About Iterum Therapeutics plc DUBLIN, Ireland and CHICAGO, May 06, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Company), 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 announced that the Company will release its first quarter 2025 financial results before the open of the U.S. financial markets on Tuesday, May 13, 2025. Management will host a conference cal ...

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]

Financial Performance - As of December 31, 2024, the company had an accumulated deficit of $486.1 million, indicating significant operating losses since inception [606]. - Operating loss for the year ended December 31, 2024, was $18.7 million, a decrease of $28.8 million compared to a loss of $47.5 million in 2023 [626]. - The company reported a loss before income taxes of $24.5 million for 2024, an improvement of $13.2 million from a loss of $37.8 million in 2023 [626]. - Total operating expenses decreased to $18.7 million in 2024 from $47.5 million in 2023, primarily due to a significant reduction in research and development expenses [626]. - The decrease in CRO and other preclinical and clinical trial expenses was $29.6 million, primarily due to the completion of enrollment in the REASSURE clinical trial [629]. - The company has incurred significant operating losses and negative cash flows, generating limited revenue primarily from a funding arrangement with Boston University under the CARB-X program [644]. Cash and Funding - Company had cash and cash equivalents of $24.1 million as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern [609]. - The company raised $198.3 million from the sale of Series A and Series B preferred shares and ordinary shares through various offerings [644]. - In the year ended December 31, 2024, the company sold 10,327,787 ordinary shares under the Sales Agreement at an average price of $1.94 per share, resulting in net proceeds of $19.4 million [646]. - The company completed the 2024 Rights Offering, selling 6,121,965 units at a subscription price of $1.21 per unit, resulting in net proceeds of approximately $5.4 million [653]. - For the year ended December 31, 2024, the company used $26.8 million in cash for operating activities, resulting from a net loss of $24.8 million and changes in operating assets and liabilities of $12.7 million [655]. - Financing activities generated $26.7 million in net cash in 2024, mainly from the sale of ordinary shares amounting to $19.4 million [659]. - As of December 31, 2024, the company had cash and cash equivalents of $24.1 million, with expected cash usage for the next 12 months indicating a need for additional capital to fund operations [661]. Research and Development - Research and development expenses primarily relate to the sulopenem program, including costs for clinical trials and regulatory compliance [613]. - Research and development expenses for 2024 were $10.5 million, down $29.5 million from $40.0 million in 2023, mainly due to lower costs associated with the REASSURE clinical trial [628][629]. - The company expects to incur significant expenses and increasing operating losses as it prepares to commercialize ORLYNVAH™ [660]. Strategic Focus - Company is focusing on a strategic process to sell, license, or dispose of rights to sulopenem to maximize stakeholder value [605]. - The company plans to focus on selling or licensing its rights to sulopenem to maximize shareholder value following positive data from the REASSURE trial [660]. - The company is evaluating strategic alternatives with the assistance of a financial advisor, but there is no assurance of successful transactions [611]. Expenses and Obligations - Company may incur significant costs associated with operating as a public company, including legal and accounting expenses [606]. - Interest expense includes accrued interest on Exchangeable Senior Subordinated Notes and a promissory note related to a milestone payment to Pfizer [617]. - The company has contractual obligations to make milestone payments to Pfizer based on sales milestones ranging from $250 million to $1 billion for each product type [666]. - The company is obligated to make payments on RLNs based on a percentage of net revenues from U.S. sales of specified sulopenem products, with a payment rate of 15% [667]. - Interest expense, net increased by $1.1 million in 2024, primarily due to decreased interest income and interest accruing on the Pfizer Promissory Note [632]. Market and Economic Conditions - The company anticipates that inflation may increase its operating costs, particularly in labor and research and development [674]. - The company does not currently engage in hedging activities against foreign currency exchange rate risk, and realized net foreign currency gains and losses did not materially affect its operations [673].

