Disc Medicine(IRON) - 2024 Q4 - Annual Report

Financial Performance - The company reported total operating expenses of $129.72 million for the year ended December 31, 2024, an increase of $38.60 million from $91.13 million in 2023[577]. - The net loss for the year ended December 31, 2024, was $109.36 million, compared to a net loss of $76.43 million in 2023, representing an increase in loss of $32.93 million[577]. - The company reported a net cash used in operating activities of $93.9 million for 2024, compared to $73.5 million in 2023, primarily due to a net loss of $109.4 million[589]. - The company has an accumulated deficit of $298.0 million as of December 31, 2024, and anticipates ongoing significant expenses[586]. - The company expects to continue incurring significant operating losses and may require additional capital to fund operations, potentially through equity or debt financing[583]. Expenses - Research and development expenses rose to $96.67 million in 2024, up from $69.26 million in 2023, reflecting an increase of $27.41 million[577]. - Selling, general and administrative expenses increased to $33.05 million in 2024, compared to $21.86 million in 2023, marking an increase of $11.19 million[577]. - Research and development expenses increased to $96.7 million in 2024 from $69.3 million in 2023, a rise of $27.4 million, primarily due to higher personnel-related costs and external development expenses[578]. - Selling, general and administrative expenses rose to $33.0 million in 2024 from $21.9 million in 2023, an increase of $11.2 million, mainly driven by higher personnel-related costs[580]. Cash and Securities - The company had cash, cash equivalents, and marketable securities of $489.9 million as of December 31, 2024, and raised approximately $243.3 million from a public offering in January 2025[567]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $489.9 million, an increase from $360.4 million as of December 31, 2023[617]. - The company completed an underwritten offering in January 2025, expected to generate net proceeds of approximately $243.3 million[585]. - Total contractual obligations as of December 31, 2024, amounted to $3.98 million, with payments due over various periods[597]. Product Development - Bitopertin, the lead product candidate, showed significant reduction in the toxic metabolite protoporphyrin IX (PPIX) in clinical trials, with plans to submit a New Drug Application (NDA) for accelerated approval in the second half of 2025[562]. - DISC-0974, another key product candidate, completed a Phase 1 clinical trial with positive results and is currently in Phase 1b/2 trials for anemia of myelofibrosis and chronic kidney disease[563]. - The company plans to initiate a Phase 2 clinical trial for DISC-3405 in polycythemia vera in the first half of 2025, following the completion of initial trials[566]. - The company has not generated any revenue since inception and does not expect to do so in the near future, pending successful commercialization of product candidates[568]. Income and Interest - Interest income increased to $21.29 million in 2024 from $14.80 million in 2023, while interest expense was $572, reflecting a new debt issuance[577]. - Other income increased to $20.7 million in 2024 compared to $14.8 million in 2023, reflecting a $5.9 million rise in interest income[581]. Market and Economic Factors - If U.S. market interest rates were to increase by one percentage point, the net fair value of the company’s marketable securities would decrease by approximately $1.4 million[617]. - The company has minimal exposure to foreign currency exchange rate fluctuations due to the short duration of transactions[618]. - Inflation has not materially affected the company’s business, financial condition, or results of operations during the years ended December 31, 2024, and 2023[619]. Accounting and Valuation - The company’s stock-based compensation expense is based on fair value estimates using the Black-Scholes option-pricing model, which involves subjective assumptions[606]. - Prior to the merger closing, the estimated fair value of the company’s common stock was determined based on third-party valuations and management assessments[609]. - After the merger, the fair value of the company’s common stock is now determined based on the quoted market price[613]. - The company was classified as an "emerging growth company" until December 31, 2024, allowing it to benefit from certain reporting exemptions[615]. - The company’s accounting policies and estimates are critical to the preparation of its consolidated financial statements, affecting reported amounts of assets and liabilities[602].