Iterum Expects To Start Additional Sulopenem Trial In Urinary Tract Infections In 2H22

Iterum Therapeutics plc ITRM has incurred a Q4 FY21 EPS loss of $(0.02) versus $(0.28) reported a year ago and beating the consensus of $(0.04).

• The company said that based on recent interactions with the FDA, it had made progress towards an agreement on the additional Phase 3 trial design required to support the resubmission of NDA for oral sulopenem in uncomplicated urinary tract infections (uUTI).
• Subject to the finalization of the clinical program, the company expects to start the study in 2H of 2022.
• In July last year, the FDA rejected Iterum Therapeutics's Sulopenem Application.
• Iterum completed the term loan repayment with Silicon Valley Bank in March 2022.
• In March, the company received written notification from Nasdaq that a 180-day extension to regain compliance with Nasdaq's minimum bid price requirement was granted until September 5.
• The company held cash and equivalents of $81.3 million as of December 31, 2021. 
• Based on the current operating plan and subject to the final determination of an additional sulopenem trial, Iterum expects that its cash balance is sufficient to fund its operations into 2024. 
• Price Action: ITRM shares are down 13.6% at $0.39 on Monday's last check.