Soligenix

What Soligenix does

Soligenix, Inc. (NASDAQ: SNGX) is a late-stage biopharmaceutical company founded in 1987 and headquartered in Princeton, NJ. It operates two reporting segments: Specialized BioTherapeutics, focused on oncology and rare disease therapeutics, and Public Health Solutions, focused on biodefense and emerging infectious disease vaccines. The Specialized BioTherapeutics pipeline has historically been anchored by HyBryte (synthetic hypericin) in cutaneous T-cell lymphoma, supported by dusquetide in oral mucositis, SGX945 in Behçet's disease, and SGX302 in psoriasis. The Public Health Solutions pipeline targets filovirus threats (Ebola, Marburg) and is built around the proprietary ThermoVax platform, a thermostabilization technology designed to enable ambient-temperature vaccine storage and reduce cold-chain dependence.

The company is pre-revenue with no commercialized products and a small organization of 11-50 employees. Its business model is a hybrid of equity-financed clinical development for the therapeutic segment and milestone-based, non-dilutive government funding (historically from NIAID, DTRA, and BARDA, and prospectively from CEPI) for the vaccine segment. Regulatory positioning includes FDA Fast Track status and both FDA and EMA orphan drug designations across multiple candidates, providing extended market exclusivity and accelerated review pathways contingent on eventual approval.

In April 2026 the Phase 3 FLASH2 trial of HyBryte was halted for futility, the CTCL program was terminated in June 2026, and the company announced it is exploring strategic alternatives including a potential M&A transaction. The combination of a failed pivotal trial, loss of the lead asset, an exploratory strategic review, and reliance on capital raises and government grants defines the company's current risk profile and sets the context for any forward-looking investment analysis.

Name

Soligenix

Legal name

Soligenix, Inc.

Website

https://soligenix.com

Company type

Public

Founded year

1987

Operating status

Operating

Headcount range

11–50 employees

Short description

Soligenix is a late-stage, pre-revenue biopharmaceutical company developing orphan-indicated therapeutics and biodefense vaccines, supported by the proprietary ThermoVax platform, FDA/EMA orphan designations, and non-dilutive government funding from agencies such as NIAID, DTRA, BARDA, and CEPI.

Ownership category

akta.pro rank

Product category

Specialty Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Immunology & Inflammation Pharmaceuticals (HLAIAAAD)

akta.pro secondary industries

Infectious Disease & Pandemic Preparedness Vaccines (emerging pathogens) (HLAAAEAC), Cytokines, Interferons & Immunomodulatory Proteins (HLAAAAAC)

Keywords

• Orphan disease therapeutics
• Biodefense vaccine development
• Photodynamic therapy
• Innate defense regulators
• Thermostable vaccine platform

Headquarters

HQ city

Princeton

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Product Sales (Future): Soligenix is pre-revenue with no commercialized products. The company is developing a pipeline of biopharmaceutical products for rare diseases and biodefense. Upon regulatory approval, products would be commercialized through specialty pharmaceutical sales channels targeting rare disease specialists, oncologists, and dermatologists.
2. Government Grants and Contracts: Significant non-dilutive funding from US government agencies including NIAID, DTRA, and BARDA supporting vaccine and biodefense programs. Additional funding from FDA Orphan Products Development grants and various state tax credit programs.
3. Strategic Partnerships and Licensing: Potential future revenue through licensing agreements or strategic partnerships for commercialization rights to pipeline products in various territories or indications.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels8 records

Core offering

Soligenix is a late-stage biopharmaceutical company developing two business segments. The Specialized BioTherapeutics segment focuses on orphan and unmet-need therapies including HyBryte (synthetic hypericin photodynamic therapy for CTCL), SGX302 (psoriasis), SGX942 and SGX945 (dusquetide for oral mucositis and Behçet's Disease). The Public Health Solutions segment develops thermostable biodefense vaccines including RiVax (ricin toxin), CiVax (COVID-19), and filovirus vaccines, funded entirely by US government grants.

