Core Insights - Iterum Therapeutics plc is set to release its third quarter 2025 financial results on November 14, 2025, before the U.S. markets open, followed by a conference call at 8:30 a.m. ET to discuss the results and business updates [1] Company Overview - Iterum Therapeutics plc focuses on developing next-generation oral and IV antibiotics to combat 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 with both oral and IV formulations, showing potent in vitro activity against various resistant bacteria [3] - Iterum has received FDA approval for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women, along with QIDP and Fast Track designations for its formulations in seven indications [3]

Core Insights - Iterum Therapeutics plc is focused on developing next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens in both community and hospital settings [1] Group 1: Conference Participation - The company will present two posters at the IDWeek 2025 conference in Atlanta, GA from October 19-22, 2025 [1] - A Learning Lounge session titled "An Overview of Urinary Tract Infection in Adult Women: Focus on Oral Sulopenem" will be conducted on October 21, 2025 [2] - The two posters include: 1. "Risk factors for treatment failure in patients with uncomplicated urinary tract infection" presented by Steven I. Aronin, MD on October 20, 2025 [2] 2. "In vitro activity of sulopenem and comparator agents against U.S. Enterobacterales clinical isolates, SENTRY antimicrobial surveillance program, 2023" presented by Steven I. Aronin, MD on October 21, 2025 [2] Group 2: Product Information - ORLYNVAH™ is a novel oral penem antibiotic specifically designed for treating uncomplicated urinary tract infections (uUTIs) [3] - ORLYNVAH™ is effective against Enterobacterales species that produce extended spectrum beta-lactamases (ESBL) or AmpC-type β-lactamases, which confer resistance to third-generation cephalosporins [3] Group 3: Company Overview - Iterum Therapeutics plc aims to address the global crisis of multi-drug-resistant pathogens with differentiated anti-infectives [4] - The company is advancing sulopenem, a novel penem anti-infective compound, which has shown potent in vitro activity against various resistant bacteria [4] - ORLYNVAH™ has received FDA approval for treating uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited treatment options and is commercially available in the U.S. [4]

Core Insights - Iterum Therapeutics is set to launch ORLYNVAH™, the first branded antibiotic for uncomplicated urinary tract infections (uUTIs) in over 25 years, addressing the rising issue of antimicrobial resistance [2][5] - The company reported a net loss of $6.5 million for Q2 2025, an increase from a net loss of $5.0 million in Q2 2024, indicating ongoing financial challenges as it prepares for the product launch [10][18] - Iterum's cash and cash equivalents were $13.0 million as of June 30, 2025, with expectations to fund operations into 2026, supported by additional proceeds from an at-the-market offering [4][20] Product Launch and Partnerships - ORLYNVAH™ is expected to be commercially launched by the end of August 2025, with pre-commercialization activities already underway [5] - The company has partnered with EVERSANA for the commercialization of ORLYNVAH™, which includes sales, marketing, and regulatory services [5] - A manufacturing agreement with ACS Dobfar S.p.A has been established for the production of ORLYNVAH bilayer tablets [5] Financial Performance - Research and development expenses decreased to $1.0 million in Q2 2025 from $2.1 million in Q2 2024, primarily due to reduced clinical trial costs [7] - General and administrative expenses increased to $4.2 million in Q2 2025 from $1.9 million in Q2 2024, reflecting higher spending on pre-commercialization activities [8] - The total operating expenses for Q2 2025 were $5.5 million, compared to $4.0 million in Q2 2024 [18] Market Position and Intellectual Property - ORLYNVAH™ is the only FDA-approved oral penem antibiotic in the U.S., targeting resistant Gram-negative bacteria, including ESBL-producing Enterobacterales [2][15] - Iterum has expanded its patent estate with a new Canadian patent covering the use of sulopenem etzadroxil and probenecid for treating uUTIs, set to expire in December 2039 [5] Debt and Financial Obligations - Iterum has extended the repayment term for a $20.0 million regulatory milestone payment to Pfizer until October 25, 2029, providing some financial relief [5]

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 is a novel penem anti-infective compound with both oral and IV formulations [3] Financial Results Announcement - The company will release its second quarter 2025 financial results before the U.S. financial markets open on August 5, 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 - Sulopenem has shown potent in vitro activity against a variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics [3] - The company has received approval for its NDA for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options [3] - Iterum has also 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 focused on delivering next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens [1][3] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [3] Recent Developments - Iterum has granted a non-statutory share option to purchase 200,000 ordinary shares to Christine Coyne, the newly appointed Chief Commercial Officer [1][2] - The share option has an exercise price of $0.97 per share, equal to the closing price on the date of grant, and vests over four years [2] Product Information - ORLYNVAH™ is a novel oral penem antibiotic developed by Iterum for the treatment of uncomplicated urinary tract infections (uUTIs) [3][4] - ORLYNVAH™ is effective against Enterobacterales species that are resistant to third-generation cephalosporins due to extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases [4]

