secwatch.observer — SEC 8-K summary
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Issuer:     Iterum Therapeutics plc (ITRMF)
CIK:        0001659323
Form:       8-K
Filed at:   2023-11-14T23:59:59+00:00
Accession:  0000950170-23-063350
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1659323/000095017023063350/0000950170-23-063350-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1659323/000095017023063350/itrm-20231115.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-063350

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer