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 ...

U.S. Commercial Launch of ORLYNVAHTM by Q4 2025; First Oral Penem Available in the U.S. Management to host a conference call at 4:30 p.m. ET today DUBLIN and CHICAGO, June 11, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum”), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported that it entered into a Product Commercialization Agree ...

Iterum Therapeutics (ITRM) Q1 2025 Earnings Call May 13, 2025 08:30 AM ET Company Participants Louise Barrett - Senior Vice President of Legal Affairs & SecretaryCorey Fishman - CEOJudith Matthews - Chief Financial OfficerMatthew Keller - Equity Research Associate Operator Hello, everyone, and thank you for joining the Ichorum Therapeutics plc First Quarter twenty twenty five Earnings and Business Update Call. My name is Lucy, and I'll be coordinating your call today. I will now hand over to your host, Loui ...

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporatio ...

Financial Performance - The net loss for Q1 2025 was $4.9 million, an improvement from a net loss of $7.1 million in the same period of 2024[10]. - Non-GAAP net loss for Q1 2025 was $3.3 million, compared to a non-GAAP net loss of $5.8 million in Q1 2024[10]. - Research and development expenses for Q1 2025 were $0.6 million, a significant decrease from $4.0 million in Q1 2024, primarily due to reduced clinical trial costs[7]. - General and administrative expenses increased to $2.8 million in Q1 2025 from $2.2 million in Q1 2024, driven by pre-commercialization activities[8]. Cash and Funding - The company extended its cash runway into 2026, raising approximately $5 million from a registered direct offering and an additional $1 million from its at-the-market offering program[3][5]. - As of March 31, 2025, Iterum had cash and cash equivalents of $12.7 million, which, along with recent fundraising, is expected to fund operations into 2026[5]. - Cash, cash equivalents, and short-term investments dropped significantly to $12,652 million from $24,125 million, a decrease of about 47.5%[23]. Assets and Liabilities - As of March 31, 2025, total assets decreased to $32,975 million from $44,595 million as of December 31, 2024, representing a decline of approximately 26.3%[23]. - Total liabilities decreased to $35,529 million from $48,676 million, reflecting a reduction of approximately 26.9%[23]. - Total shareholders' deficit improved to $(2,554) million from $(4,081) million, indicating a positive change of approximately 37.5%[23]. - Inventory stood at $533 million as of March 31, 2025, with no prior inventory reported[23]. - Other assets decreased to $386 million from $724 million, a decline of about 46.6%[23]. - Other liabilities increased to $3,504 million from $3,142 million, reflecting an increase of approximately 11.5%[23]. Shareholder Information - Iterum has approximately 40.0 million ordinary shares outstanding as of May 12, 2025[5]. Strategic Focus - The company is focused on addressing the increasing rate of antimicrobial resistance and the lack of innovation in uUTI treatments over the past 25 years[2]. Debt Management - The company repaid its 6.500% Exchangeable Senior Subordinated Notes due 2025 in January 2025[4]. - The Pfizer Promissory Note increased to $20,705 million from $20,300 million, a rise of about 2.0%[23]. - Royalty-linked notes rose to $11,320 million from $10,771 million, an increase of approximately 5.1%[23]. - Exchangeable notes were not reported as of March 31, 2025, compared to $14,463 million as of December 31, 2024[23].

Core Viewpoint - Iterum Therapeutics plc has successfully completed a registered direct offering of 5,555,556 ordinary shares at a price of $0.90 per share, raising approximately $5 million in gross proceeds to support its operations and strategic initiatives [1][3]. Group 1: Offering Details - The offering was conducted with a single institutional investor and facilitated by H.C. Wainwright & Co. as the exclusive placement agent [2][3]. - The net proceeds from the offering are intended for working capital and general corporate purposes, including funding ongoing strategic processes and pre-commercialization activities [3]. Group 2: Company Overview - Iterum Therapeutics focuses on developing next-generation oral and IV antibiotics to combat multi-drug resistant pathogens, with its lead compound being sulopenem [6]. - Sulopenem has shown potent in vitro activity against various resistant bacteria and has received FDA approval for its oral formulation, ORLYNVAH™, for treating uncomplicated urinary tract infections in adult women [6].

