UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38503 Iterum Therapeutics plc (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or ...

Sulopenem Development and Clinical Trials - Iterum is developing sulopenem, an oral and IV penem antibiotic, for serious bacterial infections[1] - Oral sulopenem demonstrated superiority to ciprofloxacin in uUTI patients with quinolone non-susceptible pathogens (p-value < 0001)[5] - Iterum is conducting an additional Phase 3 clinical trial in uUTI under SPA agreement with the FDA, with topline data expected in the first half of 2024[6] - Over 3,700 patients have been enrolled in Phase 3 studies, with over 1,800 treated with sulopenem[21] Market Opportunity and Commercialization - Approximately 33 million annual prescriptions (TRx) are written for uUTIs in the US, with an estimated addressable market for sulopenem > 10 million TRxs[10] - The three leading uUTI antibiotics have an estimated market share of ~75% but each demonstrates severe limitations[16] - Macrobid has an estimated market share of ~33%[16] - Ciprofloxacin has an estimated market share of ~20%[17] - Bactrim has an estimated market share of ~20%[17] Financial Status - As of June 30, 2022, Iterum had $689 million in cash, cash equivalents, and short-term investments[46] - The company has $126 million in 6500% Exchangeable Senior Subordinated Notes due 2025[47]

Financial Data and Key Metrics Changes - Total operating expenses for Q3 2022 were $7 million, up from $4.9 million in Q3 2021, and year-to-date expenses were $22.4 million compared to $17.7 million in 2021 [14] - Research and development (R&D) costs increased to $4.4 million in Q3 2022 from $1.8 million in Q3 2021, primarily due to the initiation of the REASSURE trial [14] - The net loss on a U.S. GAAP basis was $29.1 million for Q3 2022, compared to a net loss of $39.3 million year-to-date [16] - Non-GAAP net loss was $5.3 million for Q3 2022, compared to $3.7 million in Q3 2021, reflecting higher R&D expenses [17] Business Line Data and Key Metrics Changes - The REASSURE trial for uncomplicated urinary tract infections has begun enrollment, with approximately 1,966 patients expected to be enrolled [6][8] - R&D costs year-to-date were $11.8 million in 2022 versus $7 million in 2021, driven by costs associated with the REASSURE trial [15] Market Data and Key Metrics Changes - There are approximately 33 million uncomplicated urinary tract infections in the U.S. annually, with about 30% caused by quinolone non-susceptible organisms [9] - The need for new oral antibiotics remains high due to 1% of infections being caused by pathogens resistant to all commonly available oral antibiotics [9] Company Strategy and Development Direction - The company is focused on resubmitting the NDA for oral sulopenem in the second half of 2024, contingent on the success of the REASSURE trial [12][17] - A U.S. patent for the bilayer tablet of oral sulopenem has been granted, extending patent protection until at least 2039, which is crucial for the long-term commercial value [10][25] - The company is exploring new areas of unmet medical need for sulopenem and plans to discuss potential new indications with the FDA in the first half of 2023 [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash position of $64 million as of September 30, 2022, which is expected to fund operations into 2024 [12][17] - The company remains optimistic about the potential of oral sulopenem to treat multidrug-resistant infections and is looking forward to completing ongoing clinical work [31] Other Important Information - The company regained compliance with NASDAQ's bid price rule through a 1-for-15 reverse share split in August 2022 [12] - As of September 30, 2022, there were approximately 12.2 million ordinary shares outstanding [18] Q&A Session Summary Question: About the powering of the study and patent details - The study is powered based on assumptions including a point estimate for sulopenem and Augmentin at 90%, with an interim analysis planned at 50% enrollment [23] - The new patent is a composition of matter patent for the bilayer tablet, not merely a formulation patent [24][25] Question: Clarification on cash runway and class action lawsuit - The company has sufficient cash to get through the top line data readout, but specific timing is uncertain due to enrollment [27] - There is no new information regarding the class action lawsuit, with a conference scheduled for December 7 [27]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpor ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents Iterum Therapeutics plc's unaudited condensed consolidated financial statements and detailed notes for the period ended June 30, 2022 [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section provides Iterum Therapeutics plc's unaudited condensed consolidated financial statements and notes, highlighting ongoing losses and liquidity for operations into 2024 - Iterum Therapeutics is a clinical-stage pharmaceutical company developing sulopenem as a potential first oral penem in the U.S. and the first oral and IV branded penem globally[142](index=142&type=chunk) - The FDA issued a Complete Response Letter (CRL) for oral sulopenem's NDA in July 2021, requiring additional clinical and non-clinical data. An agreement with the FDA on a Phase 3 clinical trial design for uUTIs was reached in July 2022, with enrollment expected in Q4 2022[143](index=143&type=chunk) - The company had an accumulated deficit of **$388.7 million** as of June 30, 2022, and expects to fund operations into 2024 with existing cash, cash equivalents, and short-term investments totaling **$68.9 million**[144](index=144&type=chunk)[148](index=148&type=chunk) - The company is evaluating corporate, strategic, financial, and financing alternatives to maximize stakeholder value, including potential licensing, sale of assets, merger, or other strategic transactions[149](index=149&type=chunk) Condensed Consolidated Balance Sheets (June 30, 2022 vs. December 31, 2021) | Metric ($ thousands) | June 30, 2022 | December 31, 2021 | | :-------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $9,209 | $27,446 | | Short-term investments | $59,666 | $53,898 | | Total current assets | $70,926 | $83,266 | | Total assets | $76,687 | $91,509 | | **Liabilities** | | | | Total current liabilities | $7,493 | $12,941 | | Total liabilities | $32,801 | $41,275 | | **Shareholders' Equity** | | | | Accumulated deficit | $(388,728) | $(378,493) | | Total shareholders' equity | $43,886 | $50,234 | Condensed Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended June 30) | Metric ($ thousands) | June 30, 2022 | June 30, 2021 | | :-------------------- | :------------ | :------------ | | Operating expenses | $(8,050) | $(6,987) | | Operating loss | $(8,050) | $(6,987) | | Interest expense, net | $(766) | $(980) | | Adjustments to fair value of derivatives | $2,155 | $15,794 | | Other income, net | $269 | $93 | | Total other income / (expense), net | $1,658 | $14,907 | | Loss / (income) before income taxes | $(6,392) | $7,920 | | Income tax expense | $(343) | $(122) | | Net (loss) / income and comprehensive (loss) / income | $(6,735) | $7,798 | | Net (loss) / income per share – basic | $(0.04) | $0.04 | | Net (loss) / income per share – diluted | $(0.04) | $0.04 | Condensed Consolidated Statements of Operations and Comprehensive Loss (Six Months Ended June 30) | Metric ($ thousands) | June 30, 2022 | June 30, 2021 | | :-------------------- | :------------ | :------------ | | Operating expenses | $(15,423) | $(12,834) | | Operating loss | $(15,423) | $(12,834) | | Interest expense, net | $(1,805) | $(3,932) | | Adjustments to fair value of derivatives | $7,332 | $(74,309) | | Other income, net | $431 | $134 | | Total other income / (expense), net | $5,958 | $(78,107) | | Loss / (income) before income taxes | $(9,465) | $(90,941) | | Income tax expense | $(770) | $(182) | | Net (loss) / income and comprehensive (loss) / income | $(10,235) | $(91,123) | | Net (loss) / income per share – basic | $(0.06) | $(0.63) | | Net (loss) / income per share – diluted | $(0.06) | $(0.63) | Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Metric ($ thousands) | June 30, 2022 | June 30, 2021 | | :-------------------- | :------------ | :------------ | | Net cash used in operating activities | $(9,669) | $(9,473) | | Net cash used in investing activities | $(6,268) | $(55,064) | | Net cash (used in) / provided by financing activities | $(2,251) | $86,390 | | Net (decrease) / increase in cash, cash equivalents and restricted cash | $(18,237) | $21,851 | | Cash, cash equivalents and restricted cash, at end of period | $9,273 | $36,667 | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Basis of Presentation](index=8&type=section&id=1.%20Basis%20of%20Presentation) - Iterum Therapeutics plc is a clinical-stage pharmaceutical company focused on developing sulopenem as a potential first oral penem in the U.S. and the first oral and IV branded penem globally[26](index=26&type=chunk) - The company has incurred significant operating losses since inception, with net losses of **$10.235 million** and **$91.123 million** for the six months ended June 30, 2022 and 2021, respectively, and an accumulated deficit of **$388.728 million** as of June 30, 2022[30](index=30&type=chunk) - Management believes its cash and cash equivalents (**$9.209 million**) and short-term investments (**$59.666 million**) at June 30, 2022, are sufficient to fund operations into 2024[30](index=30&type=chunk) - The company is evaluating corporate, strategic, financial, and financing alternatives to maximize stakeholder value, including potential licensing, sale of assets, merger, or other strategic transactions[31](index=31&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - No material changes in significant accounting policies, other than the adoption of ASU 2020-06, ASU 2021-04, and ASU 2021-05, which did not have a material impact on the financial statements[34](index=34&type=chunk)[46](index=46&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk) - Significant estimates include valuation of share-based compensation, Royalty-Linked Notes (RLNs), and Derivative liabilities (embedded features in Exchangeable Notes)[35](index=35&type=chunk) - The company operates as a single business segment focused on developing treatments for drug-resistant bacterial infections[43](index=43&type=chunk) [3. Fair Value of Financial Assets and Liabilities](index=11&type=section&id=3.%20Fair%20Value%20of%20Financial%20Assets%20and%20Liabilities) Fair Value of Financial Assets and Liabilities (June 30, 2022 vs. December 31, 2021) | Metric ($ thousands) | June 30, 2022 (Total) | December 31, 2021 (Total) | Level 1 (2022) | Level 2 (2022) | Level 3 (2022) | | :-------------------- | :-------------------- | :------------------------ | :------------- | :------------- | :------------- | | Short-term investments | $59,666 | $53,898 | $59,666 | — | — | | Long-term exchangeable note | $8,502 | $9,495 | — | $10,244 | — | | Derivative liability | $1,622 | $6,058 | — | — | $1,622 | | Royalty-linked notes | $15,071 | $17,968 | — | — | $15,071 | | Total Liabilities | $25,195 | $32,583 | — | $10,244 | $16,693 | - The Derivative liability, consisting of an embedded exchange option and change of control premium in the Exchangeable Notes, decreased by **$4.436 million** for the six months ended June 30, 2022, primarily due to a decrease in the company's share price and market capitalization[54](index=54&type=chunk)[55](index=55&type=chunk)[57](index=57&type=chunk) - The fair value of Royalty-Linked Notes (RLNs) was **$15.071 million** at June 30, 2022, determined using DCF analysis based on expected U.S. sulopenem sales and a **20% risk-adjusted discount rate**[59](index=59&type=chunk)[60](index=60&type=chunk) [4. Short-term Investments](index=13&type=section&id=4.%20Short-term%20Investments) - Short-term investments are classified as available for sale, reported at fair value, and consist of highly liquid, minimum 'A-' rated corporate commercial paper and U.S. Treasury and Agency Bonds with maturities over three months[62](index=62&type=chunk) Short-term Investments by Security Type (June 30, 2022 vs. December 31, 2021) | Security Type ($ thousands) | Cost (2022) | Fair Value (2022) | Cost (2021) | Fair Value (2021) | | :--------------------------- | :---------- | :---------------- | :---------- | :---------------- | | Commercial paper | $37,321 | $37,187 | $37,549 | $36,996 | | U.S. Treasury and Agency Bonds | $22,909 | $22,479 | $16,984 | $16,902 | | Total | $60,230 | $59,666 | $54,533 | $53,898 | [5. Prepaid Expenses and Other Current Assets](index=13&type=section&id=5.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid Expenses and Other Current Assets (June 30, 2022 vs. December 31, 2021) | Item ($ thousands) | June 30, 2022 | December 31, 2021 | | :------------------ | :------------ | :---------------- | | Prepaid insurance | $1,215 | $624 | | R&D tax credit receivable | $304 | $840 | | Other prepaid assets | $180 | $56 | | Prepaid R&D expenses | $144 | — | | Interest receivable | $123 | $290 | | Short-term deposits | $34 | $37 | | Value added tax receivable | $21 | $75 | | Total | $2,021 | $1,922 | [6. Intangible Asset, net](index=13&type=section&id=6.%20Intangible%20Asset%2C%20net) Intangible Asset, net ($ thousands) | Metric | June 30, 2022 | December 31, 2021 | | :----- | :------------ | :---------------- | | Gross intangible asset | $5,148 | $5,148 | | Less: accumulated amortization | $(2,571) | $(1,713) | | Net intangible asset | $2,577 | $3,435 | - The intangible asset represents a reservation right for a tableting facility, amortized over a three-year term from January 1, 2021, to December 31, 2023[66](index=66&type=chunk) [7. Property and Equipment, net](index=14&type=section&id=7.%20Property%20and%20Equipment%2C%20net) Property and Equipment, net ($ thousands) | Metric | June 30, 2022 | December 31, 2021 | | :----- | :------------ | :---------------- | | Leasehold improvements | $148 | $148 | | Furniture and fixtures | $120 | $120 | | Laboratory equipment | — | $86 | | Computer equipment | $33 | $23 | | Total gross | $301 | $377 | | Less: accumulated depreciation | $(255) | $(286) | | Net property and equipment | $46 | $91 | - Depreciation expense was **$55 thousand** for the six months ended June 30, 2022[67](index=67&type=chunk) [8. Leases](index=14&type=section&id=8.%20Leases) - The company has operating leases for office space and commercial property, with remaining terms ranging from four months to six years[68](index=68&type=chunk) - Operating lease costs were **$410 thousand** for the six months ended June 30, 2022, and rental expenses on short-term leases were **$121 thousand**[68](index=68&type=chunk) Operating Lease Liabilities ($ thousands) | Metric | June 30, 2022 | December 31, 2021 | | :----- | :------------ | :---------------- | | Other assets (Right-of-use) | $2,214 | $3,741 | | Other current liabilities | $292 | $464 | | Other liabilities | $1,735 | $3,436 | | Total lease liabilities | $2,027 | $3,900 | | Weighted-average remaining lease term | 5.8 years | 13.97 years | | Weighted-average discount rate | 7.2% | 7.0% | [9. Accrued Expenses](index=15&type=section&id=9.%20Accrued%20Expenses) Accrued Expenses ($ thousands) | Item | June 30, 2022 | December 31, 2021 | | :--- | :------------ | :---------------- | | Accrued payroll and bonus expenses | $1,823 | $771 | | Accrued other expenses | $402 | $256 | | Accrued clinical trial costs | $335 | $45 | | Accrued manufacturing expenses | $201 | $77 | | Accrued professional fees | $193 | $16 | | Total | $2,954 | $1,165 | [10. Debt](index=15&type=section&id=10.%20Debt) - The secured credit facility with SVB, with an initial **$15 million** draw, was fully repaid on March 1, 2022, terminating the agreement[72](index=72&type=chunk)[73](index=73&type=chunk)[75](index=75&type=chunk) - The Paycheck Protection Program (PPP) loan of **$744 thousand** was fully repaid on March 17, 2022, after **$340 thousand** was forgiven in November 2020[86](index=86&type=chunk)[198](index=198&type=chunk) - As of June 30, 2022, **$12.607 million** aggregate principal amount of 2025 Exchangeable Notes remained outstanding, with **$39.201 million** having been exchanged for **53,888,331 ordinary shares** since January 21, 2021[78](index=78&type=chunk)[85](index=85&type=chunk) Scheduled Principal Payments on Outstanding Debt ($ thousands) | Year Ending June 30, | Amount | | :------------------- | :----- | | 2023 | $— | | 2024 | $— | | 2025 | $12,607 | | 2026 | $— | | 2027 | $— | | Thereafter | $104 | | Total | $12,711 | [11. Royalty-Linked Notes](index=18&type=section&id=11.%20Royalty-Linked%20Notes) - The company issued **2,579,400 Royalty-Linked Notes (RLNs)** in January 2020 and an additional **11,000** in September 2020, entitling holders to payments based on a percentage of U.S. net revenues from specified sulopenem products[89](index=89&type=chunk) - RLNs are subject to a maximum return of **$160.00 per note** and require FDA approval of a sulopenem product by December 31, 2025, to trigger payments[89](index=89&type=chunk) Royalty-Linked Notes Liability ($ thousands) | Metric | June 30, 2022 | | :----- | :------------ | | Total liability related to the sale of future royalties, on inception | $10,990 | | Liability related to the sale of future royalties, arising from the Rights Offering | $51 | | Amortization of discount and debt issuance costs | $3,666 | | Adjustments to fair value | $364 | | Total liability related to the sale of future royalties at June 30, 2022 | $15,071 | | Long-term Portion | $15,071 | [12. Shareholders' Equity](index=19&type=section&id=12.%20Shareholders'%20Equity) Shareholders' Equity Reconciliation (Six Months Ended June 30, 2022) | Item | Amount ($ thousands) | | :--- | :-------------------- | | Shareholders' equity at January 1, 2022 | $50,234 | | Share-based compensation expense | $3,879 | | Issuance of ordinary shares, net | $8 | | Net loss | $(10,235) | | Shareholders' equity at June 30, 2022 | $43,886 | - The company's authorized ordinary shares increased to **300,000,000 shares** of **$0.01 par value** each as of June 30, 2022, following shareholder approval on January 28, 2021[97](index=97&type=chunk) - Various warrants to purchase ordinary shares were issued in connection with debt facilities and offerings, with significant exercises occurring in 2021, generating net proceeds of **$13.885 million** from October 2020 Offering warrants and **$546 thousand** from February 2021 Underwritten Offering warrants[98](index=98&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) [13. Share-Based Compensation](index=21&type=section&id=13.