As a global venture that challenges the world's huge pharmaceutical market, we are developing innovative drugs. We aim for approval from drug regulatory agencies in major countries, including the US FDA, and conduct clinical development in the most suitable regions.

In order to steadily promote international development, we have established a system centered on management and R&D personnel with extensive overseas experience. In addition to collaborating with professional contract companies and consultants in Europe and the United States, we are also developing joint research with the world's leading academia in the field of target diseases. Specific joint research targets include Georgetown University in the United States, which is conductingjoint research on multiple sclerosis, a university in the United States that is preparing for a doctor-initiated trial for KRAS-mutated colorectal cancer, the Mayo Clinic in the United States, which is conductingjoint research in specific disease areas, and a Nordic university that is jointly conducting clinical research on multiple sclerosis. In addition, we aim to improve our development strategy and research activities by continuously obtaining advice from globally active experts and to create results at a global level.

As a concrete result of this global development system, our lead compound, Nanburan Lat, was granted orphan drug designation by the U.S. FDA in April 2022. In addition, after the completion of the Phase 2 clinical trial in Japan, we will continue to discuss with the US FDA for more than two years, and we plan to start a global Phase 3 clinical trial by the end of FY2025. It is rare for a global Phase 3 clinical trial to proceed to a global Phase 3 clinical trial after a review by the U.S. FDA based solely on domestic clinical data, which is almost unprecedented for a Japan bioventure.

In addition, we expect to obtain IND approval from the U.S. FDA for our second drug, JPH034, by the end of FY2025, and begin Phase 1 clinical trials in the United States. These achievements support our R&D system and international capabilities, forming a solid foundation for future value creation.