Core Viewpoint - Adaptimmune Therapeutics plc is set to report its financial results and business updates for Q4 and the full year of 2024 on March 20, 2025, before US markets open, followed by a live webcast [1]. Company Overview - Adaptimmune is a clinical-stage biopharmaceutical company focused on developing cell therapies aimed at treating solid tumor cancers [3]. - The company utilizes a unique engineered T-cell receptor (TCR) platform to create T-cells that target and destroy various solid tumor types [3]. Upcoming Events - The financial results announcement will be accompanied by a live webcast at 8:00 a.m. EDT on the same day [1]. - Investors can access the press release in the investor section of Adaptimmune's corporate website and participate in the live webcast [2].

Core Insights - Adaptimmune Therapeutics has received U.S. FDA breakthrough therapy designation for letetresgene autoleucel (lete-cel) aimed at treating unresectable or metastatic myxoid/round cell liposarcoma (MRCLS) in patients who have undergone prior anthracycline-based chemotherapy and express the NY-ESO-1 antigen [1][3][4] Group 1: FDA Designation and Clinical Data - The breakthrough therapy designation for lete-cel was based on results from the Phase II IGNYTE-ESO trial, where 42% of patients with synovial sarcoma or MRCLS showed RECISTv1.1 responses, including 6 complete responses and 21 partial responses [3] - The response rates were 41% for synovial sarcoma and 43% for MRCLS, with a median duration of response of 12.2 months for MRCLS and 18.3 months for synovial sarcoma [3] - Safety findings were consistent with previous data, with common adverse events including cytopenias, cytokine release syndrome (CRS), and rash, all of which were manageable [3] Group 2: Future Plans and Presentations - The company plans to present updates on its sarcoma franchise and cell therapy pipeline at the Annual J.P. Morgan Healthcare Conference on January 14, 2025 [2][6] - A rolling Biologics License Application for lete-cel is expected to be initiated later this year, targeting both sarcoma indications [4][5] - The Allo-T program will also be featured at the Biotech Showcase™ and the Wuxi Global Forum 2025 [6] Group 3: Company Overview - Adaptimmune is focused on redefining cancer treatment through its engineered T cell receptor (TCR) platform, developing personalized medicines for difficult-to-treat solid tumors [7]

Financial Data and Key Metrics Changes - The company reported approximately $186 million in total liquidity after a $25 million drawdown from its debt facility following the FDA approval of Tecelra [30] - Total operating expenditure for Q3 was $55.6 million, with expectations for Q4 operating expenses to remain consistent with the first three quarters of 2024 [30] Business Line Data and Key Metrics Changes - The launch of Tecelra is tracking well, with nine authorized treatment centers (ATCs) currently accepting patients, exceeding the initial guidance of six to ten centers within the first 90 days [15][17] - The company anticipates activating a full network of approximately 30 ATCs by the end of 2025, ahead of previous projections [18] Market Data and Key Metrics Changes - Insurance plans covering Tecelra now represent over 67% of commercial lives, with ongoing engagement from insurers [19] - The company has confirmed 15 patients as double positive for biomarkers, with an additional 25 patients in various stages of biomarker testing [21][22] Company Strategy and Development Direction - The new strategic business plan focuses on streamlining operations, prioritizing high-return R&D programs, and achieving operating breakeven by 2027 [5][9] - The company plans to reduce headcount by approximately 33% and total operating expenses by about 25% in 2025, aiming for savings of $50 million to $60 million [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed increased confidence in achieving $400 million in combined U.S. peak revenue for TCR T-cell and lete-cel, driven by positive trial results and the successful launch of Tecelra [8][96] - The company is focused on maximizing the value of its sarcoma franchise, with a clear path towards two FDA-approved products [9][13] Other Important Information - The pivotal IGNYTE-ESO trial for lete-cel met its primary endpoint, showing a 42% overall response rate, with a complete response rate of almost 10% [26] - The company plans to file a Biologics License Application (BLA) for lete-cel in 2025, with ongoing work on the CMC aspects of the filing [27][81] Q&A Session Summary Question: Can you remind us how long the process takes from physician interest to treatment for patients? - The estimated timeline from physician interest to treatment is approximately three to four months, assuming patients are tested and treated promptly [36] Question: Can you speak to the decision around SURPASS-3 and the evolving data? - The decision was based on capital allocation, prioritizing the sarcoma franchise with high return potential over other opportunities [41] Question: What is the risk regarding bridging studies for lete-cel? - The company plans to use the established commercial process for lete-cel, minimizing risks associated with manufacturing changes [48] Question: What is the expected conversion rate for patients testing positive for both biomarkers? - It is too early to provide metrics, but the expectation is that the majority of double positive patients will be treated with Tecelra in the first two quarters of next year [55] Question: How will the headcount reduction impact early-stage programs like PRAME and CD70? - The focus will be on advancing PRAME and CD70 into the clinic, with resources allocated accordingly [61] Question: What are the remaining items needed before filing the rolling BLA for lete-cel? - Key components include positive clinical data, CMC validation, and a parallel filing for the NY-ESO diagnostic [81] Question: How will patients choose between Tecelra and lete-cel? - Patient choice will likely depend on target expression and physician familiarity, with both therapies providing transformative options for patients [86]

