Iterum Therapeutics plc 2025年季度报告

For the transition period fromtoCommission File Number:001-38503 Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject tosuch filing requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required tosubmit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerginggrowth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying withany new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒As of May 12, 2025, the registrant had40.0million ordinary shares, $0.01 par value per share, outstanding. Table of Contents PART I.FINANCIAL INFORMATION1Item 1.Financial Statements (Unaudited)1CondensedConsolidated Balance Sheets1Condensed Consolidated Statements of Operations and Comprehensive Loss2Condensed Consolidated Statements of Cash Flows3Condensed Consolidated Statements of Stockholders' Equity4Notes to Unaudited Condensed Consolidated Financial Statements5Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations22Item 3.Quantitative and Qualitative Disclosures About Market Risk33Item 4.Controls and Procedures33PART II.OTHER INFORMATION34Item 1.Legal Proceedings34Item 1A.Risk Factors34Item 5.Other Information89Item 6.Exhibits90Signatures91 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. Allstatements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In somecases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,”“estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or thenegative of these words or other comparable terminology. These forward-looking statements include, but are not limited to,statements about: •our use of cash reserves;•our ability to continue as a going concern;•the design, initiation, timing, progress and results of our preclinical studies and clinical trials, and our research anddevelopment programs;•our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualifiedprofessionals;•our ability to advance product candidates into, and successfully complete, clinical trials;•the potential advantages of our product candidates;•the timing or likelihood of regulatory filings and approvals;•the commercialization of our product candidates, if approved;•our manufacturing plans;•our sales, marketing and distribution capabilities and strategy;•the market opportunity for and the potential market acceptance of ORLYNVAH™ for uncomplicated urinary tractinfections caused by certain designated microorganisms in adult women who have limited or no alternative oralantibacterial treatment options;•market acceptance of any product we successfully commercialize;•the pricing, coverage and reimbursement of our product candidates, if approved;•the implementation of our business model and strategic plans for our business and product candidates;•the scope of protection we are able to establish and maintain for intellectual property rights covering our productcandidates and our ability to defend and enforce any such intellectual property rights;•our ability to enter into strategic arrangements, collaborations and/or commercial partnerships in the United States andother territories and the potential benefits of such arrangements;•our estimates regarding expenses, capital requirements and needs for additional financing;•our expectations regarding how far into the future our cash on hand will fund our ongoing operations;•our financial performance;•developments relating to our competitors and our industry;•our ability to maintain compliance with listing requirements of the Nasdaq Capital Market;•the impact of gen