Soligenix (NASDAQ: SNGX) Positioning for Impact in Growing Rare-Disease Landscape

• The World Health Organization’s recent recognition of rare diseases as a global health priority underscores their collective impact.
• Soligenix remains focused on delivering meaningful progress in rare disease-based therapeutics and public health.
• In its Specialized Biotherapeutics segment, Soligenix is advancing candidates designed for orphan diseases and other serious conditions where treatment options are limited.

As the global burden of rare diseases continues to rise, there is increasing urgency for innovative therapies that address unmet medical needs. More than 300 million people worldwide live with one or more rare diseases, many of which have limited or no approved treatment options, and diagnostic delays can persist for years, prolonging suffering and reducing quality of life. Amid this growing demand, Soligenix (NASDAQ: SNGX) is advancing a diversified pipeline of specialized biotherapeutics and public health solutions targeting rare and orphan conditions as it heads into 2026. 

Rare diseases collectively affect a substantial share of the global population. Although each individual rare disease may impact a small number of people, the World Health Organization’s recent recognition of rare diseases as a global health priority underscores their collective impact, noting that more than 300 million people worldwide live with one of more than 7,000 rare conditions. These diseases are often chronic, debilitating and life threatening, and many have no effective therapies. Patients may experience long diagnostic journeys, on average six to eight years, before receiving a definitive diagnosis, and even then fewer than 10% of rare diseases have an FDA-approved treatment. 

In the United States, an estimated one in 10 households is affected by a rare disease or undiagnosed illness, reflecting both the prevalence and the challenges these conditions pose for healthcare systems and families. The combination of diagnostic complexity, limited treatment options and substantial symptom burden drives a compelling need for expanded research, innovation and regulatory focus in rare disease drug development. Initiatives such as the World Health Assembly’s first-ever resolution on rare diseases in 2025, calling for a global action plan to improve diagnosis, care and treatment access, further highlight this imperative. 

With this in mind, Soligenix remains focused on delivering meaningful progress in rare disease-based therapeutics and public health. The company’s mission is centered on developing and commercializing products to treat rare diseases where there is an unmet medical need, reflecting decades of leadership experience and specialized expertise in this space. Its pipeline is organized around two key business segments: Specialized Biotherapeutics and Public Health Solutions, each addressing distinct but complementary aspects of rare and orphan disease care. 

In its Specialized Biotherapeutics segment, Soligenix is advancing candidates designed for orphan diseases and other serious conditions where treatment options are limited. A core focus is HyBryte(TM), also known as SGX301 or synthetic hypericin, a novel photodynamic therapy being developed for cutaneous T-cell lymphoma (“CTCL”). This therapy uses visible-light activation to target malignant skin cells while aiming to minimize long-term phototoxic risks associated with ultraviolet light therapies. HyBryte has received orphan drug and fast track designations in the United States, orphan drug designation in Europe and a Promising Innovative Medicine designation from the UK Health Authority, reflecting regulatory recognition of its potential significance for a rare cancer with limited treatment alternatives. 

Beyond CTCL, the Specialized Biotherapeutics segment includes programs such as SGX302 (synthetic hypericin) for mild-to-moderate psoriasis, SGX942 for oral mucositis and SGX945 for the treatment of Behçet’s disease. In July 2025, Soligenix announced the successful transfer of synthetic hypericin manufacturing to its partner Sterling Pharma Solutions, a step that supports scaling production for multiple clinical programs. These development efforts demonstrate the breadth of Soligenix’s approach to addressing conditions that disproportionately affect small patient populations yet represent significant unmet medical needs.

Complementing its specialized therapeutics efforts is Soligenix’s Public Health Solutions segment, which is developing vaccines and treatments with potential applications for both rare disease impacts and broader health threats. This segment includes RiVax(R), a ricin toxin vaccine candidate; ThermoVax(R), a proprietary platform for heat-stable vaccines that may overcome cold-chain limitations in vaccine deployment; and other programs targeting filoviruses such as Ebola and Marburg, as well as COVID-19 vaccine candidates. Soligenix’s proprietary ThermoVax technology underpins many of these programs, with potential to enhance global vaccine stability and distribution. 

The Public Health Solutions pipeline illustrates how rare disease innovation intersects with biodefense and infectious disease preparedness. For example, RiVax seeks to prevent ricin poisoning, a rare but potentially catastrophic threat, and has progressed through early clinical stages. The ability to combine rare disease-oriented biologics with broader public health applications reflects Soligenix’s strategic positioning at the intersection of niche therapeutic needs and global health security challenges. 

As Soligenix moves into 2026, its portfolio of clinical candidates and technology platforms positions the company to address gaps in rare disease treatment while advancing solutions with wider societal relevance. With key programs progressing through clinical milestones, including ongoing phase 3 evaluation of HyBryte for CTCL and advanced vaccine development leveraging ThermoVax, the company is advancing toward potential regulatory and commercial inflection points. Recent corporate updates also highlight near-term catalytic milestones across the rare disease pipeline with the potential for significant global annual sales, underscoring investor interest in the company’s progress. 

The landscape for rare disease research and treatment continues to evolve, driven by scientific innovation, regulatory engagement and increased awareness of the collective impact of rare conditions. Soligenix’s focused approach, including spanning specialized rare disease therapeutics and public health solutions, reflects the complexity of this challenge and the need for diverse strategies to improve outcomes for patients with limited treatment options. As global rare-disease recognition grows and treatment gaps remain pronounced, companies such as Soligenix are stepping into roles that may shape future standards of care and public health preparedness.

For more information, visit www.Soligenix.com.

NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://nnw.fm/SNGX

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