Iterum Therapeutics (ITRM) Investor Presentation summary

Product overview and market need

• ORLYNVAH™ is the first and only FDA-approved oral penem antibiotic for uncomplicated urinary tract infections (UUTIs), launched in August 2025, and targets at-risk adult women with limited oral treatment options.

• Demonstrates a favorable safety profile across four Phase 3 clinical trials and is positioned as a novel solution amid rising antimicrobial resistance and lack of innovation in UUTI therapies.

• Addresses a significant U.S. market with approximately 40 million UUTI prescriptions annually, with about 26 million for at-risk patients.

• Competing oral therapies face high resistance rates and safety concerns, highlighting the need for new alternatives.

• ORLYNVAH™ is protected by multiple U.S. and international patents, with exclusivity expected into 2039.

Clinical efficacy and safety

• Phase 3 studies (REASSURE and SURE-1) showed ORLYNVAH™ was non-inferior or superior to amoxicillin/clavulanate and ciprofloxacin in key patient populations.

• Demonstrated higher response rates in quinolone-resistant infections and maintained efficacy in both quinolone-susceptible and non-susceptible populations.

• Safety profile is favorable, with low rates of serious adverse events and discontinuations; most common side effects include diarrhea, nausea, and headache.

Commercial launch and early performance

• Achieved $0.4M in Q3 2025 product sales, with over 100 unique physician prescribers and a 40% prescription fill rate expected to rise as payer coverage expands.

• Early adoption includes use in women with recurrent infections and to avoid hospital admissions for IV therapy.

• Positive feedback from healthcare providers and high interest from key opinion leaders and group practices.