Financial Data and Key Metrics Changes - Total operating expenses increased to $5.5 million in Q2 2025 from $4 million in Q2 2024 [24] - R&D costs decreased to $1 million in Q2 2025 from $2.1 million in Q2 2024, primarily due to reduced costs associated with the ReAssure trial [24] - G&A costs rose to $4.2 million in Q2 2025 from $1.9 million in Q2 2024, driven by pre-commercialization activities [24] - Net loss on a GAAP basis was $6.5 million in Q2 2025 compared to a net loss of $5 million in Q2 2024 [25] - Non-GAAP net loss was $5.1 million in Q2 2025 compared to $3.8 million in Q2 2024, with the increase attributed to higher G&A expenses [25] - Cash and cash equivalents stood at $13 million as of June 2025, expected to fund operations into 2026 [26] Business Line Data and Key Metrics Changes - The company is preparing to launch Orlynda, targeting the uncomplicated urinary tract infection market in the U.S. [6][8] - The market generates approximately 40 million prescriptions annually, with about 26 million for at-risk patients [9] - The initial launch phase will focus on 20 targeted geographic territories, covering around 2,300 high-value physician targets [10][11] Market Data and Key Metrics Changes - The uncomplicated urinary tract infection market in the U.S. has not seen a new branded oral treatment in over 25 years, indicating a significant opportunity for Orlynda [9] - Rising rates of antimicrobial resistance are eroding the efficacy of existing treatments, highlighting the need for new therapies [10] Company Strategy and Development Direction - The company aims to successfully launch Orlynda to address unmet needs in the uncomplicated urinary tract infection market [7] - A commercial supply agreement has been executed with ACS Dabfahr for the production of Orlynda, ensuring a reliable supply chain [15][16] - The company plans to optimize physician targeting and resource allocation based on market dynamics and prescription patterns [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Orlynda, emphasizing the significant need for new treatment options in the U.S. market [31] - The company is focused on building a strong commercial presence and ensuring access to Orlynda for patients [12][21] Other Important Information - The FDA has granted Orlynda ten years of market exclusivity, expiring in October 2034 [19] - The company has requested authorization for an additional 80 million shares to ensure financial flexibility for strategic objectives [27][28] Q&A Session Summary - No questions were registered during the Q&A session, indicating a lack of immediate inquiries from investors [30]

Financial Data and Key Metrics Changes - Total operating expenses increased to $5.5 million in Q2 2025 from $4 million in Q2 2024 [26] - Research and development (R&D) costs decreased to $1 million in Q2 2025 from $2.1 million in Q2 2024, primarily due to reduced costs associated with the ReAssure trial [26] - General and administrative (G&A) costs rose to $4.2 million in Q2 2025 from $1.9 million in Q2 2024, driven by pre-commercialization activities [26] - Net loss on a US GAAP basis was $6.5 million in Q2 2025 compared to a net loss of $5 million in Q2 2024 [27] - Non-GAAP net loss was $5.1 million in Q2 2025, up from $3.8 million in Q2 2024, mainly due to higher G&A expenses [27] - Cash and cash equivalents stood at $13 million as of June 2025, expected to fund operations into 2026 [28] Business Line Data and Key Metrics Changes - The company is preparing to launch Orlynda, targeting the uncomplicated urinary tract infection market in the U.S. [6][9] - The market generates approximately 40 million prescriptions annually, with about 26 million for at-risk patients [10] - The initial launch phase will focus on 20 targeted geographic territories, primarily in major metropolitan areas across seven states [12] Market Data and Key Metrics Changes - The uncomplicated urinary tract infection market has not seen a new branded oral treatment in over 25 years, indicating a significant opportunity for Orlynda [11] - Rising rates of antimicrobial resistance are eroding the efficacy of existing treatments, highlighting the need for new therapies [11] Company Strategy and Development Direction - The company aims to successfully launch Orlynda to address unmet needs in the uncomplicated urinary tract infection market [8] - A commercial supply agreement has been executed with ACS Dabfahr for the manufacturing of Orlynda, ensuring a reliable supply chain [18] - The company has received FDA market exclusivity for Orlynda, which will last until October 2034 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Orlynda and its potential to meet significant market needs [24] - The company is focused on optimizing physician targeting and resource allocation in key geographies to maximize revenue generation [16] - Management highlighted the importance of speed to therapy for patients suffering from uncomplicated urinary tract infections [17] Other Important Information - The company has deferred a $20 million regulatory payment to Pfizer, now due in October 2029, alleviating near-term financial obligations [21] - The company is seeking authorization for an additional 80 million shares to ensure financial flexibility for strategic objectives [29] Q&A Session Summary - No questions were registered during the Q&A session, indicating a lack of immediate inquiries from investors [32]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

EXHIBIT 99.1 Iterum Therapeutics Reports Second Quarter 2025 Financial Results -- Launch of ORLYNVAHTM Expected August 2025— --Cash Runway into 2026-- --Company to host conference call today at 8:30amET-- DUBLIN, Ireland and CHICAGO, August 5, 2025 -- 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 secon ...

