Iterum Therapeutics(ITRM) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's discussion and analysis of the company's financial condition and results of operations Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of cash flows, and statements of stockholders' equity, along with detailed notes explaining the basis of presentation, significant accounting policies, fair value measurements, and other financial commitments Condensed Consolidated Balance Sheets Presents the company's financial position, including assets, liabilities, and equity, at specific points in time Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $13,026 | $24,125 | | Total current assets | $14,890 | $24,787 | | Total assets | $34,014 | $44,595 | | Total current liabilities | $5,533 | $17,605 | | Total liabilities | $37,901 | $48,676 | | Total shareholders' deficit | $(3,887) | $(4,081) | Condensed Consolidated Statements of Operations and Comprehensive Loss Details the company's revenues, expenses, and net loss over specific reporting periods Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Cost of sales | $(345) | $— | $(687) | $— |\n| Research and development | $(1,000) | $(2,075) | $(1,591) | $(6,052) |\n| General and administrative | $(4,184) | $(1,901) | $(6,961) | $(4,087) |\n| Total operating expenses | $(5,529) | $(3,976) | $(9,239) | $(10,139) |\n| Operating loss | $(5,529) | $(3,976) | $(9,239) | $(10,139) |\n| Net loss | $(6,509) | $(4,997) | $(11,400) | $(12,098) |\n| Net loss per share (basic and diluted) | $(0.16) | $(0.30) | $(0.31) | $(0.76) | Condensed Consolidated Statements of Cash Flows Summarizes the cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(7,811) | $(19,842) |\n| Net cash (used in) / provided by investing activities | $(2) | $11,408 |\n| Net cash (used in) / provided by financing activities | $(3,268) | $7,384 |\n| Net decrease in cash, cash equivalents and restricted cash | $(11,099) | $(1,095) |\n| Cash, cash equivalents and restricted cash, at end of period | $13,060 | $5,010 | Condensed Consolidated Statements of Stockholders' Equity Outlines changes in the company's equity accounts, including ordinary shares, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Metric | Balance at December 31, 2024 (in thousands) | Issuance of ordinary shares, net (in thousands) | Net loss (in thousands) | Balance at June 30, 2025 (in thousands) | | :-------------------------------------- | :---------------------------------------- | :---------------------------------------------- | :---------------------- | :-------------------------------------- | | Ordinary Shares (Amount) | $315 | $106 | $— | $421 |\n| Additional Paid-in Capital | $481,676 | $11,339 | $— | $493,164 |\n| Accumulated Deficit | $(486,072) | $— | $(11,400) | $(497,472) |\n| Total Shareholders' Deficit | $(4,081) | $11,445 | $(11,400) | $(3,887) | Notes to Unaudited Condensed Consolidated Financial Statements Provides detailed explanations and disclosures for the unaudited financial statements Note 1. Basis of Presentation Explains the foundational principles and assumptions used in preparing the financial statements - Iterum Therapeutics plc is focused on maximizing the commercial potential of ORLYNVAH™, the first oral branded penem in the U.S., with commercial launch expected by the end of August 2025[33][34] - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern for the next 12 months, with an accumulated deficit of $497.5 million as of June 30, 2025, and net losses of $11.4 million for the six months ended June 30, 2025[46][50] Note 2. Summary of Significant Accounting Policies Outlines the key accounting principles and methods applied in the financial reporting - There have been no material changes in the company's significant accounting policies compared to its Annual Report on Form 10-K for the year ended December 31, 2024[53] - Inventory capitalization began following FDA approval of ORLYNVAH™ on October 25, 2024[62] Anti-dilutive Securities | Anti-dilutive Securities | June 30, 2025 | June 30, 2024 | | :----------------------- | :------------ | :------------ | | Options to purchase ordinary shares | 760,906 | 986,488 |\n| Warrants | 8,138,498 | 480,178 |\n| Exchangeable Notes | — | 1,504,767 |\n| Total | 8,899,404 | 2,971,433 | Note 3. Fair Value of Financial Assets and Liabilities Details the valuation methods and fair values of the company's financial instruments Fair Value of Financial Liabilities (in thousands) | Liability (in thousands) | June 30, 2025 Book Value | June 30, 2025 Fair Value | December 31, 2024 Book Value | December 31, 2024 Fair Value | | :----------------------- | :----------------------- | :----------------------- | :--------------------------- | :--------------------------- | | Short-term