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Iterum Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results --Topline data from cUTI and uUTI pivotal trials on track to report around the end of Q1-- DUBLIN, Ireland and CHICAGO, March 12, 2020 (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 fourth quarter and year ended December 31, 2019. “2019 was a year of incredible progress for Iterum. We completed enrollment in all three Phase 3 clinical trials of sulopenem and reported topline results from our complicated intra-abdominal infections (cIAI) trial,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc. “2020 is a pivotal year for the company. We started the year by raising additional capital to fund the company through topline results of the remaining two Phase 3 studies, complicated urinary tract infections (cUTI) and uncomplicated urinary tract infections (uUTI), planned submission of two new drug applications (NDAs) to the U.S. Food and Drug Administration (FDA) and preparations for a potential commercial launch in 2021.” 2019 Highlights and Recent Events
Fourth Quarter and Full Year 2019 Financial Results As of December 31, 2019, Iterum had cash and cash equivalents of $4.8 million and approximately 14.5 million shares outstanding. In January 2020, Iterum received net proceeds of $46.7 million from the private placement with accredited investors of 6.500% exchangeable senior subordinated notes due 2025 and limited recourse royalty-linked senior subordinated notes. Iterum expects that its current cash and cash equivalents, including the proceeds from this recent financing, will be sufficient to fund its operations into the second half of 2020. Research and development (R&D) expenses for the fourth quarter and full year 2019 were $20.9 million and $90.8 million, respectively, compared to $21.5 million and $68.6 million for the same periods in 2018. 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, partially offset by milestone payments made to Pfizer Inc. of $7.5 million in the fourth quarter of 2018 and $15.0 million in the 2018 twelve-month period. General and administrative (G&A) expenses for the fourth quarter and full year 2019 were $2.3 million and $11.3 million, respectively, compared to $2.7 million and $8.8 million for the same periods in 2018. The increase for the full year was primarily due to increased costs associated with operating as a public company and additional headcount to support business activities. For the fourth quarter and full year 2019, Iterum reported a net loss of $23.6 million and $103.1 million, respectively, compared to a net loss of $24.3 million and $77.1 million for the same periods in 2018. Upcoming Scientific and Investor Presentations
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 avoidance of hospitalization or 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 pivotal Phase 3 clinical trials of uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections. The U.S. Food and Drug Administration (FDA) has granted Special Protocol Agreements (SPA) and Qualified Infectious Disease Product (QIDP) designations for oral and IV sulopenem in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which will provide five years of additional regulatory exclusivity and expedited Fast Track FDA review. About Iterum Therapeutics plc Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with oral and IV formulations. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit http://www.iterumtx.com. Forward Looking Statements This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding expectations about future revenue, expenses, cash flows and net income or loss, the sufficiency of cash resources, the development, therapeutic and market potential of sulopenem, and the timing, progress and results of clinical trials and regulatory submissions. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside our control, including the uncertainties inherent in the conduct of clinical trials, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, changes in public policy or legislation, commercialization plans and timelines, if approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of our expectations regarding how far into the future our cash on hand will fund our ongoing operations, the sufficiency of our cash resources and our ability to continue as a going concern, and other factors discussed under the caption “Risk Factors” in our Annual Report on Form 10- K filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2020, and other documents filed with the SEC from time to time. Forward-looking statements represent our beliefs and assumptions only as of the date of this press release. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Investor Contact:
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