Soligenix (NASDAQ:SNGX) reported financial results for the full year ended December 31, 2025, on March 31, 2026, emphasizing a clear pathway toward critical late-stage clinical data readouts.
The company ended the fiscal year with $7.9 million in cash and cash equivalents, a position management indicates is sufficient to support operations through the primary milestones of its lead program.
For the full year 2025, Soligenix reported a net loss of $11.1 million.
The financial results reflect continued investment in the Phase 3 FLASH study of HyBryte (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).
The company confirmed that the trial remains on track, with an interim analysis scheduled for the second quarter of 2026 and top-line results expected in the second half of the year.
Beyond its lead oncology asset, Soligenix highlighted significant regulatory progress for dusquetide (SGX945) in the treatment of Aphthous Ulcers in Behcet’s Disease.
The program received Orphan Drug designation from both the European Medicines Agency (EMA) and the European Commission (EC), as well as a Promising Innovative Medicine (PIM) designation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The company also noted a high level of academic and clinical engagement throughout the year, citing several peer-reviewed publications and presentations at major medical conferences.
These publications have focused on the mechanism of action for the company's innate defense regulator (IDR) technology and the potential for HyBryte to provide a non-invasive, first-line treatment option for rare skin cancers.
Management indicated that the primary goal for 2026 is the successful execution of the HyBryte data readout.
If positive, the company intends to move rapidly toward a New Drug Application (NDA) submission in the United States.