Core Insights - Iterum Therapeutics has commercially launched ORLYNVAH™ in the United States in August 2025, targeting uncomplicated urinary tract infections (uUTIs) [1][2] - The company has extended its cash runway into Q2 2026, with cash and cash equivalents reported at $11.0 million as of September 30, 2025 [1][4] - The company anticipates modest sales for ORLYNVAH™ in 2025, with expected net product sales ranging between $5 million and $15 million in 2026 [2] Financial Performance - Net product revenues for Q3 2025 were $0.4 million, primarily from initial stocking at specialty pharmacy locations [5] - Research and development expenses decreased to $1.3 million in Q3 2025 from $3.1 million in Q3 2024, attributed to lower chemistry, manufacturing, and control expenses [9] - Selling, general, and administrative expenses increased to $6.5 million in Q3 2025 from $1.8 million in Q3 2024, driven by the commercialization of ORLYNVAH™ [10] Loss and Adjustments - The net loss for Q3 2025 was $9.0 million, compared to a net loss of $6.1 million in Q3 2024 [12] - Non-GAAP net loss for Q3 2025 was $7.3 million, compared to a non-GAAP net loss of $4.8 million in Q3 2024 [12][14] - Adjustments to the fair value of derivatives for Q3 2025 were $0.7 million, up from $0.4 million in Q3 2024 [11] Product and Market Development - ORLYNVAH™ is positioned as a novel oral penem antibiotic with potent activity against resistant strains of bacteria, addressing a significant unmet need in the uUTI market [18] - The company has expanded its patent estate, receiving patents in China and Mexico for formulations related to ORLYNVAH™, with expiration dates projected in 2041 and 2039, respectively [7] - Iterum presented at the IDWeek 2025 conference, highlighting its commitment to addressing antibiotic resistance and promoting ORLYNVAH™ [7]

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 is focused on developing next-generation oral and IV antibiotics to combat multi-drug resistant infections in both community and hospital settings [1] Financial Overview - As of June 30, 2025, Iterum expects its cash and cash equivalents, along with $2.2 million raised from its at-the-market offering, to fund operations into 2026 [3] - The company is exploring various financing opportunities, including non-dilutive funding, to extend its operational runway [3] Product Launch and Market Access - ORLYNVAH™, an oral antibiotic, was launched in August 2025 in targeted territories across seven U.S. states, with sales representatives actively engaging with physicians [5] - The product is broadly accessible via prior authorization and medical exception pathways, with ongoing discussions for expanded access and long-term formulary positioning [5] - Iterum has received 510(k) clearance from the FDA for its Antimicrobial Susceptibility Test Disc, aiding in effective therapy for patients [5] Patent Developments - Iterum has been granted a patent in China for a combination treatment, projected to expire in March 2041, and a patent in Mexico for a bilayer tablet, set to expire in December 2039 [6] - The company is optimizing its patent strategy to ensure the expansion of its valuable patent portfolio [6] Upcoming Events - Iterum will conduct a Learning Lounge at IDWeek 2025 on October 21, 2025, focusing on urinary tract infections in adult women [6] Company Overview - Iterum Therapeutics aims to address the global crisis of multi-drug-resistant pathogens with its lead compound, sulopenem, which has shown potent activity against various resistant bacteria [7] - ORLYNVAH™ has received FDA approval for treating urinary tract infections caused by specific bacteria in adult women with limited treatment options [7][8]

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 Viewpoint - Iterum Therapeutics plc has successfully completed a registered direct offering of 5,555,556 ordinary shares at a price of $0.90 per share, raising approximately $5 million in gross proceeds to support its operations and strategic initiatives [1][3]. Group 1: Offering Details - The offering was conducted with a single institutional investor and facilitated by H.C. Wainwright & Co. as the exclusive placement agent [2][3]. - The net proceeds from the offering are intended for working capital and general corporate purposes, including funding ongoing strategic processes and pre-commercialization activities [3]. Group 2: Company Overview - Iterum Therapeutics focuses on developing next-generation oral and IV antibiotics to combat multi-drug resistant pathogens, with its lead compound being sulopenem [6]. - Sulopenem has shown potent in vitro activity against various resistant bacteria and has received FDA approval for its oral formulation, ORLYNVAH™, for treating uncomplicated urinary tract infections in adult women [6].