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November 12 , 2021 ITherapeutics Iterum Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update --Type B meeting with FDA requested to affirm design for additional Phase 3 trial needed for resubmission of NDA for Oral Sulopenem-- --Cash Runway into 2024-- --Iterum to host conference call today at 8:30 am ET-- DUBLIN , Ireland and CHICAGO , Nov. 12 , 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 third quarter ended September 30 , 2021 . " We had a productive Type A meeting with the U.S. Food and Drug Administration ( FDA ) in the third quarter in which various potential paths forward to support potential resubmission of our New Drug Application ( NDA ) for oral sulopenem for the treatment of uncomplicated urinary tract infections ( uUTI ) were discussed . We have since requested a Type B meeting with the FDA with the goal of reaching agreement on the design of a Phase 3 trial for oral sulopenem for the treatment of uUTI that , if successful , could lead to a resubmission of our NDA , " said Corey Fishman , Chief Executive Officer . Highlights and Recent Events • Held Type A Meeting with FDA in Q3 ; Type B Meeting with FDA Requested : In September 2021 , we had a Type A meeting with the FDA to discuss the steps required for potential resubmission of the NDA for oral sulopenem following receipt of the Complete Response Letter ( CRL ) in July 2021. We have requested a Type B meeting with the FDA to discuss the design of a potential new clinical trial to support such potential resubmission . • Cash runway into 2024 : 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 of oral sulopenem , we believe that we are well positioned financially to fund operations into 2024 with our existing cash resources , which includes completing the proposed additional development of oral sulopenem to support , if successful , the resubmission of our NDA to the FDA . As of September 30 , 2021 , we had approximately 182.8 million ordinary shares outstanding . Third Quarter 2021 Financial Results