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Business Update
FLASH2 Trial Recommended to Stop for Futility
On April 28, 2026, Soligenix, Inc. (NASDAQ: SNGX) announced interim results from the Phase 3 FLASH2 of HyBryte™ (SGX301 or synthetic hypericin) in the treatment of cutaneous T cell lymphoma (CTCL). Following the completion of the interim analysis by the Data Monitoring Committee, the study was recommended to halt for futility.
This was an entirely unexpected and very disappointing outcome for the trial. HyBryte had previously demonstrated a statistically significant reduction in CTCL lesions at six weeks in the FLASH trial that only improved at later timepoints. In addition, Dr. Ellen Kim reported a 75% response rate after 18 weeks of treatment in the open-label, investigator-initiated study being conducted at the University of Pennsylvania. These results gave us high confidence in a positive outcome for the FLASH2 trial, thus we are very surprised by the negative outcome.
Soligenix will continue to evaluate the data to determine why the study failed and whether there are specific subsets of patients that may benefit from HyBryte. In addition, it will analyze all potential strategic options, including merger and acquisition opportunities, along with the possibility of advancing SGX945 (dusquetide) for the treatment of Behcet’s disease, which showed promising efficacy in a prior Phase 2 study and which recently received Orphan Drug designation from the EMA.
Conclusion
We will be very interested to learn more details about the results of the FLASH2 study and what factors may have contributed to the unsuccessful outcome. With $5.9 million in cash and cash equivalents, which should fund operations into the first quarter of 2027, the company will be evaluating all potential paths forward, including the potential for a merger or acquisition. Given the uncertainty surrounding the potential for HyBryte in CTCL and where the company will focus its resources going forward, we have removed it from our model, and our valuation now stands at $2 per share.
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