Soligenix(US:SNGX) Prnewswire·2025-07-08 11:30Core Insights - Soligenix, Inc. is focused on developing and commercializing products for rare diseases with unmet medical needs, with a promising late-stage pipeline and potential strategic options including partnerships and M&A opportunities [1][3] Financial Overview - The company has sufficient capital and cash runway to meet its goals into Q1 2026, with expected peak annual net sales of HyBryte™ in the U.S. exceeding $90 million and a total addressable worldwide CTCL market estimated at over $250 million annually [2][13] - The total addressable worldwide psoriasis market opportunity with SGX302 is estimated to exceed $1 billion annually, while SGX945 in Behçet's Disease (BD) has a market opportunity of approximately $200 million annually, leading to potential global annual sales of around $2 billion [2][11] Clinical Development - The confirmatory Phase 3 FLASH2 study for HyBryte™ is ongoing, with top-line results expected in the second half of 2026, and enrollment is on track [4][5] - The ongoing Phase 2a study of SGX302 in mild-to-moderate psoriasis has shown promising results, with previous cohorts demonstrating biologic activity and early clinical success [7][10] - A pilot Phase 2a proof of concept clinical trial for SGX945 in Behçet's Disease is expected to yield top-line results in Q3 2025 [11] Market Potential - Psoriasis affects approximately 60-125 million people globally, with the global treatment market valued at around $30 billion in 2023 and projected to reach $58-67 billion by 2030 [8][9] - Behçet's Disease is an orphan disease with around 18,000 known cases in the U.S. and 50,000 in Europe, impacting the quality of life for patients [12] Manufacturing and Partnerships - The company has successfully transferred the manufacturing of synthetic hypericin to a U.S. facility, optimizing the process for larger batch production [10] - Soligenix is actively pursuing partnerships in ex-U.S. markets to enhance its marketing authorizations for HyBryte™ and explore other potential cutaneous indications [6][14]