Adaptimmune(US:ADAP)2025-05-13 20:05FDA Approval and Clinical Trials - TECELRA received FDA approval on August 1, 2024, and 28 Authorized Treatment Centers (ATCs) are available for patient treatment as of May 13, 2025[112]. - In Q1 2025, 13 patients were apheresed, and 6 patients were invoiced; in Q2 2025 to date, 8 patients have been apheresed and invoiced[112]. - The company plans to launch letetresgene autoleucel ("lete-cel") for synovial sarcoma and myxoid liposarcoma in 2026[110]. - The company anticipates filing a clinical trial authorization for a Phase 1 trial in head and neck cancer in collaboration with Galapagos during 2025[117]. Financial Performance - Product revenue for the three months ended March 31, 2025, was $4.0 million, with total revenue increasing by 28% to $7.3 million compared to $5.7 million in the same period of 2024[160][162]. - Research and development expenses decreased by 18% to $28.9 million for the three months ended March 31, 2025, down from $35.2 million in the same period of 2024[163]. - Selling, general and administrative expenses increased by 18% to $23.3 million for the three months ended March 31, 2025, compared to $19.7 million in the same period of 2024[167]. - The operating loss for the three months ended March 31, 2025, was $45.7 million, a decrease of 7% from the operating loss of $49.3 million in the same period of 2024[160]. - Interest income for the three months ended March 31, 2025, was $0.9 million, a decrease of 32% from $1.3 million in the same period of 2024[170]. - Development revenue for the three months ended March 31, 2025, was $3.2 million, a decrease of 43% from $5.7 million in the same period of 2024[160]. - The company reported a net loss of $47.6 million for the three months ended March 31, 2025[182]. Cash Flow and Liquidity - As of March 31, 2025, the company had cash and cash equivalents of $41.1 million and Total Liquidity of $59.6 million[174]. - Net cash used in operating activities increased to $66.6 million for the three months ended March 31, 2025, compared to $31.9 million for the same period in 2024[181]. - Net cash provided by investing activities was $41.2 million for the three months ended March 31, 2025, compared to a cash outflow of $0.4 million in the same period of 2024[183]. - The company incurred a net cash outflow of $25.3 million from financing activities for the three months ended March 31, 2025, compared to a net inflow of $29.2 million in the same period of 2024[184]. - Total Liquidity decreased from $151.6 million as of December 31, 2024, to $59.6 million as of March 31, 2025[185]. Strategic Decisions and Collaborations - The Galapagos Collaboration Agreement includes an upfront payment of $100 million, with $70 million received upfront and $30 million for research and development funding[132]. - The termination of the Genentech Collaboration Agreement resulted in a cumulative catch-up adjustment to revenue recognized of $101.3 million[125]. - The company is evaluating all strategic options for its programs and operations[111]. - The company is actively seeking additional funding and has engaged TD Cowen to evaluate strategic options, including potential mergers and acquisitions[177]. - The company has paused spending on preclinical programs targeting PRAME and CD70[118]. - The company has paused spending on its PRAME and CD70 programs as part of its cost-reduction strategy[177]. Tax and Regulatory Considerations - Research and development expenses are partially offset by reimbursable tax credits from the U.K. government, with a potential cash tax benefit of up to 27% for qualifying expenditures[139]. - The company is subject to a U.K. corporation tax rate of 25% for the year ended December 31, 2025[152]. - Substantial doubt exists regarding the company's ability to continue as a going concern within one year from the date of the financial statements[178].