Financial Performance - Net loss for Q4 2024 was $6.6 million, an improvement from a net loss of $12.4 million in Q4 2023[10] - Non-GAAP net loss for Q4 2024 was $3.4 million, compared to a non-GAAP net loss of $10.7 million in Q4 2023[10] - For the three months ended December 31, 2024, the net loss attributable to ordinary shareholders was $6,582,000, compared to a net loss of $12,362,000 for the same period in 2023, representing a 46% improvement[21] - The company reported a non-GAAP net loss of $3,140,000 for the three months ended December 31, 2024, compared to a non-GAAP net loss of $10,704,000 for the same period in 2023, a 71% improvement[21] - The net loss per share attributable to ordinary shareholders for the year ended December 31, 2024, was $(1.26), down from $(2.96) in 2023, indicating a 57% improvement[21] Expenses - Research and development (R&D) expenses for Q4 2024 were $1.3 million, a decrease from $9.7 million in Q4 2023, primarily due to reduced clinical trial costs[7] - General and administrative (G&A) expenses for Q4 2024 were $2.1 million, up from $1.7 million in Q4 2023, mainly due to increased legal fees[8] - The total operating expenses for the year ended December 31, 2024, were $18,696,000, down from $47,468,000 in 2023, indicating a 61% reduction[21] - Research and development expenses for the year ended December 31, 2024, were $10,458,000, a decrease of 74% from $39,992,000 in 2023[21] Cash and Assets - As of December 31, 2024, Iterum had cash and cash equivalents of $24.1 million, expected to fund operations into the second half of 2025[5] - Cash, cash equivalents, and short-term investments increased to $24,159,000 as of December 31, 2024, compared to $23,964,000 as of December 31, 2023[23] - Total assets rose to $44,595,000 as of December 31, 2024, up from $26,259,000 in 2023, reflecting a 70% increase[23] Debt and Shareholder Equity - Long-term debt, less current portion, was reported at $20,300,000 as of December 31, 2024, with no long-term debt reported in 2023[23] - The total shareholders' deficit improved to $(4,081,000) as of December 31, 2024, from $(6,403,000) in 2023[23] Product Development and Approvals - Iterum Therapeutics received FDA approval for ORLYNVAH™ for uncomplicated urinary tract infections (uUTIs) in Q4 2024, marking the first branded uUTI product in the U.S. in over 25 years[3] - Iterum is focused on pre-commercialization activities for ORLYNVAH™ to address the unmet need for effective uUTI treatments[2] - The Australian Patent Office issued a Notice of Allowance for a patent covering the use of sulopenem etzadroxil and probenecid, expected to be issued after administrative processes are completed[4] Other Financial Adjustments - Adjustments to the fair value of derivatives for Q4 2024 were $2.0 million, significantly higher than $0.3 million in Q4 2023[9] - Iterum repaid its 6.500% Exchangeable Senior Subordinated Notes due 2025 in January 2025[3] Shareholder Information - The weighted average ordinary shares outstanding increased to 26,687,281 for the three months ended December 31, 2024, compared to 13,180,447 for the same period in 2023[21]

Core Insights - Iterum Therapeutics has received FDA approval for ORLYNVAH, a novel oral penem antibiotic for uncomplicated urinary tract infections (uUTIs), marking a significant milestone as it is the first branded uUTI product in the U.S. market in over 25 years [3][9][16] - The company has extended its cash runway, expecting its cash and cash equivalents to fund operations into the second half of 2025, bolstered by recent fundraising efforts [5][11] - Iterum is actively pursuing strategic partnerships while preparing for the commercialization of ORLYNVAH to address unmet medical needs in treating uUTIs [3][9] Financial Performance - As of December 31, 2024, Iterum reported cash and cash equivalents of $24.1 million, with expectations to sustain operations through the second half of 2025 [5][23] - Research and development (R&D) expenses decreased to $10.5 million for the full year 2024 from $40.0 million in 2023, primarily due to reduced clinical trial costs [7] - General and administrative (G&A) expenses increased to $8.0 million in 2024 from $7.5 million in 2023, attributed to higher legal fees and consultant costs [8] Losses and Adjustments - The net loss for the fourth quarter and full year 2024 was $6.6 million and $24.8 million, respectively, showing improvement compared to losses of $12.4 million and $38.4 million in the same periods of 2023 [11][21] - Non-GAAP net loss for the fourth quarter and full year 2024 was $3.4 million and $17.9 million, respectively, compared to $10.7 million and $43.8 million in 2023 [11][21] - Adjustments to the fair value of derivatives for the fourth quarter and full year 2024 were $2.0 million and $3.3 million, respectively, reflecting changes in the fair value of Royalty-Linked Notes following FDA approval [10] Strategic Developments - Iterum has expanded its patent estate with a Notice of Allowance for an Australian patent covering the use of sulopenem etzadroxil in treating uUTIs, set to expire in June 2039 [9] - The company has repaid its 6.500% Exchangeable Senior Subordinated Notes due 2025, enhancing its financial position [9] - Iterum is focused on pre-commercialization activities for ORLYNVAH, aiming to ensure timely availability for patients [3][9]

