Soligenix Reports Q3 2025 Financial Results and Key Clinical Milestones for Rare Disease Treatments

Soligenix Inc. (NASDAQ: SNGX) reported third quarter 2025 financial results and outlined significant clinical milestones for its rare disease treatment pipeline, positioning the company for potential regulatory submissions and commercialization opportunities. The biopharmaceutical company confirmed upcoming top-line Phase 2a results for SGX302 in psoriasis and provided an enrollment update for its confirmatory Phase 3 HyBryte™ study in cutaneous T-cell lymphoma (CTCL), highlighting progress across multiple therapeutic areas with unmet medical needs.

Chief Executive Officer Christopher J. Schaber, PhD, announced that the first Data Monitoring Committee review for HyBryte™ found no safety concerns, maintaining the treatment's consistent safety profile across clinical trials. This development is particularly important for CTCL patients who currently face limited treatment options, as HyBryte™ represents a novel photodynamic therapy utilizing safe visible light rather than more damaging ultraviolet radiation typically used in phototherapy treatments.

The company's financial position remains stable with $10.5 million in cash as of September 30, 2025, providing an operating runway expected to extend through 2026 while management evaluates strategic options to advance its late-stage pipeline. This financial stability is crucial for maintaining momentum in clinical development programs that target rare diseases often overlooked by larger pharmaceutical companies due to smaller patient populations.

Soligenix's Specialized BioTherapeutics business segment continues to drive toward potential commercialization of HyBryte™ following successful completion of the second Phase 3 study. The company plans to seek regulatory approvals worldwide to support global commercialization efforts. Additional development programs in this segment include expansion of synthetic hypericin (SGX302) into psoriasis treatment, representing a potential new therapeutic approach for this chronic autoimmune condition affecting millions worldwide.

The company's pipeline also includes first-in-class innate defense regulator technology with dusquetide (SGX942) for inflammatory diseases including oral mucositis in head and neck cancer patients, and SGX945 in Behçet's Disease. These programs address significant unmet medical needs in patient populations that often struggle with limited treatment options and substantial quality of life impacts.

Soligenix's Public Health Solutions business segment continues development of RiVax®, the company's ricin toxin vaccine candidate, along with vaccine programs targeting filoviruses including Marburg and Ebola. The segment also includes CiVax™, a vaccine candidate for COVID-19 prevention. These programs incorporate the company's proprietary heat stabilization platform technology ThermoVax®, which could potentially address vaccine storage and distribution challenges in resource-limited settings. This business segment has been supported by government grant and contract funding from multiple agencies including the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA).

The clinical progress and financial stability reported by Soligenix represents important developments for patients suffering from rare diseases who often face limited treatment options. For more detailed information about the company's latest developments, visit https://ibn.fm/SNGX. The continued advancement of these therapeutic candidates through clinical trials brings hope for new treatment alternatives in disease areas where medical needs remain substantially unmet.