Efficacy - Two patients achieved RECIST responses, one with esophagogastric junction (EGJ) cancer and another with head and neck cancer[5, 27] - Initial tumor reductions were observed in 5 out of 6 patients[5, 25, 27] - The data supports further investigation of ADP-A2M4CD8 as an active product[4, 27] Safety - All 6 patients (100%) experienced adverse events (AEs), with all 6 (100%) having Grade ≥3 AEs[14] - Common AEs (any grade) included leukopenia, lymphopenia/lymphocyte decrease, and neutropenia/neutrophil decrease, each occurring in 6 patients (100%)[14] - Other frequent AEs (any grade) were anemia/red blood cell decrease (4 patients, 67%), cytokine release syndrome (4 patients, 67%), fatigue (4 patients, 67%), headache (4 patients, 67%), and nausea (4 patients, 67%)[14] - One serious adverse event (SAE) of cytokine release syndrome was reported in a patient in Cohort 2 and was considered related to the T-cell infusion[15] - Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or cancer immunotherapy[5, 15, 26] Trial Design and Next Steps - The SURPASS trial is a first-in-human dose-escalation trial[8] - The trial is focusing on enrolling patients with gastroesophageal, head and neck, lung, and bladder cancers[5, 7, 28] - A Phase 2 trial is planned for 2021 with ADP-A2M4CD8 in patients with gastroesophageal cancers[5, 7, 17, 28]

Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q3 2020 Earnings Conference Call November 5, 2020 8:30 AM ET Company Participants Juli Miller - Senior Director, IR Adrian Rawcliffe - CEO Elliot Norry - Senior VP and Chief Medical Officer Helen Tayton-Martin - Co-Founder and Chief Business Officer Conference Call Participants Tony Butler - ROTH Capital David Ruch - SVB Leerink Gabriel Fung - Mizuho Securities Operator Ladies and gentlemen, thank you for standing by, and welcome to Adaptimmune's Third Quarter 2020 ...

PART I [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) Unaudited condensed consolidated financial statements for Q3 2020 reveal significant asset growth and a narrowed net loss Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $78,466 | $50,412 | | Marketable securities | $321,442 | $39,130 | | **Total Assets** | **$479,022** | **$181,543** | | **Liabilities & Equity** | | | | Total liabilities | $102,816 | $57,905 | | Total stockholders' equity | $376,206 | $123,638 | | **Total Liabilities & Equity** | **$479,022** | **$181,543** | Condensed Consolidated Statement of Operations Highlights (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Revenue | $2,456 | $394 | | Research and development | $(65,791) | $(77,147) | | General and administrative | $(32,557) | $(32,662) | | **Operating loss** | **$(95,892)** | **$(109,415)** | | **Net loss** | **$(93,479)** | **$(107,801)** | | Net loss per share | $(0.11) | $(0.17) | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(24,375) | $(99,979) | | Net cash (used in) provided by investing activities | $(286,532) | $71,262 | | Net cash provided by financing activities | $339,929 | $366 | | **Net increase (decrease) in cash** | **$27,999** | **$(28,749)** | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, collaboration revenue recognition, and public offering impact on stockholders' equity - The company entered a collaboration agreement with Astellas on January 13, 2020, receiving a **$50.0 million** non-refundable upfront payment for co-development of T-cell therapies for up to three targets[41](index=41&type=chunk) - Deferred revenue increased from **$2.1 million** at the start of 2020 to **$49.8 million** at September 30, 2020, primarily due to the upfront payment from the Astellas collaboration[39](index=39&type=chunk) - The company raised net proceeds of **$90.5 million** from a public offering in January 2020 and **$243.8 million** from another public offering in June 2020[65](index=65&type=chunk)[66](index=66&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results of operations, covering business overview, performance analysis, and liquidity [Overview](index=21&type=section&id=Overview) The company, a leader in engineered T-cell therapies for solid tumors, aims for a 2022 commercial launch of ADP-A2M4 and advances other clinical programs and collaborations - The company aims to commercially launch its lead product, **ADP-A2M4**, in 2022, subject to successful completion of the SPEARHEAD-1 study and FDA approval[71](index=71&type=chunk) - Enrollment is ongoing in the SURPASS Phase 1 trial for the next-generation SPEAR T-cell, **ADP-A2M4CD8**, which has shown partial responses in patients with EGJ and head and neck cancers[73](index=73&type=chunk) - The company is collaborating with Astellas to co-develop and co-commercialize up to three targets for "off-the-shelf" allogeneic cell therapies[77](index=77&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) This section analyzes financial results for the three and nine months ended September 30, 2020 and 2019, noting increased revenue and decreased R&D expenses Comparison of Results for the Nine Months Ended September 30 (in thousands) | Line Item | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $2,456 | $394 | $2,062 | 523% | | R&D Expenses | $(65,791) | $(77,147) | $11,356 | (15)% | | G&A Expenses | $(32,557) | $(32,662) | $105 | (0)% | | **Operating Loss** | **$(95,892)** | **$(109,415)** | **$13,523** | **(12)%** | - The decrease in R&D expenses for the nine-month period was primarily driven by a **$5.0 million** decrease in accrued purchase commitments and a **$3.7 million** decrease in in-process R&D costs compared to the same period in 2019[121](index=121&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity significantly strengthened to **$399.9 million** by September 30, 2020, primarily from public offerings and collaboration payments, sufficient for operations into 2022 Total Liquidity (Non-GAAP, in thousands) | Component | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $78,466 | $50,412 | | Marketable securities | $321,442 | $39,130 | | **Total Liquidity** | **$399,908** | **$89,542** | - Financing activities in the first nine months of 2020 provided **$339.9 million** in cash, primarily from net proceeds of **$334.4 million** from public offerings[136](index=136&type=chunk) - Net cash used in operating activities decreased significantly to **$24.4 million** for the nine months ended Sep 30, 2020, from **$100.0 million** in the prior year, largely due to the receipt of the **$50.0 million** upfront payment from Astellas[133](index=133&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Adaptimmune is not required to provide the information requested in this item - The company is exempt from this disclosure requirement due to its status as a smaller reporting company[143](index=143&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of September 30, 2020, with no material changes in internal control over financial reporting - The CEO and CFO concluded that as of September 30, 2020, the company's disclosure controls and procedures were effective[144](index=144&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[145](index=145&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) As of September 30, 2020, the company was not a party to any material legal proceedings [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including the COVID-19 pandemic, financial condition, development of cell therapies, and reliance on third parties [Risks Related to the COVID-19 pandemic](index=44&type=section&id=Risks%20Related%20to%20the%20COVID-19%20pandemic) The COVID-19 pandemic poses material risks, potentially delaying clinical trials, disrupting supply chains, and impacting workforce effectiveness - The pandemic has delayed the company's ability to obtain data from clinical trials and will extend the time required to complete enrollment[151](index=151&type=chunk) - Work-from-home policies and social distancing requirements limit workforce effectiveness and may cause delays in manufacturing, development, and research activities[150](index=150&type=chunk) [Risks Related to Financial Condition and Capital Requirements](index=46&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) The company has a history of net losses and requires substantial future financing, with failure to raise capital potentially impacting development and commercialization efforts - The company has incurred net losses every year since inception and expects to continue incurring them, with an accumulated deficit of **$549.1 million** as of September 30, 2020[158](index=158&type=chunk)[159](index=159&type=chunk) - Although current liquidity is believed to be sufficient into 2022, the company will require additional capital for further development and commercialization of its cell therapies[162](index=162&type=chunk)[168](index=168&type=chunk) [Risks Related to the Development of Our Cell Therapies](index=51&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Cell%20Therapies) The company's business is highly dependent on novel, unproven SPEAR T-cell candidates, facing risks including cross-reactivity, complex manufacturing, and uncertain clinical trial outcomes with reported serious adverse events - The business is highly dependent on its wholly-owned SPEAR T-cell candidates (**ADP-A2M4**, **ADP-A2M4CD8**, **ADP-A2AFP**), which require significant additional clinical testing[172](index=172&type=chunk) - Manufacturing and administering cell therapies is complex, costly, and subject to potential failures in process, logistics, or starting materials, which can delay trials and affect patient outcomes[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk) - Serious adverse events (SAEs) have been reported across trials, including **CRS**, neurotoxicity, and pancytopenia, with two treatment-related fatal SAEs in the **ADP-A2M4** pilot trial[213](index=213&type=chunk)[262](index=262&type=chunk) [Risks Related to Reliance Upon Third Parties](index=106&type=section&id=Risks%20Related%20to%20Our%20Reliance%20Upon%20Third%20Parties) The company heavily relies on third parties for collaborations, technology, manufacturing, and supply, with their performance largely outside the company's control and critical to clinical and commercial plans - The company's collaboration with GSK is subject to GSK's decisions on progressing targets, and GSK can terminate the agreement or specific programs with 60 days' notice[362](index=362&type=chunk)[363](index=363&type=chunk) - The collaboration with Universal Cells (Astellas) is critical for developing allogeneic 'off-the-shelf' therapies, but milestone payments and program progression are not guaranteed[368](index=368&type=chunk)[370](index=370&type=chunk) - The company relies on a limited number of third-party manufacturers for clinical trial supplies, exposing it to risks of supply disruption, quality issues, and regulatory compliance failures at these external sites[382](index=382&type=chunk)[383](index=383&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=141&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period [Defaults Upon Senior Securities](index=141&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities [Other Information](index=141&type=section&id=Item%205.%20Other%20Information) The company reported no other information [Exhibits](index=142&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and financial data in iXBRL format

Financial Data and Key Metrics Changes - The company raised approximately $244 million, finishing the quarter with total liquidity of $419 million, funding operations into 2022 [7] - Recruitment delays in clinical trials were noted due to COVID-19, impacting overall progress [8] Business Line Data and Key Metrics Changes - New responses were reported in gastroesophageal, lung, and head and neck cancers, with a total of six different solid tumor types showing responses, including a complete response in liver cancer [5] - The company initiated a Phase II trial combining ADP-A2M4 with pembrolizumab in head and neck cancer and plans to start a new Phase II trial in gastroesophageal cancers [5][10] Market Data and Key Metrics Changes - The European Medicines Agency granted PRIME regulatory support for ADP-A2M4, validating its potential to meet significant unmet medical needs for patients with synovial sarcoma [6] Company Strategy and Development Direction - The company aims to increase manufacturing capacity to meet the needs of ongoing and planned clinical trials, while also ramping up commercial preparations [10] - The focus remains on owning the manufacturing process to innovate and improve efficiency, including vector production [11] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the ongoing impact of COVID-19 on clinical trial recruitment but expressed confidence in the ability to adapt and progress as conditions allow [8] - The company is committed to transforming the lives of cancer patients through innovative cell therapies and is exploring outpatient settings for future treatments [59] Other Important Information - The company was recognized as one of the best places to work in Philadelphia, reflecting its commitment to a supportive work environment [11] - Discussions on racial equity and inclusivity were highlighted, emphasizing the company's commitment to creating a welcoming workplace [12] Q&A Session Summary Question: Will the AFP presentation occur alongside the EASL presentation? - The company will not present the non-HCC cohort at EASL, focusing instead on safety updates and specific patient data [15] Question: How is patient screening affected by COVID-19? - Screening has improved since the initial COVID-19 impact, but varies by region, with some areas experiencing renewed challenges [18] Question: How will pembrolizumab be sequenced with cell therapy in trials? - Patients are generally screened who are pembrolizumab naive or have recently started treatment, with cell therapy administered after non-response [21] Question: What is the timeline for the first program with Astellas? - The first program is moving forward successfully, but specific timelines for clinical entry are not disclosed [42] Question: How does the company view outpatient therapy? - The company is exploring outpatient settings but has not finalized plans, focusing on safety as a primary concern [59] Question: What is the company's stance on multiple dosing options for cell therapies? - The company acknowledges the potential for multiple dosing but emphasizes the need for further research to determine its effectiveness [62]

PART I — FINANCIAL INFORMATION [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited condensed consolidated financial statements for the periods ended June 30, 2020, are presented, detailing balance sheets, operations, and cash flows Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $122,359 | $50,412 | | Marketable securities | $296,629 | $39,130 | | Total assets | $512,201 | $181,543 | | Total liabilities | $104,616 | $57,905 | | Total stockholders' equity | $407,585 | $123,638 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $502 | $157 | $1,263 | $157 | | Research and development | $(20,460) | $(25,511) | $(41,724) | $(47,530) | | General and administrative | $(10,295) | $(10,148) | $(19,556) | $(21,921) | | Net loss | $(29,880) | $(41,087) | $(58,047) | $(68,499) | | Net loss per share | $(0.04) | $(0.07) | $(0.07) | $(0.11) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,058) | $(70,371) | | Net cash (used in) provided by investing activities | $(258,952) | $36,217 | | Net cash provided by financing activities | $339,463 | $366 | - The company entered into a collaboration agreement with Astellas in January 2020, receiving a **$50.0 million** non-refundable upfront payment[40](index=40&type=chunk) - This significantly increased deferred revenue, which grew from **$2.1 million** at the start of the year to **$48.1 million** by June 30, 2020[41](index=41&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage biopharmaceutical business, the impact of COVID-19, key clinical trial progress, and an analysis of financial results and liquidity - The company is a clinical-stage biopharmaceutical company focused on its proprietary SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform for solid tumors, aiming to be the first to have a TCR T-cell approved for a solid tumor indication[70](index=70&type=chunk) - The COVID-19 pandemic has restricted the ability of many clinical sites to treat patients, but the company's facilities in the U.S. and U.K. remain open to support manufacturing and R&D[71](index=71&type=chunk) - Key clinical programs include the SPEARHEAD-1 Phase 2 trial with ADP-A2M4, with plans for a commercial launch in 2022, and the SURPASS Phase 1 trial with next-generation ADP-A2M4CD8, which has shown initial responses in head and neck and esophagogastric junction cancers[73](index=73&type=chunk)[75](index=75&type=chunk) - The company closed two underwritten public offerings in Q1 and Q2 2020, generating combined net proceeds of approximately **$334.3 million**[67](index=67&type=chunk)[68](index=68&type=chunk)[83](index=83&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of the company's operating results for the three and six-month periods ended June 30, 2020, highlighting changes in revenue and expenses Comparison of Operating Results for the Three Months Ended June 30 (in thousands) | Line Item | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $502 | $157 | $345 | 220% | | Research and development expenses | $(20,460) | $(25,511) | $5,051 | (20)% | | General and administrative expenses | $(10,295) | $(10,148) | $(147) | 1% | | Operating loss | $(30,253) | $(35,502) | $5,249 | (15)% | | Loss for the period | $(29,880) | $(41,087) | $11,207 | (27)% | Comparison of Operating Results for the Six Months Ended June 30 (in thousands) | Line Item | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $1,263 | $157 | $1,106 | 704% | | Research and development expenses | $(41,724) | $(47,530) | $5,806 | (12)% | | General and administrative expenses | $(19,556) | $(21,921) | $2,365 | (11)% | | Operating loss | $(60,017) | $(69,294) | $9,277 | (13)% | | Loss for the period | $(58,047) | $(68,499) | $10,452 | (15)% | - The decrease in R&D expenses for Q2 2020 was primarily due to a **$2.0 million** reduction in subcontracted expenditure (partly due to COVID-19 delays), a **$1.8 million** decrease in employee-related costs, and a **$2.0 million** decrease in in-process R&D costs compared to the prior year[109](index=109&type=chunk)[113](index=113&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company details its funding sources, liquidity position as of June 30, 2020, and management's outlook on capital sufficiency, driven by recent public offerings and collaboration payments Total Liquidity (Non-GAAP, in thousands) | Component | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $122,359 | $50,412 | | Marketable securities | $296,629 | $39,130 | | **Total Liquidity** | **$418,988** | **$89,542** | - Net cash provided by financing activities was **$339.5 million** for the six months ended June 30, 2020, primarily from two public offerings that generated net proceeds of **$90.5 million** and **$243.8 million**, respectively[136](index=136&type=chunk) - Net cash used in operating activities decreased significantly to **$8.1 million** for the first six months of 2020 from **$70.4 million** in the same period of 2019, largely due to the receipt of a **$50.0 million** upfront payment from Astellas[131](index=131&type=chunk) - Management believes that its Total Liquidity of **$419.0 million** as of June 30, 2020, will be sufficient to fund operations into 2022[128](index=128&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Adaptimmune is not required to provide the information requested in this item - The company is not required to provide information for this item as it qualifies as a smaller reporting company[142](index=142&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2020 - Based on an evaluation as of June 30, 2020, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[143](index=143&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2020, that have materially affected, or are reasonably likely to materially affect, internal controls[144](index=144&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2020, the company reports that it was not a party to any material legal proceedings - As of June 30, 2020, the company was not a party to any material legal proceedings[145](index=145&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including the impact of COVID-19, financial condition, challenges in cell therapy development, regulatory