- Soligenix has multiple late-stage assets with orphan and fast-track designations, providing a clear regulatory pathway toward potential approvals.
- The company’s pipeline has a total addressable market exceeding $2 billion, spanning rare diseases, inflammation, and biothreat applications.
- Soligenix has benefited from significant non-dilutive government funding, which reduces operational expenses and financial risk while supporting its public health initiatives.
- The company is well-positioned for multiple development and regulatory catalysts, and commercial milestones, with lead candidates in cutaneous T-cell lymphoma, psoriasis, oral mucositis, and Behçet’s disease.
- Soligenix is led by an experienced management team with a strong track record of success.
Soligenix (NASDAQ: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for rare diseases with high unmet medical needs. Operating through two key segments, the company’s Specialized BioTherapeutics division is dedicated to oncology and inflammation therapies, while its Public Health Solutions segment advances vaccines and therapeutics targeting biothreats and infectious diseases.
The company is actively advancing multiple late-stage clinical programs, including HyBryte™ (“SGX301”), a novel photodynamic therapy for cutaneous T-cell lymphoma (“CTCL”). Additional candidates in development target psoriasis (“SGX302”), oral mucositis (“SGX942”), and Behçet’s disease (“SGX945”), while its public health efforts focus on heat-stable vaccines for ricin poisoning (“RiVax®”), Ebola (“SuVax™”), and Marburg (“MarVax™”) viruses, that have been supported by non-dilutive government grants and contracts of approximately $60 million to date.
With a diversified pipeline, multiple orphan and fast-track designations, and collaborations with government agencies, Soligenix is uniquely positioned for potential regulatory approvals and commercialization.
The company is headquartered in Princeton, New Jersey.
Pipeline and Development Programs
Specialized BioTherapeutics
Soligenix’s Specialized BioTherapeutics division develops treatments for oncology and inflammatory diseases, focusing on conditions with few or no effective therapeutic options. HyBryte™ (synthetic hypericin) has completed a Phase 3 study for CTCL, demonstrating statistically significant efficacy, and a second confirmatory Phase 3 trial is actively enrolling patients to support potential regulatory submissions worldwide. If approved, it would be the first non-mutagenic photodynamic therapy for early-stage CTCL, addressing an unmet medical need. It has received orphan drug designations in the U.S. and Europe, as well as Fast Track designation in the U.S.
SGX302, a photodynamic therapy based on the same active ingredient as HyBryte™, is in clinical development for mild-to-moderate psoriasis, with positive Phase 1/2 proof-of-concept results, it is actively enrolling patients in a Phase 2a clinical trial.
SGX942, designed to reduce inflammation and tissue damage in oral mucositis associated with cancer treatment, is progressing as a potential first-in-class therapy.
SGX945, targeting aphthous ulcers in Behçet’s disease, is actively enrolling in a Phase 2a clinical trial and has received fast-track designation, highlighting the urgency of developing effective treatments for this rare inflammatory condition.
Public Health Solutions
The company’s Public Health Solutions segment focuses on medical countermeasures for biothreats and emerging infectious diseases, leveraging non-dilutive government funding to advance its programs. RiVax®, a ricin toxin vaccine, has demonstrated strong preclinical and early clinical results and may be eligible for government procurement under the Strategic National Stockpile initiative.
The company’s RiVax®, as well as its vaccine candidates for Ebola and Marburg viruses are based on its proprietary ThermoVax® technology, which stabilizes vaccines for long-term storage without refrigeration. This approach could be transformative in regions where maintaining cold-chain logistics is challenging.
The ongoing development of these vaccines is supported by funding from NIH, BARDA, and DTRA, with the potential for up to three priority review vouchers (“PRVs”) upon regulatory approval, to be used for future programs or sold. Notably, PRVs have previously sold for roughly $100 million.
Market Opportunity
Soligenix targets markets with significant commercial potential, focusing on rare diseases and biodefense applications. HyBryte™ addresses CTCL, a disease affecting over 68,000 patients across the U.S. and Europe, with a total market opportunity exceeding $250 million. SGX302, the company’s therapy for mild-to-moderate psoriasis, serves a much larger population, as over eight million people in the U.S. are affected by the condition, representing a global market opportunity exceeding $1 billion.
SGX942, developed for oral mucositis in head and neck cancer patients, is aimed at a market worth more than $500 million, while SGX945 for Behçet’s disease serves a niche segment valued at over $200 million worldwide.
In addition to its rare disease programs, Soligenix’s Public Health Solutions division has the potential to generate significant revenue through government procurement contracts. By focusing on both orphan drug markets and government-funded biodefense initiatives, Soligenix has positioned itself for sustained revenue growth through multiple high-value opportunities.
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.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at http://ibn.fm/SNGX
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