Core Viewpoint - Iterum Therapeutics plc has entered into a definitive agreement for a registered direct offering of 5,555,556 ordinary shares at a price of $0.90 per share, expected to close around April 30, 2025 [1][3] Group 1: Offering Details - The gross proceeds from the offering are anticipated to be approximately $5 million before deducting fees and expenses [3] - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The offering is conducted under a shelf registration statement filed with the SEC, effective since October 17, 2022 [4] Group 2: Use of Proceeds - The net proceeds will be used for working capital and general corporate purposes, including ongoing strategic processes and pre-commercialization activities [3] - Specific uses for the proceeds have not been identified, but they may fund expenses related to the commercialization of ORLYNVAH™, including manufacturing, sales, and marketing [3][6] Group 3: Company Overview - Iterum Therapeutics focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens [6] - The company is advancing its first compound, sulopenem, which has shown potent activity against various resistant bacteria [6] - ORLYNVAH™ has received FDA approval for treating uncomplicated urinary tract infections in women with limited treatment options [6]

Company Overview - Iterum Therapeutics plc focuses on developing next-generation oral and IV antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [1][2] - The company is advancing its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [2] - Iterum has received FDA approval for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections (uUTI) in adult women with limited or no alternative treatment options [2] Recent Developments - A poster titled "Impact of age on antibiotic resistance and efficacy of antibiotics for women with uncomplicated urinary tract infection (uUTI)" was presented at the 35th Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID) [1] - The poster was presented by Dr. Sailaja Puttagunta on April 13, 2025, and will be available on the company's website [1] Product Information - ORLYNVAH™ is a novel oral penem antibiotic specifically designed for treating uUTI, demonstrating strong activity against Enterobacterales species that are resistant to third-generation cephalosporins [3]

Financial Data and Key Metrics Changes - Total operating expenses for Q4 2024 were $3.7 million, compared to $11.4 million in Q4 2023, and for the full year 2024, they were $18.7 million compared to $47.5 million in 2023, indicating a significant reduction in expenses [20] - R&D costs decreased to $1.3 million in Q4 2024 from $9.7 million in Q4 2023, and for the full year, they were $10.5 million compared to $40 million in 2023, primarily due to the completion of the REASSURE trial [21] - The net loss on a GAAP basis was $6.6 million for Q4 2024 and $24.8 million for the full year, while on a non-GAAP basis, the net loss was $3.1 million for Q4 and $17.6 million for the full year, showing a decrease from $10.7 million and $43.8 million respectively in 2023 [22] Business Line Data and Key Metrics Changes - The approval of ORLYNVAH, the first and only oral penem in the U.S., is expected to address the significant unmet need in the uncomplicated urinary tract infection market, which generates approximately 40 million prescriptions annually [10][11] - ORLYNVAH is positioned as a new treatment option for patients with limited or no alternative oral antibacterial treatments, particularly for those with rising resistance rates to existing medications [12][13] Market Data and Key Metrics Changes - The uncomplicated urinary tract infection market in the U.S. has seen rising resistance rates, with some commonly used products having resistance rates approaching 20% to 30%, creating a challenge for physicians [12] - ORLYNVAH's market exclusivity is confirmed for a total of 10 years from the date of approval, providing a competitive edge against potential generic products [15][16] Company Strategy and Development Direction - The company is focused on maximizing value for stakeholders through a strategic process to sell, license, or otherwise dispose of its rights to ORLYNVAH, while also evaluating other options for commercialization [17][18] - Pre-commercial activities are being planned to ensure a targeted launch of ORLYNVAH, contingent on raising sufficient capital [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for ORLYNVAH in the market, highlighting the substantial unmet need for effective treatment options in the uncomplicated urinary tract infection space [31] - The company expects its cash resources to be sufficient to fund operations into the second half of 2025, allowing for continued development and commercialization efforts [19][23] Other Important Information - The company repaid the principal and interest due under its exchangeable notes at the end of January 2025, and it has deferred a $20 million regulatory milestone payment to Pfizer for two years [23][24] Q&A Session Summary Question: Feedback on ongoing discussions with potential partners - Management indicated that discussions are ongoing with dozens of companies, including both pharmaceutical companies and financial investors, but specific details could not be disclosed [26][27] Question: Highlights of commercial preparations - Current activities include engaging with payers and physicians, as well as conducting analytics to prepare for a potential commercial launch, whether independently or with a partner [28][29]