royalty-linked notes | $190 | $190 | $— | $— |\n| Long-term promissory note | $20,653 | $21,127 | $20,300 | $20,412 |\n| Long-term royalty-linked notes | $11,715 | $11,715 | $10,771 | $10,771 |\n| Short-term exchangeable notes | $— | $— | $14,463 | $14,444 | - The Exchangeable Notes matured and were repaid in full on January 31, 2025, for an aggregate principal amount of $11.1 million and accrued interest of $3.6 million[74] - The Royalty-Linked Notes (RLNs) are carried at a fair value of $11.9 million as of June 30, 2025, determined using a discounted cash flow analysis (Level 3 measurement) with a 22% discount rate[75] Note 4. Inventory Provides details on the composition and valuation of the company's inventory Inventory (in thousands) | Inventory Type | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------- | :--------------------------- | :------------------------------- | | Finished Goods | $948 | $— | - The company began capitalizing inventory costs following FDA approval of ORLYNVAH™ in October 2024, with production commencing in February 2025[77] Note 5. Prepaid Expenses and Other Current Assets Details the components of prepaid expenses and other current assets Prepaid Expenses and Other Current Assets (in thousands) | Item | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :---------------------------------- | :--------------------------- | :------------------------------- | | Prepaid insurance | $565 | $389 |\n| Other prepaid assets | $266 | $138 |\n| Research and development tax credit receivable | $80 | $18 |\n| Prepaid research and development expenses | $5 | $4 |\n| Right of use assets, net | $— | $65 |\n| Total | $916 | $614 | Note 6. Intangible Asset, net Describes the company's intangible assets, their amortization, and related accounting policies Intangible Asset, Net (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Gross intangible asset | $20,000 | $20,000 |\n| Less: accumulated amortization | $(941) | $(254) |\n| Net intangible asset | $19,059 | $19,746 | - A $20.0 million regulatory milestone payment to Pfizer upon FDA approval of ORLYNVAH™ on October 25, 2024, was capitalized and is being amortized over 14.4 years[79][80] - The deferral period for the milestone payment was extended by three years to October 25, 2029, with the annual interest rate increasing to 10% from October 26, 2026[80] Note 7. Property and Equipment, net Details the company's property and equipment, including depreciation Property and Equipment, Net (in thousands) | Item (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Leasehold improvements | $103 | $148 |\n| Furniture and fixtures | $120 | $120 |\n| Computer equipment | $97 | $95 |\n| Total gross property and equipment | $320 | $363 |\n| Less: accumulated depreciation | $(308) | $(340) |\n| Net property and equipment | $12 | $23 | - Depreciation expense for the six months ended June 30, 2025, was $13 thousand[82] Note 8. Leases Outlines the company's lease arrangements and associated financial impacts Cash Paid for Operating Lease Liabilities (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash paid for operating lease liabilities | $68 | $200 | - The weighted-average remaining lease term for operating leases was 0.09 years as of June 30, 2025[86] Note 9. Accrued Expenses Details the various categories of accrued expenses recognized by the company Accrued Expenses (in thousands) | Accrued Expense (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Accrued manufacturing expenses | $2,020 | $1,148 |\n| Accrued pre-commercial expenses | $1,041 | $— |\n| Accrued payroll and bonus expenses | $608 | $1,138 |\n| Accrued professional fees | $175 | $246 |\n| Accrued other expenses | $107 | $119 |\n| Total | $3,951 | $2,651 | Note 10. Debt Provides information on the company's debt obligations, including maturities and interest rates - The Exchangeable Notes matured on January 31, 2025, and were repaid in full, including $11.1 million in principal and $3.6 million in accrued interest[89] - The Pfizer Promissory Note's deferral period was extended by three years to October 25, 2029, with the annual interest rate increasing from 8% to 10% starting October 26, 2026[94] Principal Payments on Outstanding Debt (in thousands) | Year Ending June 30, | Principal Payments on Outstanding Debt (in thousands) | | :------------------- | :-------------------------------------------------- | | 2026 | $— |\n| 2027 | $— |\n| 2028 | $— |\n| 2029 | $20,000 |\n| 2030 | $— |\n| Thereafter | $104 |\n| Total | $20,104 | Note 11. Royalty-Linked Notes Describes the terms and accounting treatment of the company's royalty-linked notes - Royalty-Linked Notes (RLNs) entitle holders to payments