SEED Receives FDA Rare Pediatric Disease and Orphan Drug Designations for Lead Oncology Asset RBM39 Degrader and Enters Strategic Transactions with New Investors

Core Insights - SEED Therapeutics Inc. has received Rare Pediatric Disease and Orphan Drug designations from the FDA for its molecular glue ST-01156, which targets RBM39, an RNA splicing factor involved in solid tumors [1][5] - The company is preparing to file an Investigational New Drug (IND) application for ST-01156 in the first half of 2025, which may lead to a priority review voucher upon approval [2] - BeyondSpring Inc., SEED's largest shareholder, is selling a portion of its Series A-1 Preferred Shares, retaining approximately 14.4% of SEED's outstanding shares post-transaction [3] Company Progress - SEED is transitioning into a clinical-stage company with the planned IND filing for ST-01156, marking a significant milestone in its journey to develop innovative therapies [4] - The FDA designations for ST-01156 are expected to expedite the development and commercialization process, addressing significant unmet needs in rare oncology [5] - The recent transactions are aimed at diversifying SEED's shareholder base, aligning its capital structure with institutional investor expectations, and enhancing its ability to advance its clinical pipeline [5] Company Overview - SEED Therapeutics focuses on discovering and developing targeted protein degradation therapeutics, leveraging its RITE3™ platform to address diseases with limited treatment options [6] - The company collaborates with Eli Lilly and Company and Eisai Co., Ltd., and has a robust pipeline of novel drug candidates nearing clinical development [6]