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Iterum Therapeutics (ITRM) investor relations material
Iterum Therapeutics Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary5 Aug, 2025
Executive summary
ORLYNDA/ORLYNVAH is set for U.S. launch in August 2025 for uUTIs in adult women, marking the first branded oral treatment in over 25 years and targeting a large unmet need.
Commercialization led by a new Chief Commercial Officer, with EVERSANA as partner for U.S. sales and ACS Dobfar for supply.
Initial launch targets 20 territories and 2,300 high-value physicians, with expansion plans based on early results.
Canadian patent granted, U.S. exclusivity for 10 years, and key patents expiring between 2039 and 2041.
Strategic alternatives for sulopenem rights are ongoing after no transaction was reached.
Financial highlights
Q2 2025 net loss was $6.5M (GAAP), up from $5.0M in Q2 2024; non-GAAP net loss was $5.1M versus $3.8M.
Operating expenses for Q2 2025 were $5.5M, up from $4.0M, mainly due to pre-commercialization activities.
R&D expenses decreased to $1.0M from $2.1M year-over-year, reflecting lower clinical trial costs.
General and administrative expenses rose to $4.2M from $1.9M, driven by pre-commercialization spending.
Cash and equivalents were $13.0M at June 30, 2025, with $2.2M raised post-quarter.
Outlook and guidance
Cash and recent capital raise expected to fund operations into 2026, including the commercial launch.
Additional capital is required to support ongoing activities; current cash is not sufficient for 12 months.
Expansion of commercial resources and geographies planned if initial launch is successful.
Ongoing evaluation of strategic, financial, and corporate alternatives.
Explain the EVERSANA partnership terms.
Assess ORLYNVAH's market acceptance risks.
How does Iterum plan to maintain Nasdaq listing?
How will Iterum defray patient out-of-pocket expenses?
What factors determined the 20 initial target territories?
What market dynamics create need for new UTI treatments?
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Next Iterum Therapeutics earnings date
Q3 202513 Nov, 2025
Next Iterum Therapeutics earnings date
Q3 202513 Nov, 2025
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Frequently asked questions
Iterum Therapeutics plc is a clinical-stage pharmaceutical company focused on developing novel anti-infective therapies. The company is working on next-generation oral and intravenous antibiotics designed to combat infections caused by multi-drug resistant pathogens, which are a growing global health concern. Iterum's lead product candidate, sulopenem, is a novel penem antibiotic that has shown potent activity against a broad spectrum of bacteria, including strains that are resistant to other antibiotics. Iterum Therapeutics is headquartered in Dublin, Ireland, and its shares are listed on the NASDAQ.
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