TEXT-EXTRACT 2 filename2.txt Mail Stop 3561 October 9, 2018 Dr. Julian Adams Chief Executive Officer Gamida Cell Ltd. 5 Nahum Heftsadie Street Givaat Shaul, Jerusalem 91340 Israel Re: Gamida Cell Ltd. Registration Statement on Form F-1 Filed September 28, 2018 File No. 333-227601 Dear Dr. Adams: We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our September 6, 2018 letter. Business NAM-NK: Our Immuno-Oncology Product Candidate Phase 1 trial of NAM-NK in patients with MM or NHL, page 98 1. Your revised disclosure on pages 3 and 87 indicates that you have now reported preliminary data from your Phase 1 trial of NAM-NK in patients with MM or NHL. Please update this section to describe the preliminary data. Dr. Julian Adams Gamida Cell Ltd. October 9, 2018 Page 2 Certain Relationships and Related Party Transactions Agreements and Arrangements with Directors and Executive Officers, page 137 2. We note your revised disclosure in this section regarding your letter agreements with Mr. Blum and Dr. Adams. Please file these agreements as exhibits to your registration statement. Refer to Item 8.a of Form F-1 and Item 601(b)(10)(iii)(A) of Regulation S-K. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Adam Phippen, Staff Accountant, at (202) 551-3336 or Donna Di Silvio, Staff Accountant, at (202) 551-3202 if you have questions regarding comments on the financial statements and related matters. Please contact Parhaum J. Hamidi, Attorney- Adviser, at (202) 551-3421 or me at (202) 551-3720 with any other questions. Sincerely, /s/ Mara L. Ransom Mara L. Ransom Assistant Director Office of Consumer Products