ADAP Adaptimmune Therapeutics plc

5.5
+0.42  (+8%)
Previous Close 5.08
Open 5.12
52 Week Low 3.37
52 Week High 10.24
Market Cap $858,486,470
Shares 156,088,449
Float 124,959,569
Enterprise Value $580,152,624
Volume 2,141,216
Av. Daily Volume 2,230,839
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Upcoming Catalysts

Drug Stage Catalyst Date
Afami-cel (ADP-A2M4)
Solid tumors
Phase 1
Phase 1
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Afami-cel - (SPEARHEAD‑1)
Synovial sarcoma or myxoid/round cell liposarcoma (MRCLS)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
ADP-A2M4CD8 (SURPASS)
Solid tumors
Phase 1
Phase 1
Phase 1 data released September 16, 2021 - 4.5% of patients received CR, 31.8% received PR, 50% received SD, 13% received PD. Phase 2 trial, SURPASS-2, will start later 2021 for patients with esophageal and EGJ cancers.
AFP (ADP-A2AFP)
Hepatocellular carcinoma
Phase 1
Phase 1
Phase 1 data displayed one complete response and a disease control rate of 64% with stable disease for ≥16 weeks in two patients. Phase 1 top-line data has an acceptable safety profile. Dose escalation is complete September 5, 2021.
ADP-A2M4CD8 (SURPASS-2)
Esophageal and esophagogastric junction cancers
Phase 2
Phase 2
Phase 2 trial to commence 3Q 2021.

Latest News

  1. - Confirmed complete response in ovarian cancer, and confirmed partial responses in ovarian, head and neck, esophagogastric junction, bladder, and synovial sarcoma cancers -

    - Majority of patients experienced antitumor activity with a disease control rate of 86% -

    - ADP-A2M4CD8 cell therapy shows improved tumor cell killing and engagement of the broader immune system to fight cancer -

    PHILADELPHIA and OXFORD, U.K., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, announced updated data from its Phase 1 SURPASS trial in multiple solid tumors to be presented in a digital poster at the upcoming European Society for Medical Oncology (ESMO) annual meeting. The poster will…

    - Confirmed complete response in ovarian cancer, and confirmed partial responses in ovarian, head and neck, esophagogastric junction, bladder, and synovial sarcoma cancers -

    - Majority of patients experienced antitumor activity with a disease control rate of 86% -

    - ADP-A2M4CD8 cell therapy shows improved tumor cell killing and engagement of the broader immune system to fight cancer -

    PHILADELPHIA and OXFORD, U.K., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, announced updated data from its Phase 1 SURPASS trial in multiple solid tumors to be presented in a digital poster at the upcoming European Society for Medical Oncology (ESMO) annual meeting. The poster will be displayed on the ESMO congress web site on Thursday, September 16th. The Company has also released a video of Adrian Rawcliffe, Adaptimmune's Chief Executive Officer (CEO), and Elliot Norry, Adaptimmune's Chief Medical Officer, describing these data in more detail that can be accessed here: https://bit.ly/38ZQCGt.

    "It is no longer a question of whether our SPEAR T-cells are effective against a range of MAGE-A4 expressing tumors — they undoubtedly are. Now, our focus is on turning them into approved therapies. This begins with ongoing recruitment in this SURPASS trial for people with lung, bladder, gastroesophageal, head and neck, and now ovarian cancer, and continues with the recently initiated SURPASS 2 trial in esophageal and EGJ cancers," said Adrian Rawcliffe, Adaptimmune's CEO. "These data bring us closer to identifying further indications to take into late-stage development and confirm our expertise in developing and enhancing cell therapies. ADP-A2M4CD8 does exactly what we designed it to do — kill cancer cells and more effectively engage the broader immune system to deliver improved potency and clinical benefit."

    Dr. David Hong, Professor, Deputy Chairman in the Department of Investigational Cancer Therapeutics (Phase I Program) at The University of Texas MD Anderson Cancer Center said, "We are encouraged by these promising early data from the SURPASS trial. Having previously seen strong responses with afami-cel, this next-generation cell therapy appears safe and demonstrated antitumor activity for a majority of patients across many cancer indications."

    Topline results from the Phase 1 SURPASS trial (data cut-off August 2, 2021)

    Emerging efficacy and durability data are promising with responses in five solid tumor indications

    • As of the data cut-off date, 25 patients had received the next-generation cell therapy, ADP-A2M4CD8, in the Phase 1 SURPASS trial, 22 patients were evaluable for efficacy with at least one post-baseline scan meeting the ≥4-week duration for evaluation of stable disease
    • All patients had advanced metastatic disease and had received multiple prior regimens of systemic therapy (median: 3; range 1-6)
    • The overall response rate was 36% and the disease control rate was 86%
    • There was a complete response reported in a patient with ovarian cancer, which remains ongoing at 6 months post‑infusion (data on file at Adaptimmune)
    • Initial durability is encouraging. As of the data cut-off, 11 patients remain on study. Of the 8 responders, 5 remain in response with some remaining progression free >24 weeks



    Best Overall Response (n=22)*Overall, n (%)Cancer Indication

    (n=1 unless otherwise noted)
    Complete response (CR)1 (4.5)Ovarian
    Partial response (PR)7 (31.8)Ovarian (2); head and neck (2)**; esophagogastric junction (EGJ)**; bladder; synovial sarcoma
    Stable disease (SD)11 (50.0)Ovarian cancer (3); EGJ (2); esophageal (2); lung cancer, MRCLS, melanoma,
    Progressive disease (PD)3 (13.6)EGJ, lung, ovarian
    Overall response rate (CR, PR)8 (36.4)
    Disease control rate (CR, PR, SD)19 (86.4)

    * Of 25 patients who received ADP-A2M4CD8, 3 were not evaluable at the time of data cut-off: 2 patients (ovarian or esophageal cancers) did not have post-baseline scans; 1 patient (EGJ) had a post-baseline scan that did not meet the ≥4-week duration for evaluation of stable disease

    ** One PR in head and neck cancer and one PR in EGJ cancer were reported previously at SITC 2020

    ADP-A2M4CD8 demonstrated an acceptable safety profile

    • Eighteen (72%) patients experienced cytokine release syndrome (CRS) related to T-cell infusion, most of which were lower grade: Grade 1 or 2 (n=14); Grade 3 (n=4)
    • The most common serious adverse event (SAE) of any grade (> 30% of patients) was CRS
    • Four (16%) patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS) related to T-cell infusion: Grade 1 (n=1); Grade 2 (n=1); Grade 3 (n=2)
    • Five (20%) patients experienced prolonged cytopenia at Week 4
    • One patient experienced a fatal (Grade 5) SAE of pancytopenia (previously reported in the Company's 10K Report filed with the Securities and Exchange Commission on February 25, 2021)

    ADP-A2M4CD8 was designed to be more potent than the first-generation product

    • Adaptimmune's Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cell therapies are a mix of CD8+ ("killer") and CD4+ ("helper") T-cells engineered with a T-cell receptor (TCR) designed with Adaptimmune's proprietary affinity enhancement technology to recognize a cancer target
    • ADP-A2M4CD8 is a next-generation T-cell therapy engineered to target MAGE-A4 positive tumors, and to express a CD8α co-receptor
    • ADP-A2M4CD8 uses the same engineered T-cell receptor that recognizes MAGE-A4 as Adaptimmune's first-generation T-cell therapy, afami-cel, which has shown compelling results in synovial sarcoma and myxoid/round cell liposarcoma (presented at ASCO 2021)
    • Co-expression of CD8α adds CD8+ killer cell capability to CD4+ helper T-cells, while maintaining or enhancing the CD4+ helper function (i.e., producing the inflammatory cytokines IFN-γ and IL-2)

    Initial translational data confirm that ADP-A2M4D8 is more potent and better engages the immune system, compared to the first-generation product

