Soligenix Inc. (NASDAQ: SNGX) Strengthens Pipeline as European Commission Grants SGX945 Orphan Status

• Designations from established global organizations such as the European Commission carry meaningful implications for biotechnology companies.
• Soligenix announced that the European Commission granted orphan drug designation to SGX945 for the treatment of Behçet’s disease.
• SGX945 is based on dusquetide, a synthetic peptide belonging to a class of compounds known as innate defense regulators.

Recognition from global regulatory authorities can serve as a powerful validation of a therapy’s potential, particularly in the rare disease space where development challenges are significant and patient needs are urgent. Soligenix (NASDAQ: SNGX) has secured that type of validation, as the European Commission granted orphan drug designation to its investigational therapy SGX945 for the treatment of Behçet’s disease, reinforcing both the promise of the therapy and the company’s broader development strategy.

Designations from established global organizations such as the European Commission carry meaningful implications for biotechnology companies. Orphan drug designation in the European Union (“EU”) is specifically intended to encourage the development of treatments for rare diseases, which are defined as conditions affecting no more than five in 10,000 people in the EU. These designations provide important incentives, including protocol assistance, reduced regulatory fees and up to 10 years of market exclusivity following approval, all of which are designed to support the advancement of therapies that might otherwise face significant development barriers.

Such recognition also signals that a therapy addresses a condition with a high unmet medical need and demonstrates the potential to provide meaningful clinical benefit. The European Medicines Agency notes that orphan designation is granted when a product is intended to diagnose, prevent or treat a life-threatening or chronically debilitating condition and where existing treatment options are limited or inadequate. For companies such as Soligenix, this type of validation can help accelerate development, attract investment and enhance visibility within the global healthcare community.

The condition targeted by SGX945, Behçet’s disease, is a rare and chronic inflammatory disorder characterized by inflammation of blood vessels throughout the body. Behçet’s disease can cause recurring symptoms such as painful oral and genital ulcers, skin lesions and inflammation affecting multiple organ systems, and it may lead to serious complications depending on the organs involved. The disease is often relapsing in nature and can significantly impact quality of life, underscoring the need for effective and well-tolerated treatment options.

Against this backdrop, Soligenix announced that the European Commission, acting on a positive recommendation from the European Medicines Agency’s Committee for Orphan Medicinal Products, granted orphan drug designation to SGX945 (dusquetide) for the treatment of Behçet’s disease. This designation represents a key milestone in the development of the therapy and aligns with the company’s focus on addressing rare and difficult-to-treat conditions.

SGX945 is based on dusquetide, a synthetic peptide belonging to a class of compounds known as innate defense regulators. These molecules are designed to modulate the body’s immune response, promoting an anti-inflammatory and tissue-healing profile while enhancing the body’s ability to respond to infection. This mechanism represents a novel therapeutic approach for inflammatory and immune-mediated diseases, including Behçet’s Disease, where dysregulated immune activity plays a central role.

Orphan drug designation in the European Union provides a range of development and commercial advantages. These include eligibility for protocol assistance from the European Medicines Agency, access to centralized marketing authorization procedures and a 10-year period of market exclusivity upon approval, all of which are intended to support the successful development and commercialization of therapies for rare conditions.

In addition to its regulatory benefits, the designation reinforces the clinical rationale for SGX945. The therapy has demonstrated encouraging results in earlier studies, including improvements in oral ulcer outcomes among patients with Behçet’s disease and a favorable tolerability profile. These findings support continued development and suggest that the therapy may offer a meaningful alternative to existing treatment approaches.

The importance of SGX945 extends beyond a single indication. As part of Soligenix’s broader pipeline, the therapy reflects a platform-based approach that seeks to leverage scientific expertise across multiple programs targeting rare inflammatory and immune-related conditions. This strategy enables the company to pursue a range of therapeutic opportunities while maintaining a focused development framework.

The European Commission’s decision to grant orphan drug designation to SGX945 represents a meaningful step forward in that effort. By providing both regulatory support and commercial incentives, the designation helps position the therapy for continued advancement while highlighting its potential to address a significant unmet medical need. For patients living with Behçet’s Disease, where treatment options remain limited, such progress offers the possibility of improved outcomes and a better quality of life.

As Soligenix continues to advance its clinical programs, milestones such as this underscore the importance of collaboration between biotechnology innovators and global regulatory authorities. Together, these efforts play a critical role in bringing new therapies to patients with rare and challenging conditions, while reinforcing the value of scientific innovation in addressing unmet medical needs.

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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