| Item 7.01 | Regulation FD Disclosure |
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 oftop-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 onForm 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 onForm 8-K.
Forward-Looking Statements
This Current Report on Form8-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 Form10-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.
