DUBLIN and CHICAGO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (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 provided a general business update. ORLYNVAHTM Launch Update In partnership with EVERSANA Life Science Services, LLC (“EVERSANA”), ORLYNVAH™ was launched in August 2025 into the community market in the U.S. in targeted territori ...

Core Viewpoint - Iterum Therapeutics has launched ORLYNVAH™, the first oral penem antibiotic in the U.S. for treating uncomplicated urinary tract infections (uUTIs) in women, addressing a significant unmet medical need in the face of rising antibiotic resistance [1][5]. Group 1: Product Launch and Approval - ORLYNVAH™ (sulopenem etzadroxil and probenecid) received FDA approval in October 2024 for adult women with uUTIs caused by specific pathogens [1][5]. - This product is the first new branded treatment for uUTIs in over 25 years, providing a critical option for patients with limited oral antibacterial alternatives [1][5]. Group 2: Market Need and Impact - Approximately 60% of women experience a urinary tract infection in their lifetime, with 44% having three or more episodes annually, highlighting the prevalence of this condition [2]. - The increasing resistance to antibiotics is expected to inflate healthcare costs and lead to poor patient outcomes, emphasizing the urgent need for new therapies [2]. Group 3: Clinical and Patient Benefits - Clinicians have expressed that ORLYNVAH™ offers impressive efficacy data and a much-needed treatment option for women suffering from difficult-to-treat uUTIs [3]. - The introduction of ORLYNVAH™ is anticipated to reduce emergency department visits and hospital admissions, positively impacting patients' quality of life [3]. Group 4: Company Mission and Future Plans - Iterum Therapeutics aims to address the global crisis of multi-drug-resistant pathogens by developing differentiated anti-infectives [5]. - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its formulations, indicating a strong commitment to innovation in this therapeutic area [5].

Highlights From the Quarter: Financial and Operational Developments The company reported no revenue in the quarter, which matches its pre-launch status and analyst forecasts. Non-GAAP EPS was a loss of $0.13, steeper than the anticipated $0.11 non-GAAP loss, largely due to a substantial increase in general and administrative (G&A) spending. This rise in G&A costs—from $1.9 million in the prior-year quarter to $4.2 million (GAAP)—was linked to investments in pre-commercialization work, such as market researc ...

Financial Data and Key Metrics Changes - Total operating expenses increased to $5.5 million in Q2 2025 from $4 million in Q2 2024 [24] - R&D costs decreased to $1 million in Q2 2025 from $2.1 million in Q2 2024, primarily due to reduced costs associated with the ReAssure trial [24] - G&A costs rose to $4.2 million in Q2 2025 from $1.9 million in Q2 2024, driven by pre-commercialization activities [24] - Net loss on a GAAP basis was $6.5 million in Q2 2025 compared to a net loss of $5 million in Q2 2024 [25] - Non-GAAP net loss was $5.1 million in Q2 2025 compared to $3.8 million in Q2 2024, with the increase attributed to higher G&A expenses [25] - Cash and cash equivalents stood at $13 million as of June 2025, expected to fund operations into 2026 [26] Business Line Data and Key Metrics Changes - The company is preparing to launch Orlynda, targeting the uncomplicated urinary tract infection market in the U.S. [6][8] - The market generates approximately 40 million prescriptions annually, with about 26 million for at-risk patients [9] - The initial launch phase will focus on 20 targeted geographic territories, covering around 2,300 high-value physician targets [10][11] Market Data and Key Metrics Changes - The uncomplicated urinary tract infection market in the U.S. has not seen a new branded oral treatment in over 25 years, indicating a significant opportunity for Orlynda [9] - Rising rates of antimicrobial resistance are eroding the efficacy of existing treatments, highlighting the need for new therapies [10] Company Strategy and Development Direction - The company aims to successfully launch Orlynda to address unmet needs in the uncomplicated urinary tract infection market [7] - A commercial supply agreement has been executed with ACS Dabfahr for the production of Orlynda, ensuring a reliable supply chain [15][16] - The company plans to optimize physician targeting and resource allocation based on market dynamics and prescription patterns [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Orlynda, emphasizing the significant need for new treatment options in the U.S. market [31] - The company is focused on building a strong commercial presence and ensuring access to Orlynda for patients [12][21] Other Important Information - The FDA has granted Orlynda ten years of market exclusivity, expiring in October 2034 [19] - The company has requested authorization for an additional 80 million shares to ensure financial flexibility for strategic objectives [27][28] Q&A Session Summary - No questions were registered during the Q&A session, indicating a lack of immediate inquiries from investors [30]

Financial Data and Key Metrics Changes - Total operating expenses increased to $5.5 million in Q2 2025 from $4 million in Q2 2024 [26] - Research and development (R&D) costs decreased to $1 million in Q2 2025 from $2.1 million in Q2 2024, primarily due to reduced costs associated with the ReAssure trial [26] - General and administrative (G&A) costs rose to $4.2 million in Q2 2025 from $1.9 million in Q2 2024, driven by pre-commercialization activities [26] - Net loss on a US GAAP basis was $6.5 million in Q2 2025 compared to a net loss of $5 million in Q2 2024 [27] - Non-GAAP net loss was $5.1 million in Q2 2025, up from $3.8 million in Q2 2024, mainly due to higher G&A expenses [27] - Cash and cash equivalents stood at $13 million as of June 2025, expected to fund operations into 2026 [28] Business Line Data and Key Metrics Changes - The company is preparing to launch Orlynda, targeting the uncomplicated urinary tract infection market in the U.S. [6][9] - The market generates approximately 40 million prescriptions annually, with about 26 million for at-risk patients [10] - The initial launch phase will focus on 20 targeted geographic territories, primarily in major metropolitan areas across seven states [12] Market Data and Key Metrics Changes - The uncomplicated urinary tract infection market has not seen a new branded oral treatment in over 25 years, indicating a significant opportunity for Orlynda [11] - Rising rates of antimicrobial resistance are eroding the efficacy of existing treatments, highlighting the need for new therapies [11] Company Strategy and Development Direction - The company aims to successfully launch Orlynda to address unmet needs in the uncomplicated urinary tract infection market [8] - A commercial supply agreement has been executed with ACS Dabfahr for the manufacturing of Orlynda, ensuring a reliable supply chain [18] - The company has received FDA market exclusivity for Orlynda, which will last until October 2034 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Orlynda and its potential to meet significant market needs [24] - The company is focused on optimizing physician targeting and resource allocation in key geographies to maximize revenue generation [16] - Management highlighted the importance of speed to therapy for patients suffering from uncomplicated urinary tract infections [17] Other Important Information - The company has deferred a $20 million regulatory payment to Pfizer, now due in October 2029, alleviating near-term financial obligations [21] - The company is seeking authorization for an additional 80 million shares to ensure financial flexibility for strategic objectives [29] Q&A Session Summary - No questions were registered during the Q&A session, indicating a lack of immediate inquiries from investors [32]

[PART I. FINANCIAL INFORMATION](index=9&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) 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)](index=9&type=section&id=Item%201.%20Financial%20Statements%20(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](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) 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](index=14&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures for the unaudited financial statements [Note 1. Basis of Presentation](index=14&type=section&id=Note%201.%20Basis%20of%20Presentation) 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](index=33&type=chunk)[34](index=34&type=chunk) - 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](index=46&type=chunk)[50](index=50&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=18&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) 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](index=53&type=chunk) - Inventory capitalization began following FDA approval of ORLYNVAH™ on **October 25, 2024**[62](index=62&type=chunk) 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](index=22&type=section&id=Note%203.%20Fair%20Value%20of%20Financial%20Assets%20and%20Liabilities) 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](index=74&type=chunk) - 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](index=75&type=chunk) [Note 4. Inventory](index=23&type=section&id=Note%204.