Iterum Therapeutics(US:ITRM) Globenewswire·2025-11-14 12:00Core 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]