Adaptimmune(US:ADAP)2022-11-07 16:00Clinical Trials and Research - The company is prioritizing the submission of the BLA for afami-cel and progressing the SURPASS family of trials in ovarian, urothelial, and head & neck cancers [91]. - In the SPEARHEAD-1 Phase 2 trial, the overall response rate (ORR) in synovial sarcoma is 38.6% with a median duration of response of 50.3 weeks [92]. - The SURPASS Phase 1 trial with ADP-A2M4CD8 shows an ORR of 37% across all indications, with a 52% ORR in head & neck, ovarian, and urothelial cancers [93]. - The company plans to stop the SURPASS-2 trial in esophageal and esophagogastric junction cancers to focus on other indications [95]. - The company is targeting 2025 for the submission of the first IND for an allogeneic cell therapy due to a change in the cell line being used [97]. Financial Performance - Revenue increased by $5.8 million to $7.0 million for the three months ended September 30, 2022, compared to $1.2 million for the same period in 2021, primarily due to increased development activities under collaboration agreements [127]. - Revenue increased by $11.4 million to $16.1 million for the nine months ended September 30, 2022, compared to $4.7 million for the same period in 2021, representing a 241% increase [140]. - Operating loss for the three months ended September 30, 2022, was $42.99 million, slightly higher than the $42.18 million loss for the same period in 2021, reflecting a 2% increase [125]. - Operating loss for the nine months ended September 30, 2022 was $136.7 million, an increase of 15% from a loss of $119.4 million in the same period in 2021 [139]. - Loss for the period decreased slightly by 2% to $41.42 million for the three months ended September 30, 2022, from $42.40 million in the same period in 2021 [125]. Expenses and Costs - Research and development expenses rose by 18% to $33.2 million for the three months ended September 30, 2022, up from $28.2 million in the same period in 2021 [128]. - Research and development expenses rose by 28% to $104.7 million for the nine months ended September 30, 2022, up from $81.6 million in the same period in 2021 [141]. - General and administrative expenses increased by 11% to $16.8 million for the three months ended September 30, 2022, from $15.2 million in the same period in 2021 [134]. - General and administrative expenses increased by 13% to $48.2 million for the nine months ended September 30, 2022, compared to $42.5 million for the same period in 2021 [145]. - Subcontracted expenditure increased significantly by 82% to $18.4 million for the three months ended September 30, 2022, compared to $10.1 million in the same period in 2021 [133]. - Subcontracted costs for the nine months ended September 30, 2022 were $47.9 million, compared to $32.4 million in the same period of 2021 [144]. Cash and Liquidity - Total liquidity as of September 30, 2022 was $199.7 million, including cash and cash equivalents of $79.0 million [151]. - Total Liquidity as of September 30, 2022, is $199,670,000, down from $369,580,000 as of December 31, 2021, representing a decrease of approximately 46% [160]. - Cash and cash equivalents decreased from $149,948,000 on December 31, 2021, to $79,001,000 on September 30, 2022, a decline of about 47% [160]. - Marketable securities decreased from $219,632,000 on December 31, 2021, to $120,669,000 on September 30, 2022, a reduction of approximately 45% [160]. - Net cash used in operating activities was $143.8 million for the nine months ended September 30, 2022, compared to $123.2 million for the same period in 2021 [154]. Strategic Collaborations and Funding - The company received a $150 million upfront payment from Genentech for the strategic collaboration to develop allogeneic T-cell therapies [108]. - The company has received $50 million as an upfront payment from Astellas for a collaboration agreement to co-develop T-cell therapies [105]. - The GSK Collaboration Agreement has resulted in milestone payments of $4.2 million in 2021 and $3.2 million following the nomination of a target [102]. Taxation and Financial Planning - The company benefits from the U.K. SME R&D Tax Credit Scheme, allowing for a payable tax credit of up to approximately 33.4% of eligible R&D expenditures [111]. - The company benefits from reimbursable tax credits in the U.K. through the SME R&D Tax Credit Scheme and the RDEC Scheme, which provide tax relief at 13% of allowable R&D costs [114]. - The U.K. corporation tax rate is set to increase to 25% in 2023, impacting future financial planning [120]. - Income tax expense increased to $1.5 million for the nine months ended September 30, 2022, up from $0.6 million for the same period in 2021, reflecting changes in U.S. taxation laws [148]. Company Restructuring - The company is undertaking a restructuring, including a headcount reduction of approximately 25% to 30% to extend its cash runway into early 2025 [99]. - The company plans to restructure, including a headcount reduction of approximately 25% to 30% to extend cash runway into early 2025 [151]. Market Risk - There have been no material changes to the company's market risk during the three and nine months ended September 30, 2022 [162].