Soligenix Achieves Enrollment Milestone for Planned Interim Analysis in Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell Lymphomav

• 50 of 80 patients enrolled in FLASH2 study
• Blinded Response Rate to Date Exceeds Trial Estimate

Excerpt from the Press Release:

PRINCETON, N.J., Nov. 19, 2025 /PRNewswire/ — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The confirmatory Phase 3 study (Fluorescent Light Activated Synthetic Hypericin 2, FLASH2), builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent successful comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study

“We are pleased to have reached this important milestone in patient enrollment consistent with our timelines for the FLASH2 study,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “With 50 patients enrolled, the planned interim analysis will occur in the second quarter of 2026. FLASH2 was designed as a highly powered confirmatory study with an anticipated overall blinded study response rate of 25% (based on the conservative assumptions of a 40% response rate in the HyBryte™ arm and a 10% response rate in the placebo arm through 18 weeks). When considering all patients that have completed the treatment phase of the study to date, our overall blinded study response rate is 48%. We look forward to completing this study on schedule with topline results in the second half of 2026.”

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