Annual report [Section 13 and 15(d), not S-K Item 405]

Contingencies and commitments

v3.25.1
Contingencies and commitments
12 Months Ended
Dec. 31, 2024
Contingencies and commitments  
Contingencies and commitments

Note 10 — Contingencies and commitments

Leases

Lease payments under operating leases as of December 31, 2024 and information about the Company’s lease arrangements are disclosed in Note 8.

Capital commitments

As of December 31, 2024, the Company had commitments for capital expenditure totaling $1,477,000 primarily relating to future payments relating to intangible assets such as software licenses, of which the Company expects to incur $894,000 within one year and $583,000 within one to three years.

Commitments for clinical materials, clinical trials, software and contract manufacturing

As of December 31, 2024, the Company had non-cancellable commitments for purchase of clinical materials, contract manufacturing, commercial activities, maintenance, and up to $16,558,000, which the Company expects to incur $11,165,000 within one year, $3,837,000 within one to three years and $1,556,000 within three to five years. The amount and timing of these payments vary depending on the rate of progress of development. Future clinical trial expenses have not been included within the purchase commitments because they are contingent on enrollment in clinical trials and the activities required to be performed by the clinical sites. The Company’s subcontracted costs for clinical trials and contract manufacturing were $52,061,000, $48,416,000 and $54,689,000 for the years ended December 31, 2024, 2023, and 2022 respectively.

MD Anderson Strategic Alliance

On September 26, 2016, the Company announced that it had entered into a multi-year strategic alliance with The University of Texas MD Anderson Cancer Center (“MD Anderson”) designed to expedite the development of T-cell therapies for multiple types of cancer. The Company and MD Anderson collaborated on a number of studies including clinical and preclinical development of the Company’s T-cell therapies.

Under the terms of the agreement, the Company committed at least $19,644,000 to fund studies. Payment of this funding was contingent on mutual agreement to study orders under the alliance agreement and the performance of set milestones by MD Anderson. The Company made an upfront payment of $3,412,000 to MD Anderson in the year ended December 31, 2017 and subsequent milestone payments of $2,326,000, $3,549,000, $454,000 and $2,326,000 in the years ended December 31, 2018, 2020, 2021 and 2022, respectively. These costs were expensed to research and development as MD Anderson renders the services under the strategic alliance agreement.

The collaboration ended on March 23, 2022, and enrolment has ceased, therefore the remaining clinical milestones totaling $4,070,000 will not be met or become payable by the Company. The remaining preclinical work can continue until completion; the Company expects that the remaining billing upon completion less amounts invoiced to date totals approximately $452,000.

On 2 December 2024, MD Anderson served litigation in the District Court of Harris County against Adaptimmune LLC relating to the strategic alliance. MD Anderson claims damages of over $21 million (excluding legal fees and costs of court) caused by Adaptimmune’s breach of contract. Alternatively, MD Anderson brings an action for quantum meruit, promissory estoppel, unjust enrichment, negligent misrepresentation and reformation. The Company provided its Original Answer, Affirmative Defenses, Special Exceptions and Counterclaims on January 22, 2025 denying all allegations of the MD Anderson petition and counterclaiming for breach of contract. MD Anderson filed a motion to dismiss the Company’s counterclaim, Special Exceptions and Original Answer to the counterclaim denying all allegations in the counterclaim on 11 February 2025.

The case has not yet proceeded to discovery stage and the Company does not believe there is any merit to the claims being brought by MD Anderson. As such, no provision for a loss contingency has been made as of December 31, 2024.

Universal Cells Research, Collaboration and License Agreement and Co-development and Co-commercialization agreement

On November 25, 2015, the Company entered into a Research, Collaboration and License Agreement relating to gene editing and Human Leukocyte Antigen (“HLA”) engineering technology with Universal Cells, Inc. (“Universal Cells”). The agreement was amended and re-stated as of January 13, 2020, primarily to reflect changes to the development plan agreed between the parties. The agreement was further amended as of July 22, 2022, primarily to make certain changes to development milestones and to agree on the status thereof, as agreed between the parties. Following the amendment, milestone payments of $500,000, $600,000 and $400,000 were made in the year ended December 31, 2022. The upfront license and start-up fee and milestone payments were expensed to Research and development when incurred.

This Agreement was terminated by notice on January 27, 2023, effective 30 days following receipt of notice of termination. As a result of termination, all licenses between the parties to the Agreement ceased and each party was required to return all confidential information of the other party.

Astellas Collaboration Agreement

Under the Astellas Collaboration Agreement, described further in Note 3, if Adaptimmune had unilaterally developed a product with technology contributed by Astellas, Astellas could have been eligible to receive milestones and royalties relating to future commercialization and sales. As a result of the termination of the collaboration, Astellas no longer has the right to receive these milestones or royalties in future.

Noile-Immune Collaboration Agreement

On August 26, 2019, the Company entered into a collaboration and license agreement relating to the development of next-generation T-cell products with Noile-Immune. An upfront exclusive license option fee of $2,500,000 was paid to Noile-Immune in 2019. This was recognized within Research and Development in the Consolidated Statement of Operations for the year ended December 31, 2019. Under the agreement, development and commercialization milestone payments up to a maximum of $312,000,000 may be payable if all possible targets are selected and milestones achieved. Noile-Immune would also receive mid-single-digit royalties on net sales of resulting products.

Alpine Collaboration Agreement

On May 14, 2019, the Company entered into a Collaboration Agreement relating to the development of next-generation T-cell products with Alpine. The Company paid an upfront exclusive license option fee of $2,000,000 to Alpine in June 2019. Under the agreement, Adaptimmune will pay Alpine for ongoing research and development funding costs and development and commercialization milestone payments up to a maximum of $288,000,000 may be payable if all possible targets are selected and milestones achieved. The upfront payment of $2,000,000 and the payments for ongoing research was recognized within Research and development in the Consolidated Statement of Operations for the year ended December 31, 2019. A further payment of $1,000,000 was paid and recognized within Research and development in the Consolidated Statement of Operations for the year ended December 31, 2022. Alpine would also receive low single-digit royalties on worldwide net sales of applicable products.

ThermoFisher License Agreement

In 2012, the Company entered into a series of license and sub-license agreements with Life Technologies Corporation, part of ThermoFisher Scientific, Inc. (“ThermoFisher”) that provided the Company with a field-based license under certain intellectual property rights owned or controlled by ThermoFisher.  The Company paid upfront license fees of $1,000,000 relating to the license and sublicense agreements and had an obligation to pay minimum annual royalties, milestone payments and a low single-digit running royalty payable on the net selling price of each licensed product. The minimum annual royalties have been expensed as incurred. The patents underlying these licenses expired in January 2024 and the Company is no longer obligated to pay further milestones or royalties.

Regulatory Assay Development

As part of the process of obtaining regulatory approval for its products, the Company entered into various agreements for the development of assays for commercial supply, some of which have milestone or other payments that trigger on or after regulatory approval is received from the FDA, and upon the occurrence of future sales or commercial usage of the respective assay.