%20Inventory) 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](index=77&type=chunk) [Note 5. Prepaid Expenses and Other Current Assets](index=23&type=section&id=Note%205.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) 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](index=23&type=section&id=Note%206.%20Intangible%20Asset,%20net) 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](index=79&type=chunk)[80](index=80&type=chunk) - 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](index=80&type=chunk) [Note 7. Property and Equipment, net](index=25&type=section&id=Note%207.%20Property%20and%20Equipment,%20net) 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](index=82&type=chunk) [Note 8. Leases](index=25&type=section&id=Note%208.%20Leases) 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](index=86&type=chunk) [Note 9. Accrued Expenses](index=26&type=section&id=Note%209.%20Accrued%20Expenses) 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](index=26&type=section&id=Note%2010.%20Debt) 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](index=89&type=chunk) - 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](index=94&type=chunk) 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](index=29&type=section&id=Note%2011.%20Royalty-Linked%20Notes) 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](index=97&type=chunk) - 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](index=98&type=chunk)[99](index=99&type=chunk) [Note 12. Segment Reporting](index=29&type=section&id=Note%2012.%20Segment%20Reporting) 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](index=100&type=chunk) 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](index=31&type=section&id=Note%2013.%20Shareholders'%20Equity) 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](index=107&type=chunk)[109](index=109&type=chunk) - 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](index=112&type=chunk) - The company's authorized ordinary shares increased to **80,000,000** as of June 30, 2025[111](index=111&type=chunk) [Note 14. Share-Based Compensation](index=34&type=section&id=Note%2014.%20Share-Based%20Compensation) 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](index=136&type=chunk)[138](index=138&type=chunk) 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](index=136&type=chunk)[140](index=140&type=chunk) [Note 15. Income Taxes](index=38&type=section&id=Note%2015.%20Income%20Taxes) 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](index=144&type=chunk) [Note 16. Commitments and Contingencies](index=40&type=section&id=Note%2016.%20Commitments%20and%20Contingencies) 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](index=145&type=chunk) - 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](index=146&type=chunk) - The company has agreements with contract service providers for research and development, manufacturing, and commercial activities, which represent significant costs[147](index=147&type=chunk) [Note 17. Condensed Consolidating Financial Statements](index=42&type=section&id=Note%2017.%20Condensed%20Consolidating%20Financial%20Statements) 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](index=150&type=chunk) - The Company and its Subsidiary Guarantors provide a full and unconditional guarantee of Iterum Bermuda's obligations under the RLNs[151](index=151&type=chunk) [Note 18. Subsequent Events](index=42&type=section&id=Note%2018.%20Subsequent%20Events) 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](index=152&type=chunk) - 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](index=153&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=43&type=section&id=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](index=156&type=chunk) - 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](index=157&type=chunk) - Significant expenses and increased operating losses are expected as the company prepares for commercialization and further development of its sulopenem program[158](index=158&type=chunk) [Commercialization Activities](index=43&type=section&id=Commercialization%20Activities) 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](index=159&type=chunk) - EVERSANA will provide sales, commercial operations, marketing, logistics, channel management, regulatory, and medical affairs services[159](index=159&type=chunk) - 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](index=161&type=chunk) [Going Concern](index=45&type=section&id=Going%20Concern) 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](index=164&type=chunk) - 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](index=168&type=chunk) - 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](index=166&type=chunk)[168](index=168&type=chunk) [Components of Our Results of Operations](index=47&type=section&id=Components%20of%20Our%20Results%20of%20Operations) 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](index=171&type=chunk) - Research and development expenses include costs for CROs, CMOs, clinical trials, manufacturing scale-up, personnel, and regulatory compliance[172](index=172&type=chunk)[178](index=178&type=chunk) - General and administrative expenses cover salaries, benefits, share-based compensation, professional fees, and market preparation expenses, expected to increase significantly with ORLYNVAH™ commercialization[173](index=173&type=chunk)[174](index=174&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=49&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) 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](index=182&type=chunk) [Results of Operations](index=49&type=section&id=Results%20of%20Operations) Analyzes the company's financial performance over specific reporting periods [Comparison of the three months ended June 30, 2025 and 2024](index=49&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030,%202025%20and%202024) 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](index=185&type=chunk)[186](index=186&type=chunk) - General and administrative expenses increased by **$2.3 million**, mainly due to a rise in professional and consulting fees for pre-commercialization activities[187](index=187&type=chunk) [Comparison of the six months ended June 30, 2025 and 2024](index=51&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030,%202025%20and%202024) 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](index=194&type=chunk) - General and administrative expenses increased by **$2.9 million**, mainly due to a rise in professional and consulting fees for pre-commercialization activities[195](index=195&type=chunk) [Liquidity and Capital Resources](index=53&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet its short-term and long-term financial obligations [Overview of Funding](index=53&type=section&id=Overview%20of%20Funding) 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](index=204&type=chunk) - The company has filed universal shelf registration statements (**2022 for $100 million** and **2025 for $150 million**) to raise capital through various securities[202](index=202&type=chunk)[203](index=203&type=chunk) - 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](index=204&type=chunk) [Pfizer Promissory Note](index=55&type=section&id=Pfizer%20Promissory%20Note) 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](index=206&type=chunk)[207](index=207&type=chunk) - 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](index=208&type=chunk)[209](index=209&type=chunk) [Registered Direct Offerings](index=57&type=section&id=Registered%20Direct%20Offerings) 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](index=213&type=chunk) - 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](index=218&type=chunk) [Cash Flows Analysis](index=59&type=section&id=Cash%20Flows%20Analysis) 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](index=220&type=chunk)[221](index=221&type=chunk) - 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](index=223&type=chunk)[224](index=224&type=chunk) [Funding Requirements](index=61&type=section&id=Funding%20Requirements) 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](index=226&type=chunk)[227](index=227&type=chunk) - Future funding requirements are substantial and depend on commercialization costs for ORLYNVAH™, R&D for sulopenem, regulatory approvals, and market conditions[229](index=229&type=chunk)[232](index=232&type=chunk) - Raising additional capital may cause dilution to shareholders or involve restrictive debt covenants, and the company is evaluating various strategic and financing alternatives[236](index=236&type=chunk) [Contractual Obligations and Commitments](index=65&type=section&id=Contractual%20Obligations%20and%20Commitments) 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](index=237&type=chunk) - 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](index=239&type=chunk)[240](index=240&type=chunk) - 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](index=238&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=68&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=242&type=chunk) - 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](index=243&type=chunk) - Inflation has not had a material effect on the company's financial statements to date, but future increases could affect operating costs[244](index=244&type=chunk) [Item 4. Controls and Procedures](index=68&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=245&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended **June 30, 2025**[246](index=246&type=chunk) [PART II. OTHER INFORMATION](index=69&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information, including legal proceedings, comprehensive risk factors, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=69&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=249&type=chunk) - 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](index=249&type=chunk) [Item 1A. Risk Factors](index=69&type=section&id=Item%201A.%20Risk%20Factors) 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](index=69&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Requirements) 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](index=251&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk) - 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](index=254&type=chunk) - 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](index=259&type=chunk)[261](index=261&type=chunk) [Risks Related to Product Development and Commercialization](index=80&type=section&id=Risks%20Related%20to%20Product%20Development%20and%20Commercialization) 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](index=291&type=chunk) - The company has no prior history of successfully conducting commercial activities, which makes evaluating future viability difficult[294](index=294&type=chunk) - 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](index=296&type=chunk)[305](index=305&type=chunk) [Risks Related to Our Dependence on Third Parties](index=103&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) 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](index=360&type=chunk)[362](index=362&type=chunk) - 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](index=363&type=chunk)[368](index=368&type=chunk) - 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](index=375&type=chunk)[377](index=377&type=chunk)[381](index=381&type=chunk) [Risks Related to Our Intellectual Property](index=111&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) 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](index=386&type=chunk) - 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](index=390&type=chunk)[393](index=393&type=chunk) - 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](index=415&type=chunk)[417](index=417&type=chunk) [Risks Related to Regulatory Approval and Other Legal Compliance Matters](index=128&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) 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](index=440&type=chunk)[444](index=444&type=chunk) - 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](index=462&type=chunk)[464](index=464&type=chunk) - 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](index=475&type=chunk)[476](index=476&type=chunk) [Risks Related to Employee Matters and Managing Growth](index=153&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth) 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](index=525&type=chunk)[526](index=526&type=chunk) - Difficulties in managing growth, particularly in manufacturing, regulatory affairs, sales, and marketing, could disrupt operations, increase expenses, and reduce revenue potential[527](index=527&type=chunk)[528](index=528&type=chunk) - 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](index=530&type=chunk) [Risks Related to Taxation](index=155&type=section&id=Risks%20Related%20to%20Taxation) 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](index=535&type=chunk)[538](index=538&type=chunk) - 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](index=545&type=chunk)[546](index=546&type=chunk) - 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](index=542&type=chunk)[543](index=543&type=chunk)[544](index=544&type=chunk) [Risks Related to Our Ordinary Shares](index=159&type=section&id=Risks%20Related%20to%20Our%20Ordinary%20Shares) 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](index=549&type=chunk)[550](index=550&type=chunk)[551](index=551&type=chunk) - 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](index=555&type=chunk) - 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](index=563&type=chunk)[572](index=572&type=chunk)[576](index=576&type=chunk) [Item 5. Other Information](index=173&type=section&id=Item%205.%20Other%20Information) 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](index=598&type=chunk) [Item 6. Exhibits](index=174&type=section&id=Item%206.