based on 15% of net revenues from U.S. sales of specified sulopenem products, capped at $160.00 per note, through December 31, 2045[97] - The RLNs are accounted for as a derivative and remeasured to fair value at each reporting date, with a total liability of $11.9 million as of June 30, 2025[98][99] Note 12. Segment Reporting Presents financial information by business segment and geographic area - The company operates as a single business segment focused on the development and commercialization of innovative treatments for drug-resistant bacterial infections[100] Segment Expenses (in thousands) | Segment Expense (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------- | :----------------------------- | :----------------------------- | | Segment research and development | $(1,551) | $(5,922) |\n| Segment general and administration | $(6,871) | $(3,996) |\n| Share-based compensation expense | $(117) | $(206) |\n| Depreciation and amortization | $(700) | $(15) |\n| Operating loss | $(9,239) | $(10,139) | Long-Lived Assets by Geography (in thousands) | Long-lived assets (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------- | :------------ | :---------------- | | Ireland | $19,082 | $19,759 |\n| U.S. | $8 | $15 |\n| Total | $19,090 | $19,774 | Note 13. Shareholders' Equity Details changes in the company's shareholders' equity, including share issuances and capital raises - In April 2025, the company issued 3,040,000 ordinary shares and 2,515,556 pre-funded warrants in a registered direct offering, generating net proceeds of $4.177 million; all pre-funded warrants were exercised by June 30, 2025[107][109] - During the three months ended June 30, 2025, the company sold 889,156 ordinary shares under the Sales Agreement for net proceeds of $957 thousand[112] - The company's authorized ordinary shares increased to 80,000,000 as of June 30, 2025[111] Note 14. Share-Based Compensation Explains the accounting for share-based compensation plans and related expenses - No share options or restricted share units (RSUs) were granted to employees and directors during the six months ended June 30, 2025 and 2024[136][138] Share-Based Compensation Expense (in thousands) | Share-Based Compensation Expense (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :----------------------------- | :----------------------------- | | Research and development expense | $35 | $122 |\n| General and administrative expense | $82 | $84 | - Total unamortized share-based compensation expense for options was $127 thousand as of June 30, 2025, expected to be recognized over a remaining average vesting period of 0.75 years[136][140] Note 15. Income Taxes Provides information on the company's income tax expense, deferred taxes, and tax loss carryforwards Income Tax Expense (in thousands) | Income Tax Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Income tax expense | $59 | $31 | $119 | $79 | - The company has net operating loss carryforwards in Ireland of approximately $45.8 million as of June 30, 2025, for which a full valuation allowance has been recognized due to a history of losses[144] Note 16. Commitments and Contingencies Discloses the company's contractual obligations, potential liabilities, and legal matters - Under the Pfizer License, the company is obligated to make potential future regulatory and sales milestone payments (ranging from $250 million to $1 billion) and royalties (single-digit to mid-teens percentage) based on net sales of licensed products[145] - Royalty-Linked Notes (RLNs) entitle holders to payments based on 15% of net revenues from U.S. sales of specified sulopenem products, with a maximum return of $160.00 per note, through December 31, 2045[146] - The company has agreements with contract service providers for research and development, manufacturing, and commercial activities, which represent significant costs[147] Note 17. Condensed Consolidating Financial Statements Presents financial information for the parent company and its consolidated subsidiaries - Iterum Bermuda, a wholly-owned finance subsidiary, issued Exchangeable Notes and Royalty-Linked Notes (RLNs)[150] - The Company and its Subsidiary Guarantors provide a full and unconditional guarantee of Iterum Bermuda's obligations under the RLNs[151] Note 18. Subsequent Events Reports significant events that occurred after the balance sheet date but before the financial statements were issued - From July 1, 2025, through August 1, 2025, the company sold 2,525,578 ordinary shares under the Sales Agreement for net proceeds of $2.175 million[152] - On July 29, 2025, the company's subsidiary entered into a Commercial Manufacturing and Supply Agreement with ACS Dobfar S.p.A. for ORLYNVAH™ materials[153] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, highlighting the focus on commercializing ORLYNVAH™ following FDA approval, the ongoing need for additional capital due to significant operating losses, and a detailed comparison of financial performance for the three and six months ended June 30, 2025 and 2024 Overview Provides a general summary of the company's business and strategic focus - FDA approved ORLYNVAH™ for uncomplicated urinary tract infections (uUTIs) in adult women with limited or no alternative oral antibacterial treatment options on October 25, 2024[156] - The company is focusing efforts on the commercial launch of ORLYNVAH™ in the U.S. by the end of August 2025 with commercialization partner EVERSANA[157] - Significant expenses and increased operating losses are expected as the company prepares for commercialization and further development of its sulopenem program[158] Commercialization Activities Details the company's strategies and partnerships for bringing products to market - Iterum Therapeutics US Limited (ITUS) entered into a Product Commercialization Agreement with EVERSANA Life Science Services, LLC for commercialization of ORLYNVAH™ in the United States[159] - EVERSANA will provide sales, commercial operations, marketing, logistics, channel management, regulatory, and medical affairs services[159] - Iterum Therapeutics International Limited (ITIL) entered into a Commercial Manufacturing and Supply Agreement with ACS Dobfar S.p.A. in July 2025 for ORLYNVAH™ materials[161] Going Concern Discusses the company's ability to continue operations and its need for future funding - The company has incurred significant operating losses since inception, with an accumulated deficit of $497.5 million as of June 30, 2025[164] - As of June 30, 2025, cash and cash equivalents were $13.0 million, which is insufficient to fund operating expenses for the next 12 months, raising substantial doubt about the company's ability to continue as a going concern[168] - The company's ability to continue as a going concern is dependent on obtaining additional funding through equity/debt offerings, collaboration agreements, or strategic alliances[166][168] Components of Our Results of Operations Explains the key revenue and expense categories contributing to financial performance - Cost of sales primarily consists of amortization related to the intangible asset recognized for the regulatory milestone payment to Pfizer upon ORLYNVAH™ approval[171] - Research and development expenses include costs for CROs, CMOs, clinical trials, manufacturing scale-up, personnel, and regulatory compliance[172][178] - General and administrative expenses cover salaries, benefits, share-based compensation, professional fees, and market preparation expenses, expected to increase significantly with ORLYNVAH™ commercialization[173][174] Critical Accounting Policies and Significant Judgments and Estimates Highlights the accounting policies requiring significant management judgment and estimation - There have been no significant changes to the company's critical accounting estimates from those described in its Annual Report on Form 10-K filed on February 7, 2025[182] Results of Operations Analyzes the company's financial performance over specific reporting periods Comparison of the three months ended June 30, 2025 and 2024 Compares the financial performance for the three-month periods ended June 30, 2025 and 2024 Comparison of Expenses (Three Months Ended June 30, 2025 and 2024, in thousands) | Expense Category (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :------------------------------ | :------------ | :------------ | :----- | | Cost of sales | $(345) | $— | $(345) |\n| Research and development | $(1,000) | $(2,075) | $1,075 |\n| General and administrative | $(4,184) | $(1,901) | $(2,283) |\n| Operating loss | $(5,529) | $(3,976) | $(1,553) |\n| Net loss | $(6,509) | $(4,997) | $(1,512) | - Research and development expenses decreased by $1.1 million, primarily due to lower CRO, personnel, and CMC related expenses after the completion of the REASSURE trial[185][186] - General and administrative expenses increased by $2.3 million, mainly due to a rise in professional and consulting fees for pre-commercialization activities[187] Comparison of the six months ended June 30, 2025 and 2024 Compares the financial performance for the six-month periods ended June 30, 2025 and 2024 Comparison of Expenses (Six Months Ended June 30, 2025 and 2024, in thousands) | Expense Category (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :------------------------------ | :------------ | :------------ | :----- | | Cost of sales | $(687) | $— | $(687) |\n| Research and development | $(1,591) | $(6,052) | $4,461 |\n| General and administrative | $(6,961) | $(4,087) | $(2,874) |\n| Operating loss | $(9,239) | $(10,139) | $900 |\n| Net loss | $(11,400) | $(12,098) | $698 | - Research and development expenses decreased by $4.5 million, primarily due to lower CRO, personnel, and CMC related expenses after the completion of the REASSURE trial[194] - General and administrative expenses increased by $2.9 million, mainly due to a rise in professional and consulting fees for pre-commercialization activities[195] Liquidity and Capital Resources Assesses the company's ability to meet its short-term and long-term financial obligations Overview of Funding Summarizes the company's current cash position and capital raising activities - The company had $13.0 million in cash and cash equivalents as of June 30, 2025[204] - The company has filed universal shelf registration statements (2022 for $100 million and 2025 for $150 million) to raise capital through various securities[202][203] - During the six months ended June 30, 2025, the company sold 5,015,057 ordinary shares under the Sales Agreement for net proceeds of $7.3 million[204] Pfizer Promissory Note Details the terms and amendments of the promissory note with Pfizer Inc - The $20.0 million regulatory milestone payment to Pfizer for ORLYNVAH™ approval was deferred for two years until October 25, 2026[206][207] - On May 13, 2025, the promissory note was amended to extend the deferral period by an additional three years, until October 25, 2029, with the annual interest rate increasing from 8% to 10% starting October 26, 2026[208][209] Registered Direct Offerings Describes the capital raised through registered direct offerings and rights offerings - The April 2025 Registered Direct Offering resulted in net proceeds of approximately $4.2 million from the issuance of ordinary shares and pre-funded warrants, all of which were exercised by June 30, 2025[213] - The 2024 Rights Offering generated net proceeds of approximately $5.4 million from the sale of 6,121,965 units, each consisting of one ordinary share and warrants[218] Cash Flows Analysis Analyzes the company's cash inflows and outflows from operating, investing, and financing activities Cash Flow Activities (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(7,811) | $(19,842) |\n| Net cash (used in) / provided by investing activities | $(2) | $11,408 |\n| Net cash (used in) / provided by financing activities | $(3,268) | $7,384 | - Net cash used in operating activities significantly decreased to $7.8 million in 2025 from $19.8 million in 2024, primarily due to a reduced net loss and changes in operating assets and liabilities[220][221] - Financing activities shifted from providing $7.4 million in cash in 2024 to using $3.3 million in 2025, mainly due to the $14.7 million repayment of Exchangeable Notes[223][224] Funding Requirements Outlines the company's anticipated capital needs and potential financing strategies - As of June 30, 2025, the company had $13.0 million in cash and cash equivalents, which is not sufficient to fund operating expenses for the next 12 months, raising substantial doubt about its ability to continue as a going concern[226][227] - Future funding requirements are substantial and depend on commercialization costs for ORLYNVAH™, R&D for sulopenem, regulatory approvals, and market conditions[229][232] - Raising additional capital may cause dilution to shareholders or involve restrictive debt covenants, and the company is evaluating various strategic and financing alternatives[236] Contractual Obligations and Commitments Details the company's significant contractual obligations and future financial commitments - Under the Pfizer License, the company is obligated to make potential one-time sublicensing payments, future regulatory and sales milestone payments (ranging from $250 million to $1 billion), and royalties (single-digit to mid-teens percentage) on net sales of licensed products[237] - Holders of Royalty-Linked Notes (RLNs) are entitled to payments equal to 15% of net revenues from U.S. sales of specified sulopenem products, capped at $160.00 per note, until December 31, 2045[239][240] - The company has agreements with contract service providers for research and development, manufacturing, and commercial activities, which may require upfront payments and long-term commitments[238] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section discusses the company's exposure to market risks, primarily foreign currency fluctuations and inflation; it notes that while these factors have not materially affected financial statements to date, they could impact future operations - As of June 30, 2025, the company had $13.0 million in cash