Regulatory Approvals and Collaborations - Tecelra received FDA approval on August 1, 2024, for the treatment of advanced synovial sarcoma, with a reported overall response rate (ORR) of 43% in the SPEARHEAD-1 trial[111][114]. - The Galapagos Collaboration Agreement includes an upfront payment of $70 million and potential milestone payments of up to $465 million, with initial payments received in June 2024[135]. - The Genentech Collaboration Agreement was terminated, resulting in a cumulative catch-up adjustment to revenue of $101.3 million recognized at the date of termination[130][131]. - The company received a $12.5 million payment from Genentech as part of a Mutual Release Agreement, resolving all past disputes related to the collaboration[119][131]. Financial Performance - Revenue increased by $33.6 million to $40.9 million for the three months ended September 30, 2024, representing a 459% increase compared to $7.3 million for the same period in 2023[162]. - Revenue increased by $114.8 million to $174.8 million for the nine months ended September 30, 2024, compared to $60.1 million for the same period in 2023, primarily due to the termination of the Genentech Collaboration Agreement[172]. - The company reported a profit of $3.4 million for the period ended September 30, 2024, compared to a loss of $65.9 million in the same period in 2023[170]. - Operating profit for the nine months ended September 30, 2024 was $4.8 million, a significant improvement from a loss of $89.9 million in the same period in 2023[170]. Expenses and Cost Management - Research and development expenses decreased by 9% to $34.3 million for the three months ended September 30, 2024, down from $37.8 million in the same period in 2023[165]. - The decrease in research and development expenses was primarily due to a reduction in subcontracted costs, which were $10.6 million in Q3 2024 compared to $16.6 million in Q3 2023[165]. - Selling, general, and administrative expenses increased by 32% to $21.3 million for the three months ended September 30, 2024, compared to $16.2 million in the same period in 2023[162]. - Research and development expenses rose by 18% to $110.0 million for the nine months ended September 30, 2024, up from $93.3 million in the same period in 2023[174]. - Selling, general and administrative expenses increased by 6% to $60.1 million for the nine months ended September 30, 2024, compared to $56.6 million in the same period in 2023[178]. Workforce and Strategic Focus - The company plans to reduce its workforce by approximately 33%, with expected pre-tax costs of $9-11 million related to severance and other employee-related expenses[112][121]. - The company has ceased investment in non-core programs, including the SURPASS-3 trial in ovarian cancer, to prioritize its commercial sarcoma franchise[112]. - The company is focusing on preclinical programs targeting PRAME and CD70, with ADP-600 and ADP-520 currently in preclinical testing[117][118]. Cash Flow and Liquidity - Net cash used in operating activities decreased to $39.0 million for the nine months ended September 30, 2024, from $126.2 million in the same period in 2023, due to the receipt of research and development credits and upfront payments[182]. - Total liquidity as of September 30, 2024, was $186.1 million, up from $146.9 million as of December 31, 2023[191]. - Net cash provided by financing activities increased to $78.7 million for the nine months ended September 30, 2024, compared to $0.8 million for the same period in 2023[189]. - Cash and cash equivalents as of September 30, 2024, were $116.7 million, compared to $143.9 million as of December 31, 2023[191]. Other Financial Metrics - The operating loss for the three months ended September 30, 2024, was $14.7 million, a significant improvement of 69% compared to an operating loss of $46.6 million in Q3 2023[162]. - Loss before income tax expense decreased by 63% to $16.8 million for the three months ended September 30, 2024, compared to $44.9 million in Q3 2023[162]. - The company recognized $25 million in deferred revenue from the termination of the Genentech Collaboration Agreement and an additional $12.5 million payment in Q3 2024[164]. - Subcontracted expenditure decreased by 3% to $36.0 million for the nine months ended September 30, 2024, compared to $37.2 million in the same period in 2023[177]. - Share-based compensation expense increased by 31% to $2.9 million for the nine months ended September 30, 2024, compared to $2.2 million in the same period in 2023[174].

