ADAP Adaptimmune Therapeutics plc

4.78
-0.09  -2%
Previous Close 4.87
Open 4.99
52 Week Low 0.709
52 Week High 13.4
Market Cap $739,042,927
Shares 154,611,491
Float 125,305,788
Enterprise Value $346,454,156
Volume 857,971
Av. Daily Volume 995,688
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Upcoming Catalysts

Drug Stage Catalyst Date
MAGE-A4 (ADP-A2M4CD8 - SURPASS)
Solid tumors
Phase 1
Phase 1
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MAGE-A4 (ADP-A2M4)
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
MAGE-A4 (SPEARHEAD‑1)
Synovial sarcoma or myxoid/round cell liposarcoma (MRCLS)
Phase 2
Phase 2
Phase 2 enrolment to be completed 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. PHILADELPHIA and OXFORDSHIRE, U.K., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, will report financial results and provide a business update for Q3 2020, before the U.S. markets open on Thursday, November 5, 2020. Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EST (1:00 p.m. GMT) on the same day (details below).

    The press release and 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…

    PHILADELPHIA and OXFORDSHIRE, U.K., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, will report financial results and provide a business update for Q3 2020, before the U.S. markets open on Thursday, November 5, 2020. Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EST (1:00 p.m. GMT) on the same day (details below).

    The press release and 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.

    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

    Primary Logo

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  2. PHILADELPHIA and OXFORDSHIRE, United Kingdom, Oct. 15, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc ("Adaptimmune") (NASDAQ:ADAP), a leader in cell therapy to treat cancer is aware of the early release of the abstract entitled "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" by the Society for the Immunotherapy of Cancer ("SITC") Conference.

    The full abstract is attached to this release.

    The Company will update on the full dose escalation cohort of the SURPASS trial (6 patients in total) at the virtual SITC conference on November 11, 2020 at 9 AM EST when posters are made available…

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Oct. 15, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc ("Adaptimmune") (NASDAQ:ADAP), a leader in cell therapy to treat cancer is aware of the early release of the abstract entitled "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" by the Society for the Immunotherapy of Cancer ("SITC") Conference.

    The full abstract is attached to this release.

    The Company will update on the full dose escalation cohort of the SURPASS trial (6 patients in total) at the virtual SITC conference on November 11, 2020 at 9 AM EST when posters are made available online.

    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.  

    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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  3. PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 28, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc ("Adaptimmune")(NASDAQ:ADAP), a leader in cell therapy to treat cancer, presented data from its Phase 1 trial with SPEAR T-cells targeting AFP at the virtual International Liver Congress (ILC). One patient out of four dosed with 5 billion or more cells had a complete response, which was reported previously. The data also demonstrate an acceptable safety profile in patients with hepatocellular carcinoma (HCC).

    "A complete response in a patient with advanced liver cancer, and the anti-tumor activity we have reported in other patients with an acceptable safety profile, to date, further support the continued investigation of ADP-A2AFP…

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 28, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc ("Adaptimmune")(NASDAQ:ADAP), a leader in cell therapy to treat cancer, presented data from its Phase 1 trial with SPEAR T-cells targeting AFP at the virtual International Liver Congress (ILC). One patient out of four dosed with 5 billion or more cells had a complete response, which was reported previously. The data also demonstrate an acceptable safety profile in patients with hepatocellular carcinoma (HCC).

    "A complete response in a patient with advanced liver cancer, and the anti-tumor activity we have reported in other patients with an acceptable safety profile, to date, further support the continued investigation of ADP-A2AFP," said Elliot Norry, Adaptimmune's Chief Medical Officer. "We remain encouraged by the potential of this therapy and we are fully committed to developing ADP‑A2AFP for people with HCC. We have reported results for four patients at doses of 5 billion cells or more and we are looking forward to sharing more data as we continue to treat patients in the expansion phase of the trial. Further, we continue to review our translational findings and are evaluating ways to improve the therapy, if necessary."

    Dr. Bruno Sangro of Clinica Universidad de Navarra presented data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1 trial during an oral presentation at ILC. Tim Meyer of University College London presented additional data from Cohorts 1 and 2 during a poster presentation. A video is available on Adaptimmune's website (https://youtu.be/qAHamb3Yi8Y) of Elliot Norry, and Mark Dudley, SVP of Early Stage Development, discussing these data. The oral presentation and poster presentation are available online through the congress web site.