%20Share-Based%20Compensation) - The company granted **2,286,889 share options** and **792,877 Restricted Share Units (RSUs)** during the six months ended June 30, 2022[120](index=120&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) Share-Based Compensation Expense ($ thousands) | Expense Type | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2022 | | :------------- | :------------------------------- | :----------------------------- | | R&D expense | $614 | $1,140 | | G&A expense | $1,370 | $2,739 | | Total | $1,984 | $3,879 | - Total unamortized share-based compensation expense for options and RSUs was **$19.578 million** as of June 30, 2022, expected to be recognized over a remaining average vesting period of **2.61 years**[126](index=126&type=chunk) [14. Income Taxes](index=24&type=section&id=14.%20Income%20Taxes) - Income tax expense was **$770 thousand** for the six months ended June 30, 2022, compared to **$182 thousand** for the same period in 2021[127](index=127&type=chunk) - The company has net operating loss carryforwards in Ireland of approximately **$34.566 million** as of June 30, 2022, for which a full valuation allowance has been recognized due to uncertainty of realization[128](index=128&type=chunk) [15. Commitments and Contingencies](index=24&type=section&id=15.%20Commitments%20and%20Contingencies) - Under the Pfizer License, the company is obligated to pay potential future regulatory and sales milestone payments, as well as single-digit to mid-teens percentage royalties on net sales of licensed products[129](index=129&type=chunk)[130](index=130&type=chunk) - A class action lawsuit was filed against the company and its executives on August 5, 2021, alleging material misstatements regarding the NDA for oral sulopenem. The company denies wrongdoing and intends to vigorously defend against the lawsuit[133](index=133&type=chunk)[135](index=135&type=chunk) - The Royalty-Linked Notes (RLNs) entitle holders to payments based on a percentage of U.S. net revenues from specified sulopenem products, subject to FDA approval by December 31, 2025, and a maximum return of **$160.00 per RLN**[131](index=131&type=chunk)[132](index=132&type=chunk) [16. Condensed Consolidating Financial Statements](index=25&type=section&id=16.%20Condensed%20Consolidating%20Financial%20Statements) - Iterum Bermuda, a wholly-owned finance subsidiary, issued Exchangeable Notes and RLNs, which are fully and unconditionally guaranteed by Iterum Therapeutics plc and its Subsidiary Guarantors[138](index=138&type=chunk)[139](index=139&type=chunk) [17. Subsequent Events](index=25&type=section&id=17.%20Subsequent%20Events) - No events subsequent to the period end requiring adjustment or disclosure, other than those disclosed in the Form 8-K filed on July 8, 2022[140](index=140&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes the company's financial condition, operations, and liquidity, focusing on sulopenem development, FDA challenges, and strategic alternatives amid ongoing losses [Overview](index=26&type=section&id=Overview) [Components of Our Results of Operations](index=28&type=section&id=Components%20of%20Our%20Results%20of%20Operations) [Research and Development Expenses](index=28&type=section&id=Research%20and%20Development%20Expenses) - R&D expenses are expensed as incurred and include costs for CROs, CMOs, clinical trials, manufacturing, employee-related expenses, regulatory compliance, and third-party licensing payments[154](index=154&type=chunk) - The successful development and commercialization of sulopenem is highly uncertain, with numerous risks including the impact of COVID-19, clinical trial outcomes, regulatory approvals, and manufacturing capabilities[155](index=155&type=chunk)[157](index=157&type=chunk) [General and Administrative Expenses](index=29&type=section&id=General%20and%20Administrative%20Expenses) - G&A expenses primarily include salaries, benefits, share-based compensation for executive, finance, market research, and administrative functions, as well as professional fees and pre-commercialization activities[159](index=159&type=chunk) - Following the CRL in Q3 2021, pre-commercial activities for oral sulopenem were halted to reduce operating expenses and conserve cash, with spending limited to essential NDA resubmission costs[160](index=160&type=chunk) [Interest Expense, Net](index=29&type=section&id=Interest%20Expense%2C%20Net) - Interest expense, net, includes accrued interest and amortization of debt costs for Exchangeable Notes and Royalty-Linked Notes, interest earned on cash and investments, and interest on the SVB loan and PPP loan[161](index=161&type=chunk) [Adjustments to Fair Value of Derivatives](index=29&type=section&id=Adjustments%20to%20Fair%20Value%20of%20Derivatives) - Derivative liabilities, embedded in Exchangeable Notes, are revalued quarterly, with changes in fair value recorded as non-cash adjustments in the statements of operations[162](index=162&type=chunk) [Other Income, Net](index=29&type=section&id=Other%20Income%2C%20Net) - Other income, net, comprises realized and unrealized foreign currency gains and sub-lease income[163](index=163&type=chunk) [Provision for Income Taxes](index=29&type=section&id=Provision%20for%20Income%20Taxes) - Income taxes are recognized under the asset and liability method, with deferred taxes for temporary differences. A full valuation allowance is recognized for net deferred tax assets due to a history of losses[164](index=164&type=chunk)[166](index=166&type=chunk) [Critical Accounting Estimates](index=30&type=section&id=Critical%20Accounting%20Estimates) - No significant changes to critical accounting estimates from those described in the Annual Report on Form 10-K filed on March 28, 2022[167](index=167&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) [Comparison of the three months ended June 30, 2022 and 2021](index=30&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030%2C%202022%20and%202021) Operating Loss and (Loss) / Income Before Income Tax (Three Months Ended June 30, $ thousands) | Metric | June 30, 2022 | June 30, 2021 | Change | | :----- | :------------ | :------------ | :----- | | Operating expenses | $(8,050) | $(6,987) | $(1,063) | | Operating loss | $(8,050) | $(6,987) | $(1,063) | | Total other income, net | $1,658 | $14,907 | $(13,249) | | (Loss) / income before income taxes | $(6,392) | $7,920 | $(14,312) | - Research and development expenses increased by **$1.270 million**, primarily due to increased costs for the planned Phase 3 clinical trial and higher personnel-related costs (including share-based compensation), partially offset by decreased consulting fees[169](index=169&type=chunk) - General and administrative expenses decreased by **$0.207 million**, driven by a **$1.9 million** decrease in professional and consulting fees (due to halted pre-commercialization activities), partially offset by a **$1.6 million** increase in personnel-related costs[170](index=170&type=chunk) - Total other income, net, decreased by **$13.249 million**, mainly due to a **$13.639 million** decrease in fair value adjustments of derivatives (from **$15.794 million** income in 2021 to **$2.155 million** income in 2022), primarily linked to a decrease in ordinary share price and market capitalization[171](index=171&type=chunk)[173](index=173&type=chunk) [Comparison of the six months ended June 30, 2022 and 2021](index=31&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030%2C%202022%20and%202021) Operating Loss and Loss Before Income Tax (Six Months Ended June 30, $ thousands) | Metric | June 30, 2022 | June 30, 2021 | Change | | :----- | :------------ | :------------ | :----- | | Operating expenses | $(15,423) | $(12,834) | $(2,589) | | Operating loss | $(15,423) | $(12,834) | $(2,589) | | Total other income / (expense), net | $5,958 | $(78,107) | $84,065 | | Loss before income taxes | $(9,465) | $(90,941) | $81,476 | - Research and development expenses increased by **$2.259 million**, driven by higher costs for the planned Phase 3 clinical trial, increased personnel-related costs (including share-based compensation), and intangible asset amortization, partially offset by reduced consulting fees[176](index=176&type=chunk) - General and administrative expenses increased by **$0.330 million**, primarily due to a **$2.8 million** increase in personnel-related costs (including share-based compensation and director fees), largely offset by a **$2.8 million** decrease in professional and consulting fees[177](index=177&type=chunk) - Total other income / (expense), net, improved by **$84.065 million**, shifting from a **$(78.107) million** expense in 2021 to a **$5.958 million** income in 2022. This was primarily due to an **$81.641 million** positive change in fair value adjustments of derivatives (from **$(74.309) million** expense in 2021 to **$7.332 million** income in 2022), driven by a decrease in ordinary share price and market capitalization, and a **$2.1 million** decrease in net interest expense[178](index=178&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) - The company has funded operations through equity offerings, debt financings (SVB loan, PPP loan, Exchangeable Notes, RLNs), and a CARB-X sub-award, accumulating **$198.2 million** from share sales and **$45.0 million** from the Private Placement and Rights Offering[183](index=183&type=chunk) - As of June 30, 2022, cash, cash equivalents, restricted cash, and short-term investments totaled **$68.9 million**, expected to fund operations into 2024[184](index=184&type=chunk) - The SVB secured credit facility and PPP loan were fully repaid in March 2022. As