0000000000-20-002954.txt : 20200909 0000000000-20-002954.hdr.sgml : 20200909 20200406172144 ACCESSION NUMBER: 0000000000-20-002954 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20200406 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Iterum Therapeutics plc CENTRAL INDEX KEY: 0001659323 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L2 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: BLOCK 2 FLOOR 3, HARCOURT CENTRE STREET 2: HARCOURT STREET CITY: DUBLIN STATE: L2 ZIP: 2 BUSINESS PHONE: (872) 225-6077 MAIL ADDRESS: STREET 1: BLOCK 2 FLOOR 3, HARCOURT CENTRE STREET 2: HARCOURT STREET CITY: DUBLIN STATE: L2 ZIP: 2 FORMER COMPANY: FORMER CONFORMED NAME: Iterum Therapeutics Ltd DATE OF NAME CHANGE: 20151124 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Iterum Therapeutics US Ltd CENTRAL INDEX KEY: 0001800794 IRS NUMBER: 475472711 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 200 S. WACKER DRIVE STREET 2: SUITE 2550 CITY: CHICAGO STATE: IL ZIP: 60606 BUSINESS PHONE: 312-778-6070 MAIL ADDRESS: STREET 1: 200 S. WACKER DRIVE STREET 2: SUITE 2550 CITY: CHICAGO STATE: IL ZIP: 60606 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Iterum Therapeutics US Holding Ltd CENTRAL INDEX KEY: 0001800799 IRS NUMBER: 824384195 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 200 S. WACKER DRIVE STREET 2: SUITE 2550 CITY: CHICAGO STATE: IL ZIP: 60606 BUSINESS PHONE: 312-778-6070 MAIL ADDRESS: STREET 1: 200 S. WACKER DRIVE STREET 2: SUITE 2550 CITY: CHICAGO STATE: IL ZIP: 60606 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Iterum Therapeutics International Ltd CENTRAL INDEX KEY: 0001800801 IRS NUMBER: 981283147 STATE OF INCORPORATION: L2 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: BLOCK 2 FLOOR 3 HARCOURT CENTRE STREET 2: HARCOURT STREET CITY: DUBLIN STATE: L2 ZIP: 2 BUSINESS PHONE: 353-1-903-8920 MAIL ADDRESS: STREET 1: BLOCK 2 FLOOR 3 HARCOURT CENTRE STREET 2: HARCOURT STREET CITY: DUBLIN STATE: L2 ZIP: 2 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Iterum Therapeutics Bermuda Ltd CENTRAL INDEX KEY: 0001800802 IRS NUMBER: 981517508 STATE OF INCORPORATION: D0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: CLARENDON HOUSE STREET 2: 2 CHURCH STREET CITY: HAMILTON STATE: D0 ZIP: HM 11 BUSINESS PHONE: 312-778-6070 MAIL ADDRESS: STREET 1: CLARENDON HOUSE STREET 2: 2 CHURCH STREET CITY: HAMILTON STATE: D0 ZIP: HM 11 PUBLIC REFERENCE ACCESSION NUMBER: 0001193125-20-080783 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]4>7!E+UA/8FIE8W0O0V]L;W)3 M<&%C92]$979I8V5',Z%$;3 BU,"VEA6J % M6J %6J %6J %6J %6O ]*WOEK(,D*\X#9H:[]P]6<&19EAU+^GP>RR(B(B(B M(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B+_-A\?'^_O[V]O;Z^OKR\' MGI^?GP[$AY="%(AB43AV^=.M%A$1$1$1$9$?2,H4S\_/CX^/]_?WOP[<'=E- MR6+L]?OW[ZCAZ>GI]?5504-$1$1$1$1$+N;M[>WIZ>GAX6&_WS<"Q:]?O^[O M[^.KQW.(\K]__VZJBLJ1,EY>7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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filename2.txt April 4, 2020 Corey Fishman President and Chief Executive Officer Iterum Therapeutics plc 200 South Wacker Drive, Suite 2550 Chicago, IL 60606 Re: Iterum Therapeutics plc Registration Statement on Form S-1 Filed March 20, 2020 File No. 333-237326 Dear Mr. Fishman: We have limited our review of your registration statement to those issues we have addressed in our 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. Registration Statement on Form S-1 filed March 20, 2020 Cover Page 1. Please revise the coverpage presentation concerning the Exchangeable Notes to identify the exchange rate and clarify whether it is a fixed or floating rate. With respect to the Royalty-Linked Notes, revise the coverpage to explain and highlight briefly what these notes are and their material features. For instance, it should be clear what royalties and drug candidates are at issue, the absence of principal and interest payments, and the time horizon for the security. Also, highlight the complexities of the Royalty-Linked Notes and the tax risks applicable to U.S. holders. Also, revise the coverpage to indicate that both instruments are subject to redemption. 2. With reference to your fee table, please revise the coverpage to disclose the number of ordinary shares that you are registering. Corey Fishman Iterum Therapeutics plc April 4, 2020 Page 2 3. Please revise the third paragraph to indicate whether there is any limitation on your ability to extend the offering. The Royalty-Linked Notes, page 14 4. Please revise to: Disclose the number of Royalty-Linked Notes outstanding before and after the offering, and discuss any risks associated with potential future issuances. Clarify what 50 Notes entitles the holder to receive. For instance, please add a table to demonstrate the range of payouts that would be owed to investors under various scenarios relating to asset performance and, as applicable, the number of Royalty- Linked Notes outstanding. Discuss the development status of the drug product candidates (including development plans and timelines) relevant to the performance of these Royalty- Linked Notes. Exhibits 5. Please explain to us why counsel includes the final paragraph on page 3 of the Exhibit 5.1 legal opinion concerning the Royalty-Linked Notes. 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. Please contact Jeffrey Gabor at (202) 551-2544 or Joe McCann at (202) 551-6262 with any questions. FirstName LastNameCorey Fishman Sincerely, Comapany NameIterum Therapeutics plc Division of Corporation Finance April 4, 2020 Page 2 Office of Life Sciences FirstName LastName