Iterum Therapeutics plc Q1 FY2025 earnings call

• Company priorities include ongoing outreach to potential business development partners, with business development remaining a potential opportunity. - Believe there is urgency to bring ORLYNVAH to the U.S. market for patients with uncomplicated urinary tract infections. - U.S. UTI market is large, with approximately 40 million prescriptions annually and about 26 million for at-risk patients. - Have been preparing for potential commercialization of ORLYNVAH, working with EVERSANA on pre-commercialization activities like market research, promotional messaging, distribution strategies, etc. - Plan to launch ORLYNVAH in phases, first in limited territories based on criteria like antibiotic resistance rate, number of relevant physicians, and managed care access. - Repaid outstanding principal and interest due under exchangeable notes in January 2025, extending cash runway into 2026 with potential ORLYNVAH launch by Q4 2025, and patent protection extends to 2039.

In the first quarter of 2025, total operating expenses were $3.7 million, compared to $6.2 million in the first quarter of 2024. R&D costs were approximately $600,000 in the first quarter of 2025, down from $4 million in the same period of 2024, mainly due to the decrease in costs associated with the REASSURE trial. G&A costs were $2.8 million in the first quarter of 2025, up from $2.2 million in the same period of 2024, primarily driven by pre-commercialization activities. On a U.S. GAAP basis, net loss was $4.9 million in the first quarter of 2025, compared to a net loss of $7.1 million in the first quarter of 2024. On a non-GAAP basis, net loss was $3.3 million in the first quarter of 2025, compared to a non-GAAP net loss of $5.8 million in the first quarter of 2024. Cash and cash equivalents at the end of March 2025 were $12.7 million.

• Based on current operating plan including pre-commercialization spend and potential ORLYNVAH launch by Q4 2025, plus $1 million net proceeds from asset market offering program from April 1 to 22, 2025, and $4.2 million net proceeds from registered direct offering closed April 30, 2025, cash and cash equivalents are sufficient to fund operations into 2026.

• Uncertainties concerning the outcome, impact, effects, and results of evaluation of strategic alternatives, including terms, timing, structure, value, benefits, and cost of any strategic alternative. - Ability to complete a strategic transaction. - Ability to successfully prepare and implement commercialization plans for ORLYNVAH with a commercial partner or directly. - Design and timing of potential launch plans. - Market opportunity for and potential market acceptance of ORLYNVAH. - Ability to continue going concern. - Accuracy of expectations regarding how far into the future cash in hand will fund ongoing operations.

Q: Could you speak a little bit more to the maturity of these conversations you're having with potential commercial partners? And do you foresee any outstanding rate limiting steps ahead of launch later this year?

A: On commercial partner discussions, not much color can be added. Regarding rate limiting steps ahead of launch by Q4, there are no big hurdles seen, with a ton of work to do but no real impediments, and product already made available.