Soligenix Inc. (NASDAQ: SNGX)

Soligenix Inc. (NASDAQ: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The company operates through two business segments: Specialized BioTherapeutics and Public Health Solutions.

The Specialized BioTherapeutics segment includes HyBryte™ (SGX301 or synthetic hypericin sodium), which is being advanced toward potential commercialization for the treatment of early-stage cutaneous T-cell lymphoma (CTCL), as well as SGX302 for psoriasis and SGX945 (dusquetide) for Behçet’s Disease. The Public Health Solutions segment includes vaccine development programs supported by government funding and incorporates the company’s proprietary ThermoVax® heat stabilization platform.

Soligenix is headquartered in Princeton, New Jersey.

Specialized BioTherapeutics

HyBryte™ (SGX301) – Cutaneous T-Cell Lymphoma (CTCL)

HyBryte™ is a visible light-activated synthetic hypericin photodynamic therapy for early-stage CTCL. A pivotal Phase 3 study (FLASH) demonstrated statistically significant efficacy. The confirmatory Phase 3 trial (FLASH2) is actively enrolling 80 patients and shifts the primary endpoint assessment from 6 weeks to 18 weeks of continuous treatment, consistent with prior findings that response improves with longer treatment duration.

As of February 10, 2026, 66 patients had been enrolled. An interim analysis is expected in the second quarter of 2026, with top-line results anticipated in the second half of 2026. The company has reported that the overall blinded aggregate response rate remains consistent with what was previously reported and higher than the estimated overall response rate used to design the study. An earlier Data Monitoring Committee review identified no safety concerns.

An investigator-initiated study evaluating extended HyBryte™ treatment reported that, following 18 weeks of continuous treatment, 75% of patients achieved treatment success, with complete responses observed in certain patients. HyBryte™ has received orphan drug designation in both the United States and Europe, as well as Fast Track designation from the FDA. Upon successful completion of FLASH2, regulatory submissions are expected to support potential commercialization worldwide.

SGX302 – Mild-to-Moderate Psoriasis

SGX302 utilizes synthetic hypericin for the treatment of mild-to-moderate psoriasis. A Phase 2a exploratory study evaluated multiple cohorts, including a third cohort using an optimized gel formulation designed to improve ease of application. Across evaluable patients, improvements were observed in Investigator Global Assessment (IGA), Psoriasis Activity and Severity Index (PASI), simplified psoriasis index, Dermatology Life Quality Index and Skindex-29.

SGX302 gel therapy was well tolerated with no drug-related adverse events identified. With completion of the pilot study, the company has stated that “the table has been set for a more detailed evaluation” of SGX302 in this indication.

SGX945 (Dusquetide) – Behçet’s Disease

SGX945, which contains dusquetide, is being developed for the treatment of aphthous ulcers associated with Behçet’s Disease. Results from the Phase 2a proof-of-concept study were published in Rheumatology (Oxford) in December 2025. In the study, 7 of 8 patients experienced beneficial effects during the four-week treatment period, with improvements sustained during the four-week follow-up period.

Using the area under the curve (AUC) endpoint comparable to the Phase 3 apremilast study, the SGX945 treated group demonstrated a 40% improvement relative to placebo at four weeks. Improvement was sustained at Week 8, with a 32% improvement evaluated despite treatment having stopped at Week 4. SGX945 was well tolerated with no treatment-related adverse events reported.

In February 2026, the European Medicines Agency Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending orphan drug designation for dusquetide for the treatment of Behçet’s Disease, with ratification by the European Commission pending. SGX945 has previously received orphan drug and Fast Track designations from the U.S. FDA. The company has stated its intention to pursue reformulation to enable home-based administration and to interact with regulatory authorities regarding a follow-on placebo-controlled Phase 2b study.

Public Health Solutions

Soligenix’s Public Health Solutions segment focuses on vaccine candidates and biodefense medical countermeasures supported by non-dilutive government funding. Key programs include:

• RiVax®, a ricin toxin vaccine candidate that has demonstrated statistically significant survival in non-human primate models and positive Phase 1 safety results.
• MarVax™ and SuVax™, vaccine candidates targeting Marburg and Ebola viruses, supported by published data demonstrating thermostability and protective efficacy.
• CiVax™, a COVID-19 vaccine candidate utilizing the company’s ThermoVax® platform.
• ThermoVax®, a proprietary heat stabilization technology designed to eliminate cold-chain storage requirements, with published data supporting stability at 40°C for up to two years.

This segment has received substantial funding support from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA).

Market Opportunity

HyBryte™ targets the global CTCL market, which the company estimates exceeds $250 million annually. The company projects peak annual U.S. net sales in excess of $90 million. CTCL is a chronic orphan oncology indication with limited well-tolerated therapeutic options, and HyBryte’s visible-light mechanism is designed to avoid the long-term risks associated with ultraviolet-based therapies and systemic immunosuppressants.

SGX302 addresses the global psoriasis market, which was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027. Psoriasis affects an estimated 60 to 125 million people worldwide, with approximately 80% classified as mild-to-moderate disease. The company estimates the addressable opportunity for SGX302 exceeds $1 billion annually.

SGX945 targets Behçet’s Disease, an orphan inflammatory condition affecting approximately 18,000 individuals in the U.S., more than 50,000 in Europe and up to one million worldwide. The company estimates the global market opportunity at approximately $200 million annually.

Collectively, Soligenix estimates its rare disease portfolio represents potential global annual sales opportunities approaching $2 billion.

Leadership Team

Christopher J. Schaber, PhD, Chairman, President & CEO, brings to the company more than 35 years of experience in the biopharmaceutical industry. Before joining Soligenix, he held senior and operational leadership roles at Discovery Laboratories, Acute Therapeutics, Ohmeda Pharmaceuticals, The Liposome Company, and Wyeth Ayerst Laboratories. He has extensive expertise in drug development, regulatory affairs, and corporate strategy, positioning him to drive Soligenix’s growth and advancement toward commercialization.

Richard Straube, MD, Chief Medical Officer, has more than 35 years of experience in drug development and clinical research. Prior to joining Soligenix, he held key leadership roles at Stealth Peptides, INO Therapeutics, Ohmeda Pharmaceuticals, and Centocor. Throughout his career, he has played a crucial role in bringing innovative therapies to market, particularly in inflammatory diseases and immunology, making him a valuable asset in advancing Soligenix’s late-stage clinical programs.

Oreola Donini, PhD, Chief Scientific Officer, has more than 20 years of experience in pharmaceutical research and development, with expertise in immunology, inflammation, and rare diseases. Before joining Soligenix, she held leadership positions at Inimex Pharmaceuticals, ESSA Pharma, and Kinetek Pharmaceuticals, where she worked on novel drug discovery and translational medicine. Her experience in preclinical research and product development supports Soligenix’s continued innovation in biopharmaceuticals.

Jonathan Guarino, CPA, CGMA, Chief Financial Officer, has over 25 years of experience in corporate finance and strategic financial planning. Before joining Soligenix, he held financial leadership positions at Hepion Pharmaceuticals, Covance, BlackRock, and Barnes & Noble. His expertise in financial management, accounting, and capital markets plays a critical role in Soligenix’s financial strategy and operational efficiency.