Iterum Gets Pfizer to Extend $20M Milestone Payment for ORLYNVAH Approval to 2029

Iterum Therapeutics plc (NASDAQ:ITRM) (the "Company" or "Iterum"), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported that Pfizer Inc. ("Pfizer") has agreed to extend the term for payment of the regulatory milestone payment of $20.0 million until October 25, 2029.

"We are very pleased to announce that Pfizer has agreed to extend the due date for payment of the regulatory milestone associated with ORLYNVAH™'s approval by the FDA," said Corey Fishman, Iterum's Chief Executive Officer. "The $20.0 million promissory note was due October 2026 and is now due October 2029. As a result, any capital raised or earned in the near term from the sales of ORLYNVAH™ can be strategically invested to enable a successful launch of ORLYNVAH™, including through the expansion into new territories or concentration of resources in high prescribing geographies."

Pursuant to the license agreement entered into on November 18, 2015, by and among the Company, Iterum Therapeutics International Limited ("ITIL") and Pfizer (the "Pfizer License Agreement"), ITIL agreed to make a regulatory milestone payment of $20.0 million to Pfizer (the "Milestone Payment") upon the approval of oral sulopenem for commercial sale in the United States by the U.S. Food and Drug Administration ("FDA"). The Company had the option to deliver notice of its election to defer such payment for up to two years from the date of approval and have a promissory note issued by ITIL in the amount of the Milestone Payment to Pfizer. After receiving FDA approval for ORLYNVAH™ on October, 25, 2024, the Company notified Pfizer on October 28, 2024, that it was electing to defer payment of the Milestone Payment for two years, or until October 25, 2026 (the "Deferral Period"), and a promissory note was issued to Pfizer by ITIL.