Soligenix Inc. (NASDAQ: SNGX) Showcases Expanding Rare Disease, Public Health Pipeline in Latest Corporate Presentation

• At its core, Soligenix is a late-stage biopharmaceutical company that thrives at the intersection of urgent medical need and scientific innovation.
• SNGX’s Specialized BioTherapeutics division is anchored by its proprietary HyBryte(TM) (“SGX301”), a novel photodynamic therapy for CTCL.
• Soligenix’s Public Health Solutions division positions the company as an important contributor to biodefense and emerging infectious disease.

Soligenix (NASDAQ: SNGX) has taken a bold step forward with its latest corporate presentation, offering investors and the broader biotech community a deeper look into the company’s evolving strategy and pipeline (https://ibn.fm/YGu4N). The presentation underscores Soligenix’s dual focus: pioneering therapies for rare diseases that lack adequate treatment options while simultaneously developing critical vaccines and countermeasures for emerging infectious threats and bioterrorism risks. This combination sets the company apart as both a champion for underserved patient populations and a strategic partner in global public health preparedness.

At its core, Soligenix is a late-stage biopharmaceutical company that thrives at the intersection of urgent medical need and scientific innovation. The latest presentation highlights the company’s progress across two key business segments: Specialized BioTherapeutics, which is focused on orphan diseases and dermatological conditions, and Public Health Solutions, which develops heat-stable vaccines for high-consequence pathogens. This dual-track approach is more than just diversification—it represents a deliberate strategy to address areas where human and societal stakes are high.

The Specialized BioTherapeutics division is anchored by the company’s proprietary HyBryte(TM) (“SGX301”), a novel photodynamic therapy for cutaneous T-cell lymphoma (“CTCL”). In its first phase 3 clinical trial, HyBryte produced statistically significant results, marking the first therapy of its kind to reach this stage. A second confirmatory phase 3 trial is actively enrolling to support potential worldwide marketing approvals, reinforcing the company’s commitment to bringing HyBryte to market with robust data. With the European Medicines Agency (“EMA”) already agreeing to Soligenix’s proposed regulatory package and U.S. Food and Drug Admission (“FDA”) discussions ongoing, HyBryte is positioned to potentially become the first approved therapy in its class (https://ibn.fm/gIaZ3). Its commercial potential is substantial, given that CTCL patients face limited options and a high unmet need. 

Building on this, Soligenix is also advancing SGX302 for psoriasis, a therapy that leverages the same innovative mechanism but applies it to a vastly larger market estimated at more than $27 billion globally (https://ibn.fm/EXkZF). Early clinical data have been encouraging, and the company is advancing a phase 2a study to further validate the therapy’s promise. In addition, the company is making headway with SGX945 (dusquetide), a novel innate defense regulator targeting oral ulcers in Behçet’s disease, a rare but debilitating autoimmune condition. The FDA recently granted orphan drug designation for SGX945 following positive phase 2a results, further solidifying the drug’s potential as a first-in-class treatment option for patients who currently have limited alternatives (https://ibn.fm/AgdPg).

While these rare disease programs could drive near-term commercial success, Soligenix’s Public Health Solutions division positions the company as an important contributor to public health. Here, the company is advancing RiVax(R), a ricin toxin vaccine candidate that has received both FDA orphan drug and fast track designations. Ricin remains one of the most lethal bioterror threats, and RiVax’s development to date has been heavily supported by U.S. government contracts, reflecting both its scientific merit and strategic necessity. 

Complementing RiVax are vaccine programs targeting filoviruses such as Ebola, Marburg and  COVID-19. All of these utilize Soligenix’s proprietary ThermoVax(R) technology, which enables heat-stable vaccines, an innovation that could dramatically reduce cold-chain distribution challenges in both emergency and routine immunization campaigns.

The Soligenix presentation doesn’t shy away from the broader industry context. Between 2018 and 2024, the global digital and biotech markets surged, with funding for innovative therapies and health security reaching new heights. For Soligenix, this environment provides both opportunities and challenges: Competition in the biotech space is intense, but its niche focus on rare diseases and public health solutions gives it a defensible position that few peers can claim. In fact, the company estimates the combined annual market potential for its current pipeline to be around $2 billion, underscoring the commercial upside if even a fraction of its therapies achieve regulatory approval.

What makes Soligenix particularly compelling is not just the breadth of its science but the consistency of its execution. Orphan and rare disease programs often require navigating complex regulatory frameworks and working closely with patient advocacy groups. Meanwhile, public health initiatives depend on sustained government support, long-term funding and alignment with national security priorities. The presentation makes clear that Soligenix has been able to advance on both fronts, maintaining momentum in its late-stage rare disease trials while having secured nondilutive government funding to advance its vaccine platforms.

In sum, Soligenix’s latest corporate presentation paints a portrait of a company that is steadily building value at the intersection of science, medicine and global health and security. From its innovative dermatology pipeline to its pioneering vaccines, Soligenix is moving closer to the pivotal moment when science translates into real-world solutions. For patients facing rare diseases and for societies confronting public health threats, the company’s progress offers a much-needed source of optimism, and for investors, the presentation presents a clear view of a biotech firm charting a distinct and potentially transformative path.

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://ibn.fm/SNGX

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