Welcome to our dedicated page for Iterum Therapeutics Plc SEC filings (Ticker: ITRM), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Iterum Therapeutics plc (ITRM) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. These documents offer detailed information on Iterum’s financial condition, commercialization of ORLYNVAH™, capital-raising activities and Nasdaq listing status.
Investors can review Iterum’s current reports on Form 8-K, which have covered topics such as quarterly financial results, the U.S. commercial launch of ORLYNVAH™ (oral sulopenem) for certain uncomplicated urinary tract infections in adult women, at-the-market equity offering updates, and a commercial manufacturing and supply agreement for ORLYNVAH™ bilayer tablets. Other 8-K filings describe annual general meeting voting results and shareholder approvals or rejections of proposals related to authorized share capital, equity incentive plans and director authorities.
Filings also document Nasdaq listing compliance matters. In 2025, Iterum reported receiving Nasdaq notices regarding non-compliance with the minimum bid price requirement under Listing Rule 5550(a)(2) and the minimum market value of listed securities requirement under Listing Rule 5550(b)(2). These filings outline compliance periods, potential remedies and the possibility of appeals if delisting is proposed, while noting that the notices did not cause immediate delisting.
Through its periodic and current reports, Iterum describes non-GAAP financial measures, royalty-linked notes, license and milestone obligations, and the role of its commercialization partner EVERSANA in the U.S. launch of ORLYNVAH™. Proxy-related filings and meeting results provide insight into corporate governance and executive compensation decisions.
On Stock Titan, these SEC filings are complemented by AI-powered summaries that help explain key points from lengthy documents, including annual and quarterly reports and Form 4 insider transaction filings when available. Real-time updates from EDGAR ensure that users can monitor new Iterum Therapeutics filings as they are posted and quickly understand how they relate to the company’s anti-infective business and Nasdaq listing profile.
Iterum Therapeutics plc has received a notice from Nasdaq that it no longer meets the Nasdaq Capital Market’s continued listing standards for market value and certain financial criteria. On December 11, 2025, Nasdaq stated that Iterum’s Market Value of Listed Securities had stayed below $35 million for 30 consecutive business days, violating Listing Rule 5550(b)(2), and that the company also fails the alternative shareholder equity and net income requirements.
Iterum has 180 calendar days, until June 9, 2026, to restore its market value to at least $35 million for a minimum of 10 consecutive business days or face potential delisting, with a right to appeal. The company also remains out of compliance with Nasdaq’s $1.00 minimum bid price rule after a prior August 25, 2025 notice and has until February 23, 2026 to achieve a closing bid of at least $1.00 for 10 consecutive business days, with a possible additional 180‑day period if it meets other listing standards. Iterum’s shares continue to trade on Nasdaq for now while it works to regain compliance.
Iterum Therapeutics plc (ITRM) reported an insider share purchase by a director. On 11/18/2025, the director bought 6,000 ordinary shares at a price of $0.3652 per share in an open-market transaction coded "P." Following this trade, the director beneficially owned 241,001 ordinary shares, held as a direct ownership position. No derivative securities transactions were reported in this filing.
Iterum Therapeutics (ITRM) filed its Q3 2025 report highlighting early commercialization and liquidity pressure. The company recorded its first product revenue of $390 thousand from ORLYNVAH™, launched in August 2025, while posting a net loss of $8.98 million for the quarter. Operating expenses rose with commercialization, including $6.49 million in selling, general and administrative costs and $1.26 million in R&D.
Cash and cash equivalents were $11.0 million as of September 30, 2025, and management disclosed substantial doubt about the company’s ability to continue as a going concern without additional financing. Net cash used in operating activities was $15.26 million for the nine months. The balance sheet shows a shareholders’ deficit of $7.38 million, a Pfizer promissory note of $21.22 million, and royalty-linked notes of $12.24 million long-term and $0.28 million current. ORLYNVAH™ revenue is modest at launch, reflecting early-stage uptake through EVERSANA’s commercialization platform.
Shares outstanding were 52,787,679 as of November 13, 2025. Results underscore commercialization progress but also the need for capital to support operations and market expansion.