    • Patient manufactured product and serum samples from the first-generation Phase 1 afami-cel trial and the next-generation SURPASS trial were compared
    • In vitro tumor cell killing assays confirm that the next-generation product results in greater tumor cell killing by CD4+ SPEAR T-cells
    • Analyses of patient serum samples demonstrate increases in a subset of 22 measured serum cytokines confirming increased helper function of the next-generation CD4+ T-cells and engagement of the broader immune system
    • Additional serum analyses showed increased serum IL-12 in the SURPASS trial versus the first-generation Phase 1 trial, which is also consistent with engagement of the broader immune system, including dendritic cells, as IL-12 is not known to be produced by T-cells

    Conclusions from the Phase 1 SURPASS Trial Data at ESMO

    • Initial efficacy and durability data are encouraging with responses across five different solid tumors including a complete response in a patient with ovarian cancer ongoing at 6 months
    • The safety profile of the next-generation ADP-A2M4CD8 cell therapy was acceptable
    • Data confirm preclinical observations that the enhanced TCR interaction in ADP-A2M4CD8 results in a more potent product
    • Safety and efficacy, including duration of response, will continue to be evaluated in the ongoing SURPASS trial, which is enrolling eligible patients with gastroesophageal, head and neck, lung, bladder, and ovarian cancers
    • A Phase 2 trial, SURPASS-2, has initiated for patients with esophageal and EGJ cancers

    Overview of Phase 1 SURPASS trial design

    • This is a Phase 1, open-label, dose escalation clinical trial designed to evaluate the safety and antitumor activity of ADP-A2M4CD8 in patients with MAGE-A4+ tumors in the context of HLA-A*02
    • This is a first-in-human dose-escalation trial using a modified 3+3 design, with 2 dose cohorts plus an expansion cohort
    • The number of transduced cells ranged from 0.8x109 to 1.2x109 (Cohort 1 complete), 1.2x109 to 6.0x109 (Cohort 2 complete), and 1.2x109 to 10.0x109 (Expansion)
    • Dose-limiting toxicities are adjudicated by a Safety Review Committee, regardless of the investigator's attribution
    • Responses are assessed per RECIST v1.1

    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 Securities and Exchange Commission (SEC) on August 9, 2021 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, Corporate Affairs and Communications

    T: +44 1235 430 583

    M: +44 7718 453 176

    Sebastien.Desprez@adaptimmune.com

    Investor Relations:

    Juli P. Miller, Ph.D. — VP, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920

    Juli.Miller@adaptimmune.com 



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  2. - Combining both companies' cell therapy leadership and expertise, the collaboration covers the research and development of "off-the-shelf" cell therapies for up to five shared cancer targets and the development of a novel allogeneic personalized cell therapy platform -

    - Adaptimmune will receive $150 million upfront, $150 million over the next five years in additional payments, and development, regulatory and commercial milestones payments potentially exceeding $3 billion in aggregate value, as well as royalties, across multiple programs -

    - The Company will host a virtual update about its allogeneic platform on Thursday, September 9 at 08:00 a.m. EDT (01:00 p.m. BST) -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom…

    - Combining both companies' cell therapy leadership and expertise, the collaboration covers the research and development of "off-the-shelf" cell therapies for up to five shared cancer targets and the development of a novel allogeneic personalized cell therapy platform -

    - Adaptimmune will receive $150 million upfront, $150 million over the next five years in additional payments, and development, regulatory and commercial milestones payments potentially exceeding $3 billion in aggregate value, as well as royalties, across multiple programs -

    - The Company will host a virtual update about its allogeneic platform on Thursday, September 9 at 08:00 a.m. EDT (01:00 p.m. BST) -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, announced today that it has entered into a strategic collaboration and license agreement with Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:RHHBY) to develop and commercialize allogeneic cell therapies to treat multiple oncology indications.