and cash equivalents, primarily in cash and money market funds[242] - The company is subject to foreign currency rate fluctuations from global CRO and CMO agreements, but these have not had a material effect on results of operations for the six months ended June 30, 2025[243] - Inflation has not had a material effect on the company's financial statements to date, but future increases could affect operating costs[244] Item 4. Controls and Procedures Management, including the Chief Executive Officer and Chief Financial Officer, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025; no material changes in internal control over financial reporting occurred during the quarter - The company's disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level as of June 30, 2025[245] - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[246] PART II. OTHER INFORMATION This section provides additional information, including legal proceedings, comprehensive risk factors, and a list of exhibits filed with the report Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings and is unaware of any pending or threatened litigation that could have a material adverse effect on its business, operating results, or financial condition - The company is not currently a party to any material legal proceedings[249] - There is no awareness of any pending or threatened litigation that could have a material adverse effect on the business, operating results, or financial condition[249] Item 1A. Risk Factors This section outlines various risks that could significantly impact the company's business, financial condition, and future prospects; key areas of risk include financial position and capital requirements, product development and commercialization, dependence on third parties, intellectual property, regulatory approval and legal compliance, employee matters, managing growth, and risks related to taxation and ordinary shares Risks Related to Our Financial Position and Capital Requirements Highlights risks associated with the company's financial stability, liquidity, and need for additional funding - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern, with $13.0 million in cash and cash equivalents as of June 30, 2025, insufficient to fund operations for the next 12 months[251][252][253] - The company has incurred net losses since inception, with an accumulated deficit of $497.5 million as of June 30, 2025, and anticipates continued significant losses without successful commercialization of its sulopenem program[254] - Additional capital is required to fund operations and support the commercial launch of ORLYNVAH™ and ongoing clinical development; failure to obtain financing could delay or eliminate product development and commercialization efforts[259][261] Risks Related to Product Development and Commercialization Addresses risks concerning the successful development, regulatory approval, and market launch of products - The company is heavily dependent on the successful commercial launch of ORLYNVAH™ in the U.S. by the end of August 2025, and any failure or significant delays would materially harm the business[291] - The company has no prior history of successfully conducting commercial activities, which makes evaluating future viability difficult[294] - Clinical trials for sulopenem or other product candidates may fail to demonstrate safety and efficacy, leading to additional costs, delays, or inability to complete development and commercialization[296][305] Risks Related to Our Dependence on Third Parties Examines risks arising from reliance on external partners for licensing, manufacturing, and commercialization - The company relies heavily on the exclusive license agreement with Pfizer Inc. for patent rights and know-how related to sulopenem; failure to comply with obligations could lead to loss of these critical rights[360][362] - The company depends on collaborations with third parties, including EVERSANA, for commercialization, sales, marketing, and distribution of ORLYNVAH™ in the U.S., and their failure to perform could significantly impact commercialization[363][368] - Reliance on third-party contract manufacturers, such as ACS Dobfar S.p.A., for preclinical, clinical, and commercial supplies increases the risk of insufficient quantities, unacceptable costs, or non-compliance with cGMPs, potentially delaying or impairing development and commercialization efforts[375][377][381] Risks Related to Our Intellectual Property Covers risks concerning the protection, enforcement, and potential infringement of intellectual property rights - The company relies heavily on the Pfizer License for intellectual property rights, but all patents directed to the sulopenem compound expired