Iterum Therapeutics Files 8-K with Financial Exhibits

TL;DR

Iterum Therapeutics filed an 8-K with financial exhibits - check for updates.

AI Summary

On October 25, 2024, Iterum Therapeutics plc filed an 8-K report. The filing primarily concerns financial statements and exhibits, indicating potential updates or disclosures related to the company's financial health and operations. No specific material events or transactions were detailed in the provided excerpt.

Why It Matters

This filing provides an update on Iterum Therapeutics' financial statements and exhibits, which could contain important information for investors regarding the company's financial position.

Risk Assessment

Risk Level: low — The filing is a routine 8-K for financial statements and exhibits, with no immediate indication of significant new risks or events.

Key Players & Entities

• Iterum Therapeutics plc (company) — Registrant
• October 25, 2024 (date) — Date of earliest event reported
• +353 1 6694820 (phone_number) — Registrant's Telephone Number

FAQ

Key Financial Figures

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

Filing Documents

• itrm-20241025.htm (8-K) — 53KB
• itrm-ex99_1.htm (EX-99.1) — 46KB
• 0000950170-24-117270.txt ( ) — 227KB
• itrm-20241025.xsd (EX-101.SCH) — 26KB
• itrm-20241025_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On October 25, 2024, Iterum Therapeutics plc (the "Company") issued a press release announcing that the U.S. Food and Drug Administration ("FDA") approved ORLYNVAH (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections ("uUTIs") caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein. The Company will host a conference call to discuss the FDA approval of ORLYNVAH on Monday, October 28, 2024 at 8:30 a.m. Eastern Daylight Time. The conference call replay will be available in the Events & Presentations section of the Company's website following the call. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and Exhibit 99.1 attached hereto is "furnished" and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended.

01 Other Events

Item 8.01 Other Events. On October 25, 2024, the Company announced that the FDA approved ORLYNVAH for the treatment of uUTIs caused by the designated microorganisms Escherichia coli , Klebsiella pneumonia e, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for ORLYNVAH and the first FDA-approved product for the Company . The FDA approval of ORLYNVAH was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of ORLYNVAH compared to ciprofloxacin (SURE 1) and Augmentin (REASSURE) in the treatment of adult women with uUTI. SURE 1 showed superiority to ciprofloxacin in fluoroquinolone res#istant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin TM in the Augmentin TM susceptible population. ORLYNVAH was generally well tolerated in both SURE 1 and REASSURE clinical trials. UTIs are among the most common bacterial infections encountered in the community. uUTIs are infections of the bladder occurring mainly in women. Up to 60% of women will have an uUTI in their lifetime. Up to 40% of women with a history of uUTI will have a recurrence of their infection. There are approximately 40 million uUTIs prescriptions generated annually in the United States, and the Company's estimate approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics. Rising antibiotic resistance, an aging population with comorbidities and sub-optimal safety profiles of existing oral treatment options are making antibiotic selection more challenging for treating physicians. The Company expects to renew its efforts to achieve a strategic transaction involving ORLYNVAH with the goal of maximizing value for its stakeholders. The Company has previously enga

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Number Exhibit Description 99.1 Press Release of Iterum Therapeutics plc, date October 25, 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: October 25, 2024 By: /s/ Corey N. Fishman Corey N. Fishman Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR