Financial Performance - The company reported total operating expenses of 38.60 million from 109.36 million, compared to a net loss of 32.93 million[577]. - The company reported a net cash used in operating activities of 73.5 million in 2023, primarily due to a net loss 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 69.26 million in 2023, reflecting an increase of 33.05 million in 2024, compared to 11.19 million[577]. - Research and development expenses increased to 69.3 million in 2023, a rise of 33.0 million in 2024 from 11.2 million, mainly driven by higher personnel-related costs[580]. Cash and Securities - The company had cash, cash equivalents, and marketable securities of 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 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 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 14.80 million in 2023, while interest expense was 20.7 million in 2024 compared to 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].
Disc Medicine(IRON) - 2024 Q4 - Annual Report