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August 13 , 2021 ITERUM herapeutics Iterum Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update --Type A meeting with FDA expected late Q3 to define pathway to potential approval for Oral Sulopenem following July's Complete Response Letter-- --Cash Runway into Second Half of 2023-- --Company to host conference call today at 8:30 am ET-- DUBLIN , Ireland and CHICAGO , Aug. 13 , 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 second quarter ended June 30 , 2021 . " Despite our disappointment with the FDA's Complete Response Letter ( " CRL " ) , we've begun preparations for the Type A meeting with the FDA expected later this quarter and we hope to receive adequate guidance and agreement with the FDA on a path forward that will lead to resubmission of our New Drug Application ( " NDA " ) as quickly as possible , ” said Corey Fishman , Chief Executive Officer . Highlights and Recent Events • FDA completes review of NDA : On July 23 , 2021 , we received a CRL from the U.S. Food and Drug Administration ( " FDA ” ) with respect to our NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with a quinolone non- susceptible organism , stating that the FDA could not approve the NDA in its present form . The CRL provided that additional data are necessary to support approval of oral sulopenem and recommended that we conduct at least one additional adequate and well - controlled clinical trial , potentially using a different comparator drug . Additionally , the FDA recommended that we conduct further non - clinical investigation to determine the optimal dosing regimen , although the FDA stated that this recommendation does not raise an approvability issue . We plan to have a Type A meeting with the FDA to identify the next steps as to the potential additional clinical and non - clinical work to support a potential resubmission of the NDA for approval of oral sulopenem . The meeting is expected to take place near the end of the third quarter . • Cash runway into second half of 2023 : Based on the current operating plan and subject to final determination of the design and planned conduct of potential additional clinical and non - clinical development for sulopenem , we believe that we are well positioned financially to fund operations into the second half of 2023. Following receipt of the CRL , in order to reduce operating expenses and conserve cash resources , we