Product overview

Soligenix is a late-stage biopharmaceutical company with two distinct business segments. The Specialized BioTherapeutics segment develops orphan and unmet medical need treatments including HyBryte™ (synthetic hypericin) for cutaneous T-cell lymphoma in Phase 3, SGX302 for mild-to-moderate psoriasis in Phase 2, SGX942 (dusquetide) for oral mucositis in Phase 2/3, and SGX945 (dusquetide) for Behçet's Disease in Phase 2. The Public Health Solutions segment develops vaccines funded entirely by government grants, including the RiVax® ricin toxin vaccine, CiVax™ COVID-19 vaccine, and filovirus vaccines (Ebola/Marburg), all utilizing the proprietary ThermoVax® heat stabilization platform technology.

Differentiator

Problem solved

Functional benefit

Brands

• HyBryte: Novel photodynamic therapy using synthetic hypericin for the treatment of cutaneous T-cell lymphoma (CTCL). Activated by safe visible light.
• RiVax
• ThermoVax
• CiVax
• SGX302
• SGX942 (dusquetide)
• SGX945 (dusquetide)

Products and services

• HyBryte (Synthetic Hypericin / SGX301) A novel first-in-class photodynamic therapy using topical synthetic hypericin ointment activated by safe visible fluorescent light for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). Developed for patients with early-stage CTCL (Stages IA, IB, IIA), a population of approximately 31,000 in the US and 38,000 in Europe.
• SGX302 (Synthetic Hypericin) A topical gel formulation of synthetic hypericin for the treatment of mild-to-moderate plaque psoriasis, using photodynamic therapy with visible light instead of UV radiation to avoid DNA damage and skin cancer risks associated with conventional phototherapy. Targets the up to 8 million US and 125 million worldwide psoriasis patients.
• SGX942 (Dusquetide) An innate defense regulator (IDR) administered as a 4-minute IV infusion for the treatment of oral mucositis in head and neck cancer patients receiving chemotherapy and radiation therapy. Addresses the 40% of all chemotherapy patients and 75% of head and neck cancer patients who develop oral mucositis, for whom there is no FDA-approved treatment in the solid tumor setting.
• SGX945 (Dusquetide) An innate defense regulator (IDR) for the treatment of aphthous ulcers associated with Behçet's Disease, an autoimmune and auto-inflammatory vasculitis affecting up to 50,000 people in Europe and as many as 1 million worldwide. Received EMA Orphan Drug Designation, European Commission Orphan Drug Designation, and UK MHRA Promising Innovative Medicine Designation.
• SGX203 (Beclomethasone 17,21-dipropionate) A proprietary oral formulation of beclomethasone 17,21-dipropionate (BDP) for the prevention and treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease.
• RiVax (Ricin Toxin Vaccine) A heat-stable ricin toxin vaccine candidate developed using ThermoVax technology, intended for biodefense applications against the Category B biothreat of ricin poisoning. Funded by U.S. government grants from NIAID and DTRA.
• ThermoVax Thermostable Vaccine Platform A proprietary heat stabilization platform technology that enables vaccines to remain stable for extended periods (demonstrated 2+ years) at elevated temperatures of 40°C, eliminating the need for cold chain storage and distribution. Underpins the company's public health solutions vaccine portfolio including RiVax, CiVax, and filovirus candidates.
• Bundibugyo Ebola Virus (BDBV) Vaccine A thermostable protein-based subunit vaccine in development for Bundibugyo Ebola virus (BDBV), leveraging the ThermoVax platform. Developed in collaboration with Dr. Axel Lehrer at the University of Hawai'i at Mānoa, with prior related work demonstrating up to 100% protection in non-human primates against related filoviruses including Ebola, Sudan, and Marburg viruses.
• CiVax (COVID-19 Vaccine) A thermostable vaccine candidate for the prevention of COVID-19 caused by SARS-CoV-2, developed using the ThermoVax heat stabilization platform to enable vaccine distribution without cold chain requirements.
• Filovirus Vaccines (Ebola / Marburg / Sudan) Thermostable vaccine candidates targeting filoviruses including Ebola, Marburg, and Sudan viruses, using the ThermoVax platform for heat stabilization. Demonstrated up to 100% protection in non-human primates against severe and lethal Sudan ebolavirus and marburgvirus infection.
• SGX943 (Dusquetide) A therapeutic candidate for antibiotic-resistant and emerging infectious disease applications, utilizing the dusquetide innate defense regulator technology platform to address infectious disease threats.

