TMCnet News
Iterum Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results --On Track to Complete its Three Phase 3 Clinical Trials in 2019-- 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,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics plc. “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).” 2018 Highlights and Recent Events
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
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 uncomplicated urinary tract infections, complicated urinary tract infections, and complicated intra-abdominal infections. 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 regarding future revenue, expenses, cash flows and net income or loss, the sufficiency of cash resources, the development, therapeutic and market potential of sulopenem, the timing, progress and results of clinical trials, and the expected timing of NDA filings. 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 Iterum Therapeutics’ 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 Iterum Therapeutics’ control, including the uncertainties inherent in the initiation and conduct of clinical trials, clinical trial patient enrollment, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, commercialization plans and timelines, if approved, the actions of third-party clinical research organizations, suppliers and manufacturers and other factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 25, 2019, and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum Therapeutics’ beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum Therapeutics assumes 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:
|