Fulcrum Therapeutics(US:FULC)2025-10-29 11:10Financial Performance - Collaboration revenue for the three months ended September 30, 2025, was $0, compared to $80,000,000 for the same period in 2024, indicating a significant drop[19] - Net loss for the three months ended September 30, 2025, was $19,595,000, compared to a net loss of $21,696,000 for the same period in 2024, showing an improvement of about 9.7%[19] - For the nine months ended September 30, 2025, the company reported a net loss of $54.546 million compared to a net income of $6.843 million in the same period of 2024[25] - The net loss for the nine months ended September 30, 2025, was $54.5 million, compared to a net income of $6.8 million for the same period in 2024, primarily due to $80.0 million of collaboration revenue recognized in 2024[101] - The company has incurred significant operating losses since inception and expects to continue incurring losses over the next several years[156] Assets and Liabilities - Total current assets decreased from $249,923,000 as of December 31, 2024, to $205,863,000 as of September 30, 2025, a decline of approximately 17.7%[16] - Cash and cash equivalents decreased from $58,212,000 as of December 31, 2024, to $47,078,000 as of September 30, 2025, a decrease of approximately 19.1%[16] - Total liabilities decreased from $17,684,000 as of December 31, 2024, to $16,492,000 as of September 30, 2025, a reduction of about 6.7%[16] - Stockholders' equity decreased from $243,034,000 as of December 31, 2024, to $198,366,000 as of September 30, 2025, a decline of approximately 18.4%[16] - As of September 30, 2025, total cash equivalents and marketable securities amounted to $200,404,000, a decrease from $241,021,000 as of December 31, 2024[43][44] Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $62,076,000, down from $82,468,000 in the same period of 2024, representing a reduction of approximately 24.7%[19] - General and administrative expenses for the nine months ended September 30, 2025, were $21,389,000, down from $28,732,000 in the same period of 2024, a decrease of approximately 25.6%[19] - The company recorded total operating expenses of $21,858,000 for the three months ended September 30, 2025, down from $25,126,000 in the same period of 2024[94] - Total operating expenses decreased by $20.4 million from $82.5 million in the nine months ended September 30, 2024 to $62.1 million in the same period in 2025[127] Research and Development - Research and development expenses for the three months ended September 30, 2025, were $14,296,000, slightly down from $14,639,000 in the same period of 2024[19] - Research and development expenses fell by $11.0 million from $51.7 million in the nine months ended September 30, 2024 to $40.7 million in the same period in 2025, mainly due to decreased external research and employee compensation costs[131] - External research and development expenses for pociredir were $5.4 million for the three months ended September 30, 2025, compared to $2.2 million in the same period in 2024[113] Cash Flow - Net cash used in operating activities was $43.267 million for the nine months ended September 30, 2025, a significant decrease from $14.543 million provided in the same period of 2024[25] - The company expects its cash and marketable securities to be sufficient to fund operating expenses for at least 12 months from the date of the financial statements[32] - The company had $200.6 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to fund operations into 2028[104] Stock and Equity - Weighted-average common shares outstanding, basic, increased from 62,409,000 for the three months ended September 30, 2024, to 62,597,000 for the same period in 2025[19] - The company has reserved 28,952,871 shares of common stock for future issuance as of September 30, 2025, an increase from 26,673,185 shares as of December 31, 2024[52] - The total number of outstanding stock options increased to 11,870,785 with a weighted average exercise price of $6.57[61] Collaboration Agreements - The Company entered into a collaboration and license agreement with Sanofi in May 2024, which included an upfront payment of $80.0 million, but was terminated in April 2025[69][70] - The Company recognized no revenue associated with the Sanofi Agreement during the nine months ended September 30, 2025[74] - Collaboration revenue dropped by $80.0 million from $80.0 million in the nine months ended September 30, 2024 to $0 in the same period in 2025, due to the termination of the Sanofi collaboration agreement[128] Clinical Development and Risks - The successful development of product candidates remains uncertain, with no revenue expected from product sales for several years[105] - The company is still in the early stages of product development and has not completed development of any product candidates[156] - The company may face limitations on utilizing its net operating losses and research and development tax credit carryforwards due to an ownership change deemed to have occurred on September 12, 2024[176] - The company is subject to risks related to the lengthy and expensive clinical drug development process, which may not yield successful outcomes[184] - The company may need to conduct additional clinical trials or testing if initial results are not positive, which could delay marketing approvals[189] Market and Competition - Competition in the pharmaceutical industry is substantial, with major companies potentially developing products more successfully or rapidly[212] - Recent FDA approvals for competitive products, such as CASGEVY and LYFGENIA, could impact the company's market position[214] - The company may need to price its products at a significant premium over generic alternatives, affecting market acceptance and sales[214]