Polaryx Therapeutics, Inc.

Polaryx Therapeutics, Inc. (trading symbol not specified; exchange: The Capital Market) is a clinical-stage biotechnology company dedicated to discovering, developing, and commercializing novel disease-modifying therapies for rare, pediatric lysosomal storage disorders. The company website is not provided in the filing.

The company focuses on a multi-modal therapeutic approach integrating small molecule therapies and gene therapy to address both genetic and downstream pathological features of lysosomal storage disorders. Polaryx's pipeline centers on four primary candidates: PLX-200, an oral small molecule based on gemfibrozil being advanced through a Phase 2 proof-of-concept basket trial called SOTERIA; PLX-300, a novel oral small molecule in IND-enabling studies; PLX-100, a preclinical combination therapy pairing PLX-200 with vitamin A; and PLX-400, a preclinical gene therapy program.

The company's therapeutic focus targets approximately 50,000 lysosomal storage disorder patients across the United States, Europe, and select regions worldwide. Polaryx concentrates on neuronal ceroid lipofuscinoses, representing approximately 15 percent of the lysosomal storage disorder population, along with Krabbe disease, Tay-Sachs and Sandhoff diseases, and Niemann-Pick disease types A and B. These conditions are characterized by progressive neurodegeneration, developmental regression, seizures, blindness, and early mortality, with most lacking approved disease-modifying therapies.

Polaryx was founded in August 2014 as a Wyoming corporation and redomesticated to Nevada in October 2025. Since inception through the filing date, the company has raised $21.7 million from institutional and private investors. The company operates with a lean structure, leveraging a Services Agreement with controlling stockholder Mstone Partners Healthcare Limited, a Hong Kong-based biotechnology and healthcare incubator, which provides comprehensive operational support across preclinical and clinical development, regulatory engagement, scientific and medical affairs, business development, intellectual property management, and investor relations.

The company's lead candidate, PLX-200, has received three orphan drug designations and Fast Track designation from the FDA. PLX-200 is being pursued through the 505(b)(2) regulatory pathway as a repurposed drug, leveraging gemfibrozil's established safety profile while introducing a novel pediatric-friendly oral solution formulation and establishing optimal pediatric dosing regimens.