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Subsequent Events (Tables)
9 Months Ended
Sep. 30, 2023
Subsequent Events [Abstract]  
Schedule of remaining potential milestone payments

Under the terms of the GSK License Agreement, the Company received an upfront payment of $66.0 million for GSK to secure rights to the medicine.

 

On July 31, 2023, the Company announced it received written agreement from the U.S. Food and Drug Administration (“FDA”), under a Special Protocol Assessment ("SPA"), on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including acute pyelonephritis (AP). Under the terms of the GSK License Agreement, the Company received a $30.0 million development milestone payment during the third quarter of 2023.

 

Remaining potential payments are milestone and royalty based, and are as follows (in millions):

 

Event

Milestone payments (up to)

Development milestones from commencement of Phase 3 study through NDA submission

$120.0 (in tranched milestones)

Total potential commercial milestone payments based on first sale (US/EU)

$150.0

Total potential sales milestone payments

$225.0

Royalties

Low-single digit to low-double digit (if sales exceed $1.0 billion) tiered royalties on net product sales