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FOR IMMEDIATE RELEASE
Iterum Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results
On Track to Complete its Three Phase 3 Clinical Trials in 2019
Received Qualified Infectious Disease Product Designation in Four Additional Indications
Fast Track Designation received from the FDA in seven potential indications
DUBLIN, Ireland and CHICAGO, March 25, 2019 Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing anti-infectives against multi-drug resistant pathogens, today reported financial results for the fourth quarter and year ended December 31, 2018.
We made tremendous progress in 2018. We raised over $80 million in an IPO to fund three Phase 3 trials in three indications of our lead asset, sulopenem, which were initiated in the third quarter, said Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc. In 2019, we remain focused on completing all three trials, delivering top-line results, and preparing our New Drug Applications for submission to the U.S. Food and Drug Administration (FDA).
2018 Highlights and Recent Events
Initiated three Phase 3 pivotal clinical trials: In the third quarter of 2018, Iterum initiated three Phase 3 clinical trials in each of the following indications: uncomplicated urinary tract infections (uUTI), complicated urinary tract infections (cUTI), and complicated intra-abdominal infections (cIAI). Data from these trials are expected in the second half of 2019.
Strengthened the balance sheet: In May 2018, Iterum raised approximately $80 million of gross proceeds in an initial public offering of ordinary shares. In April 2018, Iterum completed a debt financing with Silicon Valley Bank for up to $30 million, $15 million of which was funded upfront. In February 2018, Iterum closed its Series B-2 financing raising over $32 million.
Received QIDP and Fast Track designation from the FDA: Oral sulopenem and sulopenem IV received QIDP designation in four new indications, community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease. These indications, as well as the three indications currently in Phase 3 development, have also received Fast Track designation from the FDA.
Presented data at scientific congresses: Iterum presented important data at the American Society of Microbiology MICROBE meeting and during IDWeek that underscores the need for new antibiotics, particularly oral therapies like sulopenem, which can be used in both the community and hospital settings.
The following information was filed by Iterum Therapeutics Plc (ITRM) on Monday, March 25, 2019 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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