Iterum Therapeutics : Provides Update on NDA Review (Form 8-K)

Iterum Therapeutics Provides Update on NDA Review

DUBLIN,IrelandandCHICAGO;May27,2021(GLOBENEWSWIRE)--IterumTherapeuticsplc(Nasdaq: ITRM) (the 'Company'), 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 announced that the Company participated in a late-cycle meeting with the U.S. Food and Drug Administration ('FDA') yesterday. During the meeting, the FDA shared issues still under reviewregardingtheCompany'snewdrugapplication('NDA')forsulopenemetzadroxil/probenecidforthe treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen and the Company responded to these issues. The FDA has determined that an Advisory Committee meetingisnotcurrentlynecessary.ThereviewoftheNDAisongoingandtheCompanywasinformedthat the FDA continues to work toward the PDUFA goal date of July 25,2021.

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 Therapeuticsisadvancingitsfirstcompound,sulopenem,anovelpenemanti-infectivecompound,inPhase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potentin vitroactivityagainstawidevarietyofgram-negative,gram-positiveandanaerobicbacteriaresistanttoother antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in sevenindications.

Forward-Looking Statements

Thispressreleasecontainsforward-lookingstatements.Theseforward-lookingstatementsinclude,without limitation, statements regarding the Company's plans, strategies and prospects for its business, including with respect to the timing of review by the U.S. Food and Drug Administration of the new drug application for oral sulopenem, including whether an advisory committee may be necessary and the resolution of substantive review issues raised by the FDA, and the market potential for sulopenem. 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,' 'would,' '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 the Company's actual results, performance or achievements to be materially different from any future results, performance or achievementsexpressedorimpliedbytheforward-lookingstatements.Forward-lookingstatementsinclude allmattersthatarenothistoricalfacts.Actualfutureresultsmaybemateriallydifferentfromwhatisexpected due to factors largely outside the Company's control, including the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals,changesinpublicpolicyorlegislation,commercializationplansandtimelines,iforalsulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracyoftheCompany'sexpectationsregardinghowfarintothefuturetheCompany'scashonhandwill fundtheCompany'songoingoperations,theimpactofCOVID-19andrelatedresponsivemeasuresthereto, risksanduncertaintiesconcerningtheoutcome,impact,effectsandresultsoftheCompany'sevaluationof corporate, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, strategic, financial or financing alternative and the Company's ability tocompleteoneatallandotherfactors discussedunderthecaption'RiskFactors'initsAnnualReporton Form 10- Q filed with the Securities and Exchange Commission (the 'SEC') on May 14, 2021, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company's beliefsandassumptions onlyas ofthedateofthis press release.Exceptasrequiredbylaw,theCompany

assumesnoobligationtoupdatetheseforward-lookingstatementspublicly,ortoupdatethereasonsactual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in thefuture.

Investor Contact:

Judy Matthews

Chief Financial Officer 312-778-6073

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