UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ 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 (Mark One) (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporatio ...

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 ...

EXHIBIT 99.1 FOR IMMEDIATE RELEASE Iterum Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results --Resubmission of NDA On Track for Early Q2 24— --Cash Runway into 2025, including through Potential FDA Approval in Early Q4 24-- --Company to host conference call today at 8:30amET-- DUBLIN, Ireland and CHICAGO, March 28, 2024 -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections cau ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 jurisdiction ...

Financial Data and Key Metrics Changes - Total operating expenses increased to $16.7 million in Q3 2023 from $7 million in Q3 2022, primarily driven by higher R&D expenses related to the REASSURE trial [38] - Net loss on a U.S. GAAP basis was $3.9 million for Q3 2023 compared to $29.1 million for the same period in 2022, while non-GAAP net loss was $15.7 million in Q3 2023 versus $5.3 million in Q3 2022, reflecting a $10.4 million increase due to higher R&D expenses [39] Business Line Data and Key Metrics Changes - R&D costs rose to $14.9 million in Q3 2023 from $4.4 million in Q3 2022, mainly due to costs associated with the REASSURE trial [69] Market Data and Key Metrics Changes - The market for uncomplicated urinary tract infections (uUTI) is substantial, with approximately 15 million to 17 million infections annually in the U.S. [23] Company Strategy and Development Direction - The company aims to bring the first new oral treatment for uncomplicated urinary tract infections to the U.S. market in over 20 years and is focused on efficiently raising capital to fund operations [15][18] - The timeline for key milestones has been accelerated by a quarter, with top line data expected in early Q1 2024 and potential NDA resubmission to the FDA in Q2 2024 [12][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the value of oral sulopenem for treating multidrug-resistant infections and looks forward to the upcoming top line data readout [54] - The company is exploring various financing strategies to ensure continued operations through 2024 and beyond, including potential partnerships and debt financing [50][52] Other Important Information - As of September 30, 2023, the company had cash and cash equivalents of $35.9 million, which is expected to fund operations into Q3 2024 [18][37] - The company has been granted new patents in Korea and Australia, enhancing its patent estate for oral sulopenem [36][63] Q&A Session Summary Question: When do you expect that oral sulopenem will be approved? - Approval is anticipated in Q4 2024, following a potential resubmission of the NDA in Q2 2024 [26][35] Question: How long can the company operate with its current cash on hand? - Current cash is sufficient to fund operations into Q3 2024, covering the top line data readout and NDA resubmission [37][49] Question: Can you discuss the long-term financing strategy of the company? - The company is evaluating various financing strategies, including share issuances and partnerships, to ensure sufficient capital for operations [50][52] Question: What actions are being taken for sulopenem in ex-U.S. markets? - The company plans to initiate discussions for ex-U.S. markets after obtaining data from the REASSURE trial [45]

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 September 30, 2023 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) (State or other jurisdiction of incorpor ...

Iterum Therapeutics plc (NASDAQ:ITRM) Q2 2023 Earnings Conference Call August 11, 2023 8:30 AM ET Company Participants Louise Barrett - Senior Vice President, Legal Affairs Corey Fishman - Chief Executive Officer Judy Matthews - Chief Financial Officer Conference Call Participants Thomas Yip - H.C. Wainwright Operator Good morning, and welcome to the Iterum Therapeutics Second Quarter 2023 Financial Results Call. My name is Carla, and I will be the operator of today's call. [Operator Instructions] I would n ...