Iterum Therapeutics (ITRM) Update / Briefing June 11, 2025 04:30 PM ET Speaker0 Good afternoon, everyone, and thank you for attending today's Interim Therapeutic Business Update Call. My name is Jasmine, and I will be your moderator today. All lines will be muted during the presentation portion of the call. I would now like to pass the conference over to your host, Kevin Dalton, Senior Director of Legal Affairs. You may now proceed. Speaker1 Thank you, Jasmine. Good afternoon, everyone, and thank you for jo ...

Financial Data and Key Metrics Changes - Total operating expenses decreased to $3.7 million in Q1 2025 from $6.2 million in Q1 2024 [16] - Research and development (R&D) costs significantly dropped to approximately $600,000 in Q1 2025 from $4 million in the same period in 2024, primarily due to reduced costs associated with the ReAssure trial [17] - General and administrative (G&A) expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, driven by pre-commercialization activities [18] - Net loss on a U.S. GAAP basis was $4.9 million in Q1 2025 compared to a net loss of $7.1 million in Q1 2024 [18] - Non-GAAP net loss improved to $3.3 million in Q1 2025 from $5.8 million in Q1 2024, reflecting lower R&D expenses [19] Business Line Data and Key Metrics Changes - The company is preparing for the potential commercialization of Orlynda, targeting the U.S. market for uncomplicated urinary tract infections [6][10] - The addressable market for Orlynda is estimated at 26 million prescriptions annually for at-risk patients, with a potential net sales of over $250 million if a 1% market share is captured [10] Market Data and Key Metrics Changes - The U.S. market for uncomplicated urinary tract infections generates approximately 40 million prescriptions annually, with a significant portion written for at-risk patients [9] - New competition is emerging, with a product approved in April 2024 and another from GlaxoSmithKline expected to launch in the second half of 2025, increasing urgency for Orlynda's market entry [10] Company Strategy and Development Direction - The company aims to launch Orlynda by Q4 2025, emphasizing the urgency due to the lack of innovation in the therapy area over the past 25 years [6][8] - A phased launch strategy is planned, focusing on territories with high antibiotic resistance and a significant number of prescribing physicians [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercialization timeline, stating no significant hurdles are anticipated before the launch of Orlynda [27] - The company has extended its cash runway into 2026, which includes the potential launch of Orlynda [14] Other Important Information - The company repaid outstanding principal and interest on exchangeable notes in January 2025, reducing its debt burden [13] - As of March 2025, the company had cash and cash equivalents of $12.7 million, which, along with recent fundraising, is expected to fund operations into 2026 [19] Q&A Session Summary Question: Can you elaborate on the maturity of conversations with potential commercial partners? - Management indicated ongoing discussions but noted that many potential partners may not see the timing as right for a partnership [25] Question: Are there any outstanding rate-limiting steps ahead of Orlynda's launch later this year? - Management stated there are no significant hurdles remaining and confirmed that product manufacturing is already in place [27]

Financial Data and Key Metrics Changes - Total operating expenses decreased to $3.7 million in Q1 2025 from $6.2 million in Q1 2024 [16] - Research and development (R&D) costs significantly dropped to approximately $600,000 in Q1 2025 from $4 million in the same period in 2024, primarily due to reduced costs associated with the ReAssure trial [17] - General and administrative (G&A) expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, driven by pre-commercialization activities [18] - The net loss on a U.S. GAAP basis was $4.9 million in Q1 2025, compared to a net loss of $7.1 million in Q1 2024 [18] - On a non-GAAP basis, the net loss was $3.3 million in Q1 2025, down from $5.8 million in Q1 2024, reflecting lower R&D expenses [19] Business Line Data and Key Metrics Changes - The company is preparing for the potential commercialization of Orlynda, targeting the U.S. market for uncomplicated urinary tract infections [6][10] - The addressable market for Orlynda is estimated at 26 million prescriptions annually for at-risk patients, with a potential net sales of over $250 million if a 1% market share is captured [9] Market Data and Key Metrics Changes - The U.S. market for uncomplicated urinary tract infections generates approximately 40 million prescriptions annually, with a significant portion for at-risk patients [8] - New competition is emerging, with a product approved in April 2024 and another from GlaxoSmithKline expected to launch in the second half of 2025, increasing urgency for Orlynda's market entry [10] Company Strategy and Development Direction - The company aims to launch Orlynda by Q4 2025, emphasizing the urgency due to the lack of innovation in the therapy area over the past 25 years [7][14] - The commercialization strategy involves phased launches based on antibiotic resistance rates, physician prescription volumes, and managed care access [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the market dynamics for Orlynda, highlighting the significant need for new therapies for at-risk patients [14] - There are no major hurdles anticipated before the launch, with product manufacturing already in place [30] Other Important Information - The company repaid outstanding principal and interest on exchangeable notes in January 2025, reducing debt significantly [13] - Cash and cash equivalents were reported at $12.7 million as of March 2025, with expectations to fund operations into 2026 [19] Q&A Session Summary Question: Can you elaborate on the maturity of conversations with potential commercial partners? - Management indicated ongoing discussions but noted that many potential partners may not see the timing as right for a partnership [26][28] Question: Are there any outstanding rate-limiting steps ahead of Orlynda's launch later this year? - Management stated there are no significant hurdles remaining, with all necessary product available for launch [30]