8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 27, 2021

Iterum Therapeutics plc
(Exact name of registrant as specified in its charter)
Ireland	001-38503	98-1283148
(State or other jurisdiction	(Commission File Number)	(IRS Employer Identification No.)
of incorporation)
Block 2 Floor 3, Harcourt Centre, Harcourt Street, Dublin 2, Ireland		Not Applicable
(Address of principal executive offices)		(Zip Code)
Registrant’s telephone number, including area code: +353 1 903 8920

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Ordinary Shares, par value $0.01 per share	ITRM	Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

Item 8.01. Other Events.

On May 27, 2021, Iterum Therapeutics plc (the “Company”) issued a press release announcing that on May 26, 2021 the Company participated in a late-cycle meeting with the U.S. Food and Drug Administration (“FDA”) during which, the FDA shared, and the Company responded to, issues still under review regarding the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.   The FDA has determined that an Advisory Committee meeting is not currently necessary.  The review of the NDA is ongoing and the Company was informed that the FDA continues to work toward the PDUFA goal date of July 25, 2021

The full text of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this Current Report of Form 8-K and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release of Iterum Therapeutics plc dated May 27, 2021

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Iterum Therapeutics plc
Dated: May 27, 2021
	By:	/s/ Corey N. Fishman
		Corey N. Fishman
		Chief Executive Officer

EX-99.1

EXHIBIT 99.1

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

EXHIBIT 99.1

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

IR@iterumtx.com