ADAP Adaptimmune Therapeutics plc

5.72
-0.38  -6%
Previous Close 6.1
Open 6.13
52 Week Low 2
52 Week High 13.4
Market Cap $885,334,530
Shares 154,778,764
Float 125,167,858
Enterprise Value $509,135,530
Volume 1,599,724
Av. Daily Volume 1,726,352
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Drug Pipeline

Drug Stage Notes
MAGE-A4 (ADP-A2M4)
Solid tumors
Phase 1
Phase 1
Phase 1 trial ongoing.
MAGE-A4 (SPEARHEAD‑1)
Synovial sarcoma or myxoid/round cell liposarcoma (MRCLS)
Phase 2
Phase 2
Phase 2 enrolment to be completed 1Q 2021.
MAGE-A4 (ADP-A2M4CD8 - SURPASS)
Solid tumors
Phase 1
Phase 1
Phase 1 dose update at SITC meeting November, 2020. Partial responses in 2/6 patients. Phase 2 trial to commence 1H 2021.
ADP-A2M4CD8
Gastroesophageal cancers
Phase 1
Phase 1
Phase 2 trial to commenced 1H 2021.
AFP (ADP-A2AFP)
Hepatocellular carcinoma
Phase 1
Phase 1
Phase 1 presentation at ILC noted 1/9 complete responses, 6/9 stable disease, 2/9 progressive disease.
MAGE-A10 (ADP-A2M10)
Non-Small Cell Lung Cancer (NSCLC)
Phase 1
Phase 1
Phase 1 enrolment completed 2019.

Latest News

  1. - SPEARHEAD-1 enrolment on track; planning to launch ADP-A2M4 in 2022 in the US for people with synovial sarcoma -

    - Next registration directed trial initiating with ADP-A2M4CD8 in 1H 2021 for patients with gastroesophageal cancers -

    - Efficacy with SPEAR T-cells in multiple solid tumor indications validates MAGE-A4 as a significant cancer target -

    - Plan for five new autologous products in the clinic including an HLA-independent TCR (HiT) and an enhanced tumor infiltrating lymphocyte (TIL) expressing IL-7 -

    - First two allogeneic products in the clinic by 2024 including a MAGE-A4 targeted product and a HiT targeting mesothelin partnered with Astellas -

    - Financial guidance updated: funded into early 2023 -

    - Virtual Investor Day today…

    - SPEARHEAD-1 enrolment on track; planning to launch ADP-A2M4 in 2022 in the US for people with synovial sarcoma -

    - Next registration directed trial initiating with ADP-A2M4CD8 in 1H 2021 for patients with gastroesophageal cancers -

    - Efficacy with SPEAR T-cells in multiple solid tumor indications validates MAGE-A4 as a significant cancer target -

    - Plan for five new autologous products in the clinic including an HLA-independent TCR (HiT) and an enhanced tumor infiltrating lymphocyte (TIL) expressing IL-7 -

    - First two allogeneic products in the clinic by 2024 including a MAGE-A4 targeted product and a HiT targeting mesothelin partnered with Astellas -

    - Financial guidance updated: funded into early 2023 -

    - Virtual Investor Day today from 8:00 a.m. to 10:30 a.m. EST (1:00 p.m. to 3:30 p.m. GMT) -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, will host a virtual Investor Day today, which will feature the Company's Senior Leadership team and Dr Dejka Araujo of the MD Anderson Cancer Center. The link to register is HERE and further background information on Adaptimmune and the event can be found HERE. After the event, a copy of the presentation materials and webcast links will be posted on the Events and Presentations page under the Investors section of the Adaptimmune website.

    "We will lay out the strategy confirming our leadership position as a company designing and delivering cell therapies for people with cancer," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "Over the next five years, we plan to deliver two marketed products, one in sarcoma and one in gastroesophageal cancers, and two additional BLAs in other solid tumor indications. We also plan to develop a robust autologous and allogeneic clinical pipeline that takes us towards the ultimate goal of curative and mainstream cell therapies for people with cancer."

