Iterum Therapeutics launched its first commercial product, ORLYNVAH™, in August 2025 for uncomplicated urinary tract infections, anticipating modest 2025 sales and projecting $5-15 million in 2026. The company has extended its cash runway into Q2 2026, but incurred increased SG&A expenses due to the launch, leading to a wider net loss compared to the prior year.
ORLYNVAH™ commercially launched in the United States in August 2025.
positiveCash runway extended into Q2 2026.
positiveGranted new patents in China (expiring March 2041) and Mexico (expiring December 2039) covering combinations of sulopenem etzadroxil, probenecid, and valproic acid.
positivePresented at IDWeek 2025, highlighting ORLYNVAH™ and uUTI treatment.
neutralNet loss increased to $9.0 million in Q3 2025 from $6.1 million in Q3 2024.
negativeNon-GAAP net loss increased to $7.3 million in Q3 2025 from $4.8 million in Q3 2024.
negativeSelling, general and administrative expenses increased significantly to $6.5 million in Q3 2025 from $1.8 million in Q3 2024, primarily due to the commercialization of ORLYNVAH™.
attentionCash and cash equivalents decreased to $11.0 million as of September 30, 2025, from $24.1 million as of December 31, 2024.
negativeTotal assets decreased from $44.6 million as of December 31, 2024, to $32.5 million as of September 30, 2025.
negativeTotal liabilities decreased from $48.7 million as of December 31, 2024, to $39.9 million as of September 30, 2025, but the company still has a shareholders' deficit.
negativeMargin metrics will be available once backend extracts data from insights_json
Forward-looking guidance is subject to change and does not constitute a guarantee. Actual results may differ materially from these estimates.
Thrilled to have launched ORLYNVAH™ in the United States in August 2025 for the treatment of uncomplicated urinary tract infections (uUTIs).
The significance of this milestone cannot be overstated—particularly given the importance of bringing a new treatment option to the uUTI space where antibiotic resistance continues to erode the efficacy of existing oral therapies and there have been no new branded launches for over 25 years.
Given our limited commercial infrastructure and consistent with historical antibiotic launches, we anticipate modest sales in 2025.
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