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 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 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]

Core Viewpoint - Iterum Therapeutics has launched ORLYNVAH™, the first oral penem antibiotic in the U.S. for treating uncomplicated urinary tract infections (uUTIs) in women, addressing a significant unmet medical need in the face of rising antibiotic resistance [1][5]. Group 1: Product Launch and Approval - ORLYNVAH™ (sulopenem etzadroxil and probenecid) received FDA approval in October 2024 for adult women with uUTIs caused by specific pathogens [1][5]. - This product is the first new branded treatment for uUTIs in over 25 years, providing a critical option for patients with limited oral antibacterial alternatives [1][5]. Group 2: Market Need and Impact - Approximately 60% of women experience a urinary tract infection in their lifetime, with 44% having three or more episodes annually, highlighting the prevalence of this condition [2]. - The increasing resistance to antibiotics is expected to inflate healthcare costs and lead to poor patient outcomes, emphasizing the urgent need for new therapies [2]. Group 3: Clinical and Patient Benefits - Clinicians have expressed that ORLYNVAH™ offers impressive efficacy data and a much-needed treatment option for women suffering from difficult-to-treat uUTIs [3]. - The introduction of ORLYNVAH™ is anticipated to reduce emergency department visits and hospital admissions, positively impacting patients' quality of life [3]. Group 4: Company Mission and Future Plans - Iterum Therapeutics aims to address the global crisis of multi-drug-resistant pathogens by developing differentiated anti-infectives [5]. - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its formulations, indicating a strong commitment to innovation in this therapeutic area [5].

Core Insights - Iterum Therapeutics reported no revenue for Q2 2025 as it prepares for the commercial launch of ORLYNVAH™, with a non-GAAP loss per share of ($0.13), which was $0.02 worse than analyst expectations [1][5][12] - The company experienced a significant increase in general and administrative costs, leading to a larger operating loss, while R&D expenses decreased sharply [1][6][8] Financial Performance - Non-GAAP EPS was a loss of ($0.13), compared to an estimate of ($0.11) and a loss of ($0.23) in Q2 2024, reflecting a year-over-year improvement of 43.5% [2][5] - Total operating expenses rose to $5.5 million, a 39.1% increase year-over-year, driven primarily by a rise in general and administrative expenses [2][6] - R&D expenses decreased to $1.0 million from $2.1 million in the same quarter of 2024, marking a 52.4% reduction [2][6] Operational Developments - The company is focused on the launch of ORLYNVAH™, securing patent protection, and managing its financial position [3][4] - Iterum has established agreements to ensure manufacturing supply for ORLYNVAH™ and expanded its intellectual property portfolio, including a Canadian patent [7][10] - A new chief commercial officer has been appointed to enhance market entry efforts, and a commercialization agreement with EVERSANA has been finalized to support U.S. sales [7][12] Financial Position - As of June 30, 2025, cash and equivalents totaled $13.0 million, which is expected to support operations through 2026 [8][12] - A $20.0 million milestone payment to Pfizer has been deferred until October 2029, alleviating immediate liquidity concerns [8] - The company reported approximately 44.7 million shares outstanding, reflecting new shares issued to fund operations [9] Product Overview - ORLYNVAH™ is an oral antibiotic specifically designed for treating uncomplicated urinary tract infections, particularly those caused by antibiotic-resistant bacteria [3][10] - It is the only oral penem approved by the FDA and the first branded oral antibiotic for this indication in over 25 years [10][11] Future Outlook - Management anticipates that the current cash balance and recent capital raises will cover operational and commercialization activities into 2026 [12] - There is no detailed revenue or profit guidance provided, as the focus remains on the upcoming U.S. launch of ORLYNVAH™ [12] - Expense trends, particularly in general and administrative costs, and potential equity raises are areas to monitor as the company approaches revenue generation [13]

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]