Revenue Recognition - The company recognized revenue of $0.9 million for the year ended December 31, 2023, compared to $2.3 million for the previous year, primarily from the PEACE Phase 3 trial and early access programs [443]. - The company has not generated any revenue from commercial product sales and future revenues depend on successful development and regulatory approval of product candidates [441]. - For the year ended December 31, 2024, total revenue was $0, a decrease of $886,000 or 100% compared to $886,000 in 2023 [481]. - The company did not recognize any revenue in connection with the Immedica Agreement for the year ended December 31, 2024, compared to $0.9 million in 2023 [482]. - Total revenue for 2024 was $886,000, a significant decrease from $2,329,000 in 2023, representing a decline of approximately 62% [537]. Expenses and Losses - Research and development expenses for the year ended December 31, 2023, included restructuring expenses of $6.4 million, with $5.3 million paid during the year [456]. - The company experienced an approximate 83% reduction in headcount by June 30, 2023, as part of a restructuring plan initiated in response to inconclusive interim trial results [454]. - An impairment loss of $0.9 million was recognized related to the operating lease right-of-use asset and $1.7 million for leasehold improvements after abandoning the leased office space in Austin, Texas [458]. - Research and development expenses increased by $73.3 million, or 82%, to $162.8 million for the year ended December 31, 2024, from $89.5 million in 2023 [483]. - General and administrative expenses rose by $5.8 million, or 15%, to $45.8 million for the year ended December 31, 2024, compared to $39.9 million in 2023 [481]. - The net loss for the year ended December 31, 2024, was $208.0 million, a decrease of $130.8 million from a net loss of $338.8 million in 2023 [481]. - The net loss for 2024 was $208,018,000, compared to a net loss of $338,790,000 in 2023, indicating an improvement of approximately 39% [539]. - The company reported a total comprehensive loss of $208,140,000 for 2024, down from $338,440,000 in 2023, showing a decrease of approximately 38% [539]. Financing and Cash Flow - The company completed the sale of global rights to pegzilarginase to Immedica for $15.0 million in upfront cash and up to $100.0 million in contingent milestone payments [445]. - Cash used in operating activities was $157.4 million in 2024, compared to $99.9 million in 2023 [502][503]. - Cash provided by financing activities was $410.9 million in 2024, up from $361.1 million in 2023 [506][507]. - The company anticipates needing additional financing in the future to fund further research and development [493]. - The Company raised approximately $1.3 billion in gross proceeds from various financing activities since inception [566]. - The Company completed a public offering of 8,366,250 shares of common stock at a price of $27.50 per share in November 2024, resulting in net proceeds of approximately $215.9 million [564]. Assets and Liabilities - As of December 31, 2024, the company had an accumulated deficit of $972.4 million [492]. - The company held $603.1 million in cash, cash equivalents, marketable securities, and restricted cash as of December 31, 2024 [513]. - As of December 31, 2024, total assets increased to $608.5 million from $341.9 million in 2023, representing a growth of approximately 78% [534]. - The total liabilities increased to $90.7 million in 2024 from $73.3 million in 2023, reflecting a rise of about 24% [534]. - The CVR liability as of December 31, 2024, was recorded at $61.7 million, with an increase of $19.0 million for the year, primarily due to changes in fair value [529]. - The accumulated deficit grew to $972.4 million in 2024 from $764.4 million in 2023, indicating an increase of approximately 27% [534]. - The total stockholders' equity rose to $517.8 million in 2024, up from $184.0 million in 2023, representing a growth of about 181% [534]. Internal Controls and Compliance - The Company reported a material weakness in internal control over financial reporting as of December 31, 2024, related to the evaluation of Series A and Series B Preferred Stock [520]. - The Company’s management is responsible for maintaining effective internal control over financial reporting, which was found to be ineffective in certain respects as of December 31, 2024 [520]. Research and Development - The company plans to investigate combination therapies of its proprietary antibodies to enhance efficacy in treating immune-mediated diseases [438]. - External research and development expenses increased to $140.7 million in 2024 from $72.7 million in 2023, a rise of 93% [484]. - Internal research and development expenses rose to $22.1 million in 2024 from $16.8 million in 2023, an increase of 31% [485]. - The increase in research and development expenses was primarily driven by a $43.4 million increase in manufacturing costs and a $34.0 million increase in nonclinical and clinical development [483]. Marketable Securities - The estimated fair value of total marketable securities increased to $513.67 million in 2024 from $150.38 million in 2023 [632]. - The company reported net unrealized losses on marketable securities of $0.1 million for the year ended December 31, 2024, compared to net unrealized gains of $0.3 million in 2023 [631]. - The total unrealized losses on marketable securities as of December 31, 2024, were $493,000, with significant losses attributed to U.S. government treasury securities [630]. - The company classified all marketable securities as current assets, allowing for potential sales before maturity [633].
Spyre Therapeutics(SYRE) - 2024 Q4 - Annual Report