Page 1

May 14 , 2021 ITERUM herapeutics Iterum Therapeutics Reports First Quarter 2021 Financial Results FDA Review of NDA for Oral Sulopenem Continues ; Current Prescription Drug User Fee Act ( PDUFA ) date of July 25 , 2021 Cash Runway into First Half of 2023 Company to host conference call today at 8:30 am ET DUBLIN , Ireland and CHICAGO , May 14 , 2021 ( 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 first quarter ended March 31 , 2021 . " We continue to prepare for a U.S. Food and Drug Administration ( FDA ) advisory committee meeting and look forward to clarity from the FDA on timing . In the meantime , the FDA continues its review of our new drug application ( NDA ) for oral sulopenem for the treatment of uncomplicated urinary tract infections ( uUTI ) in patients with a quinolone non - susceptible organism and has not advised us of any change to the current PDUFA goal date of July 25 , 2021 , " said Corey Fishman , Chief Executive Officer . " With an FDA decision on oral sulopenem expected in the second half of 2021 and a strong cash position , we are preparing for a launch of oral sulopenem into the community in the fourth quarter of 2021 , if approved . " Highlights and Recent Events • NDA priority review by the FDA is ongoing with current PDUFA goal date of July 25 , 2021 : In January 2021 , the FDA accepted for review our NDA for uUTI in patients with a quinolone non - susceptible organism . The FDA has designated our application as a priority review and consequently assigned a PDUFA goal date for completion of the review of oral sulopenem of July 25 , 2021. The FDA previously planned to hold an advisory committee meeting for oral sulopenem on June 2 , 2021 but this meeting was postponed to allow the FDA more time to review material provided by the Company in support of the NDA . A new date for such meeting , if required by the FDA , has not yet been confirmed . • Extended cash runway into first half of 2023 : In February 2021 , we received total net proceeds of $ 74.3 million from an underwritten public offering and a registered direct offering . Based on our current operating plans , we believe our cash , cash equivalents and short - term investments of $ 100.5 million as of March 31 , 2021 allows us to operate into the first half of 2023. As of March 31 , 2021 , we had approximately 179.1 million ordinary shares outstanding . • Ongoing collaboration with a third - party provider of commercialization services : In February 2021 , we engaged EVERSANA TM , a leading provider of commercial services to the life science industry , and we have initiated pre - launch activities . We are