of June 30, 2022, **$12.6 million** of Exchangeable Notes remained outstanding, with **$39.2 million** having been exchanged for ordinary shares[186](index=186&type=chunk)[190](index=190&type=chunk)[198](index=198&type=chunk) [Funding Requirements](index=34&type=section&id=Funding%20Requirements) - The company anticipates significant expenses and operating losses for potential marketing approval, pre-commercialization activities, and further development of sulopenem, including a planned Phase 3 clinical trial[205](index=205&type=chunk) - Future funding will depend on factors such as clinical trial timing and costs, regulatory approvals, commercialization expenses, intellectual property protection, and potential acquisitions[205](index=205&type=chunk)[206](index=206&type=chunk) - Additional capital may be raised through equity offerings, debt financings, or collaborations, which could dilute shareholders, impose restrictive covenants, or require relinquishing rights to technologies[206](index=206&type=chunk) [Contractual Obligations and Commitments](index=38&type=section&id=Contractual%20Obligations%20and%20Commitments) - The company is obligated to Pfizer for regulatory and sales milestone payments, and single-digit to mid-teens royalties on net sales under the Pfizer License[207](index=207&type=chunk) - Under the RLN Indenture, holders are entitled to payments based on U.S. net revenues from specified sulopenem products, up to a maximum return of **$160.00 per RLN**, contingent on FDA approval by December 31, 2025[208](index=208&type=chunk) Future Operating Lease Obligations ($ millions) | Period | Amount | | :----- | :----- | | Within one year | $0.5 | | Greater than one year | $1.6 | [Emerging Growth Company Status](index=38&type=section&id=Emerging%20Growth%20Company%20Status) - The company has irrevocably opted out of the extended transition period for complying with new or revised accounting standards under the JOBS Act, adhering to public company standards[210](index=210&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section details the company's exposure to market risks, primarily interest rate risk on its investments and foreign currency exchange rate risk from global operations. The company does not currently engage in hedging activities - As of June 30, 2022, the company held **$68.9 million** in cash, cash equivalents, and short-term investments, primarily in money market funds, commercial paper, and U.S. treasury and agency bills[212](index=212&type=chunk) - An immediate **100 basis point** increase in interest rates would result in a **$0.3 million** decrease in the fair market value of the investment portfolio[212](index=212&type=chunk) - The company is exposed to foreign currency fluctuations from global CRO and CMO agreements, but realized net foreign currency gains and losses did not materially affect results for the six months ended June 30, 2022[213](index=213&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2022. No material changes to internal control over financial reporting occurred during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2022[214](index=214&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2022[215](index=215&type=chunk) [PART II. OTHER INFORMATION](index=39&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section presents additional information including legal proceedings, comprehensive risk factors, recent sales of unregistered securities, and a list of exhibits [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) This section details a putative class action lawsuit filed against the company and its executives in August 2021, alleging material misstatements regarding the NDA for oral sulopenem. The company denies the allegations and intends to vigorously defend against the lawsuit - A class action lawsuit was filed on August 5, 2021, against the company, its CEO, and CFO, alleging violations of the Securities Exchange Act of 1934 related to the NDA submission for oral sulopenem[217](index=217&type=chunk) - The complaint seeks unspecified damages, attorneys' fees, expert fees, and other costs. The company filed a motion to dismiss on April 8, 2022, and denies all allegations of wrongdoing[217](index=217&type=chunk)[218](index=218&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks impacting the company's financial position, clinical development, commercialization, third-party dependence, intellectual property, and regulatory approvals - The company has incurred net losses since inception, with an accumulated deficit of **$388.7 million** as of June 30, 2022, and will require additional capital to fund operations[220](index=220&type=chunk)[224](index=224&type=chunk) - The FDA issued a Complete Response