Fulcrum Therapeutics(FULC) - 2024 Q4 - Annual Report

Financial Performance - The company reported net losses of $9.7 million and$97.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $519.4 million as of December 31, 2024[447]. - The company has not generated any revenue from product sales and does not expect to do so for several years, if at all[451]. - Collaboration revenue increased by$77.2 million from $2.8 million in 2023 to$80.0 million in 2024, primarily due to an upfront license payment from the Sanofi collaboration agreement[472]. - The company expects substantial additional funding will be needed to support ongoing operations and growth strategy[448]. - The company expects to incur substantial operating losses and negative operating cash flows for the foreseeable future due to ongoing research and development activities[484]. Research and Development - Research and development expenses totaled $63.4 million for the year ended December 31, 2024, a decrease from$71.8 million in 2023[463]. - The company plans to submit an IND for DBA during the fourth quarter of 2025, focusing on inherited aplastic anemias[445]. - The company has reinitiated the Phase 1b clinical trial for pociredir at the 12 mg dose level, with 10 patients enrolled and expected clinical data by mid-2025[442]. - The Phase 3 REACH trial of losmapimod did not achieve its primary endpoint, leading to the suspension of its future development[443]. - A strategic plan was announced to reprioritize R&D activities, resulting in a workforce reduction from 80 to 51 employees, expected to save approximately $10.0 million annually starting Q1 2025[444]. - Research and development expenses decreased by$8.4 million from $71.8 million in 2023 to$63.4 million in 2024, mainly due to reduced external research costs and laboratory expenses[473][474]. Cash and Funding - The company had $241.0 million in cash, cash equivalents, and marketable securities as of December 31, 2024, expected to fund operations into at least 2027[450]. - Net cash used in operating activities was$2.2 million in 2024, a decrease of $88.8 million compared to$91.0 million in 2023, largely due to the $80.0 million upfront license payment received[481]. - Net cash provided by investing activities was$32.2 million in 2024, an increase of $68.9 million compared to net cash used of$36.7 million in 2023, driven by net maturities of marketable securities[482]. - The company entered into a controlled equity offering agreement in February 2024 for an at-the-market offering program with an aggregate offering price of up to $100.0 million[478]. - The company expects to finance cash needs through equity offerings, debt financings, and collaboration arrangements, with no current credit facility or committed sources of capital[489]. Expenses and Cost Management - General and administrative expenses decreased by$5.2 million from $41.7 million in 2023 to$36.4 million in 2024, attributed to lower employee compensation and facility costs[475]. - A restructuring plan announced in September 2024 reduced the workforce from 80 to 51 full-time employees to focus on key research and development activities[469]. - Stock-based compensation expense is expected to increase in future periods due to existing unrecognized expenses and additional awards granted[505]. Accounting and Financial Reporting - The company recognizes revenue under ASC 606 when control of promised goods or services is obtained, reflecting expected consideration[494]. - The company assesses collaboration arrangements to determine if they involve joint operating activities and applies appropriate recognition methods[492]. - The company accounts for uncertain tax positions using a more-likely-than-not threshold, with no uncertain tax positions reported as of each balance sheet date[508]. - The company evaluates its estimates and assumptions regarding accrued expenses on an ongoing basis, with no material differences reported to date[502]. Market and Economic Conditions - The company is exposed to interest rate sensitivity, but a 10% change in interest rates would not materially affect the fair market value of its investment portfolio[510]. - The company does not currently hedge foreign currency exchange rate risk, with minimal or no liabilities denominated in foreign currencies as of December 31, 2024[511]. - Inflation has not had a material effect on the company's business or financial condition during the years ended December 31, 2024, and 2023[512].