New Drug

Our company simultaneously initiated the development of the same small molecule for the treatment of Type 1 Diabetes (PS-002) in late 2021 to expand our pipelines and mitigate the risk associated with a single product. We plan to apply for Orphan Drug Designation for PS-002 in 2023, and to launch the Phase II clinical trial for the autoimmune disease indication in the second quarter of 2024, with expected completion by the end of 2025. As PS-002 is an Orphan Drug, it has the potential to apply for Emergency Use Authorization (EUA) after completing Phase II clinical trials. Out-licensing efforts will be conducted concurrently throughout the development process.

Currently, we have begun discussing development cooperation and licensing for PS-001 with seven international pharmaceutical companies. While some companies prefer to wait until the completion of Phase I trials to negotiate, others are interested in starting collaboration now. We anticipate signing Material Transfer Agreements (MTAs) in the third quarter of 2022 to allow these companies to replicate our experimental data and enhance their confidence in a licensing deal. Following the MTAs, we will collaborate on clinical trials and proceed with licensing at an appropriate stage.

The current Series A fundraising is for NTD 300 million (New Taiwan Dollars) at NTD 30 per share, primarily to fund the PS-001 long-term toxicology studies, the application for Phase II clinical trials, and company operations.

Following the expected completion of the diabetes Phase II clinical trial in 2025, we plan to license the drug to an international big pharma company, with potential royalties of up to US $236 million, equivalent to approximately NTD 7 billion.