Company Overview - Iterum Therapeutics plc is focused on delivering next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens [1][4] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [4] Leadership Appointment - Christine Coyne has been appointed as the Chief Commercial Officer, a newly created position, to lead all commercial efforts for Iterum [1][2] - Coyne brings over 30 years of experience in the pharmaceutical industry, with a strong background in anti-infectives [2][3] Product Launch - The upcoming launch of ORLYNVAH™, an oral formulation of sulopenem, is a significant opportunity for the company to address unmet medical needs in treating uncomplicated urinary tract infections (uUTIs) [1][3][5] - ORLYNVAH™ has received FDA approval for the treatment of uUTIs caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options [4][5] Market Positioning - The company aims to accelerate launch readiness for ORLYNVAH™ and scale its capabilities for long-term growth [2][3] - ORLYNVAH™ is designed to be effective against Enterobacterales species that are resistant to third-generation cephalosporins [5]

Core Insights - Iterum Therapeutics has reported the publication of results from its Phase 3 REASSURE trial, demonstrating the efficacy of oral sulopenem compared to Augmentin for treating uncomplicated urinary tract infections (uUTIs) in women [1][2] - The trial showed that oral sulopenem was statistically superior to Augmentin, with an overall success rate of 61.7% compared to 55.0% for Augmentin [4] - The FDA has approved ORLYNVAH™, Iterum's new drug for treating uUTIs caused by specific resistant pathogens, based on robust data from the REASSURE trial and another pivotal study [5][6] Company Overview - Iterum Therapeutics focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [1][9] - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications [9] Clinical Trial Details - The REASSURE trial was a non-inferiority study designed to compare oral sulopenem with Augmentin in a population of adult women with uncomplicated uUTIs [2][4] - The trial enrolled 2,222 patients and was conducted under a Special Protocol Assessment (SPA) agreement with the FDA [2] Market Context - UTIs are among the most common bacterial infections, with approximately 15 million emergency room visits and over 40 million prescriptions for uUTIs annually in the U.S. [7] - The increasing rates of multi-drug resistance have made the treatment of uUTIs more challenging, with about 30% of uUTIs caused by quinolone non-susceptible pathogens [7]

Core Viewpoint - Iterum Therapeutics has entered into a Product Commercialization Agreement with EVERSANA to bring its oral antibiotic ORLYNVAH to the U.S. market by Q4 2025, targeting uncomplicated urinary tract infections (uUTIs) caused by multi-drug resistant pathogens [1][2]. Company Overview - Iterum Therapeutics focuses on developing next-generation oral and IV antibiotics to combat infections from multi-drug resistant pathogens in both community and hospital settings [1][5]. - The company has received FDA approval for ORLYNVAH (oral sulopenem) for treating uUTIs in adult women with limited or no alternative oral antibacterial treatment options [5][7]. Product Details - ORLYNVAH is a novel oral penem antibiotic effective against Enterobacterales species, including those resistant to third-generation cephalosporins [7]. - The treatment addresses a significant market need, as approximately 30% of uUTIs in the U.S. are caused by quinolone non-susceptible pathogens, and about 1% are resistant to all commonly available oral antibiotics [4]. Market Context - UTIs are among the most common bacterial infections, with around 15 million emergency room visits and over 40 million total prescriptions for uUTIs annually in the U.S. [4]. - Approximately two-thirds of uUTI prescriptions are for patients at elevated risk for treatment failure, highlighting the need for effective new treatments [4]. Partnership with EVERSANA - The partnership with EVERSANA aims to leverage their extensive commercial capabilities to ensure a swift market entry for ORLYNVAH [2][8]. - EVERSANA will provide a range of services including sales, marketing, logistics, and regulatory support for the commercialization of ORLYNVAH in the U.S. [1][2].

Core Insights - Iterum Therapeutics is preparing for the potential launch of ORLYNVAH, an antibiotic for uncomplicated urinary tract infections (uUTIs), by Q4 2025 [2][6] - The company has extended its cash runway into 2026, ensuring sufficient funds for operations and pre-commercialization activities [4][6] Financial Performance - As of March 31, 2025, Iterum reported cash and cash equivalents of $12.7 million, with additional funds raised through offerings expected to support operations into 2026 [4][6] - The net loss for Q1 2025 was $4.9 million, a decrease from a net loss of $7.1 million in Q1 2024, indicating improved financial performance [9][18] - Non-GAAP net loss for Q1 2025 was $3.3 million compared to $5.8 million for the same period in 2024 [9][10] Operational Highlights - Research and development expenses for Q1 2025 were $0.6 million, significantly lower than $4.0 million in Q1 2024, reflecting a strategic focus on pre-commercialization activities [5][18] - General and administrative expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, primarily due to pre-commercialization spending [7][18] Strategic Focus - The company is actively seeking a strategic transaction for its rights to sulopenem while preparing for the launch of ORLYNVAH, emphasizing the urgency to address the lack of treatment options for uUTIs [2][6] - Iterum has received FDA approval for ORLYNVAH and is targeting a commercial launch to serve patients with limited treatment alternatives [6][14]

Core Insights - Iterum Therapeutics plc is set to release its first quarter 2025 financial results on May 13, 2025, before the U.S. financial markets open [1] - The company will host a conference call at 8:30 a.m. ET on the same day to discuss financial results and business updates [1] Company Overview - Iterum Therapeutics plc focuses on developing next-generation oral and IV antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [3] - The company is advancing its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [3] - Iterum has received FDA approval for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections in adult women with limited treatment options [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]