    "We are proud to partner with Genentech, given their commitment to patients and science in the cancer immunology field. This collaboration broadens Adaptimmune's leadership position in developing allogeneic cell therapies building on our in-depth knowledge gained from our autologous clinical programs," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "Through this collaboration, our platform will form the basis of a personalized allogeneic cell therapy vision, where any patient can receive a T-cell product for their cancer; a significant step towards our goal of making cell therapies both curative and mainstream."

    "We believe allogeneic cell therapies could be a game-changing approach for developing personalized therapy platforms based on individual cancer patients' unique needs," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This partnership, which combines Adaptimmune's allogeneic platform with Genentech's expertise in developing personalized therapies, complements our other efforts to discover and develop personalized cell therapies. It holds the promise to change how we treat cancer and brings us another step closer to making personalized healthcare a reality."

    The collaboration has two components:

    1. Development of allogeneic T-cell therapies for up to five shared cancer targets
    2. Development of personalized allogeneic T-cell therapies

    For each component, Adaptimmune will be responsible for developing clinical candidates using its induced pluripotent stem cell (iPSC) derived allogeneic platform to produce T-cells (iT cells). Genentech will be responsible for the input TCRs and subsequent clinical development and commercialization.

    Under the terms of the agreement, Adaptimmune will receive an upfront payment of $150 million and additional payments of $150 million over five years, unless the agreement is earlier terminated. In addition, Adaptimmune may be eligible to receive research, development, regulatory and commercial milestones payments potentially exceeding $3 billion in aggregate value.

    Adaptimmune will also receive tiered royalties on net sales in the mid-single to low-double digits. 

    Adaptimmune has the right to opt in to a 50/50 U.S. profit/cost share on "off-the-shelf" products. If Adaptimmune elects to opt in, then Adaptimmune will be eligible to share 50 percent of profits and losses from U.S. sales on such products and is eligible to receive ex-U.S. regulatory and sales-based milestone payments, as well as royalties on ex-U.S. net sales.

    The effectiveness of the agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

    Virtual update on Adaptimmune's allogeneic platform

    Thursday, September 9, 2021 at 08:00 a.m. EDT

    The Company will host a live virtual update to discuss its allogeneic platform and future development plans at 08:00 a.m. EDT (01:00 p.m. BST), on Thursday, September 9. You can join the event with this link: https://bit.ly/3jHI4KP. More details, as well as a replay of the event, can be found on the Investor Relations tab of the Company's website: https://bit.ly/2WRDa4C.

    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 Securities and Exchange Commission (SEC) on August 9, 2021 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, Corporate Affairs and Communications

    T: +44 1235 430 583

    M: +44 7718 453 176

    Sebastien.Desprez@adaptimmune.com

    Investor Relations:

    Juli P. Miller, Ph.D. — VP, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920

    Juli.Miller@adaptimmune.com



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  3. - One complete response, and a disease control rate of 64% with stable disease for ≥16 weeks in two patients, as of the data cutoff -

    - Data presented today at the International Liver Cancer Association meeting at 12:25 p.m. CET -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Sept. 05, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, announced updated data from its Phase 1 ADP-A2AFP trial for patients with liver cancer at ILCA.

    "We have seen significant antitumor activity with this first-generation product targeting AFP that is encouraging for the potential of cell therapy for the treatment of liver cancer in these heavily pre-treated patients with late-stage disease," said Elliot…

    - One complete response, and a disease control rate of 64% with stable disease for ≥16 weeks in two patients, as of the data cutoff -

    - Data presented today at the International Liver Cancer Association meeting at 12:25 p.m. CET -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Sept. 05, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, announced updated data from its Phase 1 ADP-A2AFP trial for patients with liver cancer at ILCA.

    "We have seen significant antitumor activity with this first-generation product targeting AFP that is encouraging for the potential of cell therapy for the treatment of liver cancer in these heavily pre-treated patients with late-stage disease," said Elliot Norry, Adaptimmune's Chief Medical Officer. "We reported a complete response in one patient, and tumor reductions with stable disease that has lasted more than 16 weeks in two patients as well as disease control in most patients at the target dose. We are continuing the expansion phase and will update when new data becomes available."

    "Despite the recent advances, we need more and better systemic therapies for liver cancer," said Dr. Bruno Sangro of Clinica Universidad de Navarra. "The first results from this cell therapy trial are of great interest since they indicate obvious antitumor activity in some patients. This treatment has generally been safely applied even to cirrhotic patients."

    Oral Presentation Today at ILCA

    Dr. Bruno Sangro presented data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1 trial during an oral presentation today at ILCA. A replay will be available through the congress web site.

    Topline results from the ADP-A2AFP Phase 1 trial as of the April 5, 2021 data cutoff

    Efficacy

    • Thirteen patients with advanced hepatocellular carcinoma (HCC) received ADP-A2AFP in Cohort 3 and expansion
    • The best overall responses in Cohort 3 and expansion (per RECIST v1.1) included 1 complete response (reported in 2020), 6 stable disease and 4 progressive disease. 2 patients did not have scan results at the time of data cut-off
    • The disease control rate for patients with at least one scan was 7/11 (64%) and 2 patients had stable disease lasting beyond 16 weeks

    Safety

    • ADP-A2AFP has an acceptable safety profile with no reports of significant T-cell related hepatotoxicity and no protocol-defined dose limiting toxicities
    • Adverse events (AEs) reported in 2 or more patients and considered related to T-cell infusion included neutropenia, leukopenia, lymphopenia, pyrexia, anemia, cytokine release syndrome, febrile neutropenia, thrombocytopenia, aspartate aminotransferase increased, and alanine aminotransferase increased
    • Two patients reported a total of 3 treatment-related serious AEs including cytokine release syndrome (Grade 1), infusion-related reaction (Grade 2), and febrile neutropenia (Grade 3)

    Conclusions

    • Antitumor activity, with one complete response, sustained decreases in serum AFP, and best overall response of stable disease observed in 6 patients, indicate that ADP-A2AFP is an active product in HCC
    • ADP-A2AFP up to doses of 10 billion transduced cells has been associated with an acceptable safety profile

    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 liver cancer (hepatocellular carcinoma) 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 intended to treat up to 25 patients with doses up to 10 billion transduced cells in the expansion phase

    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 Securities and Exchange Commission (SEC) on August 9, 2021 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, Corporate Affairs and Communications

    T: +44 1235 430 583

    M: +44 7718 453 176

    Sebastien.Desprez@adaptimmune.com

    Investor Relations:

    Juli P. Miller, Ph.D. — VP, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920

    Juli.Miller@adaptimmune.com



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  4. - SPEARHEAD-1 data presented at ASCO with overall response rate of 39.3% in synovial sarcoma and MRCLS; on track to file BLA for afami-cel next year -

    - SURPASS trial data from 23 evaluable patients to be presented at ESMO -

    - ADP-A2AFP Phase 1 trial data from 11 evaluable patients in Group 3/Expansion to be presented at ILCA -

    - Financial guidance confirmed: funded into early 2023 -

    - Conference call to be held today at 4:30 p.m. EDT (9:30 p.m. BST) -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, today reported financial results for the second quarter ended June 30, 2021 and provided a business update.

    "With the data…

    - SPEARHEAD-1 data presented at ASCO with overall response rate of 39.3% in synovial sarcoma and MRCLS; on track to file BLA for afami-cel next year -

    - SURPASS trial data from 23 evaluable patients to be presented at ESMO -

    - ADP-A2AFP Phase 1 trial data from 11 evaluable patients in Group 3/Expansion to be presented at ILCA -

    - Financial guidance confirmed: funded into early 2023 -

    - Conference call to be held today at 4:30 p.m. EDT (9:30 p.m. BST) -

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, today reported financial results for the second quarter ended June 30, 2021 and provided a business update.

    "With the data presented at ASCO for afami-cel and our planned BLA filing next year, I am pleased with progress on our ‘2-2-5-2' strategy," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "We will present data updates from our Phase 1 trials, SURPASS and ADP-A2AFP, at upcoming conferences and I am confident that Adaptimmune is well-placed to maintain its leadership position in cell therapies for cancer."

    Upcoming confirmed data updates

    ADP-A2AFP Phase 1 Trial at ILCA

    • On Sunday, September 5, 2021, Dr. Bruno Sangro of Clinica Universidad de Navarra will present data from Cohort 3 and the expansion phase of the Phase 1 trial of ADP-A2AFP in liver cancer during an oral presentation scheduled for 12:25 p.m. CET at the International Liver Cancer Association's (ILCA) Annual Conference
      • As of the April 5th data cut-off used for ILCA, 13 patients had received ADP-A2AFP in Cohort 3 and expansion, 11 patients were evaluable with at least one post-baseline scan

    SURPASS Phase 1 Trial at ESMO

    • The Company will present an update from its Phase 1 SURPASS trial in an e-poster at the European Society for Medical Oncology (ESMO) congress that will be available online September 16th
      • As of the August 2nd data cut-off, 25 patients had received ADP-A2M4CD8, 23 patients had at least one post-baseline scan
      • The trial continues to recruit in lung, gastroesophageal, head and neck, and bladder cancers – focus indications, for which there have been early signs of efficacy, including responses, with SPEAR T-cells targeting MAGE-A4
      • Based on early data from patients with ovarian cancer treated in the trial, the Company is planning to add this as a focus indication to the SURPASS trial

    SPEARHEAD-1 and afami-cel BLA

    • As presented at ASCO 2021, the Company reported an overall response rate for patients with at least one scan (evaluated by RECIST 1.1 per investigator assessment) of 39.3% (13/33), 41.4% (12/29) for synovial sarcoma, including two complete responses, and 25.0% (1/4) for MRCLS from its Phase 2 SPEARHEAD-1 trial
    • Of the 29 patients with synovial sarcoma, the disease control rate (defined as either response or stable disease) was 86.2% (25/29 patients) with 2 complete responses and 10 partial responses
    • This data set is intended to support planned BLA filing next year
    • Next data update planned at CTOS 2021
    • The European Medicines Agency and the FDA have agreed to Adaptimmune's pediatric investigational plans
    • Working with key industry leaders to prepare for a successful commercial launch
      • Adaptimmune has partnered with Agilent for the development, manufacturing, and supply of a companion diagnostic for the MAGE-A4 biomarker
      • The Company is also working with Miltenyi Biotec for the process validation, manufacture, and supply of the lentiviral vector for use in the product for commercial launch

    Further indications for next-gen SPEAR T-cell therapies

    SURPASS-2

    • Planning to initiate a Phase 2 clinical trial with ADP-A2M4CD8, SURPASS-2, in esophageal and esophagogastric junction cancers in the third quarter of 2021

    Other early-stage programs

    • The Company ceased enrollment in the Radiation Sub-Study of the afami-cel Phase 1 trial at the end of July. Five patients were treated in this sub-study and the Company plans to provide a data update at an upcoming congress

    Corporate

    • The Company received a development milestone payment of $4.2 million in the three months ended June 30, 2021

    Financial Results for the three and six months ended June 30, 2021

    • Cash / liquidity position: As of June 30, 2021, Adaptimmune had cash and cash equivalents of $50.5 million and Total Liquidity1 of $285.4 million.
    • Revenue: Revenue for the three and six months ended June 30, 2021 was $3.1 million and $3.5 million, respectively, compared to $0.5 million and $1.3 million for the same periods in 2020. Revenue has increased primarily due to an increase in development activities under the Astellas Collaboration Agreement.
    • Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2021 were $28.9 million and $53.4 million, respectively, compared to $20.5 million and $41.7 million for the same periods in 2020. R&D expenses increased due to an increase in the number of employees engaged in research and development, and increases in costs related to the development of a companion diagnostic assay and our Phase 2 clinical trial associated with ADP-A2M4CD8. These increases were partially offset by an increase in reimbursements receivable for research and development tax and expenditure credits.
    • General and administrative (G&A) expenses: G&A expenses for the three and six months ended June 30, 2021 were $13.5 million and $27.4 million, respectively, compared to $10.3 million and $19.6 million for the same periods in 2020 due to increases in employee-related costs, share-based compensation expense, and professional fees.
    • Net loss: Net loss attributable to holders of the Company's ordinary shares for the three and six months ended June 30, 2021 was $39.1 million and $76.8 million respectively ($(0.04) and $(0.08) per ordinary share), compared to $29.9 million and $58.0 million ($(0.04) and $(0.07) per ordinary share) for the same periods in 2020.

