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): October 19, 2018

Iterum Therapeutics plc

(Exact name of registrant as specified in its charter)

Registrant’s telephone number, including area code: +353 1 903 8920

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:

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.  ☒

Jeff Schaffnit, Chief Commercial Officer of Iterum Therapeutics plc (“Iterum”), is leaving the company to pursue other opportunities. Mr. Schaffnit’s last day as an Iterum employee is October 19, 2018.

Iterum continues to make progress on its key milestones, all of which remain on track. Iterum continues to expect the announcement of top-line data from all three of its Phase 3 clinical trials that are currently underway in the second half of 2019 and to submit its new drug applications (NDAs) to the U.S. Food and Drug Administration by the end of 2019. In addition, Iterum plans to initiate discussions with potential commercial partners to optimize the value of the assets.

The information in this Current Report on Form 8-K is being furnished and 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 liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the timing, progress and results of clinical trials, the expected timing of NDA filings and discussions with potential strategic partners. In some cases, forward-looking statements can be identified by words such as “continues,” “expects,” “plans” or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Iterum’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside Iterum’s control, including the uncertainties inherent in the conduct of clinical trials, clinical trial patient enrollment, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, and other factors discussed under the caption “Risk Factors” in Iterum’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 with the Securities and Exchange Commission (the “SEC”), and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum’s beliefs and assumptions only as of the date of this Current Report. Except as required by law, Iterum assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.