Iterum Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results

25th March 2019

--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 (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 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. 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).”

Corey Fishman, Chief Executive Officer of Iterum Therapeutics

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.

Fourth Quarter and Full-Year 2018 Financial Results

As of December 31, 2018, Iterum had cash, cash equivalents and short-term investments of $84.6 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 the first quarter of 2020.

Research and development (R&D) expenses for the fourth quarter and full year 2018 were $21.5 million and $68.6 million, respectively, compared to $8.2 million and $25.5 million for the same periods in 2017. The increases for both the three-month and twelve-month periods were primarily due to higher clinical trial expenses associated with the three Phase 3 clinical trials initiated in the third quarter of 2018, as well as clinical milestone payments to Pfizer of $7.5 million and $15.0 million in the fourth quarter and full year, respectively.

General and administrative (G&A) expenses for the fourth quarter and full year 2018 were $2.7 million and $8.8 million, respectively, compared to $1.3 million and $4.5 million for the same periods in 2017. 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 fourth quarter and full year 2018, Iterum reported a net loss of $24.3 million and $77.1 million, respectively, compared to a net loss of $9.1 million and $29.4 million for the same periods in 2017.

Upcoming Scientific and Investor Presentations

  • Corporate presentation at the Needham & Company 18th Annual Healthcare Conference on Tuesday, April 9, 2019 at 1:30 p.m. in New York, New York
  • Multiple scientific presentations at the 29th European Congress of Clinical Microbiology and Infectious Diseases from April 13-16, 2019 in Amsterdam, Netherlands
  • Corporate presentation at the RBC Capital Markets Global Healthcare Conference from May 21-22, 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