Adaptimmune (United Kingdom)

Abingdon, Oxfordshire, United Kingdom · 67,140 · Corporate headquarters , Research, Development, Process Development, Manufacturing, Administration · October 2041

Abingdon, Oxfordshire, United Kingdom · 46,017 · Manufacturing, Process Development, Research · October 2041

Philadelphia, Pennsylvania, United States · 47,700 · Manufacturing, Process Development, Research · October 2031

Cambridge, Massachussetts, United States · 22,890 · Research, Development, Process Development · January 2026

As of December 31, 2024, all of the above sites were utilized by the Company.

We believe that our existing facilities are adequate for our near-term needs and will continue to keep our space requirements under review.

• If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our cell therapies.
• Although our financial statements have been prepared on a going concern basis there is substantial doubt about our ability to continue as a going concern.
• Our current cash projections include reliance on the ability to obtain certain tax credits and the operation of certain tax regimes within the U.K. Should these cease to be available or be reduced, this could impact our ongoing requirement for investment and the timeframes within which additional investment is required.
• Our ability to generate revenue from sales of our cell therapies and become profitable depends on our ability to progress our cell therapies through development.
• Our business is, in part, dependent on the successful commercialization of TECELRA in the United States.
• TECELRA is approved under accelerated approval in the United States, and additional confirmatory work is required in order to maintain that approval. Inability to maintain approval or to otherwise meet the requirements imposed by the FDA will have a significant impact on our ability to commercialize TECELRA.
• As part of the approval of TECELRA, certain post approval requirements apply which, if not satisfied, could impact continued approval of TECELRA.
• The approval of TECELRA is limited to adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and negative for HLA-A*02:05P, and whose tumor expresses the MAGE-A4 antigen.
• This is the first time we as an organization are marketing a product and we have limited experience as a commercial company and have never generated revenue from product sales.
• As a novel cell therapy, TECELRA may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community, including referral centers.
• Coverage, price flexibility, and reimbursement may be limited or unavailable in certain market segments for TECELRA.
• TECELRA represents a novel approach to treatment of synovial sarcoma that could result in heightened regulatory scrutiny.
• Manufacturing and supply of cell therapies is complex, and if we encounter any difficulties in manufacture or supply of TECELRA or our ability to provide supply for confirmatory clinical trials commercial supply of TECELRA could be delayed or stopped.
• We will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense as well as significant penalties if we fail to comply with regulatory requirements or experience unanticipated problems with TECELRA.
• We may not be able to obtain marketing approvals of our cell therapies including lete-cel as broadly as planned or on the timescales we plan.
• The review and approval of a BLA for lete-cel may not occur on the anticipated timelines, and we cannot be certain that the FDA will grant final marketing approval.
• Development of a commercially available cell therapy process is difficult, and we may be unable to develop the process on currently anticipated timescales or at all.
• Following grant of marketing authorization we will be subject to ongoing regulatory obligations, which may result in significant additional expense as well as significant penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our cell therapies.
• We may not be able to develop or obtain approval for the analytical assays and companion diagnostics required for commercialization of our cell therapies including lete-cel.
• Obtaining and maintaining regulatory approval of our cell therapies in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our cell therapies in other jurisdictions.
• The market opportunities for cell therapies may be limited to those patients who have failed prior treatments.
• We currently have a limited marketing and sales organization and as an organization have no experience in marketing products.
• If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our cell therapies.
• Even if we or our collaborators obtain regulatory approval of our cell therapies, they may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
• Coverage, price flexibility, and reimbursement may be limited or unavailable in certain market segments for cell therapies.
• Our cell therapies for which we intend to seek approval as biologic products may face competition sooner than anticipated.
• Our cell therapy products require significant additional clinical testing before we can seek regulatory approval and begin commercialization.
• The data produced in preclinical testing and clinical trials for our preclinical and clinical-stage cell therapies is at an early stage, and future data may not support continued progression of any of these therapies through development.
• We may not be able to commence additional clinical trials for cell therapies on the timeframes we expect.
• T-cell therapy is a novel approach to cancer treatment that creates significant increased risk in terms of side-effect profile.
• We may encounter substantial delays in our clinical trials or may not be able to conduct our trials on the timelines we expect.
• Our cell therapies represent a novel approach to cancer treatment that could result in heightened regulatory scrutiny and delays in clinical development.
• Our clinical trials may fail to demonstrate adequately the safety and efficacy of any cell therapies which would prevent or delay regulatory approval and commercialization.
• Clinical trials are expensive, time-consuming and difficult to implement.
• Validation of our cell therapies requires access to human samples which we may be unable to obtain or, if they can be obtained, that the terms under which they are provided will be favorable to us.
• Our cell therapies and their application are not fully scientifically understood and are still undergoing validation and investigation.
• We may not be able to identify and validate additional target peptides or isolate and develop affinity-enhanced TCRs or other cell therapy candidates that are suitable for validation and further development.
• Development of an “off-the-shelf” cell therapy takes a considerable amount of time and such development may not be successful.
• Manufacturing and supply of cell therapies is complex, and if we encounter any difficulties in manufacture or supply of cell therapies our ability to provide supply of our cell therapies for clinical trials or for commercial purposes could be delayed or stopped.
• Our manufacturing process needs to comply with regulations, and any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.
• We have our own manufacturing capabilities which may result in increased costs being incurred by us.
• Our autologous cell therapy products are patient-specific and we need to ensure that the correct product is administered to the correct patient.
• Regulatory authorities may impose a hold on our clinical trials.
• The FDA regulatory process can be difficult to predict, in particular whether for example, accelerated approval processes are available or further unanticipated clinical trials are required will depend on the data obtained in our ongoing clinical trials.
• We may be unable to obtain breakthrough or similar designations for our cell therapies or maintain the benefits associated with such designations.
• We will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense as well as significant penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our cell therapies.
• We may seek a conditional marketing authorization in Europe for some or all of our current cell therapies, but we may not be able to obtain or maintain such authorization.
• We may not be able to obtain or maintain orphan drug exclusivity for our cell therapies.
• Any failure by us to comply with existing regulations could harm our reputation and operating results.
• Our research and development activities utilize hazardous, radioactive and biological materials. Should such materials cause injury or be used other than in accordance with applicable laws and regulations, we may be liable for damages.
• We are subject to the U.K. Bribery Act, the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition.
• If we are found in violation of federal or state “fraud and abuse” or other health care laws, we may be required to pay a penalty and/or be suspended from participation in federal or state health care programs, which may adversely affect our business, financial condition and results of operations.
• We rely on Galapagos in relation to the performance of the collaboration agreement between us and for progression of uza-cell into the clinic.
• We rely on third parties to manufacture and supply our cell therapies and to develop next-generation cell therapies, and we may have to rely on third parties to produce and process our cell therapies, if approved.
• Certain of the components required for manufacturing of our cell therapies come from sole source or limited source suppliers.
• We rely on third parties to conduct our clinical trials.
• We may be forced to litigate to enforce or defend our intellectual property rights, and/or the intellectual property rights of our licensors.
• We may not be able to protect our proprietary technology in the marketplace or the cost of doing so may be prohibitive or excessive.
• We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.
• If third parties claim that our activities or products infringe upon their intellectual property, our operations could be adversely affected.
• Licenses may be required from third parties in relation to any of cell therapies developed or commercialized by us.
• Where we license certain technology from a third party, the prosecution, maintenance and defense of the patent rights licensed from such third party may be controlled by the third party which may impact the scope of patent protection which will be obtained or enforced.
• Issued patents protecting our T-cells or other cell therapies could be found invalid or unenforceable if challenged in court or at the USPTO.
• Risk of Legal Proceedings
• We are subject to legal proceedings, the outcome of which could be unfavorable to us
• We depend upon our key personnel and our ability to attract and retain employees.
• We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
• We expect to face intense competition, which may be from companies with greater resources and experience than we have.