DUBLIN, Ireland and CHICAGO, June 21, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (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 U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of un ...

DUBLIN, Ireland and CHICAGO, June 21, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (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 U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of un ...

DUBLIN and CHICAGO, June 05, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (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 will present a poster at the American Society for Microbiology (ASM) Microbe 2024 meeting, being held June 13-17, 2024, in Atlanta, Georgia. Data to be presented includ ...

DUBLIN and CHICAGO, May 31, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (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 U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for t ...

财务数据和关键指标变化 - 公司第一季度总运营费用为620万美元,较2023年同期850万美元下降27% [10][11] - 研发费用为400万美元,较2023年同期640万美元下降38%,主要是由于2023年REASSURE III期临床试验招募费用较高 [10] - 管理费用为220万美元,较2023年同期210万美元增加5%,主要是由于法律费用和咨询费用增加 [10][11] - 公司第一季度GAAP净亏损710万美元,较2023年同期990万美元减少28% [11] - 公司第一季度非GAAP净亏损580万美元,较2023年同期740万美元减少22%,主要是由于研发费用下降 [11] 各条业务线数据和关键指标变化 - 公司目前只有一款产品Oral Sulopenem,用于治疗复杂性尿路感染 [8][9] 各个市场数据和关键指标变化 - 公司预计尿路感染市场规模约为4000万处方,其中公司的目标高风险患者群体约占三分之二 [27] - 公司认为Oral Sulopenem作为一种青霉烯类抗生素,在医生中有很好的口碑,有望获得很好的市场反响 [27] 公司战略和发展方向及行业竞争 - 公司正在进行战略评估,包括出售、许可或以其他方式处置Sulopenem权利以最大化股东价值 [17][18][29] - 公司如果战略评估不能达成预期结果,也会考虑自行商业化Oral Sulopenem [29] - 公司认为Oral Sulopenem即使面临新药物Pivia和GSK产品的竞争,仍有很好的市场定位和商业前景 [25][26][27] 管理层对经营环境和未来前景的评论 - 公司对Oral Sulopenem获批前景持乐观态度,认为已提供足够的临床数据支持批准 [16] - 公司有望在2024年第四季度初获得FDA批准,这将是美国首个获批的口服青霉烯类抗生素 [8][9] - 公司目前有1.82亿美元现金,预计可为公司运营提供资金支持至2025年 [12] 问答环节重要的提问和回答 问题1 **Michael Okunewitch 提问** 询问公司之前CRL中提出的缺陷以及新的NDA如何解决这些问题 [15] **Corey N. Fishman 回答** 公司之前CRL要求提供更多临床数据,公司随后完成了一项2200多例患者的III期临床试验,结果显示不仅达到了非劣效性目标,还显示了对比药物的统计学显著性优势,公司对此很有信心 [16] 问题2 **Thomas Yip 提问** 询问Oral Sulopenem与最近获批的Pivia在市场定位和差异方面的情况 [24] **Corey N. Fishman 回答** 公司认为Oral Sulopenem作为一种青霉烯类抗生素,在高风险患者群体中有很好的定位和市场前景,不会与Pivia和GSK新药直接竞争 [25][26][27] 问题3 **Thomas Yip 提问** 询问公司是否考虑自行商业化Oral Sulopenem **Corey N. Fishman 回答** 公司目前优先考虑战略交易,但如果战略评估不能达成预期结果,也会考虑自行商业化Oral Sulopenem [29]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) Ireland 98-1283148 (State or other jurisdict ...

EXHIBIT 99.1 FOR IMMEDIATE RELEASE Iterum Therapeutics Reports First Quarter 2024 Financial Results --NDA Resubmitted; FDA Action Expected in Early Q4 24— --Cash Runway into 2025, including through Potential FDA Approval-- --Company to Host Conference Call Today at 8:30 a.m. EDT-- DUBLIN, Ireland and CHICAGO, May 13, 2024 -- Iterum Therapeutics plc (Nasdaq: ITRM), (Iterum) a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by mult ...

--NDA Resubmitted; FDA Action Expected in Early Q4 24-- --Cash Runway into 2025, including through Potential FDA Approval-- --Company to Host Conference Call Today at 8:30 a.m. EDT-- DUBLIN, Ireland and CHICAGO, May 13, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), (Iterum) 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 ...

DUBLIN, Ireland and CHICAGO, May 06, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (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 will release its first quarter 2024 financial results before the open of the U.S. financial markets on Monday, May 13, 2024. Management will host a conference c ...

--First Oral Penem in the U.S. and Second New Oral Treatment for uUTIs in Over 25 Years, if approved-- --Potential Approval Early Q4 2024-- DUBLIN, Ireland and CHICAGO, April 29, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (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 it has resubmitted its New Dru ...