Company Overview - Iterum Therapeutics plc focuses on delivering next-generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings [1][3] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against a variety of resistant bacteria [3] Financial Results Announcement - The company will release its fourth quarter and full year 2024 financial results before the U.S. financial markets open on February 7, 2025 [1] - A conference call will be hosted by management at 8:30 a.m. ET on the same day to discuss the financial results and provide a business update [1] Product Development and Approvals - Iterum has received FDA approval for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women [3] - The company has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem across seven indications [3]

Financial Data and Key Metrics Changes - Total operating expenses decreased to $4.9 million in Q3 2024 from $16.7 million in Q3 2023, primarily due to lower R&D expenses [18] - R&D costs were $3.1 million for Q3 2024, down from $14.9 million in the same period last year, reflecting a decrease of $11.8 million [18][20] - Net loss on a GAAP basis was $6.1 million for Q3 2024, compared to $3.9 million for Q3 2023; on a non-GAAP basis, the net loss was $4.8 million, down from $15.7 million [20] Business Line Data and Key Metrics Changes - The primary driver for the decrease in R&D expenses was the completion of the REASSURE trial, which incurred higher costs in 2023 [19] - General and administrative costs remained flat at $1.8 million for both Q3 2024 and Q3 2023 [19] Market Data and Key Metrics Changes - The approval of ORLYNVAH marks the first U.S. approval of an oral product in the penem class, addressing a significant gap in the uncomplicated urinary tract infection market [8][9] - The uncomplicated urinary tract infection market has not seen a new oral treatment in about 25 years, with existing products facing rising resistance rates [12][13] Company Strategy and Development Direction - The company aims to maximize the value of ORLYNVAH through strategic partnerships and has renewed outreach efforts to potential partners [38] - ORLYNVAH has market exclusivity for 10 years under the GAIN Act, with patent protection extending into 2039 [10][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ORLYNVAH's potential to address rising antimicrobial resistance and provide a new treatment option for at-risk patients [9][15] - The company expects to fund operations into 2025, including the repayment of exchangeable notes due January 31, 2025 [21] Other Important Information - The company has approximately $14.5 million in cash and short-term investments as of the end of September 2024 [21] - A $20 million regulatory milestone payment to Pfizer has been deferred for two years following the approval of ORLYNVAH [23] Q&A Session Summary Question: What is the coverage duration for the sulopenem portfolio in the U.S. and Europe? - Management confirmed that U.S. coverage extends to 2039, with patents pending in Europe [24] Question: Did the ORLYNVAH label meet internal expectations? - Management expressed satisfaction with the label, emphasizing its suitability for at-risk patients [26][28] Question: What is the status of strategic options discussions? - Management indicated that outreach to potential partners has been renewed following the approval of ORLYNVAH [29] Question: Will additional trials be needed for approvals outside the U.S.? - Management clarified that the EU may accept the current data package, while additional studies would be required in China and Japan [31][32] Question: Is there interest in leveraging data from the complicated UTI trial? - Management noted potential interest in the complicated UTI indication, suggesting that only one additional study would be needed for formal approval [34][35]