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]

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].

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]

[Key Highlights](index=1&type=section&id=Key%20Highlights) Adaptimmune secured FDA accelerated approval for Tecelra®, its first solid tumor cell therapy, and reported **$214.8 million** liquidity at Q2 2024 end - Received U.S. FDA accelerated approval for Tecelra® (afami-cel), the first approved engineered T-cell therapy for a solid tumor[1](index=1&type=chunk) - The company is prepared for commercial launch, with biomarker testing available and systems ready to receive orders for Tecelra®[1](index=1&type=chunk)[2](index=2&type=chunk) Liquidity Position | Metric | Amount | As of | | :--- | :--- | :--- | | Total Liquidity | $214.8 million | End of Q2 2024 | [Business and Pipeline Updates](index=1&type=section&id=Business%20and%20Pipeline%20Updates) The company focuses on commercializing its Tecelra®-led sarcoma franchise and advancing clinical and preclinical pipelines via strategic collaborations and financing [Sarcoma Franchise (Tecelra® and lete-cel)](index=1&type=section&id=Sarcoma%20Franchise%20(Tecelra%C2%AE%20and%20lete-cel)) FDA-approved Tecelra® is launching commercially for sarcoma, with a lete-cel BLA planned for 2025, targeting **$400 million** peak U.S. sales for the franchise - Tecelra® is the first engineered cell therapy approved for solid tumors and the first new treatment for synovial sarcoma in over a decade[2](index=2&type=chunk) Tecelra® SPEARHEAD-1 Trial Efficacy | Metric | Result | | :--- | :--- | | Overall Response Rate (ORR) | 43% | | Complete Response Rate | 4.5% | | Median Duration of Response | 6 months | | Patients with ≥12 month response | 39.0% | - Based on successful IGNYTE-ESO trial results (**40% ORR**), Adaptimmune plans to initiate a rolling Biologics License Application (BLA) for lete-cel in 2025 for MRCLS and synovial sarcoma[3](index=3&type=chunk) [Clinical Pipeline](index=3&type=section&id=Clinical%20pipeline) The clinical pipeline advances with a Galapagos collaboration for uza-cel in head & neck cancer, ongoing SURPASS-3 enrollment for ovarian cancer, and SURPASS Phase 1 trial conclusion - Entered a clinical collaboration with Galapagos to evaluate uza-cel in head & neck cancer using Galapagos' decentralized manufacturing platform[3](index=3&type=chunk) - The SURPASS-3 Phase 2 trial investigating uza-cel for platinum-resistant ovarian cancer is currently enrolling patients[3](index=3&type=chunk) - Enrollment for the SURPASS Phase 1 trial will cease shortly as screening has stopped[3](index=3&type=chunk) [Preclinical Pipeline](index=3&type=section&id=Preclinical%20pipeline) The wholly-owned allogeneic pipeline progresses with process optimization, advancing ADP-600 (PRAME) and ADP-520 (CD70) programs toward IND-enabling activities - The wholly-owned allogeneic pipeline is progressing with continued process optimization[4](index=4&type=chunk) - IND-enabling activities are ongoing for the ADP-600 (PRAME) and ADP-520 (CD70) programs[4](index=4&type=chunk) [Corporate Updates](index=3&type=section&id=Business%20and%20corporate%20updates) Adaptimmune secured **$100 million** from a Galapagos collaboration and a **$125 million** loan facility with Hercules Capital, enhancing financial flexibility for commercial launch and pipeline development - Under the Galapagos agreement, Adaptimmune will receive **$100 million** in initial payments (**$70M** upfront, **$30M** R&D funding), with potential for up to **$465 million** in milestones plus royalties[5](index=5&type=chunk) - Entered into a loan and security agreement with Hercules Capital for up to **$125.0 million**. Following Tecelra's FDA approval, the company is eligible to draw down a **$25.0 million** tranche[5](index=5&type=chunk) [Financial Results](index=4&type=section&id=Financial%20Results) Adaptimmune reported a significant Q2 2024 revenue increase to **$128.2 million** and a **$69.5 million** net profit, driven by terminated collaboration revenue, ending the quarter with **$214.8 million** liquidity [Financial Performance Summary (Q2 2024)](index=4&type=section&id=Financial%20Performance%20Summary%20(Q2%202024)) Q2 2024 revenue significantly increased to **$128.2 million** (from **$5.1 million**), driven by a **$101.3 million** Genentech adjustment, resulting in a **$69.5 million** net profit (vs. **$21.3 million** net loss in Q2 2023), with R&D expenses rising to **$40.4 million** Q2 Financial Performance (Three Months Ended June 30, in millions, except per share data) | Metric | Q2 2024 | Q2 2023 | Change | | :--- | :--- | :--- | :--- | | Revenue | $128.2M | $5.1M | +2414% | | R&D Expenses | $40.4M | $30.0M | +34.7% | | G&A Expenses | $19.1M | $20.1M | -5.0% | | Net Profit/(Loss) | $69.5M | $(21.3)M | Profit vs Loss | | EPS (Diluted) | $0.04 | $(0.02) | Profit vs Loss | - The significant increase in revenue in 2024 is primarily due to recognizing the majority of remaining deferred income from the terminated Genentech collaboration, including a **$101.3 million** cumulative catch-up adjustment[7](index=7&type=chunk) - R&D expenses increased due to a higher number of employees, increased subcontracted expenditures, and in-process R&D costs[7](index=7&type=chunk) [Financial Position and Liquidity](index=4&type=section&id=Financial%20Position%20and%20Liquidity) As of June 30, 2024, Adaptimmune's total liquidity stood at **$214.8 million**, a notable increase from **$146.9 million** at the end of 2023. This non-GAAP measure, comprising cash, cash equivalents, and marketable securities, reflects the company's enhanced capital position to support its operational and commercial activities Total Liquidity (in thousands) | Component | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $211,810 | $143,991 | | Marketable securities | $2,979 | $2,947 | | **Total Liquidity** | **$214,789** | **$146,938** | [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Statement of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenue | $128,231 | $133,909 | | Total operating expenses | $(59,531) | $(114,470) | | Operating profit/(loss) | $68,700 | $19,439 | | Net profit/(loss) | $69,521 | $21,018 | | Net profit/(loss) per share (Diluted) | $0.04 | $0.01 | [Balance Sheet](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Highlights (in thousands) | Metric | June 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $211,810 | $143,991 | | Total current assets | $253,770 | $207,552 | | **Total assets** | **$321,702** | **$282,616** | | Total current liabilities | $82,073 | $72,788 | | **Total liabilities** | **$225,428** | **$243,103** | | **Total stockholders' equity** | **$96,274** | **$39,513** | [Cash Flow Statement](index=9&type=section&id=Condensed%20Consolidated%20Cash%20Flow%20Statement) Cash Flow Highlights (Six Months Ended June 30, in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Net cash provided by/(used in) operating activities | $15,449 | $(81,045) | | Net cash (used in)/provided by investing activities | $(1,101) | $51,035 | | Net cash provided by financing activities | $53,747 | $210 | | **Net increase/(decrease) in cash** | **$67,659** | **$(29,402)** |

