Iterum Therapeutics Plc Q4 FY2023 earnings call

• 2023 was a good year for Iterum as it completed enrollment in the REASSURE clinical trial in adult women with uncomplicated urinary tract infections. The trial showed oral sulopenem was non-inferior and superior to Augmentin in the primary endpoint and key secondary endpoints with a solid safety profile. • Regarding the sulopenem patent estate, there are issued patents for the composition of the bilayer tablet of oral sulopenem granted in multiple countries expiring no earlier than 2039, and an issued patent in the U.S. for the method of use in treating multiple diseases. There are also pending patent applications. • The uncomplicated urinary tract market is large with a need for new efficacious and safe oral products. If approved, oral sulopenem would be the first oral penem approved in the US for this indication. • In 2024, plan to resubmit the NDA to the FDA in the first half of the second quarter, expect FDA review in the first half of the fourth quarter, cash on hand can fund operations into 2025, and initiated a strategic process to sell, license, or dispose of rights to sulopenem.

In 2023, total operating expenses were $11.4 million in the fourth quarter and $47.5 million for the full year, compared to $7.9 million and $30.4 million in the same periods of 2022. R&D costs were $9.7 million in the fourth quarter of 2023 and $40 million for the full year, versus $5.8 million and $17.6 million in 2022. The main driver of the increase in R&D expense was the cost to support the REASSURE trial. GAAP net loss was $12.4 million in the fourth quarter of 2023 and $38.4 million for the full year. Non-GAAP net loss was $10.7 million in the fourth quarter and $43.8 million for the full year 2023, compared to $6.4 million and $22.9 million in 2022. At the end of December 2023, cash, cash equivalents, and short-term investments were $23.9 million.

• Plan to resubmit the NDA for oral sulopenem for the treatment of uUTI in the first half of the second quarter of 2024. • Expect the FDA to complete review of the resubmission in the first half of the fourth quarter of 2024. • Cash on hand as of the end of December 2023, including amounts raised under the ATM agreement through February 2024, provides cash runway into 2025 including through the expected PDUFA date.

• Uncertainties inherent in the design, initiation, and conduct of clinical and nonclinical development. • Changes in regulatory requirements or decisions of regulatory authorities. • Timing or likelihood of regulatory filings and approvals, including potential resubmission of the NDA. • Changes in public policy or legislation. • Commercialization plans and timelines of oral sulopenem if approved. • Accuracy of expectations regarding how far cash in hand will fund ongoing operations. • Risk of not maintaining listing on the NASDAQ Capital Market. • Risks and uncertainties concerning the outcome, terms, timing, structure, value, benefits, and cost of the strategic process to sell, license, or dispose of rights to sulopenem.

Q: Do you have any specific dates or triggering events to decide on your strategic options considering the PDUFA is expected early in the fourth quarter and cash runway into 2025?

A: We don't have any specific dates or triggering events as these processes take whatever time is required on the counterparty side and we won't disclose further developments unless appropriate.

Q: Is Iterum still actively or planning to engage physicians and practices on an educational level ahead of any type of divestiture or partnering? And could sulo qualify under the Pasteur Act?

A: The primary focus is on strategic opportunities, with some work ongoing on refining potential commercialization parameters. Regarding the Pasteur Act, I believe sulo would qualify due to its coverage on critical pathogens similar to qualified infectious disease product designation from the FDA through the GAIN Act.