Workflow
Iterum Therapeutics Provides Business Update

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]