Soligenix Announces Recent Accomplishments and Year End 2025 Financial Results

Core Insights - Soligenix is entering a pivotal year with significant clinical and regulatory milestones, particularly the interim analysis of the Phase 3 FLASH2 trial for HyBryte™ in Q2 2026 and top-line results expected in H2 2026 [2] Recent Accomplishments - The European Commission granted orphan drug designation to dusquetide (SGX945) for Behçet's Disease on March 26, 2026, following a positive recommendation from the EMA [2] - Findings from supportive trials of HyBryte™ for CTCL were presented at the United States Cutaneous Lymphoma Consortium Workshop on March 23, 2026 [2] - A summary of clinical trials for HyBryte™ was published in the peer-reviewed journal Expert Opinion on Investigational Drugs on March 19, 2026 [2] - SGX945 received Promising Innovative Medicine designation in the UK for Behçet's Disease on March 10, 2026 [2] - The EMA COMP provided a positive recommendation for orphan drug designation for dusquetide on February 26, 2026, based on Phase 2a clinical results [2] Financial Results - Soligenix reported no revenues for the year ended December 31, 2025, compared to $0.1 million in the previous year, primarily due to the conclusion of a zero-margin grant for HyBryte™ [3] - The net loss for 2025 was $11.1 million, or ($2.14) per share, an increase from $8.3 million, or ($4.98) per share, in 2024, attributed to higher R&D costs and decreased other income [4] - Research and development expenses rose to $7.5 million in 2025 from $5.2 million in 2024, mainly due to costs associated with the Phase 2 study in Behçet's Disease and the ongoing Phase 3 CTCL study [5] - General and administrative expenses were $4.4 million in 2025, slightly up from $4.2 million in 2024, due to increased taxes and stock-related expenses [6] - As of December 31, 2025, the company's cash position was approximately $7.9 million [6]