Iterum Therapeutics(US:ITRM)2025-05-13 11:30PART I. FINANCIAL INFORMATION Financial Statements (Unaudited) The company reported a reduced net loss but faces a significant cash decrease and a going concern warning Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $12,652 | $24,125 | | Total current assets | $13,513 | $24,787 | | Total assets | $32,975 | $44,595 | | Liabilities & Shareholders' Deficit | | | | Total current liabilities | $3,628 | $17,605 | | Total liabilities | $35,529 | $48,676 | | Total shareholders' deficit | $(2,554) | $(4,081) | Condensed Consolidated Statements of Operations Highlights (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $(3,710) | $(6,163) | | Operating loss | $(3,710) | $(6,163) | | Net loss | $(4,891) | $(7,101) | | Net loss per share – basic and diluted | $(0.14) | $(0.46) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,060) | $(13,083) | | Net cash (used in) / provided by investing activities | $(2) | $7,211 | | Net cash (used in) / provided by financing activities | $(8,388) | $7,217 | | Net (decrease) / increase in cash | $(11,473) | $1,318 | - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern due to insufficient funds174042 - On January 31, 2025, the company repaid its matured Exchangeable Notes, totaling $14.7 million in principal and accrued interest336379 - Subsequent to the quarter end, the company raised approximately $957,000 through its Sales Agreement and an additional $4.2 million (net) from a direct offering132133 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses its strategic focus on sulopenem rights and a significant going concern issue - Following the FDA approval of ORLYNVAH™, the company's primary focus is a strategic process to sell or license its sulopenem rights138187216 - The company has substantial doubt about its ability to continue as a going concern, with $12.7 million in cash insufficient for the next 12 months144188 Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cost of sales | $ (342) | $ — | $ (342) | | Research and development | $ (591) | $ (3,977) | $ 3,386 | | General and administrative | $ (2,777) | $ (2,186) | $ (591) | | Total operating expenses | $ (3,710) | $ (6,163) | $ 2,453 | - Research and development expenses decreased by $3.4 million due to lower CRO costs after completing the REASSURE trial160 - General and administrative expenses increased by $0.9 million in professional fees for pre-commercialization activities161 - Net cash used in financing activities was $8.4 million, driven by a $14.7 million repayment of notes, offset by $6.4 million from share sales185 Quantitative and Qualitative Disclosures About Market Risk The company's primary market risks are foreign currency fluctuations and potential inflation impacts - The company is subject to foreign currency risk from international contracts but does not currently engage in hedging202 - Inflation is a risk that could increase operational costs but has not had a material effect to date203 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025 - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025204 - No material changes to internal control over financial reporting occurred during the first quarter of 2025205 PART II. OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings - As of the filing date, the company is not a party to any material legal proceedings208 Risk Factors The company faces significant risks including a going concern warning and dependence on its sulopenem program - The company has substantial doubt about its ability to continue as a going concern due to insufficient cash reserves210211 - The strategic process to sell or license sulopenem rights may not be successful, potentially leading to liquidation of the business248250251 - The company is heavily dependent on the success of its sulopenem program and lacks a commercial organization224254289 - The company relies on an exclusive license agreement with Pfizer for critical patent rights for sulopenem326329 - The company's reliance on third-party contract manufacturers creates risks related to supply, cost, quality, and regulatory compliance343347 - The company faces substantial competition from larger pharmaceutical companies and its products may not achieve market acceptance296301 - The company's stock price has been highly volatile, and its retail investor base may hinder corporate initiatives516520 Other Information No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the first quarter - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during Q1 2025564 Exhibits This section lists all exhibits filed with the report, including required officer certifications - The report includes required certifications from the CEO and CFO under the Sarbanes-Oxley Act565 - Exhibits incorporate by reference the Securities Purchase Agreement and Form of Pre-Funded Warrant from the April 2025 financing565