On track to complete enrollment in all three Phase 3 clinical trials before year-end

Filed patent application that may extend Iterum’s intellectual property rights into the 2040s

DUBLIN, Ireland and CHICAGO, May 14, 2019 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing anti-infectives against multi-drug resistant pathogens, today reported financial results for the first quarter ended March 31, 2019.

“The first quarter of 2019 was highlighted by the U.S. Food and Drug Administration (FDA) granting us Qualified Infectious Disease Product (QIDP) status in four new indications, as well as Fast Track designation for all seven potential indications of oral and IV sulopenem for which QIDP status has been received. We remain focused on completing enrollment of all three of our ongoing Phase 3 clinical trials this year. A new effective oral therapy in our studied indications has become critical due to the rise in multi-drug resistant infections in the community, and we are excited to be at the forefront of seeking to provide a near-term solution.”

Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc

Q1 2019 Highlights and Recent Events

• FDA granted QIDP designation and Fast Track: In the first quarter, 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, also received Fast Track designation from the FDA.

• Based on current enrollment rates, all three Phase 3 clinical trials are on track to complete enrollment before year-end; sample size adjustment review underway for uncomplicated urinary tract infection (uUTI) study: Based on current enrollment rates, all three Phase 3 clinical trials are on track to complete enrollment before year-end. Enrollment in the uUTI study has passed the 1/3 target level and this triggers the first of two pre-planned analyses relating to potential sample size adjustments. The results of this analysis are expected to be available around the end of Q2.

• Presented data showing that mismatched empiric antibiotic therapy leads to double the rate of hospitalization for a uUTI: As presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases in April 2019, culture data shows that age, gender,
  Diabetes mellitus and prior resistance to antibiotics increased the likelihood of treatment failure, and that hospitalization rates doubled to over 15% for patients whose pathogens were not susceptible to the antibiotic they received.

• Filed a non-provisional patent application with United States Patent and Trademark Office: The extensive pharmacokinetic work supporting the sulopenem program demonstrated that plasma levels of sulopenem after multiple days of oral dosing when combined with probenecid remained at or above the concentrations on Day 1, relative to dosing with oral sulopenem alone, enhancing its potential antimicrobial effect. If granted, this method of use patent on the combination of sulopenem and probenecid would provide 20 years of intellectual property protection. The current U.S. composition of matter patent on sulopenem etzadroxil expires in 2029 with potential extension to 2034 under the HatchWaxman Act.

Upcoming Scientific and Investor Presentations

• Corporate presentation at the RBC Capital Markets Global Healthcare Conference on Tuesday, May 21, 2019, in New York, New York

• Multiple scientific presentations at American Society of Microbiology (ASM) Microbe 2019 from June 20-24, 2019, in San Francisco, California

First Quarter 2019 Financial Results

As of March 31, 2019, Iterum had cash, cash equivalents and short-term investments of $69.6 million and approximately 14.4 million shares outstanding. Iterum expects that its cash, cash equivalents and short-term investments, along with its available borrowings, will be sufficient to fund operations into 2020.

Research and development (R&D) expenses for the first quarter of 2019 were $17.4 million compared to $10.9 million for the same period in 2018. The increase was primarily due to higher clinical trial expenses associated with the three Phase 3 clinical trials initiated in the third quarter of 2018.

General and administrative (G&A) expenses for the first quarter of 2019 were $3.1 million compared to $1.5 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 and market research expenses.

For the first quarter of 2019, Iterum reported a net loss of $20.6 million compared to a net loss of $12.1 million for the same period in 2018.