Core Insights - Adaptimmune received U.S. FDA accelerated approval for Tecelra® (afami-cel), marking it as the first engineered cell therapy approved for solid tumors, specifically for advanced MAGE-A4+ synovial sarcoma in adults [2][3] - The company reported significant financial growth, with Q2 2024 revenue reaching $128.2 million, a substantial increase from $5.1 million in Q2 2023, primarily due to the recognition of deferred income from a terminated collaboration with Genentech [8][11] - Adaptimmune plans to expand its sarcoma franchise with a rolling Biologics License Application (BLA) submission for lete-cel in 2025 and a commercial launch anticipated in 2026, projecting peak U.S. sales of $400 million for the sarcoma franchise [2][3] Company Updates - Tecelra® is expected to be available in 6-10 U.S. authorized treatment centers shortly, allowing patients to begin their treatment journey [2][3] - The approval of Tecelra® was based on the SPEARHEAD-1 trial, which demonstrated an overall response rate (ORR) of 43% and a median duration of response of 6 months [3] - Adaptimmune has entered a clinical collaboration with Galapagos to evaluate uza-cel for head and neck cancer, further diversifying its clinical pipeline [4] Financial Performance - As of June 30, 2024, Adaptimmune reported total liquidity of $214.8 million, up from $146.9 million at the end of 2023 [8][10] - The company recorded a net profit of $69.5 million for Q2 2024, compared to a loss of $21.3 million in Q2 2023, indicating a significant turnaround in financial performance [8][11] - Research and development expenses increased to $40.4 million for Q2 2024, reflecting the company's investment in expanding its clinical programs [8][11] Future Outlook - Adaptimmune is set to initiate a rolling BLA submission for lete-cel in 2025, targeting advanced or metastatic myxoid/round cell liposarcoma and synovial sarcoma [3] - The company anticipates that its sarcoma franchise will redefine treatment options in advanced soft tissue sarcoma, with a projected peak sales potential of $400 million in the U.S. [2][3] - The ongoing SURPASS-3 Phase 2 trial for uza-cel in platinum-resistant ovarian cancer is currently enrolling patients, showcasing the company's commitment to addressing unmet medical needs [5]

