Iterum Therapeutics plc (NASDAQ:ITRM) Q4 2024 Earnings Conference Call February 7, 2025 8:30 AM ET Company Participants Louise Barrett - SVP, Legal Affairs Corey Fishman - CEO Judy Matthews - CFO Conference Call Participants Thomas Yip - H.C. Wainwright Operator Hello, everyone. And welcome to the Iterum Therapeutics plc Fourth Quarter and Full Year 2024 financial results. My name is Ezra, and I will be your coordinator today [Operator Instructions]. I will now hand you over to Louise Barrett, Senior Vice P ...

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, 2024 (Exact name of Registrant as specified in its Charter) Ireland 98-1283148 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 3 Dublin Landings, North Wall Quay, Dublin 1, Ireland (Address of principal executive offices) Not applicable (Zip ...

EXHIBIT 99.1 FOR IMMEDIATE RELEASE Iterum Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results --ORLYNVAHTM Approved by FDA in Q4 2024— --Extended Cash Runway-- --Company to host conference call today at 8:30amET-- DUBLIN, Ireland and CHICAGO, February 7, 2025 -- Iterum Therapeutics plc (Nasdaq: ITRM), 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 ...

--ORLYNVAHTM Approved by FDA in Q4 2024— --Extended Cash Runway-- --Company to host conference call today at 8:30amET-- DUBLIN and CHICAGO, Feb. 07, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), 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 fourth quarter and year ended December 31, 2024. “While outreach to potential strat ...

DUBLIN, Ireland and CHICAGO, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Company), 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 announced that the Company will release its fourth quarter and full year 2024 financial results before the open of the U.S. financial markets on Friday, February 7, 2025. Management will host a conference call at 8:30 a ...

Financial Data and Key Metrics Changes - Total operating expenses decreased to $4.9 million in Q3 2024 from $16.7 million in Q3 2023, primarily due to lower R&D expenses [18] - R&D costs were $3.1 million for Q3 2024, down from $14.9 million in the same period last year, reflecting a decrease of $11.8 million [18][20] - Net loss on a GAAP basis was $6.1 million for Q3 2024, compared to $3.9 million for Q3 2023; on a non-GAAP basis, the net loss was $4.8 million, down from $15.7 million [20] Business Line Data and Key Metrics Changes - The primary driver for the decrease in R&D expenses was the completion of the REASSURE trial, which incurred higher costs in 2023 [19] - General and administrative costs remained flat at $1.8 million for both Q3 2024 and Q3 2023 [19] Market Data and Key Metrics Changes - The approval of ORLYNVAH marks the first U.S. approval of an oral product in the penem class, addressing a significant gap in the uncomplicated urinary tract infection market [8][9] - The uncomplicated urinary tract infection market has not seen a new oral treatment in about 25 years, with existing products facing rising resistance rates [12][13] Company Strategy and Development Direction - The company aims to maximize the value of ORLYNVAH through strategic partnerships and has renewed outreach efforts to potential partners [38] - ORLYNVAH has market exclusivity for 10 years under the GAIN Act, with patent protection extending into 2039 [10][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ORLYNVAH's potential to address rising antimicrobial resistance and provide a new treatment option for at-risk patients [9][15] - The company expects to fund operations into 2025, including the repayment of exchangeable notes due January 31, 2025 [21] Other Important Information - The company has approximately $14.5 million in cash and short-term investments as of the end of September 2024 [21] - A $20 million regulatory milestone payment to Pfizer has been deferred for two years following the approval of ORLYNVAH [23] Q&A Session Summary Question: What is the coverage duration for the sulopenem portfolio in the U.S. and Europe? - Management confirmed that U.S. coverage extends to 2039, with patents pending in Europe [24] Question: Did the ORLYNVAH label meet internal expectations? - Management expressed satisfaction with the label, emphasizing its suitability for at-risk patients [26][28] Question: What is the status of strategic options discussions? - Management indicated that outreach to potential partners has been renewed following the approval of ORLYNVAH [29] Question: Will additional trials be needed for approvals outside the U.S.? - Management clarified that the EU may accept the current data package, while additional studies would be required in China and Japan [31][32] Question: Is there interest in leveraging data from the complicated UTI trial? - Management noted potential interest in the complicated UTI indication, suggesting that only one additional study would be needed for formal approval [34][35]

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, 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 juris ...

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 ...