    Adaptimmune's Virtual Investor Day will cover the following topics:

    Opening Remarks by Adrian Rawcliffe, CEO

    • Strategic vision for Adaptimmune and core value drivers for the next five years
    • Delivering TCR T-cell therapies and building the cell therapy company of the future ​
    • MAGE-A4 is a target with large market potential across a broad range of solid tumor indications including synovial sarcoma, lung, head and neck, bladder, and gastroesophageal cancers

    Synovial sarcoma care: the need for cell therapy

    • Dejka Araujo, M.D. (Professor in the Department of Sarcoma Medical Oncology, Division of Cancer Medicine of the MD Anderson Cancer Center) will discuss the current treatment landscape and unmet medical need for people with synovial sarcoma

    Driving towards delivery of two marketed products and two further BLAs by 2025

    • An overview of plans to launch the first TCR T-cell therapy (ADP-A2M4) in synovial sarcoma as enrollment in the SPEARHEAD-1 trial is on track
    • Plan to file a BLA with ADP-A2M4D8 in gastroesophageal cancers in 2024
    • Potential addressable population across all tumor types with significant MAGE-A4 expression of ~39,000 patients per year in the US and EU factored for HLA-A21; additional BLA(s) projected with ADP-A2M4CD8 in tumor types beyond gastroesophageal cancers
    • Additional BLA projected for ADP-A2AFP (first or next-generation CD8α) with a potential market opportunity of ~16,000 patients per year based on serum AFP expression1 and factoring for HLA-A2
      • Plan to incorporate next-generation CD8α enhancement into SPEAR T-cells targeting AFP in a clinical trial next year 

    The importance of building an integrated cell therapy company for rapid execution and success

    • An overview of the Company's integrated structure with its leading capabilities for designing and delivering cell therapies
    • Case studies demonstrating the value that this integrated approach has delivered: rapid execution of clinical programs, security of vector supply, reduction of costs, and learnings applied to the allogeneic platform

    A rich cell therapy pipeline for the future over the next 5 years

    • Focusing on curative intent: leveraging translational insights for best next-generation products:
    • Positioning multiple enhancements for next-generation SPEAR T-cells including:
      • ADP-A2M4 SPEAR T-cells co-expressing IL-7, IL-15, dnTGFβ, and/ or PDE7
      • Enhancing SPEAR T-cells with IL-7 for proliferation and survival and CCL19 for migration into tumor in collaboration with Noile-Immune
      • Enhancing SPEAR T-cells using transmembrane and surface immunoregulatory mechanisms with Alpine Immune Sciences
    • Focusing on enabling mainstream access – broadening patient coverage and patient access:
      • Plans to expand into HLAs beyond A2 to increase the addressable patient population
      • Bringing forward HiT candidates for multiple targets including GPC3
      • Announcing collaboration with leading TIL therapy center (CCIT, Denmark) for nextgeneration TILs co-expressing IL-7
      • Bringing two allogeneic targets into the clinic:
        • In-house MAGE A4 targeted iPSC T-cell products
        • Mesothelin, a target expressed in multiple solid tumors, named as first HiT target in partnership with Astellas

    An update on the Company's financial position

    • Total liquidity position of $400 million as of September 30, 2020
    • Current cash runway into early 2023

    The Virtual Investor Day will also include two Q&A sessions.

    About Adaptimmune

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.  

    Media Relations:

    Sébastien Desprez — VP, Communications and Investor Relations

    T: +44 1235 430 583

    M: +44 7718 453 176

    Investor Relations:

    Juli P. Miller, Ph.D. — Senior Director, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920

    ________________

    1 Mortality figures based on American Cancer Society 2020 (US) and Global Can (EU) – Synovial sarcoma data based on internal market research; MAGE A4 expression ranges based on ADAP samples and expression cut-off criteria of ≥30% tumor cells at ≥2+ intensity; HLA-A2 expression of 41% based on ADAP samples (1,043 patient samples); Serum AFP expression ranges based on internal samples (62 patients) and expression cut off >100ng/mL 



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  2. - Data support confidence in SPEARHEAD-1 as a registrational trial -