Core Insights - Adaptimmune Therapeutics plc is set to report its financial results and business updates for Q2 2024 on August 12, 2024, before US markets open [2] - The company specializes in cell therapies aimed at treating solid tumor cancers, utilizing a unique engineered T-cell receptor (TCR) platform [3] Financial Reporting - The financial results will cover the second quarter ended June 30, 2024, and will be announced before the market opens on August 12, 2024 [2] - A live webcast will follow the announcement at 8:00 a.m. EDT, providing an opportunity for stakeholders to engage with the company [2] Company Overview - Adaptimmune is a clinical-stage biopharmaceutical company focused on developing cell therapies to improve cancer treatment outcomes [3] - The company's TCR platform is designed to engineer T-cells that specifically target and destroy various solid tumor types [3]

Core Viewpoint - Adaptimmune Therapeutics plc is positioned for significant growth with a 12-month price target of $3.00, driven by its innovative T-cell receptor (TCR) platform aimed at treating various solid tumor cancers [1][8]. Group 1: Unique T-cell Therapy - Adaptimmune's mission is to revolutionize cancer treatment by engineering TCRs to recognize specific cancer biomarkers, enhancing the immune response to target cancer cells while sparing healthy cells [1][5]. - The company has developed a proprietary technology platform over 15 years that allows for the genetic engineering of TCRs from a patient's own T-cells (autologous) or from stem cells (allogeneic) [1][5]. Group 2: Commercialization Inflection Point - The anticipated launch of afami-cel, pending FDA approval, signifies Adaptimmune's transition from a clinical-stage to a commercial-stage company [3][4]. - The FDA has accepted the Biologics License Application (BLA) for afami-cel, with a Prescription Drug User Fee Act (PDUFA) date set for August 4, 2024, and plans for an initial launch at six to ten Authorized Treatment Centers (ATCs) [4][6]. Group 3: Robust Product Pipeline - Adaptimmune has a diversified pipeline that includes late-stage programs and a deep preclinical pipeline for various autologous and allogeneic cell therapies targeting multiple cancer types [5][6]. - Collaborations with cancer centers of excellence are in place to advance clinical and preclinical studies for T-cell therapies across various indications [5][6]. Group 4: Economic Opportunity - While net losses are expected in the near term, the ramp-up of afami-cel sales post-FDA approval is crucial for future profitability, with projected gross sales of approximately $80 million in 2025 and peak sales of $400 million for the sarcoma franchise [6][7]. - Adaptimmune's current liquidity and funding arrangements, including a $125 million term loan facility and a $200 million at-the-market facility, are expected to support operations into late 2025 [7]. Group 5: Valuation Insights - A probability-weighted DCF model indicates significant upside potential for Adaptimmune's stock, based on three late-stage clinical programs and a near-term eligible patient population of approximately 4,600 per year [8].

Core Insights - Adaptimmune and Galapagos have entered a clinical collaboration agreement to evaluate the safety and efficacy of uza-cel, a next-generation TCR T-cell therapy targeting MAGE-A4 in head & neck cancer [1][3] - Uza-cel has shown an overall response rate of 80% in a Phase 1 trial, with partial responses in four out of five patients [2][3] - Galapagos will utilize its decentralized manufacturing platform to produce uza-cel, which may enhance the efficacy and durability of the treatment [2][6] Financial Terms - Adaptimmune will receive an initial payment of $100 million, including $70 million upfront and $30 million for R&D funding [1][5] - Additional payments could reach up to $465 million in development and sales milestones, along with tiered royalties on net sales [1][5] - Galapagos has the option to exclusively license uza-cel for global development and commercialization, with a maximum option fee of $100 million [1][4] Manufacturing and Development - Galapagos' decentralized manufacturing platform allows for a median vein-to-vein time of seven days, facilitating rapid access to treatment for patients [2][6] - Adaptimmune will manage the clinical proof-of-concept trial and supply the vector for manufacturing, while Galapagos will deliver the fresh product [3][4] Strategic Vision - The partnership aligns with Galapagos' strategic vision to advance novel cell therapies and expand its oncology portfolio [3] - Adaptimmune aims to leverage the collaboration to enhance the effectiveness of its TCR T-cell therapy for patients with late-stage cancers [3][4]