---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-063350"
form_type: "8-K"
ticker: "ITRMF"
cik: "0001659323"
company_name: "Iterum Therapeutics plc"
filed_at: "2023-11-14T23:59:59+00:00"
generated_at: "2026-06-08T03:41:43.728520+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-23-063350
- form_type: 8-K
- ticker: ITRMF
- cik: 0001659323
- company_name: Iterum Therapeutics plc
- filed_at: 2023-11-14T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1659323/000095017023063350/0000950170-23-063350-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1659323/000095017023063350/itrm-20231115.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-063350
- JSON: https://secwatch.observer/filing/0000950170-23-063350.json
- Plain text: https://secwatch.observer/filing/0000950170-23-063350.txt

## Key facts
- Earnings Releases
  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
  source text: Iterum Therapeutics Reports Third Quarter 2023 Financial Results
  evidence_url: https://www.sec.gov/Archives/edgar/data/1659323/000095017023063350/0000950170-23-063350-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.