Iterum completes REASSURE enrollment; NDA resubmission for uUTI expected Q2 2024

Iterum Therapeutics plc

Enrolled 2,229 patients in pivotal Phase 3 REASSURE trial; top-line data expected early Q1 2024.
NDA resubmission for uncomplicated UTI planned Q2 2024; FDA action expected Q4 2024.
Cash and investments $35.9M as of Sept 30, 2023; expected to fund operations into Q3 2024.
GAAP net loss $3.9M in Q3 2023 vs $29.1M in Q3 2022; non-GAAP net loss $15.7M vs $5.3M.
New composition patents for oral sulopenem granted in Korea and Australia, expiring no earlier than 2039.

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.95

Iterum Therapeutics plc reported the third quarter ended September 30, 2023 results: net income Net loss for the third quarter 2023 was $3.9 million.

Period: the third quarter ended September 30, 2023
Net income: Net loss for the third quarter 2023 was $3.9 million
Result: reported results

Exact text from the filing

Iterum Therapeutics Reports Third Quarter 2023 Financial Results

View on SEC.gov

36 earnings releases filed in the last 30 days. Browse all earnings releases →

Iterum Therapeutics plc filing history →

Source: SEC EDGAR

accession 0000950170-23-063350

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