Iterum Therapeutics plc filed a Form 8-K announcing it has furnished a press release with its financial results for the third quarter ended September 30, 2025. The press release is included as Exhibit 99.1.
The company states the information is being furnished—not deemed “filed” under Section 18 of the Exchange Act—and will not be incorporated by reference into other SEC filings. The filing is administrative in nature and includes the Inline XBRL cover page as Exhibit 104.
Iterum Therapeutics plc filed a prospectus supplement to sell up to $20,000,000 of ordinary shares in an at-the-market program through H.C. Wainwright & Co., not to exceed 21,756,057 ordinary shares. Sales may be made on the Nasdaq Capital Market or by other permitted methods, with Wainwright acting as sales agent.
The program is limited to the company’s authorized but unissued share capacity. Based on 21,756,057 shares currently available for issuance and an assumed price of $0.7377, the company indicates it could sell up to approximately $16,049,443 under the agreement. Iterum will pay a 3.0% sales commission to Wainwright and would receive the net proceeds.
This supplement supersedes the prior ATM supplement, moving the remaining $4,775,345 capacity under that document into this one. Iterum reports aggregate gross proceeds of approximately $36.2 million previously raised under the sales agreement. Ordinary shares outstanding were 48,051,157 as of September 15, 2025. The shares trade on Nasdaq as “ITRM.”
Iterum Therapeutics (ITRM) filed a prospectus supplement to sell ordinary shares from time to time under its existing at‑the‑market program, targeting additional aggregate gross proceeds of up to $20,000,000, not to exceed 21,756,057 shares, through H.C. Wainwright & Co. as sales agent.
The company previously sold approximately $36.2 million of shares under the same Sales Agreement and earlier prospectuses. Iterum also noted it commercially launched ORLYNVAH™ in the U.S. community market in August 2025 and expects modest sales in 2025 during the early commercialization phase.
Iterum Therapeutics plc reported the results of its 2025 annual general meeting. Shareholders elected David Kelly as a Class I director, with 10,795,342 votes for, 2,848,953 against and 665,812 abstentions, and ratified KPMG as independent registered public accounting firm for the fiscal year ended December 31, 2025, with 17,986,081 votes for and 3,759,990 against.
However, shareholders did not approve several key proposals. The advisory vote on executive compensation failed, with 5,406,944 votes for and 8,449,597 against. Proposals to increase authorized share capital, grant updated authority to allot and issue securities, opt out of pre-emption rights under Irish law, and add 4,000,000 shares to the equity incentive plan were all rejected by wide margins, limiting the board’s flexibility to issue new shares or expand equity-based compensation.
Iterum Therapeutics plc reported receiving a Nasdaq notice on August 25, 2025 stating that its ordinary shares no longer meet the exchange’s minimum bid price requirement. The company fell out of compliance with Nasdaq Listing Rule 5550(a)(2), which requires a closing bid price of at least $1.00 per share based on the last 30 consecutive business days.
The notice does not immediately remove Iterum’s shares from The Nasdaq Capital Market. The company has 180 calendar days, until February 23, 2026, for its closing bid price to reach at least $1.00 for a minimum of 10 consecutive business days to regain compliance. If it fails to do so, Iterum may qualify for an additional 180-day period if it meets other Nasdaq listing standards and formally indicates how it plans to cure the deficiency, potentially including a reverse share split.
Nasdaq could ultimately move to delist the shares if compliance is not restored, though Iterum could appeal any such decision. The company plans to monitor its share price and consider available options but acknowledges there is no assurance it will regain compliance or avoid delisting.
Iterum Therapeutics plc has begun the U.S. commercial launch of ORLYNVAH™ (sulopenem etzadroxil and probenecid) oral tablets. The drug is intended to treat adult women with uncomplicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis who have limited or no alternative oral antibacterial options. The launch marks Iterum’s move from development to commercial availability for this product in the United States.
Michael W. Dunne, a director of Iterum Therapeutics plc (ITRM), filed a Form 4 reporting a transaction on 08/08/2025. The filing shows a reported acquisition of 15,000 ordinary shares at $0.7236. Following the transaction, Mr. Dunne beneficially owned 235,001 shares on a direct basis. The Form 4 bears his signature dated 08/12/2025.