prior to the license, and no patent rights cover the IV formulation of sulopenem[386] - Inability to obtain and maintain broad patent protection or other intellectual property rights for ORLYNVAH™ and other product candidates could hinder successful commercialization and effective competition[390][393] - The company may become involved in costly, time-consuming, and potentially unsuccessful lawsuits to protect or enforce its intellectual property, or defend against third-party infringement claims[415][417] Risks Related to Regulatory Approval and Other Legal Compliance Matters Discusses risks associated with obtaining and maintaining regulatory approvals and adhering to healthcare laws - Delays or inability to obtain required regulatory approvals for future product candidates will materially impair the ability to commercialize them and generate revenue[440][444] - ORLYNVAH™ and any other approved product candidates are subject to ongoing regulatory obligations and continuing review, which may result in significant additional expense, restrictions, or market withdrawal if compliance fails or unanticipated problems arise[462][464] - Relationships with customers, healthcare providers, and third-party payors are subject to anti-kickback, fraud, abuse, and other healthcare laws, potentially exposing the company to penalties, criminal sanctions, and reputational harm[475][476] Risks Related to Employee Matters and Managing Growth Addresses risks related to retaining key personnel, managing organizational expansion, and international operations - The company's future success depends on its ability to retain its Chief Executive Officer and other key executives, and to attract, retain, and motivate qualified personnel in a competitive industry[525][526] - Difficulties in managing growth, particularly in manufacturing, regulatory affairs, sales, and marketing, could disrupt operations, increase expenses, and reduce revenue potential[527][528] - Conducting business in markets outside the United States subjects the company to additional risks, including intellectual property protection, tariffs, economic instability, and political unrest[530] Risks Related to Taxation Outlines potential adverse tax consequences, including PFIC status and changes in tax laws - The company could be classified as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes, which could subject U.S. Holders to adverse tax consequences[535][538] - Future transfers of ordinary shares not effected through DTC may be subject to Irish stamp duty (1%), and dividends paid may be subject to Irish dividend withholding tax (25%), though exemptions exist[545][546] - Changes to U.S. federal income tax laws, such as the Inflation Reduction Act of 2022 and the One Big Beautiful Bill Act, could have material consequences for the company and U.S. Holders of its ordinary shares[542][543][544] Risks Related to Our Ordinary Shares Covers risks associated with the trading, valuation, and ownership of the company's ordinary shares - An active trading market for the company's ordinary shares may not be sustained, and the share price has been, and could continue to be, volatile, potentially leading to a decline in investment value[549][550][551] - Failure to comply with Nasdaq Capital Market listing requirements could result in delisting, negatively impacting the share price, access to capital markets, and financial condition[555] - The issuance of additional ordinary shares or convertible debt securities may dilute existing shareholders' ownership, and Irish law differs from U.S. law, potentially affording less protection to security holders[563][572][576] Item 5. Other Information This section reports that no directors or executive officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended June 30, 2025 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[598] Item 6. Exhibits This section lists the exhibits filed or furnished as part of the Quarterly Report on Form 10-Q, including key agreements and certifications - Exhibit 10.1 is the Product Commercialization Agreement with EVERSANA Life Science Services, LLC, dated June 6, 2025[599] - Exhibit 10.2 is the Amended and Restated Promissory Note with Pfizer Inc., dated May 13, 2025[599] - Exhibits 31.1, 31.2, 32.1, and 32.2 include certifications of the Principal Executive Officer and Principal Financial Officer[599] Signatures The report is officially signed by Corey Fishman, President and Chief Executive Officer, and Judith Matthews, Chief Financial Officer, on behalf of Iterum Therapeutics plc on August 5, 2025 - The report was signed by Corey Fishman, President and Chief Executive Officer, and Judith Matthews, Chief Financial Officer, on August 5, 2025[603]