Acquisition and Partnerships - The company acquired Pre-Merger Spyre on June 22, 2023, a pre-clinical stage biotechnology firm, to enhance its intellectual property portfolio[125]. - The company exercised options under the Paragon Agreement for multiple research programs, securing exclusive licenses for various antibody products targeting specific integrins and cytokines[157]. - The company is obligated to pay up to $22.0 million to Paragon upon achieving specific development milestones for each licensed product[158]. Clinical Trials and Product Development - The company has initiated the SKYLINE Phase 2 platform trial in May 2025, evaluating SPY001, SPY002, SPY003, and their combinations in patients with moderately to severely active ulcerative colitis (UC)[131]. - The SKYWAY Phase 2 basket trial for SPY072 in rheumatic diseases began in September 2025, with topline proof-of-concept data expected in 2026[133][135]. - SPY001, the most advanced product candidate, has shown a favorable safety profile and potential for quarterly or biannual maintenance dosing based on Phase 1 trial results[138]. - SPY002 and SPY072 have demonstrated complete suppression of free TL1A for up to 20-24 weeks at a single 100mg dose, advancing to the SKYLINE and SKYWAY trials respectively[142]. - SPY003, targeting IL-23, exhibited a favorable safety profile and a differentiated pharmacokinetic profile, supporting its advancement to the SKYLINE Phase 2 trial[146]. - The company plans to investigate combinations of its proprietary antibodies in clinical trials to evaluate potential greater efficacy compared to monotherapies in inflammatory bowel disease (IBD)[128]. - The company has completed enrollment for Phase 1 trials of SPY001, SPY002, SPY072, and SPY003, with interim results indicating favorable safety and pharmacokinetic profiles across all candidates[137][141][145]. Financial Performance - Research and development expenses increased by $14.7 million, or 13%, to $127.0 million for the nine months ended September 30, 2025, compared to $112.3 million for the same period in 2024[169]. - General and administrative expenses rose by $1.0 million, or 9%, to $11.6 million for the three months ended September 30, 2025, from $10.6 million in the same period of 2024[166]. - Total operating expenses for the three months ended September 30, 2025, were $56.9 million, an increase of $1.5 million, or 3%, from $55.4 million in 2024[162]. - Other income increased by $59.1 million for the three months ended September 30, 2025, primarily due to changes in the fair value of the contingent value right (CVR) liability[167]. - The net loss for the three months ended September 30, 2025, was $11.2 million, a significant improvement compared to a net loss of $69.0 million in the same period of 2024[162]. - External research and development expenses for the nine months ended September 30, 2025, totaled $98.2 million, compared to $98.0 million in 2024, reflecting a stable expenditure despite changes in project focus[171]. - The company reported a loss before income tax expense of $92.7 million for the nine months ended September 30, 2025, compared to a loss of $151.7 million in the same period of 2024[169]. - Compensation costs in internal research and development increased by 111% to $16.1 million for the nine months ended September 30, 2025, from $7.6 million in 2024[171]. - Internal research and development expenses increased to $28.8 million for the nine months ended September 30, 2025, up from $14.3 million in the same period of 2024, primarily due to an increase in headcount[172]. - General and administrative expenses rose by $0.4 million, or 1%, to $35.4 million for the nine months ended September 30, 2025, compared to $35.0 million in 2024, mainly driven by higher compensation costs[173]. - The company recognized a gain of $10.0 million related to the sale of the legacy Aeglea asset pegzilarginase during the nine months ended September 30, 2025, with no similar gain in 2024[174]. - Interest income increased to $17.7 million for the nine months ended September 30, 2025, from $15.5 million in 2024, attributed to higher investment balances[175]. - Other income, net, surged by $61.9 million for the nine months ended September 30, 2025, primarily due to changes in the fair value of the CVR liability[177]. - The company has an accumulated deficit of $1.1 billion as of September 30, 2025, having raised approximately $1.3 billion in gross proceeds since inception[179]. Cash Flow and Financial Position - Cash used in operating activities was $124.7 million for the nine months ended September 30, 2025, reflecting a net loss of $92.7 million[186]. - Cash provided by investing activities was $103.9 million for the nine months ended September 30, 2025, primarily from maturities and sales of marketable securities[188]. - Cash used in financing activities was $3.8 million for the nine months ended September 30, 2025, mainly due to a payment to CVR holders[190]. - As of September 30, 2025, the company held $486.2 million in cash, cash equivalents, and marketable securities, all denominated in U.S. dollars[196].
Aeglea BioTherapeutics, Inc.(AGLE) - 2025 Q3 - Quarterly Report