Soligenix Reports 2025 Results with Phase 3 CTCL Trial Progress and Orphan Drug Designation Momentum

Soligenix Inc. (NASDAQ: SNGX) reported 2025 results highlighting progress across its rare disease pipeline, including advancing its Phase 3 FLASH2 trial of HyBryte(TM) for cutaneous T-cell lymphoma with interim analysis expected in Q2 2026 and top-line results anticipated in the second half of the year. The company also noted regulatory momentum with orphan drug designation for dusquetide in Behçet’s Disease, ongoing development of SGX302 and SGX945 programs and a year-end cash position of approximately $7.9 million, as it continues to pursue strategic options to support late-stage development.

This announcement matters because it demonstrates tangible progress in addressing significant unmet medical needs in rare diseases. The advancement of the Phase 3 FLASH2 trial for cutaneous T-cell lymphoma represents a critical step toward potential regulatory approval and commercialization of HyBryte(TM), which utilizes novel photodynamic therapy with safe visible light. The orphan drug designation for dusquetide in Behçet’s Disease provides regulatory advantages and underscores the company's focus on conditions with limited treatment options.

The implications of this progress are substantial for patients suffering from these rare conditions. Cutaneous T-cell lymphoma is a rare form of non-Hodgkin lymphoma that affects the skin, and current treatment options are limited. The successful completion of the Phase 3 trial could provide a new therapeutic approach for patients. Similarly, Behçet’s Disease is a rare inflammatory disorder that can affect multiple body systems, and the orphan drug designation for dusquetide could accelerate development of a novel treatment option.

Soligenix's financial position of approximately $7.9 million in cash at year-end 2025 provides resources to continue advancing these programs while pursuing strategic options for additional support. The company's focus on rare diseases with unmet medical needs positions it in a specialized segment of the biopharmaceutical industry where successful development can lead to significant patient impact and commercial opportunity. The ongoing development of SGX302 for psoriasis expansion and SGX945 for Behçet’s Disease further demonstrates the company's commitment to building a diversified rare disease portfolio.

The company's Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (SGX301 or synthetic hypericin sodium) 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. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, first-in-class innate defense regulator technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and SGX945 in Behçet’s Disease.

For more information about the company's programs, visit https://ibn.fm/SNGX. The company's Public Health Solutions business segment includes development programs for RiVax(R), its ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses and CiVax(TM), its vaccine candidate for the prevention of COVID-19. The development of these vaccine programs incorporates the use of proprietary heat stabilization platform technology known as ThermoVax(R). 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.