    - Projected to complete recruitment of all patients in Q1 2021 -

    - Median duration of response was 28 weeks with ongoing responses beyond 72 weeks in two patients; median overall survival has not been reached –

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, presented durability of response data from patients with synovial sarcoma from the Phase 1 ADP-A2M4 trial at the virtual Connective Tissue Oncology Society (CTOS) annual meeting. The oral presentation given by Dr. Brian Van Tine of the Washington University School of Medicine is available on-demand…

    - Data support confidence in SPEARHEAD-1 as a registrational trial -

    - Projected to complete recruitment of all patients in Q1 2021 -

    - Median duration of response was 28 weeks with ongoing responses beyond 72 weeks in two patients; median overall survival has not been reached –

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, presented durability of response data from patients with synovial sarcoma from the Phase 1 ADP-A2M4 trial at the virtual Connective Tissue Oncology Society (CTOS) annual meeting. The oral presentation given by Dr. Brian Van Tine of the Washington University School of Medicine is available on-demand for congress attendees. Dr. Van Tine will also participate in a "live stream" session entitled - Immunotherapy in Sarcoma: Alveolar Soft Part Sarcoma, Clear Cell Sarcoma, Synovial Sarcoma (Proffered Papers Panel Discussion) scheduled for 9 AM EST today (November 19).

    "The impact on patients treated with ADP-A2M4 is transformative, as they benefit from a durable response from a single treatment. This leads to the highest quality of life I have been able to provide patients with synovial sarcoma after treatment," said Dr. Brian Van Tine, Associate Professor of Medicine, Division of Oncology, Section of Medical Oncology, Washington University School of Medicine.

    "Data from this trial have enabled rapid execution of our pivotal trial, SPEARHEAD-1, and support our aim to commercialize ADP-A2M4 as the first engineered TCR T-cell product in the US in 2022," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "However, this is only the beginning of the tremendous potential of our products targeting MAGEA4. We will rapidly pursue additional indications, starting with the Phase 2 trial in gastroesophageal cancers with ADP-A2M4CD8 expected to initiate in the first half of 2021."

    Data presented at CTOS were updated durability of response and safety data from the 16 patients with synovial sarcoma who were treated in the Phase 1 ADP-A2M4 trial, presented earlier this year at ASCO. The data cut-off for this presentation was September 1, 2020 and results are summarized below:

    • Seven out of 16 patients (44%) had confirmed partial responses (PRs) per RECIST criteria, with disease control in 15 patients (94%)
    • There was a median duration of response of 28 weeks (range: 12-72+ weeks) with two PRs that were ongoing beyond 72 weeks at the time of data cut-off
    • Eleven out of 16 patients were alive at data cut-off and median overall survival had not been reached
    • Translational data indicate that induction of the IFNγ-related pathway by serum analyses is an emerging biomarker of response. MAGE-A4 expression and transduced cell dose correlate with tumor reduction
    • Most adverse events were consistent with those typically experienced by cancer patients undergoing lymphodepletion chemotherapy and cellular therapy including low blood counts and cytokine release syndrome

    About Adaptimmune

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

    Media Relations:

    Sébastien Desprez — VP, Communications and Investor Relations

    T: +44 1235 430 583

    M: +44 7718 453 176

    Investor Relations:

    Juli P. Miller, Ph.D. — Senior Director, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920



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  3. PHILADELPHIA and OXFORDSHIRE, United Kingdom, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, will host a virtual Investor Day on November 20, 2020 at 8AM EST/ 1PM GMT. A link to register is available HERE and further details are on the Investor Relations tab of the Adaptimmune website.

    The Company plans to showcase the market potential for its SPEAR T-cell portfolio as well as provide details about its early stage pipeline with multiple cell therapies beyond its current autologous TCR T-cell products. Presentations will be given by Adaptimmune's Senior Leadership Team in addition to Dr. Dejka Araujo from the Department of Sarcoma Medical Oncology, Division of Cancer…

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, will host a virtual Investor Day on November 20, 2020 at 8AM EST/ 1PM GMT. A link to register is available HERE and further details are on the Investor Relations tab of the Adaptimmune website.

    The Company plans to showcase the market potential for its SPEAR T-cell portfolio as well as provide details about its early stage pipeline with multiple cell therapies beyond its current autologous TCR T-cell products. Presentations will be given by Adaptimmune's Senior Leadership Team in addition to Dr. Dejka Araujo from the Department of Sarcoma Medical Oncology, Division of Cancer Medicine of the MD Anderson Cancer Center.

    About Adaptimmune 

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. 

    Forward-Looking Statements 

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances. 

    Media Relations:

    Sébastien Desprez — VP, Communications and Investor Relations

    T: +44 1235 430 583

    M: +44 7718 453 176

    Investor Relations:

    Juli P. Miller, Ph.D. — Senior Director, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920

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  4. - Data support continued development of ADP-A2M4CD8 -

    - On track to start Phase 2 trial in gastroesophageal cancers in the first half of 2021 -

    PHILADELPHIA, Pa. and OXFORDSHIRE, UK., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, presented data from the dose escalation cohorts of its Phase 1 SURPASS trial using ADP-A2M4CD8 in a poster at the Society for the Immunotherapy of Cancer ("SITC") Conference.

    In these cohorts of heavily pre-treated patients with advanced cancers (n=6), three were treated with target doses of 1 billion SPEAR T-cells, and three with target doses of 5 billion. Most adverse events were consistent with those typically experienced by cancer patients…

    - Data support continued development of ADP-A2M4CD8 -

    - On track to start Phase 2 trial in gastroesophageal cancers in the first half of 2021 -

    PHILADELPHIA, Pa. and OXFORDSHIRE, UK., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, presented data from the dose escalation cohorts of its Phase 1 SURPASS trial using ADP-A2M4CD8 in a poster at the Society for the Immunotherapy of Cancer ("SITC") Conference.

    In these cohorts of heavily pre-treated patients with advanced cancers (n=6), three were treated with target doses of 1 billion SPEAR T-cells, and three with target doses of 5 billion. Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or cancer immunotherapy.

    "We have seen responses in two out of six patients treated in the safety cohorts of the SURPASS trial as well as antitumor activity in five of them. The responses and antitumor activity we have seen with our next-generation ADP-A2M4CD8 SPEAR T-cells, across a range of solid tumors, support our belief that this is a highly active product," said Ad Rawcliffe, Adaptimmune's Chief Executive Officer. "Based on these data, we will initiate the Phase 2 trial in gastroesophageal cancers in the first half of 2021 and look forward to identifying additional indications to take into late-stage development."

    There were two confirmed partial responses (PRs): one in a patient with esophagogastric junction (EGJ) cancer, previously reported, and one in a patient with head and neck cancer, reported as unconfirmed in May. The four other patients had best overall responses of stable disease (SD). Overall, five out of six patients treated had initial tumor shrinkage.

    In vitro translational data using the manufactured products from patients in the SURPASS trial indicate that co-expression of the CD8α co-receptor on CD4+ ADP-A2M4 SPEAR T-cells enables them to kill MAGE-A4 expressing target cells with equal potency as CD8+ SPEAR T-cells targeting MAGE-A4. These data, combined with the responses and antitumor activity observed at low doses, indicate that ADPA2M4D8 may be a more potent product than the first-generation ADPA2M4 SPEAR T-cells.

    Best Overall Response (BOR) and maximum changes from baseline in target lesions in Cohorts 1 and 2

    IndicationDose x 109BORTumor reduction
    Head and neck4.6PR-63.16%
    EGJ1.2PR-51.52%
    EGJ1.0SD-34.07%
    Ovarian1.1SD-16.13%
    Esophageal6.0SD-13.37%
    MRCLS5.7SD+1.35%

    As of data cut-off: October 1, 2020

    At SITC, Adaptimmune also presented a poster entitled "Inhibition of AKT signaling during expansion of TCR-engineered T-cells from patient leukocyte material generates SPEAR T-cells with enhanced functional potential in vitro." These preclinical data indicate that AKT inhibition during the manufacture of SPEAR T-cells results in a more consistent expansion and phenotype of the final product. This process is currently being used for manufacture of ADP-A2M4CD8 for the SURPASS trial.

    The Company also presented two posters summarizing data for the two completed Phase 1 trials with ADP-A2M10 (a previously terminated program).

    About Adaptimmune

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.  

    Media Relations:

    Sébastien Desprez — VP, Communications and Investor Relations

    T: +44 1235 430 583

    M: +44 7718 453 176

    Investor Relations:

    Juli P. Miller, Ph.D. — Senior Director, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920





    SITC Abstract

    Title: Initial safety, efficacy, and product attributes from the SURPASS trial with ADPA2M4CD8, a SPEAR T-cell therapy incorporating an affinity optimized TCR targeting MAGE-A4 and a CD8α co-receptor

    Authors: David S. Hong1, Jeffrey Clarke2, Tanner Johanns3, Partow Kebriaei1, John V. Heymach1, Ahmed Galal2, Samuel D. Saibil4, Adrian Sacher4, Francine E. Brophy5, Gareth Betts6, Natalie Bath6, Will Spinner6, Alex Tipping6, Jessica Tucci5, Raymond Luke5, Trupti Trivedi5, Quan Lin5, JeanMarc Navenot5, Paula M. Fracasso5, Karen Miller6, Elliot Norry5, Mark Dudley5, Marcus O. Butler4

    Affiliations (Institution, City, State, Country):

    1The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America, 2Duke Cancer Center, Durham, NC, United States of America, 3Washington University School of Medicine, St. Louis, MO, United States of America,4Princess Margaret Cancer Centre, Toronto, Ontario, Canada, 5Adaptimmune, Philadelphia, PA, United States of America, 6Adaptimmune, Abingdon, United Kingdom

    Abstract Body:

    Background: The ongoing SURPASS trial (NCT04044859) evaluates safety and efficacy of next-generation ADP-A2M4CD8 SPEAR T-cells co-expressing the CD8α co-receptor with the engineered MAGE-A4c1032 Tcell receptor (TCR).

    Methods: First-in-human trial in HLA-A*02 positive patients (pts) with advanced cancers expressing MAGE-A4 antigen by immunohistochemistry. Eligible pts undergo apheresis, Tcells are isolated, transduced with a Lentiviral vector containing the MAGE-A4c1032 TCR and CD8α coreceptor, and expanded. Expansion, transduction level, cellular composition and function of the manufactured product (MP) are assessed in vitro. Prior to infusion, pts receive lymphodepletion with fludarabine 30 mg/m2/day for 4 days and cyclophosphamide 600 mg/m2/day for 3 days.

    Results:   As of 16 July 2020, 5 pts (1 with MRCLS, 2 with esophagogastric junction [EGJ] cancers, 1 with ovarian cancer, and 1 with head and neck cancer) were treated with ADP-A2M4 CD8 (range ~1 to 5.7 billion transduced cells). No DLTs or SAEs have been reported. To date, 1 pt with EGJ cancer had a partial response (PR per RECIST) and has had progression-free survival >6 months. One pt with head and neck cancer also had a PR. All other pts have had best overall response of stable disease.

    MP expanded by an average of 15.3fold during manufacturing (range 5.9 to 25.6-fold). On average, 43% of Tcells in the MP expressed the TCR (range 23 to 63%). The fraction of CD4+ cells in the final MP varied (range 45 to 84%). Coexpression of the MAGE-A4 TCR and CD8α in CD4+ T-cells in the patient MP enabled CD4+ T-cells to kill tumor target cells directly in vitro. MAGE-A4 expression in tumor biopsies varied (H-score range 55 to 300). Transduced T-cells were detected in peripheral blood of all pts. IFNgamma increased transiently in the serum of 1 pt who responded.

    Conclusions: ADP-A2M4CD8 SPEAR T-cells have shown an acceptable safety profile and pts with EGJ cancer and head and neck cancer have demonstrated evidence of antitumor activity. Translational data and early clinical results indicate that co-expression of the CD8α co-receptor on CD4+ SPEAR T-cells may increase the potency of the product by conferring additional killing activity to the helper T-cell subset. This dose escalation trial is ongoing and updated clinical and translational data will be presented.

