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SEC Comment Letter for Iterum Therapeutics plc (ITRM) (CIK 0001659323) (ITRM) — Apr 6, 2020

Iterum Therapeutics plc (ITRM) (CIK 0001659323)
Date: April 6, 2020 · CIK: 0001659323 · Accession: 0000000000-20-002954

AI Filing Summary & Sentiment

File numbers found in text: 333-237326

Date
April 4, 2020
Author
Not clearly detected
Form
UPLOAD
Company
Iterum Therapeutics plc (ITRM) (CIK 0001659323)

Letter

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.

FirstName LastNameCorey Fishman Comapany NameIterum Therapeutics plc April 4, 2020 Page 2 FirstName LastName 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. Sincerely, Division of Corporation Finance Office of Life Sciences

Show Raw Text
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.

 FirstName LastNameCorey Fishman
 Comapany NameIterum Therapeutics plc
 April 4, 2020 Page 2
 FirstName LastName
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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences