Soligenix Expands European Medical Advisory Board to Advance HyBryte Phase 3 Study in Cutaneous T-Cell Lymphoma

Soligenix Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on treatments for rare diseases, announced the expansion of its European Medical Advisory Board to guide its confirmatory Phase 3 trial of HyBryte in early-stage cutaneous T-cell lymphoma. The 18-week study is enrolling approximately 80 patients with top-line results expected in the second half of 2026. This strategic expansion represents a significant step in strengthening European engagement ahead of potential commercialization of the novel photodynamic therapy.

The company's Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. The development programs in this business segment also include expansion of synthetic hypericin into psoriasis, the company's first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases including oral mucositis in head and neck cancer, and additional development in Behcet's Disease.

Soligenix's Public Health Solutions business segment includes development programs for RiVax, the company's ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses such as Marburg and Ebola and CiVax, the vaccine candidate for the prevention of COVID-19 caused by SARS-CoV-2. The development of these vaccine programs incorporates the use of the proprietary heat stabilization platform technology known as ThermoVax. This business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency and the Biomedical Advanced Research and Development Authority. Additional information about the company is available in their newsroom at https://ibn.fm/SNGX.

The expansion of the European Medical Advisory Board comes at a critical juncture as the company prepares for the advanced stages of clinical development and potential market entry in European territories. The advisory board's expertise will be instrumental in navigating the complex regulatory landscape and ensuring the trial design meets European standards, potentially accelerating the path to commercialization for patients suffering from this rare disease who currently face limited treatment options.