Iterum Therapeutics Files 8-K

TL;DR

Iterum Therapeutics filed an 8-K, expect updates soon.

AI Summary

Iterum Therapeutics plc filed an 8-K on March 6, 2024, to report other events and financial statements. The filing does not contain specific details on new events or financial figures but serves as a notification of these items being filed.

Why It Matters

This filing indicates that Iterum Therapeutics plc has submitted important corporate updates and financial information to the SEC, which could contain material information for investors.

Risk Assessment

Risk Level: low — The filing is a standard procedural notification without immediate disclosed material changes.

Key Players & Entities

• Iterum Therapeutics plc (company) — Registrant
• March 06, 2024 (date) — Date of Report

FAQ

Key Financial Figures

• $0.01 — registered Ordinary Shares, par value $0.01 per share ITRM The Nasdaq Stock Mar

Filing Documents

• itrm-20240306.htm (8-K) — 48KB
• itrm-ex99_1.htm (EX-99.1) — 15KB
• 0000950170-24-026878.txt ( ) — 184KB
• itrm-20240306.xsd (EX-101.SCH) — 26KB
• itrm-20240306_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events. On March 6, 2024, Iterum Therapeutics plc (the "Company") issued a press release providing a business update. The Company announced that it now expects to resubmit its new drug application ("NDA") for oral sulopenem to the U.S. Food and Drug Administration ("FDA") in the first half of the second quarter of 2024, earlier than originally planned. Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter ("CRL") the Company received from the FDA in July 2021, the Company expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the first half of the fourth quarter of 2024). Based on its current operating plan, the Company believes that its existing cash and cash equivalents and short-term investments as of December 31, 2023, together with the net proceeds from the sale of ordinary shares under its "at-the-market" offering agreement through February 29, 2024, are expected to fund its operating expenses into 2025, including through the expected Prescription Drug User Fee Act date in the first half of the fourth quarter of 2024. The Company plans to engage a financial advisor in the near-term to assist management and the Board in evaluating the Company's strategic alternatives. The full text of the press release issued in connection with the business update is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Cautionary Note Regarding Forward-looking Statements This Current Report contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation the Company's ability to address the deficiencies set out in the complete response letter received in July 2021, the expected timing of resubmission of the NDA, the expected timing of review by the FDA, the sufficiency of the Company's ca

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. The following exhibit relates to Item 8.01, and shall be deemed to be furnished, and not filed: (d) Exhibits. Number Exhibit Description 99.1 Press Release of Iterum Therapeutics plc, dated March 6, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Iterum Therapeutics plc Date: March 6, 2024 By: /s/ Corey N. Fishman Corey N. Fishman Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR