Core Points - Iterum Therapeutics plc has received FDA approval for ORLYNVAH™ (Oral Sulopenem) to treat uncomplicated urinary tract infections (uUTIs) [2][4] - ORLYNVAH™ is the first oral penem approved in the U.S. and the first FDA-approved product for Iterum [2] - The approval addresses uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial options [2][4] Company Overview - Iterum Therapeutics focuses on developing differentiated anti-infectives to combat multi-drug resistant pathogens [1][4] - The company is advancing sulopenem, a novel penem anti-infective compound, available in both oral and IV formulations [4] - Sulopenem has shown potent in vitro activity against various resistant bacteria, and Iterum has received QIDP and Fast Track designations for its formulations in seven indications [4]

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]

Core Viewpoint - Iterum Therapeutics plc is awaiting a decision from the FDA regarding its new drug application for oral sulopenem, which is intended for the treatment of uncomplicated urinary tract infections in adult women, with a decision expected on October 25, 2024 [5] Group 1: FDA Meeting and Drug Application - The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) met on September 9 to evaluate the benefits and risks of oral sulopenem for treating urinary tract infections in women over 18 years old [2] - AMDAC acknowledged oral sulopenem as an important treatment option and emphasized the need for proper use to limit antimicrobial resistance [4] - The FDA did not request a vote from the AMDAC during the meeting [2] Group 2: Market Reaction and Stock Performance - Following the AMDAC meeting, Iterum's stock fell by 12% on September 10, reflecting investor concerns about the potential limitations on sulopenem's approval [3] - Year-to-date, Iterum's shares have decreased by 51.8%, contrasting with a minor industry decline of 0.8% [3] Group 3: Previous Regulatory Challenges - In 2021, Iterum received a complete response letter from the FDA regarding its initial NDA for oral sulopenem, indicating that additional data was required for approval [7] - The company resubmitted the NDA based on positive results from the pivotal REASSURE study announced in January 2024 [8] Group 4: Competitive Landscape - Iterum currently holds a Zacks Rank of 2 (Buy), while other biotech stocks like Illumina, Krystal Biotech, and Fulcrum Therapeutics have higher rankings of 1 (Strong Buy) [9]

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]

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]

DUBLIN and CHICAGO, Aug. 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 subscription period of its previously announced rights offering (the "Rights Offering") expired at 5:00 p.m., Eastern Time, on August 6, 2024. As previously disclosed, the C ...

Core Viewpoint - Iterum Therapeutics plc has completed its rights offering, which allows shareholders and eligible warrant holders to purchase units consisting of ordinary shares and warrants at a specified subscription price [1][2][3]. Group 1: Rights Offering Details - The subscription period for the rights offering expired on August 6, 2024, at 5:00 p.m. Eastern Time [1]. - A total of 17,007,601 non-transferable subscription rights were distributed, allowing the purchase of 8,503,800 units at a subscription price of $1.21 per unit [2]. - Rights holders subscribed for 6,121,965 units during the offering, and all over-subscription requests were honored, resulting in an additional 5,091,550 units being exercised [3]. Group 2: Financial Proceeds - The company estimates gross proceeds of approximately $7.4 million from the rights offering, excluding estimated expenses of about $1.1 million [4]. Group 3: Company Overview - Iterum Therapeutics is focused on developing next-generation oral and IV antibiotics to combat multi-drug resistant pathogens, with its lead compound being sulopenem [8]. - Sulopenem has shown potent in vitro activity against various resistant bacteria and has received FDA designations for its formulations [8].