%20Exhibits) 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](index=599&type=chunk) - Exhibit **10.2** is the Amended and Restated Promissory Note with Pfizer Inc., dated **May 13, 2025**[599](index=599&type=chunk) - Exhibits **31.1, 31.2, 32.1, and 32.2** include certifications of the Principal Executive Officer and Principal Financial Officer[599](index=599&type=chunk) [Signatures](index=175&type=section&id=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](index=603&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) Iterum Therapeutics reported Q2 2025 results, focusing on the upcoming August 2025 launch of ORLYNVAH™ for uUTIs, a significant development in antibiotic treatment [Q2 2025 Overview and Key Announcements](index=1&type=section&id=Q2%202025%20Overview%20and%20Key%20Announcements) Iterum Therapeutics reported Q2 2025 financial results, with a significant focus on the anticipated August 2025 launch of ORLYNVAH™ for uncomplicated urinary tract infections (uUTIs) - Iterum Therapeutics expects to launch ORLYNVAH™ for uUTIs in **August 2025**, marking the **first branded antibiotic for uUTIs in over 25 years**[2](index=2&type=chunk)[3](index=3&type=chunk) - ORLYNVAH™ is the **only FDA-approved oral penem antibiotic** in the U.S., offering a much-needed option for patients with limited alternatives due to resistant Gram-negative bacteria, including ESBL-producing Enterobacterales[3](index=3&type=chunk) [Recent Business Developments](index=1&type=section&id=Recent%20Business%20Developments) Iterum Therapeutics advanced ORLYNVAH™ commercialization through partnerships, expanded intellectual property, and secured a debt repayment extension [Commercialization and Partnerships](index=1&type=section&id=Commercialization%20and%20Partnerships) Iterum Therapeutics has advanced its commercialization strategy for ORLYNVAH™ through key partnerships and personnel appointments - Iterum expects to launch ORLYNVAH™ for uUTIs in the U.S. by the **end of August 2025**, focusing most resources on pre-commercialization activities[4](index=4&type=chunk) - A Product Commercialization Agreement was signed with EVERSANA Life Science Services, LLC in **June 2025** for sales, commercial operations, marketing, logistics, and regulatory services for ORLYNVAH™ in the U.S[4](index=4&type=chunk) - A Commercial Manufacturing and Supply Agreement was entered into with ACS Dobfar S.p.A in **July 2025** for the manufacture and supply of ORLYNVAH™ bilayer tablets[4](index=4&type=chunk) - Christine Coyne was appointed **Chief Commercial Officer** to lead all commercial efforts for Iterum, including the ORLYNVAH™ launch[9](index=9&type=chunk) [Clinical and Intellectual Property Updates](index=2&type=section&id=Clinical%20and%20Intellectual%20Property%20Updates) The company expanded its patent estate in Canada for sulopenem etzadroxil and probenecid combinations, extending protection until December 2039 - The Canadian Patent Office issued patent 3,129,337 covering the use of sulopenem etzadroxil and probenecid combinations, expiring in **December 2039**[9](index=9&type=chunk) - Results from Iterum's **REASSURE Phase 3 clinical trial** comparing oral sulopenem to oral Augmentin® in adult women with uUTIs were published in **NEJM Evidence**[9](index=9&type=chunk) [Corporate Finance and Debt](index=2&type=section&id=Corporate%20Finance%20and%20Debt) Iterum secured an extension for the repayment of its $20.0 million regulatory milestone payment to Pfizer Inc. until October 25, 2029 - Pfizer Inc. agreed to extend the deferral term for payment of the **$20.0 million** regulatory milestone payment until **October 25, 2029**[9](index=9&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Iterum Therapeutics reported a cash position of $13.0 million, increased operating expenses due to pre-commercialization, and a higher net loss for Q2 2025 [Cash Position and Outlook](index=2&type=section&id=Cash%20Position%20and%20Outlook) As of June 30, 2025, Iterum's cash and cash equivalents stood at $13.0 million, with a projected cash runway into 2026 Cash Position and Shares Outstanding | Metric | Value | | :----------------------------------- | :------------------- | | Cash and cash equivalents (June 30, 2025) | $13.0 million | | Net proceeds from ATM offering (July 1 - Aug 1, 2025) | $2.2 million | | Cash runway estimate | Into 2026 | | Ordinary shares outstanding (Aug 1, 2025) | 44.7 million | [Operating Expenses Analysis](index=2&type=section&id=Operating%20Expenses%20Analysis) Operating expenses for Q2 2025 totaled $5.5 million, an increase from $4.0 million in Q2 2024, driven by pre-commercialization activities Q2 2025 Operating Expenses (YoY Change, in thousands) | Expense Category | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------------------------ | :--------------------- | :--------------------- | :----------- | | Cost of sales | $(345) | $0 | N/A | | Research and development | $(1,000) | $(2,075) | Decrease of $1.1M | | General and administrative | $(4,184) | $(1,901) | Increase of $2.3M | | Total