SNGX · Soligenix, Inc.

Soligenix's Phase 3 FLASH2 trial, evaluating HyBryte™ (synthetic hypericin) as a photodynamic therapy for cutaneous T-cell lymphoma, was halted for futility based on the Data Monitoring Committee's interim efficacy analysis conducted on April 28, 2026. This confirmatory study followed the initial Phase 3 FLASH trial, which showed positive results including 16% response rate in Cycle 1 (vs. 4% placebo, p=0.04) and up to 49% in patients completing three cycles. Despite replicating key design elements like the double-blind, placebo-controlled structure over 18 weeks, FLASH2 did not replicate the efficacy signal observed after 6 weeks in the first study. Management expressed disappointment and plans to analyze the full dataset for insights, particularly in patient subsets, and engage regulators. With $5.9 million in cash, the company faces heightened going concern risks and is pivoting to strategic alternatives, including M&A and advancing dusquetide (SGX942/SGX945), an innate defense regulator that showed promising Phase 2 efficacy in Behçet’s Disease and recently received EMA orphan designation. This development significantly impacts Soligenix's lead pipeline asset, potentially delaying or derailing regulatory approval for HyBryte™, which had FDA orphan drug, fast track, and EMA orphan designations, and underscores the need for capital raises or partnerships to sustain operations.