Company Overview - Iterum Therapeutics plc focuses on delivering next-generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings [1][3] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against a variety of resistant bacteria [3] Financial Results Announcement - The company will release its fourth quarter and full year 2024 financial results before the U.S. financial markets open on February 7, 2025 [1] - A conference call will be hosted by management at 8:30 a.m. ET on the same day to discuss the financial results and provide a business update [1] Product Development and Approvals - Iterum has received FDA approval for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women [3] - The company has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem across seven indications [3]

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]

-- 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 ...

Core Insights - Iterum Therapeutics has received FDA approval for ORLYNVAH™, the first oral penem antibiotic in the U.S. for uncomplicated urinary tract infections (uUTIs) in adult women with limited treatment options [1][2] - ORLYNVAH™ is positioned as a novel treatment to address antimicrobial resistance and offers a new alternative in the underserved uUTI market [2][12] Company Overview - Iterum Therapeutics is focused on developing differentiated anti-infectives to combat multi-drug resistant pathogens, with ORLYNVAH™ being its first FDA-approved product [12] - The company aims to maximize stakeholder value through strategic transactions involving ORLYNVAH™ following its FDA approval [2] Product Details - ORLYNVAH™ is indicated for treating uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women [5] - The approval was based on two pivotal Phase 3 clinical trials (SURE 1 and REASSURE), demonstrating ORLYNVAH™'s efficacy compared to ciprofloxacin and Augmentin™ [2][4] Market Context - UTIs are among the most common bacterial infections, with up to 60% of women experiencing a uUTI in their lifetime [4] - Approximately 40 million uUTI prescriptions are generated annually in the U.S., with an estimated 1% caused by pathogens resistant to commonly available oral antibiotics [4] Clinical Data - SURE 1 trial showed ORLYNVAH™'s superiority over ciprofloxacin in fluoroquinolone-resistant infections, while REASSURE trial indicated non-inferiority and statistical superiority to Augmentin™ [2] - ORLYNVAH™ was generally well tolerated in both clinical trials [2] Future Plans - The company will host a conference call on October 28, 2024, to discuss the implications of the FDA approval and future strategies [3]

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 ...

Company Overview - Iterum Therapeutics plc is a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to combat multi-drug resistant pathogens in community settings [3] - The company is advancing its first compound, sulopenem, which is a novel penem anti-infective with both oral and IV formulations [3] - Sulopenem has shown potent in vitro activity against a variety of resistant bacteria, including gram-negative, gram-positive, and anaerobic strains [3] Product Development - Iterum has submitted a New Drug Application (NDA) for oral sulopenem aimed at treating uncomplicated urinary tract infections in adult women, which has been accepted for review by the U.S. Food and Drug Administration [3] - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for both oral and IV formulations of sulopenem across seven indications [3] Upcoming Events - Iterum Therapeutics will participate in the 2024 Maxim Healthcare Virtual Summit, with CEO Corey Fishman joining a Fireside Chat on October 16, 2024 [1][2] - The Maxim Healthcare Summit is scheduled to take place from October 15 to 17, 2024, and will be accessible live on MVest [2]

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]

Company Overview - Iterum Therapeutics plc is 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 [3] - The company is advancing its first compound, sulopenem, which is a novel penem anti-infective compound with both oral and IV formulations [3] - Sulopenem has shown potent in vitro activity against a wide variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics [3] Financial Results Announcement - The company will release its second quarter 2024 financial results before the U.S. financial markets open on August 14, 2024 [1] - Management will host a conference call at 8:30 a.m. ET on the same day to discuss the financial results and provide a business update [1] Regulatory Progress - Iterum Therapeutics has submitted a New Drug Application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections in adult women, which has been accepted for review by the U.S. Food and Drug Administration [3] - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications [3]