Afamitresgene Autoleucel

TECELRA® launch 2025 YTD metrics: 28 ATCs available; 21 patients aphresed; and 14 doses invoiced $4.0 million Tecelra net sales in Q1 2025 Instituting 2025 Tecelra full year sales guidance of $35-$45 million Lete-cel on track to initiate rolling BLA submission late 2025; approval anticipated in 2026 Adaptimmune had Total Liquidity1 of $60 million as of March 31, 2025; call at 8 a.m. EDT today Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - May 13, 2025) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today reported financial results and provided a business update for the first quarter ended March 31, 2025. Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "The launch of Tecelra continues to rapidly accelerate, as evidenced by all launch metrics. In Q4 2024 we invoiced 2 patients, in Q1 2025 we invoiced 6 patients, and in Q2 to-date we have invoiced 8 patients. The shape of the pipeline of patients being tested and apheresed continues to support a robust acceleration of sales in Q2 and the second half of the year, and we continue to experience 100% manufacturing success rates and no payer denials. As a result, we are now providing guidance for 2025 Tecelra sales in the range of $35-$45 million. I'm confident in the team's ability to identify eligible patients, manufacture a personalized engineered T cell treatment and ultimately deliver product, demonstrating that we have built a successful business platform for cell therapies in solid tumors, paving the way for an equally successful lete-cel launch in 2026." Tecelra launch momentum increasing - first commercial product in Adaptimmune's sarcoma franchise 28 Authorized Treatment Centers (ATCs) now accepting referrals On track to have the full network of approximately 30 ATCs open by the end of the year Invoiced 2 patients in Q4 2024, 6 in Q1 2025, and 8 in Q2 to-date (as of May 9, 2025) Apheresed 3 patients in Q4 2024, 13 in Q1 2025, and 8 in Q2 to-date (as of May 9, 2025) 100% success rate in manufacturing to date, with no capacity constraints and an average turnaround of 27 days Successful patient access to Tecelra with no payer denials to date Lete-cel - next product in Adaptimmune's sarcoma franchise Pivotal trial met primary endpoint with 42% ORR including 6 complete responses (CTOS 2024) On track to initiate rolling BLA submission in late 2025; approval anticipated in 2026 Lete-cel will more than double the addressable patient population in the sarcoma franchise Launch readiness activities are on track Corporate updates Review of strategic options with TD Cowen in progress Debt principal paydown of $25 million made in Q1 2025 Upcoming milestones Updates on Tecelra launch momentum Initiate rolling BLA for lete-cel to treat synovial sarcoma and MRCLS in Q4 2025 Financial Results for the three months ended March 31, 2025 Cash / liquidity position: As of March 31, 2025, Adaptimmune had cash and cash equivalents of $41.1 million and Total Liquidity2 of $59.6 million, compared to $91.1 million and $151.6 million respectively, as of December 31, 2024. Revenue: Revenue for the three months ended March 31, 2025, was $7.3 million, compared to $5.7 million for the same period in 2024. Revenue has increased primarily due to $4.0 million in product sales following the FDA approval of TECELRA on August 1, 2024. This was offset by a $2.4 million decrease in development revenue due to revenue from Galapagos replacing Genentech revenue and Galapagos generating comparatively lower revenue due to the collaboration being at an earlier stage of progress than the Genentech collaboration was in the first quarter of 2024. Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2025, were $28.9 million, compared to $35.2 million for the same period in 2024. R&D expenses decreased due to a decrease in the average number of employees engaged in R&D following the restructuring and reprioritization of activities that was announced in November 2024 and a decrease in subcontracted expenditure, offset by a decrease in offsetting reimbursements receivable for R&D tax and expenditure credits. Selling, general and administrative (SG&A) expenses: SG&A expenses for the three months ended March 31, 2025, were $23.3 million, compared to $19.7 million for the equivalent period in 2024. SG&A expenses increased due to restructuring charges for the restructuring program initiated in the fourth quarter of 2024 for which there was no equivalent in the first quarter of 2024 and an increase in accounting, legal and professional fees due to fees relating to business development work, offset by a decrease in share-based compensation expense due to forfeitures arising as a result of the restructuring program. Net loss: Net loss attributable to holders of the Company's ordinary shares for the three months ended March 31, 2025, was a loss of $47.6 million ($0.03 per ordinary share), compared to $48.5 million ($0.03 per ordinary share), for the equivalent period in 2024. Going Concern Our 2024 Annual Report on Form 10-K, which the Company filed on March 24, 2025, disclosed that there is substantial doubt about our ability to continue as a going concern. We are continuing to implement cost reduction measures and explore the strategic options outlined above. Today's Webcast Details A live webcast and replay can be accessed at https://www.gowebcasting.com/14032. Call in information is as follows: 1-833-821-0158 (US or Canada) or 1-647-846-2266 (International). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call. About Adaptimmune Adaptimmune is a fully integrated cell therapy company working to redefine how cancer is treated. With its unique engineered T cell receptor (TCR) platform, the Company is developing personalized medicines designed to target and destroy difficult-to-treat solid tumor cancers and to radically improve the patient's cancer treatment experience. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements address our expected future business, financial performance, financial condition, as well as the results of operations and often contain words such as "anticipate" "believe," "expect," "may," "plan," "potential," "will," and similar expressions. Such statements are based only upon current expectations of Adaptimmune. Reliance should not be placed on these forward-looking statements because they involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2024, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances. Total Liquidity (a non-GAAP financial measure) Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities (available-for-sale debt securities). Each of these components appears separately in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in thousands): The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its assessment of overall solvency and liquidity, financial flexibility, capital position and leverage. Condensed Consolidated Statement of Operations (unaudited, in thousands, except per share data) Condensed Consolidated Balance Sheets (unaudited, in thousands, except share data) Condensed Consolidated Cash Flow Statement (unaudited, in thousands) Adaptimmune Contact Investor Relations Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations T : +1 215 825 9310 M : +1 215 460 8920 Juli.Miller@adaptimmune.com Media Relations Dana Lynch, Senior Director of Corporate Communications M: +1 267 990 1217 Dana.Lynch@adaptimmune.com 1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below 2 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below To view the source version of this press release, please visit https://www.newsfilecorp.com/release/251851 SOURCE Adaptimmune Therapeutics PLC Released May 13, 2025