Adaptimmune(ADAP)

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Adaptimmune's Lete-cel Achieves Primary Endpoint in Pivotal Trial
Newsfile· 2024-11-13 14:00
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]
Adaptimmune to Participate in Scientific and Medical Conferences this November and December
Newsfile· 2024-11-05 14:19
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].
Adaptimmune to Report Q3 2024 Financial and Business Updates on Wednesday, November 13, 2024
Newsfile· 2024-10-31 21:20
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].
Adaptimmune to Participate in Two Bank Conferences this September
Newsfile· 2024-08-28 12:00
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]
Adaptimmune(ADAP) - 2024 Q2 - Earnings Call Transcript
2024-08-12 15:42
Financial Data and Key Metrics Changes - The company reported total liquidity of $215 million at the end of Q2 2024, an increase from approximately $144 million at the end of Q1 2024, indicating strong financial positioning for the launch of Tecelra and pipeline development [9][10]. - Total expenditures for the first half of 2024 were approximately $114 million, with expectations for operating expenses to remain consistent over the next 18 months [10][11]. Business Line Data and Key Metrics Changes - Tecelra, the company's first product in the sarcoma franchise, was launched following FDA approval, marking a significant milestone as the first engineered cell therapy for solid tumors [6][7]. - The company plans to activate 6 to 10 authorized treatment centers (ATCs) during the launch period, with five ATCs already available on their locator tool [8][9]. Market Data and Key Metrics Changes - The company anticipates that the ATCs will represent about 80% of the patients in sarcoma centers of excellence, which is estimated to be 50% to 70% of all sarcoma patients across the country [23]. - The expected peak US sales for the sarcoma franchise is estimated at $400 million, with a patient split of approximately 40% for Tecelra and 60% for lete-cel [35]. Company Strategy and Development Direction - The company is transitioning into a commercial cell therapy company, focusing on the successful launch of Tecelra and the development of its pipeline, including lete-cel and uza-cel [11][12]. - The company aims to redefine treatment for solid tumor cancers through its integrated cell therapy approach, leveraging its experience from Tecelra's regulatory submission for future products [11][12]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of Tecelra and the potential for significant patient engagement, noting the enthusiasm from treatment centers and the sarcoma community [16][25]. - The company is focused on establishing a robust referral network and ensuring patient support through its Adaptimmune Assist program [8][25]. Other Important Information - The company has signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules, enhancing its financial flexibility [9]. - The regulatory pathway for lete-cel will mirror that of Tecelra, with expectations for primary data presentation from the IGNYTE-ESO trial later this year [37]. Q&A Session Summary Question: Early patient flow through ATCs - Management noted enthusiasm from treatment centers and reported that patients are beginning the testing journey for Tecelra, primarily from other sarcoma centers of excellence [14][16]. Question: ADP-600 program and next-generation enhancements - The Chief Scientific Officer indicated that next-gen approaches are being evaluated for the ADP-600 program, with updates to follow [18][20]. Question: Proportion of synovial sarcoma patients at ATCs - Management stated that the five active ATCs represent about 80% of the patients in sarcoma centers of excellence, with onboarding of additional centers expected [22][23]. Question: Enrollment in SURPASS-3 trial - Management confirmed that enrollment is progressing well, with a mix of US and ex-US sites, and they anticipate completing enrollment next year [30][31]. Question: Revenue split between Tecelra and lete-cel - Management provided a breakdown of expected peak sales, estimating 40% for Tecelra and 60% for lete-cel, emphasizing the importance of a gradual sales ramp-up [35][36]. Question: Timeline from patient screening to infusion - The timeline from screening to infusion is expected to take several weeks, with initial patients anticipated to be treated in the first quarter of the following year [50][51]. Question: Coverage and reimbursement for Tecelra - Medicare coverage is already established, with commercial coverage expected to follow a similar path to CAR-T therapies, initially through single-case negotiations [51][52].
Adaptimmune(ADAP) - 2024 Q2 - Quarterly Report
2024-08-12 11:23
Drug Approvals and Clinical Trials - Tecelra received FDA approval on August 1, 2024, for the treatment of advanced synovial sarcoma, showing an overall response rate (ORR) of 43% in a trial with 44 patients[115] - The median duration of response for Tecelra was 6 months, with 39% of responsive patients maintaining a response for 12 months or longer[115] - Lete-cel, targeting the NY-ESO antigen, reported an ORR of 40% in the IGNYTE-ESO trial, with a median duration of response of approximately 11 months[116] - The company is focusing on developing T-cell therapies directed to PRAME and CD70, with preclinical testing ongoing for ADP-600 and ADP-520[119] Financial Performance - Revenue increased by $123.1 million to $128.2 million for the three months ended June 30, 2024, compared to $5.1 million for the same period in 2023, primarily due to the termination of the Genentech collaboration[161] - The company reported a profit of $69.5 million for the period ended June 30, 2024, compared to a loss of $21.4 million in the same period in 2023, marking a 425% improvement[160] - Revenue increased by $81.2 million to $133.9 million for the six months ended June 30, 2024, primarily due to the termination of the Genentech collaboration, resulting in a cumulative catch-up adjustment of $101.3 million[175] - Operating loss for the six months ended June 30, 2024, was $19.4 million, a significant improvement compared to an operating loss of $43.3 million for the same period in 2023[174] Research and Development Expenses - Research and development expenses rose by 35% to $40.4 million for the three months ended June 30, 2024, compared to $30.0 million in the same period in 2023[160] - Research and development expenses for the six months ended June 30, 2024, increased by 36% to $75.7 million from $55.5 million in the same period in 2023[177] - The net increase in research and development expenses for the six months ended June 30, 2024, was primarily driven by a $9.4 million increase in salaries and related costs due to the acquisition of TCR2[179] - Subcontracted costs for the three months ended June 30, 2024, were $14.0 million, compared to $9.5 million in the same period of 2023, including $9.7 million directly associated with afami-cel, lete-cel, and uza-cel T-cells[167] Collaborations and Agreements - A clinical collaboration agreement with Galapagos NV includes an upfront payment of $70 million and potential milestone payments of up to $465 million for the TCR T-cell therapy candidate uza-cel[123] - The company expects to receive initial payments of $100 million from the Galapagos collaboration, including $70 million upfront and $30 million for research and development funding[138] - The company will recognize revenue from the Galapagos collaboration based on the percentage of completion of the proof-of-concept trial[139] - The company received an upfront payment of £7.5 million from Adaptimmune as part of the GSK Termination and Transfer Agreement[135] Cash Flow and Liquidity - The company had cash and cash equivalents of $211.8 million and Total Liquidity of $214.8 million as of June 30, 2024[187] - Net cash provided by operating activities was $15.4 million for the six months ended June 30, 2024, compared to a net cash used of $81.0 million for the same period in 2023[189] - The increase in net cash provided by operating activities was primarily due to $30.8 million in research and development credits, an $85 million upfront payment from Galapagos, and a $7.7 million milestone payment from GSK[189] - Net cash provided by financing activities was $53.7 million for the six months ended June 30, 2024, compared to $0.2 million for the same period in 2023[192] Tax and Corporate Costs - The U.K. corporation tax rate is 25% for the year ended December 31, 2024, impacting the company's tax strategy[152] - The company benefits from the U.K. SME R&D Tax Credit Scheme, allowing for a payable tax credit of up to approximately 18.6% of eligible R&D expenditures[142] - Income tax expense for the period was $1.0 million, reflecting taxable profits generated by Adaptimmune LLC in the United States[172] - The company experienced an increase of $1.8 million in other corporate costs due to higher accounting, legal, and professional fees[186] Strategic Changes and Collaborations - The termination of the Astellas Collaboration Agreement resulted in a contract modification with a transaction price of $42.4 million recognized in March 2023[130] - The termination of the Genentech collaboration led to a cumulative catch-up adjustment of $101.3 million due to the loss of future payments[134] - The gain on bargain purchase from the strategic combination with TCR2 Therapeutics Inc. occurred in June 2023[171] General and Administrative Expenses - General and administrative expenses decreased by 5% to $19.1 million for the three months ended June 30, 2024, down from $20.1 million in the same period in 2023[168] - General and administrative expenses for the six months ended June 30, 2024, decreased by 4% to $38.8 million from $40.5 million in the same period in 2023[182]
Adaptimmune(ADAP) - 2024 Q2 - Quarterly Results
2024-08-12 11:05
Exhibit 99.1 Adaptimmune Reports Q2 2024 Financial and Business Updates Adaptimmune received U.S. FDA accelerated approval of Tecelra® (afami-cel), the first approved engineered cell therapy for a solid tumor Patients can begin treatment journey; biomarker testing available; Adaptimmune systems ready to receive orders At the end of Q2, Adaptimmune had Total Liquidity 1 of $214.8 million PHILADELPHIA, PA. and OXFORD, UK, August 12, 2024 – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the ...
Adaptimmune Reports Q2 2024 Financial and Business Updates
Newsfile· 2024-08-12 11:00
Adaptimmune received U.S. FDA accelerated approval of Tecelra® (afami-cel), the first approved engineered cell therapy for a solid tumorPatients can begin treatment journey; biomarker testing available; Adaptimmune systems ready to receive ordersAt the end of Q2, Adaptimmune had Total Liquidity[1] of $214.8 millionPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - August 12, 2024) - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers ...
Adaptimmune to Report Q2 2024 Financial and Business Updates on Monday, August 12, 2024
Newsfile· 2024-08-05 12:00
Adaptimmune to Report Q2 2024 Financial and Business Updates on Monday, August 12, 2024August 05, 2024 8:00 AM EDT | Source: Adaptimmune Therapeutics PLCPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - August 5, 2024) - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, will report financial results and provide business updates for the second quarter ended June 30, 2024, before the US markets open on ...
ADAP: Initiating Coverage of Adaptimmune, a Leading T-Cell Therapy Company
Benzinga· 2024-06-17 18:05
Loading...Loading...By Michael KimREAD THE FULL ADAP RESEARCH REPORTWe are initiating coverage of Adaptimmune Therapeutics plc ADAP with a 12-month price target of $3.00, translating into sizeable upside from the stock's current price. Adaptimmune designs, develops, manufactures, and delivers innovative cell therapies via the company's unique T-cell receptor (TCR) platform to treat cancers across multiple solid tumor types.Our investment thesis revolves around:1. Unique T-cell therapy: Adaptimmune's mission ...