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DUBLIN and CHICAGO - Iterum Therapeutics plc (NASDAQ:ITRM), a pharmaceutical company specializing in the development of antibiotics with a current market capitalization of $34.1 million, announced on Monday that it has renegotiated the terms of its payment obligations to Pfizer Inc. related to the regulatory approval of its new antibiotic, ORLYNVAH™. According to InvestingPro data, the company faces significant financial challenges, with a weak overall health score of 1.51 and negative EBITDA of $15.89 million in the last twelve months. Pfizer has agreed to extend the due date for a $20 million regulatory milestone payment from October 2026 to October 25, 2029.
The milestone payment was part of a license agreement between Iterum Therapeutics International Limited (ITIL), a subsidiary of Iterum, and Pfizer, established on November 18, 2015. Under this agreement, ITIL was to make the payment upon the U.S. Food and Drug Administration’s (FDA) approval of ORLYNVAH™, an oral antibiotic designed to treat uncomplicated urinary tract infections (uUTIs) in adult women with limited alternative treatment options.
Following the FDA’s approval of ORLYNVAH™ on October 25, 2024, ITIL elected to defer the milestone payment, originally due two years post-approval. On May 13, 2025, Iterum and ITIL amended the promissory note to extend this deferral period by an additional three years. This decision comes as InvestingPro analysis shows the company is quickly burning through cash, with negative free cash flow of $26.77 million and a total debt of $32.02 million as of Q1 2025. The amended note also increases the annual interest rate from 8% to 10% starting October 26, 2026.
As part of the agreement, ITIL has committed not to incur any senior indebtedness or liens on its assets without Pfizer’s consent, except under certain conditions. Additionally, ITIL agreed to cover a transaction fee and Pfizer’s legal expenses.
Iterum’s CEO, Corey Fishman, expressed that the extension allows the company to strategically invest near-term capital into a successful launch of ORLYNVAH™, potentially expanding into new territories or focusing on areas with high prescription rates.
ORLYNVAH™ has received both Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations in seven indications. The antibiotic has shown potent activity against a broad range of bacteria, including drug-resistant strains.
This news is based on a press release statement and reflects the latest developments in Iterum Therapeutics’ financial arrangements with Pfizer, which may influence the company’s commercial strategy for its newly approved antibiotic. For deeper insights into Iterum’s financial health and growth prospects, investors can access comprehensive analysis and additional ProTips through InvestingPro’s detailed research reports, which cover over 1,400 US stocks with expert analysis and actionable intelligence.
In other recent news, Iterum Therapeutics announced a registered direct offering to a single institutional investor, aiming to raise approximately $5 million through the sale of over 5.5 million shares at $0.90 per share. The proceeds are intended for working capital and general corporate purposes, including pre-commercialization activities for their approved treatment ORLYNVAH™. H.C. Wainwright & Co. is acting as the exclusive placement agent for this transaction. Additionally, Iterum Therapeutics has appointed Joseph J. Whalen to its Board of Directors, following the resignation of former Chairman Ronald M. Hunt. Whalen, with extensive experience in the biopharmaceutical sector, will serve as a Class III director until 2027 and join the audit and compensation committees. The company has also appointed David Kelly as the new Chairman of the Board. These board changes fulfill Nasdaq’s audit committee composition requirements. The company filed these developments in a Form 8-K with the SEC.
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