ADDED
As of March 30, 2026, the registrant had 81,446,126 ordinary shares outstanding.
In December 2025, our London manufacturing facility was granted a commercial Manufacturer s and Importer s Authorization (MIA) by the MHRA for the manufacture of advanced therapy medicinal products, or ATMPs, for genetic medicines.
It is the first commercial-scale genetic medicine manufacturing site in Ireland and is unique in its scale and integrated capabilities.
In June 2023, we received an MIA for QC testing of commercial products in our GMP compliant manufacturing facility in Shannon from the Irish Health Products Regulatory Authority ( HRPA ).
During 2024, we received $60.0 million in milestone payments from Johnson Johnson Innovative Medicine.
Hologen Transactions On March 9, 2025 (the Hologen Signing Date ), we and our affiliates entered into a strategic collaboration with Hologen Limited, a non-cellular company limited by shares incorporated in Guernsey ( Hologen ), and its affiliates.
Hologen is a leading developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development.
As part of the strategic collaboration, we and Hologen entered into the Framework Agreements (as defined below), pursuant to which we and our affiliates will receive from Hologen an upfront cash payment of $200.0 million (the Upfront Payment ) on the Hologen Closing Date (as defined below), and Hologen will provide additional funding of up to an additional $230.0 million as further described below.
As part of the strategic collaboration, we also received an aggregate of 500,000 Class A shares of Hologen at a nominal price.
During the year ended December 31, 2025, Hologen made $50.0 million in payments as part of its commitment toward the Upfront Payment, and made an additional $55.0 million in payments to date during the first quarter 2026.
REMOVED
As of March 9, 2025, the registrant had 78,854,936 ordinary shares outstanding.
It is the first commercial-scale gene therapy manufacturing site in Ireland and is unique in its scale and integrated capabilities.
In June 2023, we received a Manufacturer s/Importer s Authorization (MIA) for QC testing of commercial products in our GMP compliant manufacturing facility in Shannon from the Irish Health Products Regulatory Authority ( HRPA ).
As of December 31, 2024, we have received $60.0 million in milestone payments from Johnson Johnson Innovative Medicine.
Strategic Investment from Sanofi On October 30, 2023, we entered into an Investment Agreement (the Investment Agreement ) with Sanofi Foreign Participations B.V.
(the Sanofi Foreign Participations ), a wholly-owned subsidiary of Sanofi, and solely for the limited purposes set forth therein, Sanofi, pursuant to which, among other things and subject to the terms and conditions specified therein, we issued an aggregate of 4.0 million of our ordinary shares at a purchase price of $7.50 per share for gross proceeds of $30.0 million.
The Investment Agreement also provides Sanofi Foreign Participations and its affiliates with a right of first negotiation for use of our riboswitch gene regulation technology for certain Immunology and Inflammation (I I), including modulation of IL-4 and IL-13, and Central Nervous System (CNS) targets, as well as for GLP-1 and other gut peptides for metabolic disease, and for our Phase 2 xerostomia program, in each case, on the terms set forth therein.
Utilizing our product development platform, we have assembled a pipeline of gene therapies to treat these serious diseases .
Our criteria for selecting our initial product candidates included: unmet medical need; high potential for meaningful clinical benefit; promising preclinical data using multiple animal models as well as human stem cell derived organoids; compartmentalized anatomy of target tissue and the partially immune protected nature of target tissue; and understanding of the disease state from natural history studies and detailed long-term characterization of patients prior to entry into gene therapy treatment studies.
There were no reported severe adverse events among the patients treated, two out of three patients in each of the first three cohorts in this clinical trial were observed to have objective increases in saliva volume produced by the treated parotid gland, with increases in parotid flow ranging from 60% to 540%, and all but one of these patients showed a decrease in symptoms of dry mouth as measured by subjective visual analog scales, validated in other forms of xerostomia.