Iterum Therapeutics Plc Q2 FY2024 earnings call

• Recently closed rights offering generating $5.8 million net proceeds to fund business plan and strategy.
• Upcoming milestone: Meeting FDA's Antimicrobial Drugs Advisory Committee on September 9, 2024, to discuss resubmitted NDA for oral sulopenem.
• PDUFA action date for oral sulopenem is October 25, 2024.
• Expanded intellectual property with 2 pending U.S. patents and 1 pending Canadian patent allowed.
• Cash runway into 2025 including PDUFA date, with $11.7 million in cash as of June 30.
• Seeking shareholder approval at Extraordinary General Meeting to disapply preemption rights to raise capital for business plans, including funding strategic process and repaying $14.7 million notes due in January 2025.
• Board recommends vote in favor of preemption opt-out authority.

Total operating expenses in the second quarter of 2024 were $4 million, compared to $10.8 million in the second quarter of 2023. R&D costs were $2.1 million for Q2 2024 vs $9 million in Q2 2023. G&A costs were $1.9 million in Q2 2024, flat to Q2 2023. Net loss on GAAP basis was $5 million in Q2 2024 vs $12.2 million in Q2 2023. Non-GAAP net loss was $3.8 million in Q2 2024 vs $10 million in Q2 2023. As of June 30, cash, cash equivalents, and short-term investments were $11.7 million. Recently completed rights offering generated $5.8 million of net proceeds.

• Current cash, cash equivalents, and short-term investments plus rights offering proceeds provide runway into 2025, including PDUFA date.
• Seeking shareholder approval for preemption opt-out to quickly raise capital for business plans and strategic process.
• Intention to fund continued execution of business plans and repay $14.7 million notes due in January 2025.

• Uncertainties in clinical/nonclinical development, regulatory requirements, and approvals.
• Changes in public policy/legislation affecting commercialization.
• Uncertainty regarding sufficiency of cash resources to fund operations into 2025.
• Risks related to maintaining NASDAQ listing compliance.
• Risks associated with pursuit of strategic alternatives for sulopenem rights.

Q: Can you discuss your perspective on the FDA's consideration of sulopenem approval and topics expected at the Ad Comm?

A: Corey Fishman stated the FDA is focused on stewardship (ensuring appropriate use) and appropriate patient population for uncomplicated UTI in adult women.

Q: Do you think the FDA might narrow the label and indication, and can superiority data from REASSURE study be in the label?

A: Corey Fishman said it's unclear, but the REASSURE data has non-inferiority and superiority, and it's a conversation piece for the label discussion.