Item 1.01.Entry Into a Material Definitive Agreement.
Hologen Transactions
On April 20, 2026 (the “Initial Closing Date”), MeiraGTx Holdings plc (the “Company”) and certain of its affiliates completed the initial closing of the strategic collaboration with Hologen Limited, a non-cellular company limited by shares incorporated in Guernsey (“Hologen”), and certain of its affiliates. On the Initial Closing Date, (A) the Company, MeiraGTx Neuro UK Limited, a private company limited by shares incorporated in England (“MeiraGTx Neuro UK”), Hologen Neuro AI Limited, a non-cellular company limited by shares incorporated in Guernsey (“HNAI”), and Hologen, entered into an amendment (the “Amendment to the Neuro Framework Agreement”) to that certain Framework Agreement, dated March 9, 2025 (the “Neuro Framework Agreement”), (B) MeiraGTx Manufacturing Limited, a private company limited by shares incorporated in England (“MeiraGTx Manufacturing”), MeiraGTx Limited, a private company limited by shares incorporated in England (“MeiraGTx Limited”), and Hologen, entered into an amendment (the “Amendment to the Manufacturing Framework Agreement”) to that certain Framework Agreement, dated March 9, 2025 (the “Manufacturing Framework Agreement” and together with the Neuro Framework Agreement, the “Framework Agreements”), and (C) the Company, MeiraGTx Neuro UK, MeiraGTx Neuro I, LLC, a Delaware limited liability company (“MeiraGTx Neuro US”), Hologen, HNAI and Hologen Neuro AI UK Limited, a private company limited by shares incorporated in England (“HNAI UK”), entered into the Collaboration and License Agreement (the “Collaboration Agreement”), for the research, development, manufacture and commercialization of the Company’s (i) AAV-GAD investigational gene therapy for the treatment of Parkinson’s disease, AAV-BDNF investigational gene therapy for the treatment of genetic obesity disorders and other potential locally delivered genetic medicines to the central nervous system (the “Clinical Programs”) and (ii) proprietary device designed to effect the local delivery of a gene therapy product into the central nervous system or any topographic or subcutaneous tissue modification on the face and scalp, of humans or animals (the “Delivery Device”), in each case, in accordance with the terms and conditions of the Collaboration Agreement.
Neuro Framework Agreement
Prior to the Initial Closing Date, MeiraGTx Neuro UK, HNAI and Hologen entered into a subscription agreement pursuant to which MeiraGTx Neuro UK subscribed for Class A shares in HNAI in consideration for the provision of services to HNAI and HNAI UK as specified in the Collaboration Agreement, including services relating to the development of the Clinical Programs and the Delivery Device and certain other transition services, and Hologen subscribed for Class B shares in HNAI in consideration for a portion of the $105 million in payments Hologen previously made to the Company as part of its commitment toward the upfront cash payment of $200 million provided for under the Framework Agreements (the “Upfront Payment”). The Company then applied a portion of the $105 million in payments Hologen previously made to the Company equal to Hologen’s subscription price to satisfy the portion of the Upfront Payment due to MeiraGTx Neuro US under the Neuro Framework Agreement and Collaboration Agreement. On the Initial Closing Date, the parties entered into the Amendment to the Neuro Framework Agreement to, among other things, reflect the pre-closing issuance of the HNAI shares as additional conditions that needed to be met prior to Completion (as defined under the Neuro Framework Agreement) and to provide that, following Completion, Hologen shall fund the remaining portion of the Upfront Payment provided for under the Neuro Framework Agreement and the Collaboration Agreement by purchasing a portion of the Class A shares held by MeiraGTx Neuro UK, such that following the purchase, such Class A shares purchased by Hologen shall be converted to Class B shares and Hologen shall own 70% of the issued share capital of HNAI and MeiraGTx Neuro UK shall own 30% of the issued share capital of HNAI.
Manufacturing Framework Agreement
Prior to the Initial Closing Date, MeiraGTx Limited and Hologen entered into a share purchase agreement pursuant to which Hologen purchased shares in MeiraGTx Manufacturing from MeiraGTx Limited in consideration for a portion of the $105 million in payments Hologen previously made to the Company as part of the Upfront Payment. On the Initial Closing Date, the parties entered into the Amendment to the Manufacturing Framework Agreement to, among other things, reflect Hologen’s pre-closing purchase of the MeiraGTx Manufacturing shares as additional conditions that needed to be met prior to Completion (as defined under the Manufacturing Framework Agreement) and to provide that,