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]