    Topline data from ILC 1

    • One patient had a complete response and also demonstrated a sustained reduction in serum AFP. This patient experienced disease progression, having developed new lesions at Week 32
    • Overall, nine patients have been treated as of the data cutoff, of those

      - Four patients have been treated with ~5 billion or more transduced cells (three in Cohort 3 and one in the expansion phase): 1 patient with the complete response, 1 with stable disease (SD), and 2 had progressive disease (PD)

      - Five patients were previously treated in the first two dose cohorts with doses of 100 million and 1 billion transduced cells, respectively, and all patients had best responses of SD
    • ADP-A2AFP SPEAR T-cells were associated with an acceptable safety profile with no evidence of significant T-cell related hepatotoxicity and no protocol-defined dose limiting toxicities
    • Evidence of dose-dependent persistence of ADP-A2AFP SPEAR T-cells post-infusion
    • Further translational evaluation is ongoing to understand indicators of response

    ______________________________

    1 All data summarized are for patients with HCC with a data cut-off of July 6, 2020. Data from non-HCC patients to be presented at a future congress

    Overview of Trial Design

    • This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and anti-tumor activity of ADP-A2AFP in patients with HCC or other AFP-expressing tumors who are not amenable to transplant, resection, or loco-regional therapy, and who failed or were intolerant to or refused standard-of-care treatment
    • Dose escalation is complete, and this trial is enrolling in the expansion phase intended to treat up to 25 patients with doses up to 10 billion cells

    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.

    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. - Reported responses in multiple solid tumor types during ASCO with updates at upcoming congresses in Q4 -

    - Continued progress toward launch of ADP-A2M4 for sarcoma in the US in 2022 with ongoing enrollment of patients in SPEARHEAD-1 -

    - Granted access to PRIority MEdicines (PRIME) regulatory support by the European Medicines Agency for ADP-A2M4 for the treatment of synovial sarcoma -

    - Completed public offering with net proceeds of approximately $244m; guidance confirmed: funded into 2022 -

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

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer…

    - Reported responses in multiple solid tumor types during ASCO with updates at upcoming congresses in Q4 -

    - Continued progress toward launch of ADP-A2M4 for sarcoma in the US in 2022 with ongoing enrollment of patients in SPEARHEAD-1 -

    - Granted access to PRIority MEdicines (PRIME) regulatory support by the European Medicines Agency for ADP-A2M4 for the treatment of synovial sarcoma -

    - Completed public offering with net proceeds of approximately $244m; guidance confirmed: funded into 2022 -

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

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 06, 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 second quarter ended June 30, 2020.

    "We reported responses in multiple solid tumor types during the second quarter of 2020 demonstrating the potential of SPEAR T‑cells to deliver benefit to people with cancer. We also raised capital, placing us in a solid financial position to continue executing on our strategic plans," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "Despite the impact of the COVID-19 pandemic on the biotech industry, we made good progress in our preparations toward launching our first product in the US in 2022 for patients with sarcoma, whilst initiating and planning new Phase 2 clinical trials. However, as we enter the second half of the year, we expect COVID-19 to continue to have an impact and are monitoring this evolving situation closely."

    PLANNED MILESTONES 2H 2020

    • Update on ADP-A2AFP Phase 1 trial at the International Liver Congress to be held virtually from August 27 to 29

      - An oral presentation entitled "Data from the third dose cohort of an ongoing study with ADP‑A2AFP SPEAR T-cells" will be presented by Dr. Bruno Sangro of Clinica Universidad de Navarra

      - A poster summarizing data from the first two cohorts of the ADP-A2AFP Phase 1 trial will be presented by Dr. Tim Meyer of University College London
    • Updates on dose escalation cohorts from the SURPASS trial at a medical conference
    • Durability and translational data from patients with synovial sarcoma from the ADP-A2M4 Phase 1 trial at a medical conference
    • Investor Day to be held on November 20, 2020

                 

    CLINICAL UPDATES

    • With timeline continuing to support 2022 launch in the US, enrollment in the Phase 2 SPEARHEAD-1 trial of ADP-A2M4, for patients with synovial sarcoma or myxoid / round cell liposarcoma (MRCLS), continues to progress
    • The evolving COVID-19 pandemic continues to have an impact on clinical trials varying site-by-site and among countries
    • Phase 1 trials (ADP-A2AFP, radiation sub-study, and SURPASS) continue and patients are being enrolled and treated
    • First site has been initiated and has started screening patients for the SPEARHEAD-2 Phase 2 clinical trial, combining ADP‑A2M4 with pembrolizumab for people with head and neck cancer
    • Protocol design for the Phase 2 trial with ADP-A2M4CD8 in gastroesophageal cancers has commenced and sites are being identified. The Company plans to initiate this trial in the first half of 2021

    PROGRESS TOWARD GOAL OF LAUNCHING ADP-A2M4 IN SARCOMA IN THE US IN 2022

    • Granted access to PRIME regulatory support by the EMA further confirming the potential of ADP‑A2M4 to treat people with advanced sarcoma, along with the previously granted Orphan Drug Designation (ODD) in Europe, as well as the FDA's ODD and Regenerative Medicine Advanced Therapy designation

    MANUFACTURING AND SUPPLY

    • The Company has focused on manufacturing SPEAR T-cells for patients in the SPEARHEAD-1 trial and increasing capacity to provide for all ongoing and planned trials
    • Scaling up personnel, manufacturing processes and IT systems, and optimizing space in our Navy Yard facility in preparation for commercial launch in sarcoma
    • Following receipt of a Certificate of GMP Compliance from the MHRA for its vector manufacturing operations in July, the Company began using lentiviral vector produced in-house at its dedicated manufacturing space within the Cell and Gene Therapy Catapult Manufacturing Centre at Stevenage, UK for select clinical trials

                 

    FUNDING

    • Underwritten public offering closed on June 4, 2020 generating net proceeds of approximately $244 million

    Financial Results for the three and six month periods ended June 30, 2020

    • Cash / liquidity position: As of June 30, 2020, Adaptimmune had cash and cash equivalents of $122.4 million and Total Liquidity1 of $419.0 million.

       
    • Revenue: Revenue for the three and six months ended June 30, 2020 was $0.5 million and $1.3 million, respectively, compared to $0.2 million for both of the same periods in 2019. The increase in revenue is mainly due to further development of the third target nominated by GSK under the GSK Collaboration and License Agreement.

       
    • Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2020 were $20.5 million and $41.7 million, respectively, compared to $25.5 million and $47.5 million for the same periods in 2019. The decreases in both periods are primarily due to lower development costs brought about by COVID-19 delays, a reduction in the average number of employees engaged in research and development, and in-process research and development costs of $2.0m in 2019 as a result of entering into a collaboration agreement with Alpine Immune Sciences, Inc.

       
    • General and administrative (G&A) expenses: G&A expenses for the three and six months ended June 30, 2020 were $10.3 million and $19.6 million, respectively, compared to $10.1 million and $21.9 million for the same periods in 2019. The decrease in the six months ended June 30, 2020 was primarily driven by reduced travel costs and share-based compensation expense, partially offset by an increase in costs associated with commercialization. We expect that our general and administrative expenses will increase in the future as we expand our operations and move towards commercial launch.

       
    • Other (expense) income, net: Other (expense) income, net for the three and six months ended June 30, 2020 was an expense of $0.7 million and income of $0.2 million, respectively, compared to expenses of $6.3 million and $0.8 million for the same periods in 2019. Other (expense) income, net primarily comprises unrealized foreign exchange movements, which fluctuate depending on exchange rates and the amount of foreign currency assets and liabilities.

       
    • Net loss: Net loss attributable to holders of the Company's ordinary shares for the three and six  months ended June 30, 2020 was $29.9 million and $58.0 million, respectively, and $(0.04) and $(0.07) per ordinary share, respectively, compared to $41.1 million and $68.5 million and $(0.07) and $(0.11) 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 June 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. EDT (1:00 p.m. BST) today, August 6, 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 (5488705).

    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 May 14, 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):

           
      June 30,  December 31, 
      2020 2019
    Cash and cash equivalents $ 122.4 $ 50.4
    Marketable securities   296.6   39.1
    Total Liquidity $ 419.0 $ 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  Six months ended  
      June 30,  June 30,  
      2020  2019  2020  2019  
    Revenue $ 502  $ 157  $ 1,263  $ 157  
    Operating expenses             
    Research and development   (20,460)   (25,511)   (41,724)   (47,530) 
    General and administrative   (10,295)   (10,148)   (19,556)   (21,921) 
    Total operating expenses   (30,755)   (35,659)   (61,280)   (69,451) 
    Operating loss   (30,253)   (35,502)   (60,017)   (69,294) 
    Interest income   1,147    757    1,877    1,709  
    Other (expense) income, net   (749)   (6,277)   188    (847) 
    Loss before income taxes   (29,855)   (41,022)   (57,952)   (68,432) 
    Income taxes   (25)   (65)   (95)   (67) 
    Net loss attributable to ordinary shareholders $ (29,880) $ (41,087) $ (58,047) $ (68,499) 
                  
    Net loss per ordinary share             
    Basic and diluted $ (0.04) $ (0.07) $ (0.07) $ (0.11) 
                  
    Weighted average shares outstanding:             
    Basic and diluted   822,725,556    629,355,975    781,235,457    628,655,278  
                  



    Condensed Consolidated Balance Sheets


    (unaudited, in thousands, except share data)

           
      June 30,  December 31, 
      2020  2019 
    Assets      
    Current assets      
    Cash and cash equivalents $ 122,359  $ 50,412 
    Marketable securities - available-for-sale debt securities   296,629    39,130 
    Other current assets and prepaid expenses (including current portion of clinical materials)   39,099    30,947 
    Total current assets   458,087    120,489 
           
    Restricted cash   4,324    4,496 
    Clinical materials   1,744    2,503 
    Operating lease right-of-use assets, net of accumulated amortization   18,892    20,789 
    Property, plant and equipment, net of accumulated depreciation of $26,100 (2019: $23,649)   27,020    31,068 
    Intangibles, net of accumulated amortization   2,134    2,198 
    Total assets $ 512,201  $ 181,543 
           
    Liabilities and stockholders' equity      
    Current liabilities      
      Accounts payable   8,766    6,357 
    Operating lease liabilities, current   2,493    2,493 
    Accrued expenses and other accrued liabilities   23,836    23,363 
    Deferred revenue, current   3,464    2,128 
    Total current liabilities   38,559    34,341 
           
    Operating lease liabilities, non-current   20,814    22,966 
    Deferred revenue, non-current   44,651    — 
    Other liabilities, non-current   592    598 
    Total liabilities   104,616    57,905 
           
    Stockholders' equity      
    Common stock - Ordinary shares par value £0.001, 1,038,249,630 authorized and 927,668,946 issued and outstanding (2019: 785,857,300 authorized and 631,003,568 issued 

    and outstanding)
       1,324    943 
    Additional paid in capital   928,777    585,623 
    Accumulated other comprehensive loss   (8,805)   (7,264)
    Accumulated deficit   (513,711)   (455,664)
    Total stockholders' equity   407,585    123,638 
           
    Total liabilities and stockholders' equity $ 512,201  $ 181,543 



    Condensed Consolidated Cash Flow Statement

    (unaudited, in thousands)

            
      Six months ended  
      June 30,  
      2020  2019  
    Cash flows from operating activities       
    Net loss $ (58,047) $ (68,499) 
    Adjustments to reconcile net loss to net cash used in operating activities:       
    Depreciation   3,583    3,642  
    Amortization   464    333  
    Share-based compensation expense   4,072    6,675  
    Unrealized foreign exchange (gains) losses   (2,004)   1,048  
    Other   718    (166) 
    Changes in operating assets and liabilities:       
    Increase in receivables and other operating assets   (10,104)   (16,851) 
    Decrease in non-current operating assets   615    1,263  
    Increase (decrease) in payables and other current liabilities   3,571    (876) 
    Increase in deferred revenue   49,074    3,060  
    Net cash used in operating activities   (8,058)   (70,371) 
            
    Cash flows from investing activities       
    Acquisition of property, plant and equipment   (460)   (1,202) 
    Acquisition of intangibles   (407)   (922) 
    Maturity or redemption of marketable securities   39,931    54,324  
    Investment in marketable securities   (298,016)   (15,983) 
    Net cash (used in) provided by investing activities   (258,952)     36,217  
            
    Cash flows from financing activities       
    Proceeds from issuance of common stock, net of issuance costs   334,388    —  
    Proceeds from exercise of stock options   5,075    366  
    Net cash provided by financing activities     339,463    366  
            
    Effect of currency exchange rate changes on cash, cash equivalents and restricted cash   (678)   289  
    Net increase (decrease) in cash, cash equivalents and restricted cash   71,775    (33,499) 
    Cash, cash equivalents and restricted cash at start of period   54,908    72,476  
    Cash, cash equivalents and restricted cash at end of period $ 126,683  $ 38,977  

    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 May 14, 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.

    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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  5. PHILADELPHIA and OXFORDSHIRE, United Kingdom, July 23, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, announced that the European Medicines Agency (EMA) has granted access to the PRIME initiative to the Company for ADP-A2M4 for the treatment of synovial sarcoma. PRIME access provides enhanced scientific and regulatory support by the EMA to developers of medicines with the potential to significantly address unmet medical needs.

    "We are thrilled that the EMA has acknowledged the potential of ADP-A2M4 to address an unmet medical need for more effective treatment options for patients with advanced synovial sarcoma," said Dennis Williams, PharmD, Adaptimmune's Senior Vice President…

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, July 23, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, announced that the European Medicines Agency (EMA) has granted access to the PRIME initiative to the Company for ADP-A2M4 for the treatment of synovial sarcoma. PRIME access provides enhanced scientific and regulatory support by the EMA to developers of medicines with the potential to significantly address unmet medical needs.

    "We are thrilled that the EMA has acknowledged the potential of ADP-A2M4 to address an unmet medical need for more effective treatment options for patients with advanced synovial sarcoma," said Dennis Williams, PharmD, Adaptimmune's Senior Vice President, Late Stage Development. "Access to the enhanced EMA support and guidance offered in the PRIME scheme will facilitate the development of ADP-A2M4 to ensure this important medicine reaches patients with sarcoma as early as possible."

    Access to the PRIME initiative for ADP-A2M4 was granted based on clinical data from the Phase 1 trial demonstrating compelling efficacy and early promising durability, with tolerable safety in patients with synovial sarcoma. Based on these data the Company initiated the SPEARHEAD-1 trial with ADP-A2M4, enrolling people with advanced synovial sarcoma and myxoid/ round cell liposarcoma (MRCLS) at clinical sites in Canada, France, Spain, the United Kingdom, and the United States (US). The SPEARHEAD-1 trial is intended to support the registration of ADP‑A2M4 for the treatment of advanced synovial sarcoma and MRCLS.

    In recent months, the US Food and Drug Administration granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 for the treatment of soft tissue sarcomas and Regenerative Medicine Advanced Therapy designation for the treatment of synovial sarcoma. In addition, The EMA's Committee for Orphan Medicinal Products adopted a positive opinion for ODD for ADP-A2M4 for the treatment of soft tissue sarcomas.

    The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The PRIME designation is awarded by the EMA to promising medicines that target an unmet medical need. To be eligible and accepted for PRIME, a medicine must show potential to benefit patients with unmet medical needs based on early clinical data coupled with non-clinical data. Through the PRIME program, the EMA offers enhanced support to medicine developers including early interaction and dialogue, and a pathway for accelerated evaluation by the agency. The program is intended to optimize development plans and expedite the review and approval process so that these medicines may reach patients as early as possible.

    About Synovial Sarcoma

    Soft tissue sarcomas can develop from soft tissues like fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues. There are approximately 50 types of soft tissue sarcomas, including synovial sarcoma, which accounts for approximately 6% to 10% of all soft tissue sarcomas. There remains a large unmet medical need for synovial sarcoma, and approximately one-third of synovial sarcomas occur in childhood and the peak incidence is in the third decade of life. The most common locations for this cancer are the hip, knee, ankle, and shoulder.

    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 May 14, 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.

    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

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