"We remain disappointed with the unanticipated outcome of the FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Despite the fact that HyBryte™ (synthetic hypericin) demonstrated statistically significant reductions in cutaneous T-cell lymphoma (CTCL) lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from HyBryte™ therapy, then we intend to communicate our findings and explore follow-up discussions with the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)."
With approximately $6.0 million in cash at March 31, 2026, and cash runway into the 2nd quarter of 2027, we will evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities, and the potential of advancing SGX945 (dusquetide) for the treatment of Behçet's Disease, which demonstrated promising biological efficacy in a Phase 2 study last year while most recently receiving orphan drug designation from EMA and Promising Innovative Medicine (PIM) designation from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). In December, we announced the extended results of the Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis where SGX302 gel therapy was well tolerated by all patients with no drug related adverse events identified. With the completion of the pilot study, we have laid the groundwork for a more detailed evaluation in this large underserved market.
Soligenix Recent Updates
On April 28, 2026, the Company announced that the Data Monitoring Committee completed the interim efficacy analysis of its pivotal Phase 3 FLASH2 trial evaluating HyBryte™ in the treatment of CTCL and recommended the study halt for futility. To view this press release, please click here.
On April 2, 2026, the Company announced that the positive results of its comparability study evaluating HyBryte™ versus Valchlor® (mechlorethamine) for the treatment of CTCL have been published in Oncology and Therapy. To view this press release, please click here.