operating expenses | $(5,529) | $(3,976) | Increase of $1.5M | - The **decrease in R&D expenses** was primarily due to a decrease in clinical trial costs associated with the REASSURE trial[7](index=7&type=chunk) - The **increase in G&A expenses** was primarily due to increased spend associated with pre-commercialization activities[8](index=8&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) Iterum reported a GAAP net loss of $6.5 million for Q2 2025, an increase from $5.0 million in Q2 2024 Q2 2025 Net Loss (YoY Comparison, in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | | :------------------ | :--------------------- | :--------------------- | | GAAP Net Loss | $(6,509) | $(4,997) | | Non-GAAP Net Loss | $(5,074) | $(3,773) | [Non-GAAP Financial Measures](index=3&type=section&id=Non-GAAP%20Financial%20Measures) This section defines and reconciles non-GAAP net loss and non-GAAP net loss per share, excluding specific non-cash and non-recurring items [Definition and Reconciliation](index=3&type=section&id=Definition%20and%20Reconciliation) Iterum presents non-GAAP net loss and non-GAAP net loss per share to provide supplementary information for investors and management - **Non-GAAP net loss** and **non-GAAP net loss per share** are presented to supplement GAAP results, providing additional analysis for investors and management[12](index=12&type=chunk)[13](index=13&type=chunk) - Adjustments to GAAP net loss for non-GAAP calculation include **intangible asset amortization**, **share-based compensation expense**, **accrued interest and amortization on Exchangeable Notes**, **interest on Pfizer promissory note (non-cash)**, and **adjustments to fair value of Royalty-Linked Notes**[12](index=12&type=chunk)[13](index=13&type=chunk) [Company and Product Information](index=4&type=section&id=Company%20and%20Product%20Information) Iterum Therapeutics is a biopharmaceutical company focused on anti-infectives, with ORLYNVAH™ as its FDA-approved lead product for uUTIs [About Iterum Therapeutics plc](index=4&type=section&id=About%20Iterum%20Therapeutics%20plc) Iterum Therapeutics plc is a biopharmaceutical company focused on developing differentiated anti-infectives to combat multi-drug resistant pathogens - Iterum Therapeutics plc focuses on delivering **differentiated anti-infectives** to combat **multi-drug resistant pathogens** globally[15](index=15&type=chunk) - The company is advancing **sulopenem**, a **novel penem anti-infective**, with both **oral (ORLYNVAH™)** and **IV formulations**, demonstrating potent in vitro activity against various resistant bacteria[15](index=15&type=chunk) - ORLYNVAH™ (oral sulopenem) has received **FDA approval** for the treatment of **uncomplicated urinary tract infections (uUTIs)** caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options[15](index=15&type=chunk) - Sulopenem has received **Qualified Infectious Disease Product (QIDP)** and **Fast Track designations** for its oral and IV formulations in seven indications[15](index=15&type=chunk) [About ORLYNVAH™](index=4&type=section&id=About%20ORLYNVAH%E2%84%A2) ORLYNVAH™ is a novel oral penem antibiotic specifically designed for the treatment of uUTIs - ORLYNVAH™ is a **novel oral penem antibiotic** for the treatment of uUTIs[16](index=16&type=chunk) - It shows **potent activity against Enterobacterales**, including those encoding **ESBL or AmpC-type ß-lactamases**, which cause resistance to third-generation cephalosporins[16](index=16&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section provides conference call details, a cautionary note on forward-looking statements, and investor contact information [Conference Call Details](index=3&type=section&id=Conference%20Call%20Details) Iterum Therapeutics hosted a conference call on August 5, 2025, at 8:30 a.m. Eastern Time to discuss the financial results and recent developments - Iterum hosted a conference call on **August 5, 2025**, at 8:30 a.m. Eastern Time[11](index=11&type=chunk) [Cautionary Note Regarding Forward-looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward-looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, highlighting that actual results may differ materially due to various risks and uncertainties - The press release contains **forward-looking statements** regarding Iterum's plans, strategies, and prospects, including ORLYNVAH™'s potential and cash resources[17](index=17&type=chunk) - Actual future results may differ materially due to factors such as the **ability to raise capital**, **successful commercialization of ORLYNVAH™**, **market acceptance**, **regulatory changes**, and the **company's ability to continue as a going concern**[17](index=17&type=chunk)[18](index=18&type=chunk) [Investor