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

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Iterum Therapeutics plc filing history →

Source: SEC EDGAR

accession 0000950170-23-063350

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