--Phase 3 Topline Data anticipated in the fourth quarter

-- NDA filings expected in first quarter of 2020--

DUBLIN, Ireland and CHICAGO, August 14, 2019 -- 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 second quarter ended June 30, 2019.

“The second quarter was marked by continued progress in our three pivotal Phase 3 clinical trials of sulopenem. Based on current enrollment rates, we anticipate topline data from the complicated intra-abdominal (cIAI) and the complicated urinary tract infection (cUTI) trials in the fourth quarter. This would allow us the flexibility to file our new drug applications (NDAs) in the first quarter of 2020. Our trial for uncomplicated urinary tract infections (uUTI) just passed two-thirds enrollment, which triggers a pre-planned review of the blinded data for potential sample size adjustment. The outcome of this analysis will determine the enrollment timeline, which will guide our decision on the optimal filing strategy for the uUTI data.”

Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc

Recent Highlights

Presented research at ASM Microbe that supports the need for new antibiotics to treat uUTIs: In June, Iterum presented data that showed patients with uUTIs in the community treated with the most commonly prescribed antibiotic for that infection, ciprofloxacin, have a significantly greater rate of treatment failure when the organism is quinolone resistant. Based on our uUTI trial, Iterum estimates that resistance to quinolones in the community is greater than 25% in many geographies in the U.S., and greater than 30% outside of the U.S.

Second Quarter 2019 Financial Results

As of June 30, 2019, Iterum had cash and cash equivalents of $51.2 million and approximately 14.4 million shares outstanding. Iterum expects that its cash and cash equivalents will be sufficient to fund operations into 2020.

Research and development (R&D) expenses for the second quarter of 2019 were $24.4 million compared to $13.7 million for the same period in 2018. The increase was primarily due to higher clinical trial expenses associated with our three Phase 3 clinical trials initiated in the third quarter of 2018, partially offset by a reduction in chemistry, manufacturing and control-related expenses as a result of the completion of manufacturing of clinical trial materials for our Phase 3 clinical trials by our primary suppliers.
General and administrative (G&A) expenses for the second quarter of 2019 were $2.9 million compared to $1.9 million for the same period in 2018. The increase was primarily due to increased costs associated with operating as a public company, additional headcount to support business activities, and increased marketing expenses.
For the second quarter of 2019, Iterum reported a net loss of $27.6 million compared to a net loss of $15.7 million for the same period in 2018.