Contact](index=5&type=section&id=Investor%20Contact) Contact information for investor inquiries is provided, with Judy Matthews, Chief Financial Officer, listed as the primary contact - Investor contact: **Judy Matthews, Chief Financial Officer**, 312-778-6073, IR@iterumtx.com[19](index=19&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the condensed consolidated statement of operations and balance sheet data for Q2 2025, detailing financial performance and position [Condensed Consolidated Statement of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) The condensed consolidated statement of operations shows a GAAP net loss of $6.5 million for Q2 2025, compared to $5.0 million in Q2 2024 Condensed Consolidated Statement of Operations (Q2 2025 vs Q2 2024, in thousands except share and per share data) | (In thousands except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | **Costs and expenses:** | | | | | | Cost of sales | $(345) | $— | $(687) | $— | | Research and development | $(1,000) | $(2,075) | $(1,591) | $(6,052) | | General and administrative | $(4,184) | $(1,901) | $(6,961) | $(4,087) | | Total operating expenses | $(5,529) | $(3,976) | $(9,239) | $(10,139) | | Operating loss | $(5,529) | $(3,976) | $(9,239) | $(10,139) | | Interest expense, net | $(316) | $(571) | $(850) | $(1,058) | | Adjustments to fair value of derivatives | $(585) | $(407) | $(1,134) | $(793) | | Other expense, net | $(20) | $(12) | $(58) | $(29) | | Income tax expense | $(59) | $(31) | $(119) | $(79) | | **Net loss (GAAP)** | **$(6,509)** | **$(4,997)** | **$(11,400)** | **$(12,098)** | | Net loss per share – basic and diluted (GAAP) | $(0.16) | $(0.30) | $(0.31) | $(0.76) | | Weighted average ordinary shares outstanding | 39,935,213 | 16,552,214 | 37,013,653 | 15,992,454 | | **Non-GAAP Net Loss** | **$(5,074)** | **$(3,773)** | **$(8,327)** | **$(9,600)** | | Non-GAAP net loss per share – basic and diluted | $(0.13) | $(0.23) | $(0.22) | $(0.60) | [Condensed Consolidated Balance Sheet Data](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, total assets were $34.0 million, down from $44.6 million at December 31, 2024, with a decrease in total liabilities Condensed Consolidated Balance Sheet Data (in thousands) | (In thousands) | As of June 30, 2025 | As of December 31, 2024 | | :---------------------------------- | :------------------ | :---------------------- | | Cash, cash equivalents and short-term investments | $13,026 | $24,125 | | Inventory | $948 | $— | | Intangible asset, net | $19,059 | $19,746 | | Other assets | $981 | $724 | | **Total assets** | **$34,014** | **$44,595** | | Pfizer Promissory Note | $20,653 | $20,300 | | Exchangeable notes | $— | $14,463 | | Royalty-linked notes | $11,905 | $10,771 | | Other liabilities | $5,343 | $3,142 | | **Total liabilities** | **$37,901** | **$48,676** |

-- Launch of ORLYNVAH Expected August 2025— --Cash Runway into 2026-- --Company to host conference call today at 8:30amET-- DUBLIN and CHICAGO, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), 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 financial results for the second quarter ended June 30, 2025. "We are on track to launch ORLYNVAH™ this m ...

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 is a novel penem anti-infective compound with both oral and IV formulations [3] Financial Results Announcement - The company will release its second quarter 2025 financial results before the U.S. financial markets open on August 5, 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 - Sulopenem has shown potent in vitro activity against a variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics [3] - The company has received approval for its NDA for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options [3] - Iterum has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications [3]

Company Overview - Iterum Therapeutics plc is focused on delivering next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens [1][3] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [3] Recent Developments - Iterum has granted a non-statutory share option to purchase 200,000 ordinary shares to Christine Coyne, the newly appointed Chief Commercial Officer [1][2] - The share option has an exercise price of $0.97 per share, equal to the closing price on the date of grant, and vests over four years [2] Product Information - ORLYNVAH™ is a novel oral penem antibiotic developed by Iterum for the treatment of uncomplicated urinary tract infections (uUTIs) [3][4] - ORLYNVAH™ is effective against Enterobacterales species that are resistant to third-generation cephalosporins due to extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases [4]