14th May 2019
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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
Upcoming Scientific and Investor Presentations
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.