"We remain focused on multiple upcoming milestones before year-end, including top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) and an enrollment update for the confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Recently, we were pleased to announce that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 study evaluating HyBryte™ in the treatment of CTCL had concluded that there were no safety concerns, with HyBryte™ demonstrating an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. Looking ahead to 2026, Phase 3 enrollment remains on track with top-line results anticipated in the second half of 2026."
Dr. Schaber continued, "With approximately $10.5 million in cash at September 30, 2025, we're focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."
Soligenix Recent Accomplishments
On October 14, 2025, the Company announced the update of its United States (U.S.) Medical Advisory Board (MAB) for CTCL to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte™. To view this press release, please click here.
On October 7, 2025, the Company announced its first DMC meeting for its confirmatory Phase 3 study evaluating HyBryte™ in the treatment of CTCL had concluded that there were no safety concerns and that HyBryte™ has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. To view this press release, please click here.
On September 30, 2025, the Company announced the expansion of its European MAB to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 d study evaluating the safety and efficacy of HyBryte™. To view this press release, please click here.
On September 29, 2025, the Company announced the closing of its previously announced public offering with participation from existing and certain healthcare focused institutional investors. To view this ...