Product Development and Launch - Tecelra® launch is on track with 9 Authorized Treatment Centers available, expecting first commercial revenues in Q4 2024 and acceleration in treated patients throughout 2025[1] - Lete-cel pivotal trial reports a 42% overall response rate in synovial sarcoma and myxoid/round cell liposarcoma, with full data to be presented at the CTOS conference on November 16, 2024[1] - Adaptimmune plans to initiate a rolling Biologics License Application for lete-cel by the end of 2025, expanding the addressable patient population[5] - The company will cease enrollment in the SURPASS-3 Phase 2 clinical trial for uza-cel in platinum-resistant ovarian cancer[2] Financial Performance - Revenue for Q3 2024 was $40.9 million, significantly up from $7.3 million in Q3 2023, primarily due to the recognition of deferred income from terminated collaborations[10] - Revenue for the three months ended September 30, 2024, was $40,901,000, a significant increase from $7,319,000 for the same period in 2023, representing a growth of 460%[16] - Net loss for Q3 2024 was $17.6 million, an improvement compared to a loss of $45.6 million in Q3 2023[10] - Operating loss for the nine months ended September 30, 2024, was $4,759,000, compared to an operating loss of $89,885,000 for the same period in 2023, indicating a substantial improvement[16] - Net profit attributable to ordinary shareholders for the nine months ended September 30, 2024, was $3,401,000, a recovery from a net loss of $65,954,000 for the same period in 2023[19] Cost Management and Headcount - Company plans a 33% reduction in headcount in Q1 2025, targeting approximately $300 million in cost savings over the next four years to achieve operating breakeven by 2027[2] Liquidity and Assets - Total liquidity as of September 30, 2024, is $186.1 million, down from $146.9 million at the end of 2023[10] - Total current assets increased to $244,214,000 as of September 30, 2024, up from $207,552,000 as of December 31, 2023, reflecting a growth of 17.6%[17] - Cash and cash equivalents decreased to $116,741,000 as of September 30, 2024, down from $143,991,000 as of December 31, 2023, a decline of 18.9%[17] - Total liabilities decreased to $237,447,000 as of September 30, 2024, compared to $243,103,000 as of December 31, 2023, a reduction of 2.3%[17] - Total stockholders' equity increased to $79,989,000 as of September 30, 2024, from $39,513,000 as of December 31, 2023, reflecting a growth of 102.5%[18] Expenses - Research and development expenses for Q3 2024 were $34.3 million, a decrease from $37.8 million in Q3 2023, attributed to reduced clinical trial expenses[10] - Selling, general and administrative expenses for Q3 2024 were $21.2 million, an increase from $16.2 million in Q3 2023, driven by higher professional fees related to business development[10] Cash Flow - The company reported a net cash used in operating activities of $39,002,000 for the nine months ended September 30, 2024, an improvement from $126,204,000 for the same period in 2023[19] - The company issued borrowings of $49,500,000 during the nine months ended September 30, 2024, contributing to its financing activities[19] Deferred Revenue - The company experienced a decrease in deferred revenue, current, to $18,709,000 as of September 30, 2024, down from $28,973,000 as of December 31, 2023, a decline of 35.6%[17]

Core Insights - Adaptimmune Therapeutics is focusing on its sarcoma franchise with the launch of Tecelra and positive results from the lete-cel trial, projecting combined peak year sales of $400 million for both products [2][3][10] - The company is undergoing a restructuring plan that includes a 33% reduction in headcount and aims to achieve approximately $300 million in cost savings over the next four years, targeting operational breakeven by 2027 [4][20] - As of Q3 2024, Adaptimmune reported total liquidity of $186.1 million, with significant revenue growth driven by the termination of previous collaborations [17][26] Tecelra Launch - Tecelra has been approved by the FDA for treating advanced MAGE-A4+ synovial sarcoma, marking the first new treatment option in over a decade for this condition [7] - Nine Authorized Treatment Centers (ATCs) are currently available for Tecelra, with plans to expand to approximately 30 ATCs by the end of 2025, covering 80% of patients in sarcoma centers [8] Lete-cel Trial Results - The primary analysis of the pivotal IGNYTE-ESO trial showed a 42% overall response rate in patients with synovial sarcoma and myxoid/round cell liposarcoma, with durable responses observed [9][10] - Full data from the trial will be presented at the CTOS conference on November 16, 2024 [9] Financial Performance - Revenue for Q3 2024 was $40.9 million, a significant increase from $7.3 million in Q3 2023, primarily due to the recognition of deferred income from terminated collaborations [17] - Research and development expenses for Q3 2024 were $34.3 million, a decrease from $37.8 million in the same period of 2023, while selling, general, and administrative expenses increased to $21.2 million [18][19] Future Plans - The company plans to cease enrollment in the SURPASS-3 Phase 2 clinical trial for uza-cel and focus on a proof-of-concept trial for head and neck cancer in collaboration with Galapagos [5] - Adaptimmune is also advancing preclinical development of ADP-600 and ADP-520, with ongoing discussions for potential partnerships [6]

Core Insights - Adaptimmune Therapeutics announced that 42% of patients with advanced or metastatic synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) showed clinical responses to lete-cel, with six complete responses and twenty-one partial responses reported [1][3][4] - The company plans to initiate a rolling Biologics License Application (BLA) submission for lete-cel by the end of 2025, aiming to expand treatment options for these cancers [2][3] - The median duration of response for patients with synovial sarcoma was over 18 months, while for MRCLS it was over one year, indicating the potential for durable responses [3][4] Clinical Trial Data - The primary analysis included data from 64 patients who had previously received anthracycline-based therapy, with 27 out of 64 (42%) achieving RECISTv1.1 responses [3][4] - The response rates were 41% for synovial sarcoma (14/34) and 43% for MRCLS (13/30) [3] - The median duration of response was 12.2 months overall, with specific durations of 18.3 months for synovial sarcoma and 12.2 months for MRCLS [4] Safety Profile - Safety findings were consistent with previous data on lete-cel, with all patients experiencing treatment-emergent adverse events, including cytopenias, cytokine release syndrome (CRS), and rash [5] - Overall, the toxicities were manageable and aligned with an acceptable benefit-to-risk profile [5] Upcoming Events - Adaptimmune will present the findings at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting from November 13-16, 2024, in San Diego [1][5] - A virtual Key Opinion Leader (KOL) event is scheduled for November 18, 2024, featuring Dr. Sandra D'Angelo, who will discuss the IGNYTE-ESO dataset and its implications for sarcoma treatment [6] About Lete-cel and the IGNYTE-ESO Trial - Lete-cel is an investigational engineered TCR T-cell therapy targeting the NY-ESO-1 antigen, which is highly expressed in synovial sarcoma and MRCLS [8][7] - The IGNYTE-ESO trial is a pivotal Phase 2, open-label study evaluating the efficacy, safety, and tolerability of lete-cel in patients with previously treated advanced synovial sarcoma or MRCLS [7]

Core Insights - Adaptimmune Therapeutics plc is actively participating in significant scientific and medical conferences in November and December 2024 to showcase advancements in cell therapy for solid tumors [1][6]. Conference Participation - At the Society for Immunotherapy of Cancer (SITC) 39th annual meeting, Adaptimmune will present on T-cell therapy for synovial sarcoma and the mechanisms of afami-cel's anti-tumor activity [2]. - The Connective Tissue Oncology Society (CTOS) 2024 annual meeting will feature presentations on the pivotal IGNYTE-ESO trial and the impact of afami-cel on patient health states [3]. - The American Society of Hematology (ASH) 66th Annual Meeting will include a poster presentation on decentralized manufacturing of a T-cell therapy for solid tumors [4]. Company Overview - Adaptimmune is a fully integrated cell therapy company focused on developing personalized medicines targeting difficult-to-treat solid tumor cancers using its engineered T cell receptor (TCR) platform [6].

Core Viewpoint - Adaptimmune Therapeutics plc is set to report its Q3 2024 financial results and business updates on November 13, 2024, after US market close, indicating ongoing developments in its cell therapy for solid tumor cancers [2]. Company Overview - Adaptimmune is a clinical-stage biopharmaceutical company focused on designing, developing, and delivering cell therapies aimed at transforming cancer treatment [4]. - The company utilizes a unique engineered T-cell receptor (TCR) platform to create T-cells that target and destroy various solid tumor types [4]. Upcoming Events - A live webcast will follow the financial results announcement at 4:30 p.m. EDT (9:30 p.m. GMT) on the same day [2]. - Call-in information for the webcast is provided for both US/Canada and international participants, encouraging early dial-in [3]. Additional Information - The press release will be accessible in the investor section of Adaptimmune's corporate website, ensuring transparency and availability of information for stakeholders [3].

Company Participation in Conferences - Adaptimmune Therapeutics plc will participate in two investment bank conferences in September 2024, including the Wells Fargo Healthcare Conference on September 4 and the H.C. Wainwright 26th Annual Global Investment Conference on September 9 [2] - Both events will feature fireside chats and will be webcast live, with replays available for a limited time after the presentations [2] Company Overview - Adaptimmune is a fully integrated cell therapy company focused on redefining cancer treatment through its engineered T cell receptor (TCR) platform [3] - The company aims to develop personalized medicines that target and destroy difficult-to-treat solid tumor cancers, enhancing the overall cancer treatment experience for patients [3]