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  5. - Data from Phase 1 Trial with ADP-A2AFP in liver cancer presented at ILC confirm safety profile and demonstrate potential benefit for patients -

    - Safety and response data from dose escalation cohorts of the SURPASS trial to be presented at SITC -

    - Durability of response data from patients with synovial sarcoma from the Phase 1 ADP-A2M4 trial to be presented at CTOS -

    - Virtual Investor Day planned for November 20, 2020 -

    - Financial guidance confirmed: funded into 2022 -

    - Conference call to be held today at 8:00 a.m. EST (1:00 p.m. GMT) -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, today reported financial results…

    - Data from Phase 1 Trial with ADP-A2AFP in liver cancer presented at ILC confirm safety profile and demonstrate potential benefit for patients -

    - Safety and response data from dose escalation cohorts of the SURPASS trial to be presented at SITC -

    - Durability of response data from patients with synovial sarcoma from the Phase 1 ADP-A2M4 trial to be presented at CTOS -

    - Virtual Investor Day planned for November 20, 2020 -

    - Financial guidance confirmed: funded into 2022 -

    - Conference call to be held today at 8:00 a.m. EST (1:00 p.m. GMT) -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, today reported financial results and provided a business update for the third quarter ended September 30, 2020.

    "Later this month, we will present data at SITC and CTOS. Data to be presented at SITC from the dose escalation cohorts of our SURPASS trial confirm that ADP-A2M4CD8 is a highly active agent across a range of tumors. At CTOS, we will present data regarding the durability of responses in synovial sarcoma, which support our ambition to market ADP‑A2M4 in 2022. And finally, at our Investor Day, I will lay out our broader strategy including the opportunity we see for our late-stage pipeline," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "Recruitment into our clinical trials has been steadily recovering following the first wave of COVID-19 and projected patient numbers currently look good for the remainder of this year and into 2021."

    PLANNED MILESTONES Q4 2020

    • Four posters to be presented at the virtual SITC meeting (November 9-14)
      • Poster entitled "Initial safety, efficacy, and product attributes from the SURPASS trial with ADP‑A2M4CD8, a SPEAR T-cell therapy incorporating an affinity optimized TCR targeting MAGE-A4 and a CD8α co-receptor" with an update on the dose escalation cohorts (6 patients in total)
      • Poster entitled "Inhibition of AKT signaling during expansion of TCR-Engineered T-Cells from patient leukocyte material generates SPEAR T-Cells with enhanced functional potential in vitro" with data indicating that AKT inhibition during manufacture of SPEAR T-cells results in a more consistent expansion and phenotype of the final product
      • Two posters about the previously terminated ADP-A2M10 Phase 1 program: one for the lung cancer trial, and one for the triple tumor trial in melanoma, urothelial, and head & neck cancers
    • Durability of response data from patients with synovial sarcoma from the ADP-A2M4 Phase 1 trial to be presented in an oral presentation at the virtual CTOS conference ("Immunotherapy in Sarcoma" session on November 19, 2020 from 9 a.m. to 10 a.m. EST)
    • Investor Day to be held on November 20, 2020

    CLINICAL UPDATES

    • As the management of COVID-19 at clinical sites continues to evolve, there has been an increase in recruitment and enrollment during the latter part of Q3 and into Q4 for all ongoing clinical trials
    • SPEARHEAD-1 is recruiting well and remains on target to complete enrollment in the first half of 2021
    • On track to start a Phase 2 trial with ADP-A2M4CD8 in gastroesophageal cancers (gastric, esophageal, and esophagogastric junction) in the first half of 2021
    • Data update from the Phase 1 ADP-A2AFP trial presented in an oral presentation and poster, at the International Liver Congress, confirmed safety profile and demonstrated potential benefit for patients with hepatocellular carcinoma. Four patients were treated with ~5 billion or more transduced cells with best responses of one complete response, one patient with stable disease, and two patients with progressive disease.
    • Presented SPEARHEAD-2 trial-in-progress poster at ESMO summarizing design for this first combination clinical trial with ADP-A2M4 and pembrolizumab

    Financial Results for the three and nine month periods ended September 30, 2020

    • Cash / liquidity position: As of September 30, 2020, Adaptimmune had cash and cash equivalents of $78.5 million and Total Liquidity1 of $399.9 million.

       
    • Revenue: Revenue for the three and nine months ended September 30, 2020 was $1.2 million and $2.5 million, respectively, compared to $0.2 million and $0.4 million for the same periods in 2019. Revenue increased due to the commencement of development activity under the Astellas Collaboration Agreement and increased development activity under the GSK Collaboration and License Agreement.

       
    • Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2020 were $24.1 million and $65.8 million, respectively, compared to $29.6 million and $77.1 million for the same periods in 2019. R&D expenses were higher in the three and nine months ended September 30, 2019 due to recognition of accrued purchase commitment expenses related to the supply of the Dynabeads® CD3/CD28 technology of $5.0 million and in-process research and development as a result of entering into a collaboration agreement with Noile-Immune Biotech, Inc. in August 2019. The nine-month period ended September 30, 2019 also included $2.0 million of in-process research and development as a result of entering into a collaboration agreement with Alpine Immune Sciences, Inc. in May 2019.

       
    • General and administrative (G&A) expenses: G&A expenses for the three and nine months ended September 30, 2020 were $13.0 million and $32.6 million, respectively, compared to $10.7 million and $32.7 million for the same periods in 2019. The increase in the three months ended September 30, 2020 was primarily driven by an increase in professional fees, investment in our IT systems, and costs associated with the buildout of our commercial capabilities.

       
    • Net loss: Net loss attributable to holders of the Company's ordinary shares for the three and nine months ended September 30, 2020 was $35.4 million and $93.5 million, respectively, and $(0.04) and $(0.11) per ordinary share, respectively, compared to $39.3 million and $107.8 million and $(0.06) and $(0.17) per ordinary share for the same periods in 2019.

    Financial guidance

    The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company's current operations into 2022, as further detailed in the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020, to be filed with the Securities and Exchange Commission following this earnings release.

    Conference Call and Webcast Information

    The Company will host a live teleconference at 8:00 a.m. EST (1:00 p.m. GMT) today, November 5, 2020. The live webcast of the conference call will be available in the investor section of Adaptimmune's corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6183339).

    About Adaptimmune

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on August 6, 2020, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

    Total Liquidity (a non-GAAP financial measure)

    Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities. Each of these components appears separately in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in millions):

         September 30,     December 31, 
      2020 2019
    Cash and cash equivalents $78.5  50.4
    Marketable securities – available-for-sale debt securities  321.4  39.1
    Total Liquidity $399.9  89.5

    The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall liquidity, financial flexibility, capital structure and leverage.



    Condensed Consolidated Statement of Operations

    (unaudited, in thousands, except per share data)

                 
      Three months ended     Nine months ended
      September 30,  September 30, 
         2020    2019    2020    2019
    Revenue $ 1,193  $ 237  $ 2,456  $ 394 
    Operating expenses            
    Research and development (including losses accrued on firm purchase commitments of $0, $5,000, $0 and $5,000)  (24,067)  (29,617)  (65,791)  (77,147)
    General and administrative  (13,001)  (10,741)  (32,557)  (32,662)
    Total operating expenses   (37,068)   (40,358)   (98,348)   (109,809)
    Operating loss   (35,875)   (40,121)   (95,892)   (109,415)
    Interest income  2,147   615   4,024   2,324 
    Other (expense) income, net  (1,689)  291   (1,501)  (556)
    Loss before income taxes   (35,417)   (39,215)   (93,369)   (107,647)
    Income taxes  (15)  (87)  (110)  (154)
    Net loss attributable to ordinary shareholders $ (35,432) $ (39,302) $ (93,479) $ (107,801)
                 
    Net loss per ordinary share            
    Basic and diluted $ (0.04) $ (0.06) $ (0.11) $ (0.17)
                 
    Weighted average shares outstanding:            
    Basic and diluted  928,022,057   630,866,800   829,973,177   629,403,293 



    Condensed Consolidated Balance Sheets

    (unaudited, in thousands, except share data)

           
      September 30,  December 31, 
         2020    2019
    Assets      
    Current assets      
    Cash and cash equivalents $78,466  $50,412 
    Marketable securities - available-for-sale debt securities  321,442   39,130 
    Other current assets and prepaid expenses (including current portion of

    clinical materials)
      26,825   30,947 
    Total current assets   426,733    120,489 
           
    Restricted cash  4,441   4,496 
    Clinical materials  160   2,503 
    Operating lease right-of-use assets, net of accumulated amortization  18,775   20,789 
    Property, plant and equipment, net of accumulated depreciation of $28,503 (2019: $23,649)  26,943   31,068 
    Intangibles, net of accumulated amortization  1,970   2,198 
    Total assets $ 479,022  $ 181,543 
           
    Liabilities and stockholders' equity      
    Current liabilities      
    Accounts payable $4,030  $6,357 
    Operating lease liabilities, current  2,619   2,493 
    Accrued expenses and other accrued liabilities  24,615   23,363 
    Deferred revenue, current  3,635   2,128 
    Total current liabilities   34,899    34,341 
           
    Operating lease liabilities, non-current  21,090   22,966 
    Deferred revenue, non-current  46,212    
    Other liabilities, non-current  615   598 
    Total liabilities   102,816    57,905 
           
    Stockholders' equity      
    Common stock - Ordinary shares par value £0.001, 1,038,249,630 authorized and 928,525,410 issued and outstanding (2019: 785,857,300 authorized and 631,003,568 issued and outstanding)  1,325   943 
    Additional paid in capital  932,518   585,623 
    Accumulated other comprehensive loss  (8,494)  (7,264)
    Accumulated deficit  (549,143)  (455,664)
    Total stockholders' equity   376,206    123,638 
           
    Total liabilities and stockholders' equity $ 479,022  $ 181,543 



    Condensed Consolidated Cash Flow Statement

    (unaudited, in thousands)

           
      Nine months ended
      September 30, 
         2020    2019
    Cash flows from operating activities      
    Net loss $(93,479) $(107,801)
    Adjustments to reconcile net loss to net cash used in operating activities:      
    Depreciation  5,151   5,406 
    Amortization  718   511 
    Share-based compensation expense  7,352   8,495 
    Unrealized foreign exchange (gains) losses  (1,102)  522 
    Other  2,817   (208)
    Changes in operating assets and liabilities:      
    Decrease (increase) in receivables and other operating assets  3,345   (20,075)
    Decrease in non-current operating assets  2,291   1,468 
    (Decrease) increase in payables and other current liabilities  (117)  8,879 
    Increase in deferred revenue  48,649   2,824 
    Net cash used in operating activities   (24,375)   (99,979)
           
    Cash flows from investing activities      
    Acquisition of property, plant and equipment  (1,174)  (1,425)
    Acquisition of intangibles  (496)  (1,036)
    Maturity or redemption of marketable securities  78,915   92,803 
    Investment in marketable securities  (363,777)  (19,080)
    Net cash (used in) provided by investing activities   (286,532)   71,262 
           
    Cash flows from financing activities      
    Proceeds from issuance of common stock, net of issuance costs  334,388    
    Proceeds from exercise of stock options  5,541   366 
    Net cash provided by financing activities   339,929    366 
           
    Effect of currency exchange rate changes on cash, cash equivalents and

    restricted cash
      (1,023)  (398)
    Net increase (decrease) in cash, cash equivalents and restricted cash  27,999   (28,749)
    Cash, cash equivalents and restricted cash at start of period  54,908   72,476 
    Cash, cash equivalents and restricted cash at end of period $ 82,907  $ 43,727 



    Adaptimmune Contacts:

    Media Relations:

    Sébastien Desprez — VP, Communications and Investor Relations

    T: +44 1235 430 583

    M: +44 7718 453 176

    Investor Relations:

    Juli P. Miller, Ph.D. — Senior Director, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920


    1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

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