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]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=9&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported a reduced net loss but faces a significant cash decrease and a going concern warning Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,652 | $24,125 | | Total current assets | $13,513 | $24,787 | | Total assets | $32,975 | $44,595 | | **Liabilities & Shareholders' Deficit** | | | | Total current liabilities | $3,628 | $17,605 | | Total liabilities | $35,529 | $48,676 | | Total shareholders' deficit | $(2,554) | $(4,081) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $(3,710) | $(6,163) | | Operating loss | $(3,710) | $(6,163) | | Net loss | $(4,891) | $(7,101) | | Net loss per share – basic and diluted | $(0.14) | $(0.46) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,060) | $(13,083) | | Net cash (used in) / provided by investing activities | $(2) | $7,211 | | Net cash (used in) / provided by financing activities | $(8,388) | $7,217 | | Net (decrease) / increase in cash | $(11,473) | $1,318 | - The company has identified conditions that raise **substantial doubt about its ability to continue as a going concern** due to insufficient funds[17](index=17&type=chunk)[40](index=40&type=chunk)[42](index=42&type=chunk) - On January 31, 2025, the company repaid its matured Exchangeable Notes, totaling **$14.7 million** in principal and accrued interest[33](index=33&type=chunk)[63](index=63&type=chunk)[79](index=79&type=chunk) - Subsequent to the quarter end, the company raised approximately **$957,000** through its Sales Agreement and an additional **$4.2 million (net)** from a direct offering[132](index=132&type=chunk)[133](index=133&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its strategic focus on sulopenem rights and a significant going concern issue - Following the FDA approval of ORLYNVAH™, the company's primary focus is a **strategic process to sell or license its sulopenem rights**[138](index=138&type=chunk)[187](index=187&type=chunk)[216](index=216&type=chunk) - The company has **substantial doubt about its ability to continue as a going concern**, with $12.7 million in cash insufficient for the next 12 months[144](index=144&type=chunk)[188](index=188&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cost of sales | $ (342) | $ — | $ (342) | | Research and development | $ (591) | $ (3,977) | $ 3,386 | | General and administrative | $ (2,777) | $ (2,186) | $ (591) | | **Total operating expenses** | **$ (3,710)** | **$ (6,163)** | **$ 2,453** | - Research and development expenses **decreased by $3.4 million** due to lower CRO costs after completing the REASSURE trial[160](index=160&type=chunk) - General and administrative expenses **increased by $0.9 million** in professional fees for pre-commercialization activities[161](index=161&type=chunk) - Net cash used in financing activities was **$8.4 million**, driven by a $14.7 million repayment of notes, offset by $6.4 million from share sales[185](index=185&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=54&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are foreign currency fluctuations and potential inflation impacts - The company is subject to **foreign currency risk** from international contracts but does not currently engage in hedging[202](index=202&type=chunk) - **Inflation** is a risk that could increase operational costs but has not had a material effect to date[203](index=203&type=chunk) [Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025 - Management, including the CEO and CFO, concluded that the company's **disclosure controls and procedures were effective** as of March 31, 2025[204](index=204&type=chunk) - **No material changes** to internal control over financial reporting occurred during the first quarter of 2025[205](index=205&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=55&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the filing date, the company is **not a party to any material legal proceedings**[208](index=208&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a going concern warning and dependence on its sulopenem program - The company has **substantial doubt about its ability to continue as a going concern** due to insufficient cash reserves[210](index=210&type=chunk)[211](index=211&type=chunk) - The strategic process to sell or license sulopenem rights may not be successful, potentially leading to **liquidation of the business**[248](index=248&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk) - The company is **heavily dependent on the success of its sulopenem program** and lacks a commercial organization[224](index=224&type=chunk)[254](index=254&type=chunk)[289](index=289&type=chunk) - The company relies on an **exclusive license agreement with Pfizer** for critical patent rights for sulopenem[326](index=326&type=chunk)[329](index=329&type=chunk) - The company's **reliance on third-party contract manufacturers** creates risks related to supply, cost, quality, and regulatory compliance[343](index=343&type=chunk)[347](index=347&type=chunk) - The company faces **substantial competition** from larger pharmaceutical companies and its products may not achieve market acceptance[296](index=296&type=chunk)[301](index=301&type=chunk) - The company's **stock price has been highly volatile**, and its retail investor base may hinder corporate initiatives[516](index=516&type=chunk)[520](index=520&type=chunk) [Other Information](index=160&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the first quarter - **No director or officer adopted or terminated** a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during Q1 2025[564](index=564&type=chunk) [Exhibits](index=161&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including required officer certifications - The report includes required **certifications from the CEO and CFO** under the Sarbanes-Oxley Act[565](index=565&type=chunk) - Exhibits incorporate by reference the **Securities Purchase Agreement** and Form of Pre-Funded Warrant from the April 2025 financing[565](index=565&type=chunk)

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]

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]