processes, and commercialization [Risks Related to the COVID-19 pandemic](index=42&type=section&id=Risks%20Related%20to%20the%20COVID-19%20pandemic) The COVID-19 pandemic poses material risks to the business, potentially delaying clinical programs, research, financing, and impacting third-party suppliers and patient enrollment - The COVID-19 pandemic has caused many clinical trial sites to delay treatment and enrollment of patients, which will extend the time required to complete clinical trials and obtain data[150](index=150&type=chunk) - The pandemic may impact third parties necessary for commercialization, creating risks in scaling up manufacturing and ensuring timely availability of reagents, raw materials, and contract manufacturing services[151](index=151&type=chunk) [Risks Related to Our Financial Condition and Capital Requirements](index=44&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) The company faces risks due to a history of net losses and the need for additional capital, with future profitability uncertain and dependent on successful therapy development and commercialization - The company has incurred net losses every year since inception, with an accumulated deficit of **$483.8 million** as of June 30, 2020[158](index=158&type=chunk) - The company believes its total liquidity will be sufficient to fund operations into 2022, but this is based on estimates and failure to obtain additional financing in the future could raise doubt about its ability to continue as a going concern[162](index=162&type=chunk) [Risks Related to the Development of Our Cell Therapies](index=49&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Cell%20Therapies) Developing novel cell therapies involves substantial risks, including dependence on lead candidates, potential for adverse events, manufacturing complexities, and challenges in clinical trial enrollment - The business is highly dependent on its wholly-owned SPEAR T-cell candidates (ADP-A2M4, ADP-A2M4CD8, ADP-A2AFP), which require significant additional clinical testing before seeking regulatory approval[172](index=172&type=chunk) - A prior SPEAR T-cell (MAGE-A3) caused two patient deaths due to cross-reactivity with the TITIN protein in the heart, highlighting the risk of potentially fatal off-target effects for current and future therapies[184](index=184&type=chunk) - Manufacturing and administering cell therapies is a complex, highly regulated process involving patient-specific logistics, with risks of failure at multiple steps that could delay or halt clinical trials[227](index=227&type=chunk)[228](index=228&type=chunk) [Risks Related to Government Regulation](index=74&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company faces risks from a lengthy and uncertain regulatory approval process for novel cell therapies, ongoing compliance obligations, and the complexities of international approvals and anti-corruption laws - The novel nature of the company's SPEAR T-cells creates additional challenges in obtaining regulatory approval, as the FDA has limited experience with commercial development of T-cell therapies for cancer[270](index=270&type=chunk) - Even if regulatory approval is received, the company will be subject to ongoing surveillance, extensive recordkeeping, and compliance with cGMPs, with potential for significant penalties for non-compliance[292](index=292&type=chunk)[293](index=293&type=chunk) - The company benefits from the U.K. R&D tax credit regime but may lose this benefit if it no longer qualifies as a small or medium-sized enterprise (SME), which could impact its need for investment[322](index=322&type=chunk)[323](index=323&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=134&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds during the period - None[490](index=490&type=chunk) [Defaults Upon Senior Securities](index=134&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[490](index=490&type=chunk) [Mine Safety Disclosures](index=134&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[490](index=490&type=chunk) [Other Information](index=134&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None[490](index=490&type=chunk) [Exhibits](index=135&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, which include certifications by the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002, and the financial statements formatted in iXBRL - Exhibits filed include: * Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Sections 302 and 906 * Financial information from the Form 10-Q formatted in iXBRL (Inline eXtensible Business Reporting Language)[491](index=491&type=chunk)[492](index=492&type=chunk)

Adaptimmune Therapeutics plc (NASDAQ:ADAP) Q1 2020 Earnings Conference Call May 14, 2020 8:00 AM ET Company Participants Juli Miller - Director of IR Adrian Rawcliffe - CEO Helen Tayton-Martin - Chief Business Officer Elliot Norry - Chief Medical Officer Conference Call Participants Marc Frahm - Cowen and Company Tony Butler - Roth Capital Mohit Bansal - Citigroup Nick Abbott - Wells Fargo Mara Goldstein - Mizuho Operator Ladies and gentlemen, thank you for standing by. And welcome to the Adaptimmune Q1 202 ...