Soligenix (NASDAQ: SNGX) reported 2025 financial results and operational highlights, emphasizing advancements in its rare disease pipeline. The company is progressing its Phase 3 FLASH2 trial of HyBryte (SGX301) for cutaneous T-cell lymphoma (CTCL), with an interim analysis expected in the second quarter of 2026 and top-line results anticipated in the second half of the year. HyBryte is a novel photodynamic therapy utilizing visible light, and successful completion of this study could support regulatory approvals worldwide.
In addition to CTCL, Soligenix has achieved regulatory momentum with orphan drug designation for dusquetide (SGX942) in Behcet’s Disease. The company is also developing SGX302 (synthetic hypericin) for psoriasis and SGX945 for Behcet’s Disease, expanding its first-in-class innate defense regulator technology. These programs address significant unmet medical needs in rare inflammatory conditions.
Soligenix ended 2025 with a cash position of approximately $7.9 million, which it expects to support operations as it continues to pursue strategic options to fund late-stage development. The company’s pipeline also includes public health solutions, such as RiVax for ricin toxin, filovirus vaccines, and CiVax for COVID-19, leveraging its ThermoVax heat stabilization platform. These programs have been supported by government grants from NIAID, DTRA, and BARDA.
The FLASH2 trial and orphan drug milestones underscore Soligenix’s focus on bringing therapies to patients with limited treatment options. For more details, the full press release is available at https://ibn.fm/b1p2y. Updates on Soligenix can be found in the company’s newsroom at https://ibn.fm/SNGX.
Forward-looking statements in this release are subject to risks and uncertainties, including those described in the company’s SEC filings. Soligenix undertakes no obligation to update these statements unless required by law.