    Financial Guidance

    The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company's current operations into early 2023, as further detailed in the Company's Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, to be filed with the Securities and Exchange Commission following this earnings release.

    Conference Call Information

    The Company will host a live teleconference and webcast to provide additional details at 4:30 p.m. EDT (9:30 p.m. BST) today. A live webcast of the conference call and replay can be accessed at https://bit.ly/3zFas59. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (US 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 (7867634).

    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. 


    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.

    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 Securities and Exchange Commission (SEC) on May 6, 2021 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 (available-for-sale debt 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, 
      2021 2020
    Cash and cash equivalents $50,453 $56,882
    Marketable securities - available-for-sale debt securities  234,917  311,335
    Total Liquidity $ 285,370 $ 368,217
           

    The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its assessment 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,  
         2021     2020     2021     2020  
    Revenue $ 3,095  $ 502  $ 3,529  $ 1,263  
    Operating expenses             
    Research and development  (28,868)  (20,460)  (53,374)  (41,724) 
    General and administrative  (13,539)  (10,295)  (27,356)  (19,556) 
    Total operating expenses   (42,407)   (30,755)   (80,730)   (61,280) 
    Operating loss   (39,312)   (30,253)   (77,201)   (60,017) 
    Interest income  266   1,147   691   1,877  
    Other income (expense), net  54   (749)  53   188  
    Loss before income taxes   (38,992)   (29,855)   (76,457)   (57,952) 
    Income taxes  (76)  (25)  (374)  (95) 
    Net loss attributable to ordinary shareholders $ (39,068) $ (29,880) $ (76,831) $ (58,047) 
                  
    Net loss per ordinary share             
    Basic and diluted $ (0.04) $ (0.04) $ (0.08) $ (0.07) 
                  
    Weighted average shares outstanding:             
    Basic and diluted  934,228,095   822,725,556   932,667,125   781,235,457  
                  

    Condensed Consolidated Balance Sheets

    (unaudited, in thousands, except share data)

           
      June 30, December 31,
         2021     2020 
    Assets      
    Current assets      
    Cash and cash equivalents $50,453  $56,882 
    Marketable securities - available-for-sale debt securities  234,917   311,335 
    Accounts receivable, net of allowance for doubtful accounts of $0 and $0  2,158   139 
    Other current assets and prepaid expenses  49,816   29,796 
    Total current assets   337,344    398,152 
           
    Restricted cash  4,632   4,602 
    Operating lease right-of-use assets, net of accumulated amortization  17,772   18,880 
    Property, plant and equipment, net of accumulated depreciation of $34,360 (2020: $31,097)  28,663   27,778 
    Intangibles, net of accumulated amortization  1,382   1,730 
    Total assets $ 389,793  $ 451,142 
           
    Liabilities and stockholders' equity      
    Current liabilities      
    Accounts payable $6,977  $6,389 
    Operating lease liabilities, current  2,922   2,773 
    Accrued expenses and other accrued liabilities  26,606   27,079 
    Deferred revenue, current  4,911   2,832 
    Total current liabilities   41,416    39,073 
           
    Operating lease liabilities, non-current  19,723   20,938 
    Deferred revenue, non-current  50,048   49,260 
    Other liabilities, non-current  667   644 
    Total liabilities   111,854    109,915 
           
    Stockholders' equity      
    Common stock - Ordinary shares par value £0.001, 1,240,853,520 authorized and 936,237,126 issued and outstanding (2020: 1,038,249,630 authorized and 928,754,958 issued and outstanding)  1,336   1,325 
    Additional paid in capital  949,575   935,706 
    Accumulated other comprehensive loss  (10,385)  (10,048)
    Accumulated deficit  (662,587)  (585,756)
    Total stockholders' equity   277,939    341,227 
           
    Total liabilities and stockholders' equity $ 389,793  $ 451,142 
             

    Condensed Consolidated Cash Flow Statement

    (unaudited, in thousands)

           
      Six months ended
      June 30, 
         2021     2020 
    Cash flows from operating activities      
    Net loss $(76,831) $(58,047)
    Adjustments to reconcile net loss to net cash used in operating activities:      
    Depreciation  2,879   3,583 
    Share-based compensation expense  10,783   4,072 
    Unrealized foreign exchange gains  (267)  (2,004)
    Amortization on available-for-sale debt securities  2,884   702 
    Other  1,401   480 
    Changes in operating assets and liabilities:      
    Increase in receivables and other operating assets  (21,457)  (10,104)
    Decrease in non-current operating assets     615 
    Increase in payables and other current liabilities  663   3,571 
    Increase in deferred revenue  1,946   49,074 
    Net cash used in operating activities   (77,999)   (8,058)
           
    Cash flows from investing activities      
    Acquisition of property, plant and equipment  (2,924)  (460)
    Acquisition of intangibles  (143)  (407)
    Maturity or redemption of marketable securities  154,465   39,931 
    Investment in marketable securities  (81,958)  (298,016)
    Net cash provided by (used in) investing activities   69,440    (258,952)
           
    Cash flows from financing activities      
    Proceeds from issuance of common stock from offerings, net of commissions and issuance costs  2,519   334,388 
    Proceeds from exercise of stock options  578   5,075 
    Net cash provided by financing activities   3,097    339,463 
           
    Effect of currency exchange rate changes on cash, cash equivalents and restricted cash  (937)  (678)
    Net (decrease) increase in cash, cash equivalents and restricted cash  (6,399)  71,775 
    Cash, cash equivalents and restricted cash at start of period  61,484   54,908 
    Cash, cash equivalents and restricted cash at end of period $ 55,085  $ 126,683 
           

    Adaptimmune Contacts:

    Media Relations:

    Sébastien Desprez — VP, Corporate Affairs and Communications

    T: +44 1235 430 583

    M: +44 7718 453 176

    Sebastien.Desprez@adaptimmune.com 

    Investor Relations:

    Juli P. Miller, Ph.D. — VP, Investor Relations

    T: +1 215 825 9310

    M: +1 215 460 8920

    Juli.Miller@adaptimmune.com 



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  5. PHILADELPHIA and OXFORDSHIRE, United Kingdom, July 28, 2021 (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 the second quarter ended June 30, 2021, after the US markets close on Monday, August 9, 2021. Following the announcement, the Company will host a live teleconference and webcast at 4:30 p.m. EDT (9:30 p.m. BST) that same day (details below).

    The press release will be available in the investor section of Adaptimmune's corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/3zFas59.

    To participate in the live conference call, please dial (833) 652-5917…

    PHILADELPHIA and OXFORDSHIRE, United Kingdom, July 28, 2021 (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 the second quarter ended June 30, 2021, after the US markets close on Monday, August 9, 2021. Following the announcement, the Company will host a live teleconference and webcast at 4:30 p.m. EDT (9:30 p.m. BST) that same day (details below).

    The press release will be available in the investor section of Adaptimmune's corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/3zFas59.

    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 (7867634).

    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 Securities and Exchange Commission (SEC) on May 6, 2021, 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

    Sebastien.Desprez@adaptimmune.com

    Investor Relations:

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

    T: +1 215 825 9310

    M: +1 215 460 8920

    Juli.Miller@adaptimmune.com



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