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]

Summary of Iterum Therapeutics Conference Call Company Overview - **Company**: Iterum Therapeutics - **Product**: Orlynda (oral solopenem) - **Partnership**: Eversana for commercialization Key Points Industry Context - The uncomplicated urinary tract infection (UTI) market in the U.S. generates approximately **40 million prescriptions annually** [10] - **Two-thirds** of these prescriptions (about **26 million**) are for at-risk patients, including elderly women and those with comorbidities [10] - There have been **no new oral treatments** for uncomplicated UTIs in over **25 years**, with the market leader, nitrofurantoin, approved in **1953** [11] - Rising rates of **antibiotic resistance** are diminishing the effectiveness of existing treatments [12] Product Development and Commercialization - Orlynda received **FDA approval** in **October 2024** and is the only FDA-approved oral penum in the U.S. for uncomplicated UTIs [9] - Iterum has signed a **commercialization agreement** with Eversana to expedite the launch of Orlynda [8] - The expected launch date for Orlynda is by the **fourth quarter of 2025** [3][9] Financial Updates - Pfizer extended the due date for a **$20 million regulatory milestone** payment related to Orlynda from **October 2026** to **October 2029**, alleviating financial pressure [7] - Pricing strategy for Orlynda is not finalized, but expected to be between **$1,400 and $4,700** per treatment course [18] Market Dynamics and Research Insights - Physicians report a **high unmet need** for new antibiotics in the uncomplicated UTI space, with low confidence in existing treatments for at-risk patients [13] - Orlynda is viewed favorably by payers for its efficacy and safety, particularly against multidrug-resistant pathogens [13] Commercialization Strategy - A team of **national account managers** has been trained to ensure optimal market access for Orlynda [14] - The launch will occur in **phases**, with initial focus on territories with high prescription rates [15][16] - Each high-value physician in target territories writes an average of **over 500 prescriptions** for uncomplicated UTIs annually [17] Intellectual Property and Manufacturing - Orlynda has **10 years of marketing exclusivity** in the U.S. from the FDA, expiring in **October 2034** [21] - The company holds multiple patents related to Orlynda, with expiration dates ranging from **2039 to 2041** [24] - Current inventory is projected to last through **mid to late 2026**, with a shelf life of **six years** from manufacture [25] Conclusion - Iterum Therapeutics is making significant progress towards the commercialization of Orlynda, addressing a critical need in the UTI market, and anticipates a successful launch by the end of 2025 [26]

U.S. Commercial Launch of ORLYNVAHTM by Q4 2025; First Oral Penem Available in the U.S. Management to host a conference call at 4:30 p.m. ET today DUBLIN and CHICAGO, June 11, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “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 that it entered into a Product Commercialization Agree ...

Financial Data and Key Metrics Changes - Total operating expenses decreased to $3.7 million in Q1 2025 from $6.2 million in Q1 2024 [16] - Research and development (R&D) costs significantly dropped to approximately $600,000 in Q1 2025 from $4 million in the same period in 2024, primarily due to reduced costs associated with the ReAssure trial [17] - General and administrative (G&A) expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, driven by pre-commercialization activities [18] - Net loss on a U.S. GAAP basis was $4.9 million in Q1 2025 compared to a net loss of $7.1 million in Q1 2024 [18] - Non-GAAP net loss improved to $3.3 million in Q1 2025 from $5.8 million in Q1 2024, reflecting lower R&D expenses [19] Business Line Data and Key Metrics Changes - The company is preparing for the potential commercialization of Orlynda, targeting the U.S. market for uncomplicated urinary tract infections [6][10] - The addressable market for Orlynda is estimated at 26 million prescriptions annually for at-risk patients, with a potential net sales of over $250 million if a 1% market share is captured [10] Market Data and Key Metrics Changes - The U.S. market for uncomplicated urinary tract infections generates approximately 40 million prescriptions annually, with a significant portion written for at-risk patients [9] - New competition is emerging, with a product approved in April 2024 and another from GlaxoSmithKline expected to launch in the second half of 2025, increasing urgency for Orlynda's market entry [10] Company Strategy and Development Direction - The company aims to launch Orlynda by Q4 2025, emphasizing the urgency due to the lack of innovation in the therapy area over the past 25 years [6][8] - A phased launch strategy is planned, focusing on territories with high antibiotic resistance and a significant number of prescribing physicians [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercialization timeline, stating no significant hurdles are anticipated before the launch of Orlynda [27] - The company has extended its cash runway into 2026, which includes the potential launch of Orlynda [14] Other Important Information - The company repaid outstanding principal and interest on exchangeable notes in January 2025, reducing its debt burden [13] - As of March 2025, the company had cash and cash equivalents of $12.7 million, which, along with recent fundraising, is expected to fund operations into 2026 [19] Q&A Session Summary Question: Can you elaborate on the maturity of conversations with potential commercial partners? - Management indicated ongoing discussions but noted that many potential partners may not see the timing as right for a partnership [25] Question: Are there any outstanding rate-limiting steps ahead of Orlynda's launch later this year? - Management stated there are no significant hurdles remaining and confirmed that product manufacturing is already in place [27]