Quantifiable outcome

• Phase 3 FLASH study: 16% response rate (≥50% lesion reduction) with HyBryte at 8 weeks vs 4% placebo (p=0.04); 40% response rate at 12 weeks (p<0.0001 vs placebo); 49% response in patients completing 18 weeks of treatment (p<0.0001)
• +3 more outcomes

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core.

• University of Hawaiʻi at MānoacoreStrategic or Co-development Partner · 8 June 2026Collaboration with Dr. Axel Lehrer at the University of Hawaiʻi at Mānoa for the development of thermostable filovirus vaccines, including the Bundibugyo Ebola vaccine candidate. Prior work has demonstrated that the protein-based vaccine platform provides up to 100% protection in non-human primates against related filoviruses including Ebola, Sudan, and Marburg viruses.
• European Medicines Agency (EMA)coreOthersRegulatory agency providing orphan drug designation for SGX945 (dusquetide) for Behçet's Disease and reviewing HyBryte marketing approval pathway. Positive opinion received February 2026 for orphan drug designation.
• US Food and Drug Administration (FDA)coreOthersFDA awarded Orphan Products Development grant ($2.6 million over 4 years) to University of Pennsylvania for HyBryte expanded clinical study. FDA has provided orphan drug designation and fast track designation for HyBryte, and indicated requirement for second successful Phase 3 trial to support marketing approval.

Scale indicators11 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Emergent BioSolutions: Specialty biopharmaceutical company focused on biodefense vaccines and therapeutics (Anthrax, smallpox, ricin) sold primarily through government procurement. Direct overlap with Soligenix's Public Health Solutions segment and ThermoVax/RiVax programs.
• Bavarian Nordic: Vaccine company specializing in smallpox and infectious disease countermeasures, including Ebola vaccine candidates. Comparable as a government-funded biodefense/specialty vaccine developer targeting filovirus and emerging infectious disease markets.
• BioCryst Pharmaceuticals: Late-stage rare disease biopharmaceutical company developing orally administered small-molecule therapeutics for hereditary angioedema and other orphan indications. Comparable in size, commercialization stage, and rare-disease specialty focus.
• Anavex Life Sciences: Small-cap clinical-stage biopharmaceutical company developing treatments for rare neurological diseases (Rett syndrome, Alzheimer's). Comparable as a similarly sized, pre-commercial orphan-disease biotech reliant on capital markets for funding.
• Aprea Therapeutics: Small-cap clinical-stage biopharmaceutical company developing cancer therapeutics targeting tumor suppressor proteins. Comparable in size, orphan/rare-disease focus, and pre-commercial development-stage profile.
• Diffusion Pharmaceuticals: Small-cap clinical-stage biopharmaceutical company developing therapeutics for rare and orphan indications. Comparable in size, capital-markets reliance, and pre-revenue specialty pharma profile.
• Cyclacel Pharmaceuticals: Small-cap clinical-stage biopharmaceutical company developing small-molecule therapeutics for cancer and rare diseases. Comparable in scale, reliance on dilutive financings, and orphan/rare-disease clinical focus.

Broad incumbents

• Novavax: Larger vaccine platform company with proprietary recombinant nanoparticle and Matrix-M adjuvant technology, including thermostable vaccine efforts. Comparable through its vaccine platform technology approach and pandemic preparedness orientation.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights5 records

Customer concentration

• Xx.com/Soligenix_Inc
• YouTubeyoutube.com/channel/UCceDaiNPtvcceirgnwUo88Q
• Facebookfacebook.com/247569982046316
• LinkedInlinkedin.com/company/553104
• Instagraminstagram.com/soligenix

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds19 records

Investors16 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Soligenix