-- Launch of ORLYNVAH Expected August 2025— --Cash Runway into 2026-- --Company to host conference call today at 8:30amET-- DUBLIN and CHICAGO, Aug. 05, 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 second quarter ended June 30, 2025. "We are on track to launch ORLYNVAH™ this m ...

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].

--Preparing for Potential Launch of ORLYNVAH by Q4 2025-- --Extended Cash Runway into 2026-- --Company to host conference call today at 8:30amET-- DUBLIN, Ireland and CHICAGO, May 13, 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 first quarter ended March 31, 2025. "Based on pr ...

About Iterum Therapeutics plc DUBLIN, Ireland and CHICAGO, May 06, 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 first quarter 2025 financial results before the open of the U.S. financial markets on Tuesday, May 13, 2025. Management will host a conference cal ...

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].

Core Viewpoint - Iterum Therapeutics plc has entered into a definitive agreement for a registered direct offering of 5,555,556 ordinary shares at a price of $0.90 per share, expected to close around April 30, 2025 [1][3] Group 1: Offering Details - The gross proceeds from the offering are anticipated to be approximately $5 million before deducting fees and expenses [3] - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The offering is conducted under a shelf registration statement filed with the SEC, effective since October 17, 2022 [4] Group 2: Use of Proceeds - The net proceeds will be used for working capital and general corporate purposes, including ongoing strategic processes and pre-commercialization activities [3] - Specific uses for the proceeds have not been identified, but they may fund expenses related to the commercialization of ORLYNVAH™, including manufacturing, sales, and marketing [3][6] Group 3: Company Overview - Iterum Therapeutics focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens [6] - The company is advancing its first compound, sulopenem, which has shown potent activity against various resistant bacteria [6] - ORLYNVAH™ has received FDA approval for treating uncomplicated urinary tract infections in women with limited treatment options [6]