Disc Medicine(IRON) - 2025 Q3 - Quarterly Report

Financial Position - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $615.9 million[107] - Cash, cash equivalents, and marketable securities as of September 30, 2025, totaled $615.9 million, up from $489.9 million as of December 31, 2024[150] - The accumulated deficit as of September 30, 2025, was $449.7 million, reflecting ongoing operational losses since inception[132] - The company has contractual lease commitments totaling $3.34 million, with payments due over the next five years[143] - Interest income primarily consists of earnings from cash equivalents and marketable securities, contributing to the company's financial operations[117] Revenue and Losses - The company has not generated any revenue since inception and does not expect to do so in the near future[108] - Net loss for Q3 2025 was $62.3 million, compared to a net loss of $26.6 million in Q3 2024, reflecting a 134% increase in losses year-over-year[119] - Total operating expenses for Q3 2025 reached $67.7 million, up 106% from $32.9 million in Q3 2024, leading to a loss from operations of $67.7 million compared to a loss of $32.9 million in the same period last year[119] - The company expects to continue incurring significant operating losses and may require additional capital to fund operations, potentially through equity or debt financing[128][129] Expenses - Research and development expenses for Q3 2025 were $50.3 million, a 103% increase from $24.7 million in Q3 2024, primarily due to increased costs in clinical trials and personnel-related expenses[120][122] - Selling, general and administrative expenses for Q3 2025 were $17.4 million, a 113% increase from $8.2 million in Q3 2024, driven by higher personnel-related costs and professional fees[123][124] - Selling, general and administrative expenses are expected to increase significantly as the company expands its workforce and infrastructure for potential commercialization[116] - The company anticipates substantial increases in research and development expenses as clinical programs advance[112] Clinical Development - Bitopertin, the lead product candidate, has shown significant reduction in protoporphyrin IX (PPIX) levels and improvements in quality of life in clinical trials[103] - The FDA agreed that PPIX reduction could serve as a surrogate endpoint for accelerated approval of bitopertin in EPP and XLP[103] - DISC-0974 demonstrated substantial decreases in hepcidin and increases in iron levels in a Phase 1b study for anemia of myelofibrosis[105] - The company plans to initiate a Phase 2 clinical trial of DISC-0974 in patients with inflammatory bowel disease and anemia in Q1 2026[105] - The company expects substantial increases in expenses as it advances product candidates through clinical development, necessitating additional funding[140] Financing Activities - In October 2025, the company completed a public offering for net proceeds of approximately $210.9 million, which will fund operations into 2029[107] - In October 2025, the company completed a public offering that generated net proceeds of approximately $210.9 million, enhancing its capital resources[131] - Net cash provided by financing activities increased to $256.7 million in the nine months ended September 30, 2025, from $189.5 million in the same period of 2024[138][139] - Future funding may come from equity offerings, debt financings, collaborations, and licensing arrangements, but there is a risk of dilution for existing stockholders[141] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2025, was $137.1 million, significantly higher than $66.4 million for the same period in 2024, indicating increased operational expenditures[133][135] - Net cash used in investing activities for the nine months ended September 30, 2025, was $491.3 million, compared to $313.9 million for the same period in 2024[137][138] Market and Economic Factors - If market interest rates increase by one percentage point, the net fair value of marketable securities would decrease by approximately $2.6 million[150] - Inflation has not had a material effect on the company's financial condition or results of operations during the nine months ended September 30, 2025[152] - The company has minimal exposure to foreign currency risk due to the short duration of transactions[151] - There are no material changes to critical accounting estimates from the previous year, indicating stability in financial reporting[147]