Letter (CRL) for oral sulopenem's NDA, requiring additional clinical and non-clinical data, which could delay or prevent approval[220](index=220&type=chunk)[229](index=229&type=chunk)[230](index=230&type=chunk) - The company is heavily dependent on the success of its sulopenem program, and failure to obtain marketing approval or successfully commercialize it would materially harm the business[235](index=235&type=chunk)[236](index=236&type=chunk) - Indebtedness from Exchangeable Notes and Royalty-Linked Notes imposes operating restrictions and may hinder the ability to raise additional capital or settle exchanges in cash[233](index=233&type=chunk)[239](index=239&type=chunk)[243](index=243&type=chunk) [Risks Related to Our Financial Position and Capital Requirements](index=40&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Requirements) [Risks Related to Clinical Development and Commercialization](index=43&type=section&id=Risks%20Related%20to%20Clinical%20Development%20and%20Commercialization) [Risks Related to Our Dependence on Third Parties](index=55&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) [Risks Related to Our Intellectual Property](index=63&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) [Risks Related to Regulatory Approval and Other Legal Compliance Matters](index=72&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) [Risks Related to Employee Matters and Managing Growth](index=82&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth) [Risks Related to Taxation](index=84&type=section&id=Risks%20Related%20to%20Taxation) [Risks Related to Our Ordinary Shares](index=86&type=section&id=Risks%20Related%20to%20Our%20Ordinary%20Shares) [Item 2. Recent Sales of Unregistered Securities](index=95&type=section&id=Item%202.%20Recent%20Sales%20of%20Unregistered%20Securities) The company did not issue any unregistered securities during the three months ended June 30, 2022 - No unregistered securities were issued during the three months ended June 30, 2022[526](index=526&type=chunk) [Item 6. Exhibits](index=96&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed or furnished as part of this Quarterly Report on Form 10-Q, including consulting agreements, share option cancellation agreements, certifications, and XBRL documents - Exhibits include consulting agreements, share option cancellation agreements for executives, certifications of principal executive and financial officers, and Inline XBRL documents[527](index=527&type=chunk) [Signatures](index=97&type=section&id=Signatures) The report is signed by Corey Fishman, President and Chief Executive Officer, and Judith Matthews, Chief Financial Officer, on August 12, 2022, certifying compliance with the Securities Exchange Act of 1934 - The report was signed by Corey Fishman, President and CEO, and Judith Matthews, CFO, on August 12, 2022[531](index=531&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) Ireland 98-1283148 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Fitzwilliam Court 1st Floor, Leeson Close, Dublin 2, Ireland (Address of principal executive offices) Not applicable (Zip Code) (+353 ...

Iterum Therapeutics plc (NASDAQ:ITRM) Q4 2021 Earnings Conference Call March 28, 2022 8:30 AM ET Company Participants Louise Barrett - Senior Vice President of Legal Affairs Corey Fishman - Chief Executive Officer Judy Matthews - Chief Financial Officer Conference Call Participants Thomas Yip - H.C. Wainwright Operator Hello, and welcome to the Iterum Therapeutics Fourth Quarter and Full Year 2021 Financial Results Call. My name is Alex, and I will be coordinating the call today. [Operator Instructions]. I ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Iterum Therapeutics plc (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or organization) Ireland 98-1283148 (I.R.S. Employer Identification No.) Fitzwilliam Court, 1st Floor, Leeson Close, Dublin 2, Ireland (Address of principal execut ...

Iterum Therapeutics plc (NASDAQ:ITRM) Q3 2021 Earnings Conference Call November 12, 2021 8:30 AM ET Company Participants Corey Fishman – CEO Louise Barrett – Senior Vice President Legal Affairs Judy Matthews – CFO Conference Call Participants Gregory Renza – RBC Capital Markets Thomas Yip – H.C. Wainwright Operator Hello and welcome to the Iterum Therapeutic Q3 Financial Results Conference Call. My name is Alex and I will be your operator for today. [Operator Instructions] I'll now hand over to your host, L ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) WASHINGTON, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 For the transition period from to OR Commission File Number: 001-38503 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) Ireland 98-1283148 (State or other juris ...