Iterum Therapeutics is a single-asset pharmaceutical company built around ORLYNVAH (oral sulopenem etzadroxil-probenecid), the first oral penem antibiotic approved in the U.S., which received FDA approval in October 2024. ORLYNVAH is indicated for uncomplicated urinary tract infections in adult women caused by specific gram-negative bacteria who have limited or no alternative oral treatment options. The drug combines an oral prodrug of sulopenem — a thiopenem antibiotic — with probenecid, which slows renal excretion to enhance drug exposure. Iterum's primary focus is not commercialization but a strategic process to sell, license, or otherwise transfer its rights to ORLYNVAH; the company lacks a sales force or commercial infrastructure and has no product revenue. If no transaction materializes, Iterum is evaluating an independent or partnered launch targeting community-based physicians who treat elevated-risk uUTI patients — women 65+, diabetics, immunocompromised patients, and those with recurrent or drug-resistant infections. ORLYNVAH would compete against cheap, long-generic antibiotics that face growing resistance rates, positioning it as a last-resort option where existing treatments fail. IP protection includes in-licensed Pfizer composition-of-matter patents and Iterum-owned formulation patents, plus GAIN Act exclusivity running to 2034. Iterum owes Pfizer a deferred $20M regulatory milestone plus future royalties on net sales.