• Total Operating Expenses: $3.7 million in Q1 2025, down from $6.2 million in Q1 2024.

• R&D Costs: $600,000 in Q1 2025, compared to $4 million in Q1 2024.

• G&A Costs: $2.8 million in Q1 2025, up from $2.2 million in Q1 2024.

• Net Loss (GAAP): $4.9 million in Q1 2025, compared to $7.1 million in Q1 2024.

• Net Loss (Non-GAAP): $3.3 million in Q1 2025, compared to $5.8 million in Q1 2024.

• Cash and Cash Equivalents: $12.7 million at the end of March 2025.

• Outstanding Shares: Approximately 40 million as of May 12, 2025.

• Warning! GuruFocus has detected 2 Warning Signs with ITRM.

Release Date: May 13, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Iterum Therapeutics PLC (NASDAQ:ITRM) is preparing for the potential commercialization of ORLYNVAH, targeting a large U.S. market with approximately 40 million prescriptions annually for uncomplicated urinary tract infections.

• The company has extended its cash runway into 2026, providing financial stability for upcoming operations and potential product launch.

• Iterum Therapeutics PLC (NASDAQ:ITRM) has significantly reduced its operating expenses, with a decrease from $6.2 million in Q1 2024 to $3.7 million in Q1 2025.

• The company has repaid the outstanding principal and interest on its exchangeable notes, eliminating a large amount of debt.

• Iterum Therapeutics PLC (NASDAQ:ITRM) has partnered with Everson, an end-to-end commercialization firm, to prepare for the potential launch of ORLYNVAH, indicating a strategic approach to market entry.

Negative Points

• Iterum Therapeutics PLC (NASDAQ:ITRM) has not yet secured a business development transaction that the Board finds acceptable, indicating challenges in finding suitable partners.

• The company faces competition from new products approved in the uncomplicated urinary tract infection space, increasing urgency for ORLYNVAH's market entry.

• Iterum Therapeutics PLC (NASDAQ:ITRM) reported a net loss of $4.9 million for Q1 2025, although reduced from the previous year, it still indicates financial challenges.

• The increase in general and administrative expenses due to pre-commercialization activities suggests higher operational costs.

• The company's ability to expand its commercialization efforts is contingent on successfully raising additional capital, indicating potential financial constraints.

Q & A Highlights

Q: Can you speak more about the maturity of conversations with potential commercial partners and any outstanding rate-limiting steps ahead of ORLYNVAH's launch? A: Corey Fishman, CEO, stated that while there are ongoing discussions with potential partners, there is no significant update to provide. EVERSANA is considered their commercial partner for now. The urgency to launch ORLYNVAH remains high, and there are no major hurdles anticipated that would delay the planned launch by the fourth quarter. Manufacturing timelines are not a concern as product is already available.