Financial Performance - The company incurred net losses of $73.9 million and $35.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $229.9 million as of December 31, 2024[710]. - The company expects to continue incurring operating losses for the foreseeable future, with no products approved for sale and no revenue generated since inception[715]. - The accumulated deficit increased from $156.0 million in 2023 to $229.9 million in 2024[744]. Cash and Investments - The company had cash, cash equivalents, and marketable securities of $212.5 million as of December 31, 2024, sufficient to fund operations through 2027 based on current estimates[711]. - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $212.5 million, up from $106.8 million in 2023[744]. - Net cash used in operating activities was $15.6 million in 2024, compared to $20.6 million in 2023, reflecting a net loss of $73.9 million[752][753]. - Net cash used in investing activities was $121.1 million in 2024, primarily due to purchases of marketable securities totaling $132.2 million[754]. - Net cash provided by financing activities was $130.7 million in 2024, mainly from the issuance of common stock in a private placement[757]. Research and Development - Research and development expenses totaled $65.995 million for the year ended December 31, 2024, a significant increase from $15.411 million in 2023[726]. - The company anticipates substantial increases in research and development expenses as it conducts ongoing clinical trials and studies[728]. - Budoprutug, the company's cornerstone product candidate, is in clinical development for primary membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus, with FDA clearance for Phase 2 trials expected to begin in the second half of 2025[707]. - The company plans to announce preclinical data for the subcutaneous formulation of budoprutug in the first half of 2025 and initiate clinical development in the second half of 2025[707]. - CLYM116, a preclinical stage anti-APRIL monoclonal antibody, is being evaluated in IND-enabling studies, with preclinical data expected in the second half of 2025[708]. Operating Expenses - Total operating expenses increased by 103.6% from $40.3 million in 2023 to $82.0 million in 2024, primarily due to a $51.7 million expense related to acquired in-process research and development[736][737]. - General and administrative expenses decreased by 35.5% from $24.9 million in 2023 to $16.0 million in 2024, driven by a reduction in personnel-related expenses[741]. Internal Controls and Compliance - The company identified material weaknesses in internal control over financial reporting, with two remaining unremediated as of December 31, 2024[766]. - The company has a remediation plan for the identified material weaknesses in internal controls, disclosed in Item 9A of the Annual Report[766]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards until they apply to private companies[767]. - The company will remain an emerging growth company until it achieves total annual gross revenue of $1.24 billion or more, issues more than $1.0 billion of non-convertible debt, or meets other specified criteria[768]. Stock-Based Compensation - Stock-based compensation is measured based on estimated grant-date fair value, with the Black-Scholes option pricing model used for valuation[764]. - Changes in assumptions regarding stock-based compensation can materially affect the recognized expense in future periods[764]. Market Risk and Accounting Estimates - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[769]. - The preparation of consolidated financial statements involves significant estimates and assumptions that may differ from actual results[762]. - Critical accounting estimates are those that require significant estimation uncertainty and could materially affect financial condition or results of operations[763]. - The consolidated financial statements may not be comparable to those of companies that comply with new accounting pronouncements as of public company effective dates[768].
Eliem Therapeutics(ELYM) - 2024 Q4 - Annual Report