EXHIBIT 99.1

 

 

FOR IMMEDIATE RELEASE

 

Iterum Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results

 --Topline data from cUTI and uUTI pivotal trials on track to report around the end of Q1--

--NDAs anticipated to file with the FDA in mid-2020 --

 

DUBLIN, Ireland and CHICAGO, March 12, 2020

-- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the fourth quarter and year ended December 31, 2019.

 

“2019 was a year of incredible progress for Iterum. We completed enrollment in all three Phase 3 clinical trials of sulopenem and reported topline results from our complicated intra-abdominal infections (cIAI) trial,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc.  “2020 is a pivotal year for the company.  We started the year by raising additional capital to fund the company through topline results of the remaining two Phase 3 studies, complicated urinary tract infections (cUTI) and uncomplicated urinary tract infections (uUTI), planned submission of two new drug applications (NDAs) to the U.S. Food and Drug Administration (FDA) and preparations for a potential commercial launch in 2021.”

 

2019 Highlights and Recent Events

 

Completed enrollment in all Phase 3 pivotal clinical trials:  In the fourth quarter of 2019, Iterum completed patient enrollment in its two remaining clinical trials, Sulopenem for Resistant Enterobacteriaceae (SURE) 1 in uUTI and SURE 2 in cUTI.  Overall, more than 3,700 patients were enrolled in our Phase 3 clinical trials of sulopenem since initiation in the third quarter of 2018.

Announced topline results in first Phase 3 trial:  In December 2019, Iterum announced that it narrowly missed the primary endpoint of its SURE 3 clinical trial cIAI.  While the trial narrowly missed the primary endpoint, we believe the secondary supporting analysis and safety data support the potential for sulopenem in the treatment of multi-drug resistant infections.

Strengthened the balance sheet:  Iterum raised approximately $51.6 million ($46.7 million net of fees and expenses) in January 2020 through a private placement of units comprised of approximately (i) $51.6 million aggregate principal amount of its 6.500% exchangeable senior subordinated notes due 2025 and (ii) $0.1 million aggregate principal amount of its limited recourse royalty-linked senior subordinated notes.

Filed two non-provisional patent applications with United States Patent and Trademark Office:   One patent application addressed the effect of probenecid on the plasma concentrations of sulopenem after multi-day dosing and the second patent application

 


The following information was filed by Iterum Therapeutics Plc (ITRM) on Thursday, March 12, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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