Iterum Therapeutics Plc Q1 FY2024 earnings call

Corey Fishman noted they recently resubmitted the new drug application to the FDA, accomplished the resubmission within 3 months of the REASSURE clinical trial's positive top-line results, and believe the trial addressed the FDA's recommendations. He mentioned the potential approval of sulopenem could occur early in Q4 2024, marking the first oral penem approved in the U.S. and the second new oral treatment for uncomplicated urinary tract infections in over 25 years. Judith Matthews discussed operating expenses: total operating expenses were $6.2 million in Q1 2024 vs $8.5 million in Q1 2023. R&D costs were $4 million in Q1 2024 vs $6.4 million in Q1 2023, primarily due to lower costs from the completed REASSURE trial. G&A costs were $2.2 million in Q1 2024 vs $2.1 million in Q1 2023, due to increased legal fees and consultants. Net loss on GAAP basis was $7.1 million in Q1 2024 vs $9.9 million in Q1 2023, and non-GAAP net loss was $5.8 million in Q1 2024 vs $7.4 million in Q1 2023. Cash, cash equivalents, and short-term investments were $18.2 million as of March 31, providing cash runway into 2025, and they resubmitted the NDA for oral sulopenem in April 2024 with expected PDUFA date in early Q4 2024. Also, as of April 30, 2024, there were approximately 16.6 million ordinary shares outstanding and $11.1 million of exchangeable notes outstanding.

Potential approval of sulopenem in early Q4 2024. Cash as of March 31 provides a cash runway into 2025. R&D expenses related to the REASSURE trial are expected to continue decreasing as recurring costs for the trial are done.

Uncertainties inherent in clinical and nonclinical development. Changes in regulatory requirements or decisions of regulatory authorities. Timing or likelihood of regulatory filings and approvals. Sufficiency of cash resources to fund operating expenses into 2025. Risks and uncertainties concerning the outcome, impact, effects, and results of the strategic process to sell, license, or otherwise dispose of rights to sulopenem.

Q: Remind of original deficiencies in the prior CRL and why confident new NDA addresses them?

A: Original CRL was about insufficient data; they put in place a special protocol assessment agreement and conducted a substantial study with over 2,200 patients, which showed noninferiority to Augmentin and statistical superiority in the augmented susceptible population, addressing the FDA's concerns.

Q: Color on strategic review process and potential timeline for sale/license agreement?

A: Process is ongoing; will disclose when something is disclosable.

Q: Are still incurring final costs from the REASSURE trial and if R&D expense will continue to come down?

A: Recurring costs for the REASSURE trial are done, so R&D expense fund should come down further.

Q: How sulopenem positions vs Pivya approved for uncomplicated UTI?

A: Positioned for elevated risk patients, addressable market is large, and as a penem antibiotic, has a solid reputation, differing from Pivya's positioning.

Q: Option of bringing sulopenem to market independently?

A: Priority is strategic transaction, but could bring to market independently if strategic process doesn't maximize shareholder value.