Iterum Therapeutics Updates Address, Confirms Nasdaq Listing

TL;DR

**ITRM filed an 8-K updating its address and confirming its Nasdaq listing.**

AI Summary

Iterum Therapeutics plc filed an 8-K on January 30, 2024, to update its registration information, specifically changing its address to Fitzwilliam Court, 1st Floor, Leeson Close, Dublin 2, Ireland. This filing also confirms its Ordinary Shares, with a par value of $0.01 per share, are registered on The Nasdaq Stock Market LLC under the trading symbol ITRM. This matters to investors because it provides current, accurate administrative details, ensuring transparency and confirming its listing status on a major exchange.

Why It Matters

This filing provides updated administrative information and confirms the company's listing on The Nasdaq Stock Market LLC, which is crucial for investor confidence and regulatory compliance.

Risk Assessment

Risk Level: low — This filing is purely administrative and does not contain any information that would significantly impact the company's financial health or operational risks.

Analyst Insight

A smart investor would note this filing as a routine administrative update, confirming the company's current contact information and continued listing on Nasdaq, but it doesn't provide new information for investment decisions.

Key Numbers

• $0.01 — Par value per share (This is the stated par value for each Ordinary Share of Iterum Therapeutics plc.)

Key Players & Entities

• Iterum Therapeutics plc (company) — the registrant filing the 8-K
• The Nasdaq Stock Market LLC (company) — the exchange where Iterum Therapeutics plc's shares are registered
• $0.01 (dollar_amount) — par value per share of Ordinary Shares
• January 30, 2024 (date) — date of earliest event reported and filing date
• ITRM (company) — trading symbol for Iterum Therapeutics plc

FAQ

Key Financial Figures

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

Filing Documents

• itrm-20240130.htm (8-K) — 54KB
• itrm-ex99_1.htm (EX-99.1) — 42KB
• itrm-ex99_2.htm (EX-99.2) — 10KB
• itrm-ex99_2s1.jpg (GRAPHIC) — 196KB
• itrm-ex99_2s2.jpg (GRAPHIC) — 981KB
• itrm-ex99_2s3.jpg (GRAPHIC) — 365KB
• itrm-ex99_2s4.jpg (GRAPHIC) — 319KB
• itrm-ex99_2s5.jpg (GRAPHIC) — 455KB
• itrm-ex99_2s6.jpg (GRAPHIC) — 325KB
• itrm-ex99_2s7.jpg (GRAPHIC) — 328KB
• itrm-ex99_2s8.jpg (GRAPHIC) — 434KB
• itrm-ex99_2s9.jpg (GRAPHIC) — 148KB
• 0000950170-24-008530.txt ( ) — 5129KB
• itrm-20240130.xsd (EX-101.SCH) — 26KB
• itrm-20240130_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On January 30, 2024, Iterum Therapeutics plc (the "Company"), in connection with the positive topline results for its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in uncomplicated urinary tract infections ("uUTI"), issued a press release and provided an investor presentation, which will be made available on the Company's website. A copy of the press release and investor presentation are attached as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K (this "Current Report"). The information set forth in this Item 7.01 and in Exhibit 99.1 and Exhibit 99.2 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 January 30, 2024, the Company announced positive topline results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in uUTIs. The trial was conducted under special protocol assessment ("SPA") agreement with the U.S. Food and Drug Administration ("FDA"). Results demonstrate that oral sulopenem was non-inferior to Augmentin with respect to the trial's primary endpoint, overall response (combined clinical cure plus microbiologic eradication) at the test-of-cure ("TOC") visit in the microbiological-modified-intent-to-treat susceptible ("m-MITTS") population. Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin, demonstrating statistically significant superiority of oral sulopenem versus Augmentin. Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin demonstrating statistically significant superiority of oral sulopenem versus Augmentin. Favorable overall response rates at TOC were 61.7% versus 55.0% for oral sulopenem and Augmentin, respectively. Both oral sulopenem and Augmentin were well tolerated in this trial with discontinuations due to adverse events occurring in <1% of patients on both regimens. No serious adverse events ("SAE") were reported in patients receiving oral sulopenem, while five SAEs occurred in patients receiving Augmentin, with no drug-related SAEs. The safety profile for oral sulopenem was consistent with those observed in each of the previously conducted Phase 3 trials, with no new safety signals observed beyond those associated with -lactams. In addition to achieving non-inferiority for the primary endpoint of overall response at the TOC visit in the Augmentin-susceptible population in the REASSURE trial, the lower limit of the 95% confidence interval around the treatment difference was above zero, indicating statistical superiority of oral sulopenem over Augmentin for the treatment of uUTI. Furthermore, consistent results were obse

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits. The following exhibits relate to Items 7.01 and 8.01, and shall be deemed to be furnished, and not filed: Number Exhibit Description 99.1 Press Release of Iterum Therapeutics plc, dated January 30, 2024 99.2 Investor Presentation, dated January 30, 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: January 30, 2024 By: /s/ Corey N. Fishman Corey N. Fishman Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR