Preparation for a subacute spinal cord injury business based on the Spinal Cord Regeneration Lab

「In the regenerative medicine business, we are researching 5 development pipelines. For the subacute spinal cord injury pipeline, on 24 February 2026 we entered into a basic agreement with Nikon Cell Innovation Co., Ltd. concerning contract manufacturing for a company-sponsored clinical trial for regenerative medicine products. The agreement will advance technology transfer and manufacturing of clinical-trial products for the company-sponsored clinical trial for subacute spinal cord injury.」

「To build and strengthen the supply chain for our pharmaceuticals and regenerative medicine products, we entered into a basic business alliance agreement with Alfresa Corporation in November 2025 to strengthen mainly distribution for clinical-trial products and future products related to KP8011 (subacute spinal cord injury). We also entered into an investment agreement with Alfresa Corporation and issued unsecured convertible bonds with stock acquisition rights to be allocated to the company, thereby securing necessary funds including for future research and development.」

「Following the report that transplantation had been performed in 4 cases as planned, the one-year follow-up after cell transplantation had been completed, and all 4 cases had been included in the safety and efficacy evaluations, the company entered into a new joint research agreement and related agreements with 学校法人慶應義塾 on 4 April 2025, carrying forward the results of its joint research to date.」

「In the subacute spinal cord injury pipeline, following the report issued on 21 March 2025 by Keio University School of Medicine and other joint research partners concerning the clinical research “Regenerative Medicine for Subacute Spinal Cord Injury Using iPS Cell-Derived Neural Progenitor Cells” and completion of follow-up, the company entered into new joint research agreements and other arrangements with Keio Gijuku on 4 April 2025. The report stated that transplantation had been performed in the targeted 4 cases, one year of follow-up after transplantation had been completed and all 4 cases had been included in the safety and efficacy evaluations.」

「Based on the results of the clinical research being conducted primarily by Keio University, we will work with the university to promote selection of suitable iPS cells, establishment of a differentiation-induction method, evaluation using spinal cord injury model mice, study of mass-culture methods for clinical use, selection of a contractor for manufacturing clinical-use iPS cells and study of various quality-control items, so that a company-sponsored clinical trial for subacute spinal cord injury can proceed smoothly. We will also pursue alliances with pharmaceutical companies and other partners to sell the product globally as a regenerative medicine product.」

「In the regenerative medicine business, we are researching 5 development pipelines. For the subacute spinal cord injury pipeline, on 25 March 2024 we entered into a patent license agreement with Keio Gijuku for an exclusive license, including the right to sublicense, relating to the invention “Kit for Promoting Neurite Extension and Use Thereof (patent pending).”」

「In the regenerative medicine business, we are researching 5 development pipelines. For the subacute spinal cord injury pipeline, on 25 March 2024 we entered into a patent license agreement with Keio Gijuku for an exclusive license, including the right to sublicense, relating to the invention “Kit for Promoting Neurite Extension and Use Thereof (patent pending).” This is a successor patent to the license agreement concerning the invention “Neurosphere Inducer for Treating Spinal Cord Injury (patent pending),” which we entered into with Keio Gijuku on 28 March 2021. We will continue to advance research and development in cooperation with Keio Gijuku.」

「During the fiscal year, in addition to establishing a mass-culture method based on a new method for inducing differentiation into neural progenitor cells for transplantation for which a PCT application has been filed, switching to GMP-compliant reagents and obtaining data underlying product specifications, we are studying manufacturing of clinical-trial products and selecting a contract development and manufacturing organization (CDMO) for manufacturing clinical-use iPS cells, so that manufacturing can begin without delay once the clinical-use iPS cells have been selected.」

「For the subacute spinal cord injury pipeline, we opened the Keifarma-Keio Spinal Cord Regeneration Lab in February 2023 at the Comprehensive Medical Science Research Building on Keio University's Shinanomachi Campus, and will continue preparations together with Keio University.」