• CEO reports confidence about late-stage rare disease pipeline and upcoming key development milestones.
• Soligenix’s recent accomplishments reflect substantial momentum across its specialized biotherapeutics and public health solutions business segments.
• The company’s pipeline diversification strategy extends beyond CTCL treatment to encompass multiple therapeutic areas.

With pivotal phase 3 cancer trial results due in 2026 and multiple fast-tracked therapies advancing through late-stage development, Soligenix (NASDAQ: SNGX) stands at the threshold of potentially transforming treatment paradigms for rare diseases affecting millions of underserved patients worldwide. The Soligenix pipeline includes a novel photodynamic drug therapy, along with other innovative drug and vaccine technology, to tackle medical challenges where conventional treatments have failed to deliver meaningful solutions, recently reported on its progress so far this year (https://ibn.fm/1dhGj).

“As we quickly approach the latter part of 2025 into 2026, the company remains confident about its late-stage rare disease pipeline and upcoming key development milestones,” said Soligenix CEO and president Christopher J. Schaber in the update. “These include top-line results from our phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) before year end, as well as continued clinical update for the ongoing investigator-initiated study (‘IIS’) evaluating extended HyBryte(TM) (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (‘CTCL’).

“Further, we anticipate top-line results in 2026 from our actively enrolling confirmatory phase 3 study of HyBryte for early-stage CTCL, where we plan to provide an enrollment update later this year,” Schaber continued. “Recently, we were also pleased to announce the successful completion of our phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet’s disease, having achieved the study objective of demonstrating biological efficacy in this difficult to treat chronic disease.”

The company’s recent accomplishments reflect substantial momentum across its specialized biotherapeutics segment, positioning Soligenix at a critical inflection point in its development trajectory. The most significant advancement centers on the company’s flagship HyBryte (“SGX301” or synthetic hypericin sodium) program, which represents a novel photodynamic therapy utilizing safe visible light for the treatment of CTCL. This innovative approach addresses a significant unmet medical need in oncology, where traditional treatment options remain limited and often associated with substantial side effects.

The clinical promise of HyBryte extends beyond initial efficacy data to encompass sustained therapeutic benefits that distinguish it from existing treatment options. Analysis of post-treatment data from the open-label study comparing HyBryte to Valchlor(R) (mechlorethamine) demonstrated continued improvement in HyBryte-treated patients and their individual lesions even after stopping treatment. This durability of response represents a significant clinical advantage, potentially reducing treatment burden and improving quality of life for patients with this challenging condition.

Soligenix’s commitment to comprehensive clinical development is further demonstrated through the formation of a European Medical Advisory Board in November 2024 (https://ibn.fm/yzssW). This strategic initiative provides additional medical and clinical guidance as the company advances its confirmatory phase 3 multicenter, double-blind, placebo-controlled study. The international expertise represented by this advisory board reflects the global commercial potential of HyBryte and the company’s intention to pursue regulatory approvals across multiple jurisdictions.

The company’s pipeline diversification strategy extends beyond CTCL treatment to encompass multiple therapeutic areas through its synthetic hypericin technology platform. The expansion of synthetic hypericin (“SGX302”) into psoriasis treatment represents a significant market opportunity, with mild-to-moderate psoriasis affecting millions of patients worldwide (https://ibn.fm/qruXo). The ongoing phase 2 study in this indication, with top-line results anticipated in the second half of 2025, could unlock substantial additional commercial potential for the synthetic hypericin platform.

The financial foundation supporting these clinical initiatives reflects disciplined capital allocation while maintaining sufficient runway for critical development milestones. With approximately $6.5 million in cash as of July 1, 2025, the company has secured operating runway through the first quarter of 2026, enabling completion of several pivotal clinical milestones without immediate financing pressure. This financial position provides strategic flexibility as the company evaluates partnership opportunities, merger and acquisition possibilities, government grants, and potential financing options to advance its late-stage pipeline.

The company’s revenue structure reflects its dual business model, combining clinical development activities with government-funded programs supporting national biodefense initiatives. While revenues decreased to $0.1 million for 2024 compared to $0.8 million in the prior year, this fluctuation primarily reflects the timing of government grant funding rather than fundamental program changes. The company continues to receive government funding for its public health solutions segment, which includes vaccine development programs targeting critical national security threats.

Research and development expenses increased to $5.2 million in 2024 compared to $3.3 million in the prior year, reflecting the company’s commitment to advancing multiple clinical programs simultaneously. The increase primarily related to preliminary costs associated with the Behçet’s Disease Phase 2 study initiation and the second confirmatory Phase 3 CTCL trial, demonstrating active progress across the development pipeline.

The strategic positioning of Soligenix’s pipeline addresses multiple high-value therapeutic areas with significant unmet medical need. The combination of novel photodynamic therapy technology, innovative vaccine platforms, and first-in-class inflammatory disease treatments creates a diversified portfolio with multiple paths to commercial success and substantial value creation potential.

Looking ahead, the company anticipates several critical inflection points that could significantly impact valuation and strategic positioning. The expected top-line results from multiple phase 2 studies in the second half of 2025, combined with ongoing phase 3 CTCL trial progress toward 2026 readout, provide multiple near-term catalysts for value creation and potential partnership opportunities.

For investors and stakeholders seeking exposure to innovative rare disease therapeutics with significant commercial potential, Soligenix’s current positioning represents a compelling opportunity at a critical development inflection point, supported by a diversified pipeline addressing multiple high-value therapeutic areas.

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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