Exclusive Summary

• **Regulatory De-risking**: Granted **Orphan Drug Designation (ODD)** by the US FDA for Fragile X Syndrome and achieved IND approval for Phase 2 clinical trials in Korea (July 2024).
• **Targeting Core Unmet Needs**: A First-in-Class "psychedelic-inspired" precision therapy that simultaneously addresses social deficits (the core unmet need) and restricted repetitive behaviors (RRBs), unlike existing antipsychotics that only treat irritability.
• **Superior Profile**: Developed via drug repositioning strategy offering high BBB penetration and a verified safety profile—free from hallucinations (unlike psychedelics), dependence, EPS, or cardiac toxicity.

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