Soligenix, Inc.

The company is a late-stage biopharmaceutical company that develops and sells products for rare diseases with unmet medical needs. It operates through two active business segments: Specialized BioTherapeutics and Public Health Solutions. The Specialized BioTherapeutics segment focuses on developing and potentially commercializing HyBryte™ (SGX301 or synthetic hypericin sodium), a new photodynamic therapy. This therapy uses topical synthetic hypericin activated by visible light to treat cutaneous T-cell lymphoma (CTCL). Following the successful completion of the first Phase 3 FLASH study and agreement with the European Medicines Agency (EMA) on the design of a confirmatory Phase 3 placebo-controlled study, patient enrollment for the second Phase 3 study, "FLASH2," began in December 2024. Top-line results for FLASH2 are anticipated in the second half of 2026. Upon successful completion of the FLASH2 study, the company plans to seek regulatory approval for potential worldwide commercialization. This segment also includes development programs for synthetic hypericin in psoriasis (SGX302) and its Innate Defense Regulator (IDR) technology, dusquetide, for inflammatory diseases. These include aphthous ulcers in Behçet's Disease (BD) (SGX945) and oral mucositis in head and neck cancer (SGX942).