Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on rare diseases, reported its third quarter 2025 financial results and provided an update on its clinical pipeline, highlighting the nearing release of top-line Phase 2a results for SGX302 in psoriasis and an enrollment update for its confirmatory Phase 3 HyBryte study in cutaneous T-cell lymphoma (CTCL). The company also confirmed that the first Data Monitoring Committee review for the HyBryte study found no safety concerns, maintaining a consistent safety profile across trials.
As of September 30, 2025, Soligenix reported cash and cash equivalents of $10.5 million, which the company expects will fund operations through 2026 while it evaluates strategic options to advance its late-stage pipeline. The company’s focus remains on developing and commercializing treatments for rare diseases with unmet medical need, with two major programs nearing key milestones.
The HyBryte (SGX301) program, a photodynamic therapy using synthetic hypericin sodium and visible light for CTCL, is in a confirmatory Phase 3 study following the successful completion of a prior Phase 3 trial. Regulatory approvals will be sought to support potential commercialization worldwide. The company also expects to provide an enrollment update for this study in the near term.
In addition, Soligenix is advancing SGX302 (synthetic hypericin) into a Phase 2a trial for psoriasis, with top-line results anticipated soon. This program aims to expand the use of synthetic hypericin beyond CTCL into other dermatological indications. The company’s pipeline also includes dusquetide (SGX942), a first-in-class innate defense regulator for inflammatory diseases such as oral mucositis in head and neck cancer, and SGX945 for Behcet’s disease.
Soligenix’s Public Health Solutions segment continues development of RiVax, a ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses (Marburg and Ebola) and CiVax for COVID-19. These programs utilize the company’s proprietary ThermoVax heat stabilization platform technology and have been supported by government funding from NIAID, DTRA, and BARDA.
CEO Christopher J. Schaber, PhD, stated that the company is encouraged by the progress and safety data across its pipeline. The cash position provides a runway to achieve key milestones, including the upcoming psoriasis data and Phase 3 enrollment update for HyBryte. For more details, the full press release is available at https://ibn.fm/BA8C2. Additional information and updates can be found in the company’s newsroom at https://ibn.fm/SNGX.
