• Phase 3 topline data from the cIAI trial expected shortly
  • cUTI and uUTI Phase 3 trials remain on track to complete enrollment around year-end and report topline data in Q1 2020
  • NDA Filings Expected in First Half of 2020

DUBLIN, Ireland and CHICAGO, Nov. 12, 2019 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2019 and provided an update on its clinical programs.

“We look forward to reporting topline data from the first of three Phase 3 studies of sulopenem in the very near future. The remaining studies will complete enrollment around the end of the year and produce topline data in the first quarter of 2020. Assuming positive data, we anticipate submitting a New Drug Application (NDA) for our oral and IV formulations to the FDA in the first half of 2020.”

Corey Fishman, Chief Executive Officer of Iterum Therapeutics

Clinical Update

All three Phase 3 clinical trials of sulopenem have undergone pre-planned protocol specified analyses related to the potential opportunity for sample size adjustments. These analyses, performed by a Data Management Committee, were done to determine whether the initial protocol specified sample size was providing adequate statistical power.

Based on the outcome of these analyses, the Company decided to add 225 patients to the complicated UTI study for a total of 1,381 patients and 400 patients to the uncomplicated UTI study for a total of 1,764 patients. No patients were added to the complicated intra-abdominal infections study.

Third Quarter 2019 Financial Results

As of September 30, 2019, Iterum had cash and cash equivalents of $28.9 million and approximately 14.9 million shares outstanding. Iterum expects that its cash and cash equivalents will be sufficient to fund operations into 2020.

Research and development expenses for the third quarter of 2019 were $28.1 million compared to $22.6 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 the $7.5 million milestone payment made to Pfizer in the third quarter of 2018 upon first patient dosing in the SURE 1 clinical trial.

General and administrative expenses for the third quarter of 2019 were $2.9 million compared to $2.7 million for the same period in 2018. The increase was primarily due to increased costs associated with operating as a public company, and additional headcount to support business activities.

For the third quarter of 2019, Iterum reported a net loss of $31.3 million compared to a net loss of $24.9 million for the same period in 2018.

Upcoming Corporate Event

Iterum’s senior management will be presenting an overview of the Company at the Stifel 2019 Healthcare Conference on November 20, 2019 in New York City, NY.

About Sulopenem

Sulopenem, a novel penem anti-infective compound with oral and IV formulations, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. If approved, sulopenem will help address the significant clinical and economic need for new oral antibiotics that enable the effective treatment of resistant pathogens in the community, make possible the avoidance of hospitalization, and facilitate early hospital discharge by providing continuity-of-care step-down therapy. The safety profile of IV sulopenem has been documented in a Phase 2 program. Oral and IV sulopenem are being evaluated in three pivotal Phase 3 clinical trials for uUTI, cUTI, and cIAI.

Probenecid, which is being co-administered with sulopenem in a bilayer tablet, is approved as an adjuvant to therapy for elevation and prolongation of plasma levels of β-lactam compounds.