EXHIBIT 99.1 FOR IMMEDIATE RELEASE Iterum Therapeutics Reports Third Quarter 2024 Financial Results -- ORLYNVAHTM Approved by FDA on October 25, 2024— --Company to Host Conference Call Today at 8:30 a.m. EDT-- DUBLIN, Ireland and CHICAGO, November 14, 2024 -- Iterum Therapeutics plc (Nasdaq: ITRM), (Iterum), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial res ...

-- ORLYNVAHTM Approved by FDA on October 25, 2024— --Company to Host Conference Call Today at 8:30 a.m. EDT-- DUBLIN and CHICAGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), (Iterum), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the third quarter ended September 30, 2024. “With last month’s approval of ORLYNVAHTM, ...

Iterum Therapeutics plc (NASDAQ:ITRM) U.S. FDA Approval of ORLYNVAH October 28, 2024 8:30 AM ET Company Participants Louise Barrett - SVP, Legal Affairs & Secretary Corey Fishman - President, Director & CEO Steven Aronin - SVP & Head, Clinical Development Conference Call Participants Operator Hello, everyone, and welcome to Iterum Therapeutics call to discuss the recent approval of ORLYNVAH the treatment of Uncomplicated UTIs. My name is Lydia, and I'll be your operator today. I'll now hand you over to your ...

Monday, October 28, 2024, at 8:30 a.m. EDT DUBLIN and CHICAGO, Oct. 28, 2024 /PRNewswire/ -- Iterum Therapeutics plc (Nasdaq: ITRM) is focused on delivering 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. WHO: WHAT: Conference call to discuss U.S. Food and Drug Administration (FDA) approval of Iterum's ORLYNVAH™ (Oral Sulopenem) for the treat ...

ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades --Company to Host Conference Call on Monday, October 28th at 8:30 a.m. EDT-- DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum's new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated ur ...

DUBLIN and CHICAGO, Oct. 10, 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 three posters will be presented at the Infectious Disease Society of America's IDWeek 2024 conference taking place in Los Angeles, CA from October 16-19, 2024. Data to be presente ...

DUBLIN and CHICAGO, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced it will participate in the 2024 Maxim Healthcare Virtual Summit. Corey Fishman, CEO of Iterum, will join Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group, for a Fire ...

Iterum Therapeutics plc (ITRM) recently announced updates from the meeting of the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) that discussed its new drug application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. The FDA held the AMDAC meeting on Sept. 9, to discuss the overall benefits and risks of oral sulopenem in treating uUTIs in women aged more than 18 years and important factors for medical providers to know to ensure the proper u ...

Financial Data and Key Metrics Changes - Total operating expenses decreased to $4 million in Q2 2024 from $10.8 million in Q2 2023, primarily due to reduced R&D costs [10][11] - R&D expenses were $2.1 million in Q2 2024 compared to $9 million in the same period of 2023, reflecting a $6.9 million decrease [11] - Net loss on a GAAP basis was $5 million for Q2 2024, down from $12.2 million in Q2 2023; on a non-GAAP basis, the net loss was $3.8 million compared to $10 million in Q2 2023 [11][12] Business Line Data and Key Metrics Changes - The primary driver for the decrease in R&D expenses was the completion of enrollment in the REASSURE trial, which began in October 2022 and completed in October 2023 [11] Market Data and Key Metrics Changes - As of June 30, the company had $11.7 million in cash and cash equivalents, which, along with proceeds from a recent rights offering of $5.8 million, provides a runway into 2025 [8][12] Company Strategy and Development Direction - The company is focused on maximizing the value of sulopenem and preparing for an upcoming meeting with the FDA's Antimicrobial Drugs Advisory Committee regarding its resubmitted NDA for oral sulopenem [6][7] - The company is seeking shareholder approval to disapply statutory preemption rights to facilitate quicker capital raising opportunities [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming FDA meeting and the potential approval of oral sulopenem, which would be the first oral penem approved in the U.S. [6][29] - The company is preparing for discussions on appropriate patient populations and stewardship related to the use of sulopenem [17][18] Other Important Information - The company has expanded its intellectual property estate with allowed patent applications in the U.S. and Canada related to sulopenem [7][8] - The company has approximately 22.7 million ordinary shares outstanding and $11.1 million of exchangeable notes, which could lead to a $14.7 million obligation in January 2025 if not exchanged [12] Q&A Session Summary Question: Can you discuss your perspective on the FDA's concerns regarding antibiotic resistance and the approval of sulopenem? - Management believes the FDA is not reluctant to approve sulopenem but is focused on ensuring it is used appropriately for the right patients [14] Question: What topics do you anticipate will be raised at the Advisory Committee meeting? - Key topics include stewardship and the appropriate patient population for sulopenem [17][18] Question: Are you allowed to include safety data from studies outside of U.K. patients? - Yes, the company will include comprehensive safety data from multiple Phase III studies, which show a clean safety profile for sulopenem [19] Question: Do you think the FDA might narrow the label and indication for sulopenem? - Management indicated that narrowing the label could be challenging without evidence from studied populations [24][25] Question: Will the REASSURE data be discussed, and could superiority aspects be included in the label? - While it is uncertain if superiority will be included in the label, management feels confident about the strength of the data from the REASSURE study [26][27]

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 June 30, 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 jurisdicti ...