Yoda Therapeutics-KY, Taiwan’s first AI-driven new drug company, is set to debut on the Emerging Stock Board on June 3 with a reference price of NT$35 per share. CEO Yu-Feng Jane Tseng stated that the company focuses on developing treatments for central nervous system disorders and currently has four drug candidates in the pipeline. Its lead product, YA-101, targets Multiple System Atrophy (MSA) and is undergoing multi-national, multi-center clinical trials. Patient enrollment for the trial, targeting 75 participants, is expected to be completed by the third quarter of next year.
Founded in June 2019, Yoda Therapeutics was incubated through Taiwan’s national program and the global SPARK initiative at Stanford University. With a capital of NT$790 million, the company plans to launch a NT$600 million fundraising round in the fourth quarter. The funds will support the launch of a Phase III clinical trial for YA-101 in late 2025 and another Phase III trial for YA-102, a treatment for Parkinson’s disease.
Tseng emphasized that by leveraging AI in drug development and design, the company can reduce costs by over US$1 billion, shorten development timelines by more than five years, and significantly improve the success rate of new drug development.
Yoda’s drug candidates are dual modulators of the NMDA receptor and the NLRP3 inflammasome. They aim to enhance brain function and cognitive and motor abilities while suppressing neuroinflammation and preventing cell death. These mechanisms offer broad potential across various neurological and psychiatric conditions.
YA-101, the company’s most advanced candidate, is an oral treatment for MSA currently undergoing Phase II trials in the United States and Taiwan, with enrollment of 75 patients expected to conclude by Q3 2025.
YA-102, targeting Parkinson’s disease, represents the largest commercial opportunity. It is a reformulated version of YA-101 and is currently undergoing formulation optimization, with improvements likely to be completed this year and clinical trials anticipated to begin next year.
In addition, YA-201 for Alzheimer’s disease and YA-301 for schizophrenia are both in preclinical stages. YA-101 received Orphan Drug Designation (ODD) from the FDA in July 2022 for the treatment of MSA, which facilitates faster development timelines. The Phase III trial is expected to run from Q3 2025 through Q4 2028, with the company aiming to obtain marketing approval in Q1 2030. Yoda is also preparing ODD applications in Japan and the EU.
Resource: 首家AI新藥股思捷優達 明每股35元登興櫃
