Iterum Therapeutics(US:ITRM)2025-02-07 12:30Financial Performance - As of December 31, 2024, the company had an accumulated deficit of $486.1 million, indicating significant operating losses since inception [606]. - Operating loss for the year ended December 31, 2024, was $18.7 million, a decrease of $28.8 million compared to a loss of $47.5 million in 2023 [626]. - The company reported a loss before income taxes of $24.5 million for 2024, an improvement of $13.2 million from a loss of $37.8 million in 2023 [626]. - Total operating expenses decreased to $18.7 million in 2024 from $47.5 million in 2023, primarily due to a significant reduction in research and development expenses [626]. - The decrease in CRO and other preclinical and clinical trial expenses was $29.6 million, primarily due to the completion of enrollment in the REASSURE clinical trial [629]. - The company has incurred significant operating losses and negative cash flows, generating limited revenue primarily from a funding arrangement with Boston University under the CARB-X program [644]. Cash and Funding - Company had cash and cash equivalents of $24.1 million as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern [609]. - The company raised $198.3 million from the sale of Series A and Series B preferred shares and ordinary shares through various offerings [644]. - In the year ended December 31, 2024, the company sold 10,327,787 ordinary shares under the Sales Agreement at an average price of $1.94 per share, resulting in net proceeds of $19.4 million [646]. - The company completed the 2024 Rights Offering, selling 6,121,965 units at a subscription price of $1.21 per unit, resulting in net proceeds of approximately $5.4 million [653]. - For the year ended December 31, 2024, the company used $26.8 million in cash for operating activities, resulting from a net loss of $24.8 million and changes in operating assets and liabilities of $12.7 million [655]. - Financing activities generated $26.7 million in net cash in 2024, mainly from the sale of ordinary shares amounting to $19.4 million [659]. - As of December 31, 2024, the company had cash and cash equivalents of $24.1 million, with expected cash usage for the next 12 months indicating a need for additional capital to fund operations [661]. Research and Development - Research and development expenses primarily relate to the sulopenem program, including costs for clinical trials and regulatory compliance [613]. - Research and development expenses for 2024 were $10.5 million, down $29.5 million from $40.0 million in 2023, mainly due to lower costs associated with the REASSURE clinical trial [628][629]. - The company expects to incur significant expenses and increasing operating losses as it prepares to commercialize ORLYNVAH™ [660]. Strategic Focus - Company is focusing on a strategic process to sell, license, or dispose of rights to sulopenem to maximize stakeholder value [605]. - The company plans to focus on selling or licensing its rights to sulopenem to maximize shareholder value following positive data from the REASSURE trial [660]. - The company is evaluating strategic alternatives with the assistance of a financial advisor, but there is no assurance of successful transactions [611]. Expenses and Obligations - Company may incur significant costs associated with operating as a public company, including legal and accounting expenses [606]. - Interest expense includes accrued interest on Exchangeable Senior Subordinated Notes and a promissory note related to a milestone payment to Pfizer [617]. - The company has contractual obligations to make milestone payments to Pfizer based on sales milestones ranging from $250 million to $1 billion for each product type [666]. - The company is obligated to make payments on RLNs based on a percentage of net revenues from U.S. sales of specified sulopenem products, with a payment rate of 15% [667]. - Interest expense, net increased by $1.1 million in 2024, primarily due to decreased interest income and interest accruing on the Pfizer Promissory Note [632]. Market and Economic Conditions - The company anticipates that inflation may increase its operating costs, particularly in labor and research and development [674]. - The company does not currently engage in hedging activities against foreign currency exchange rate risk, and realized net foreign currency gains and losses did not materially affect its operations [673].