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Soligenix Highlights Year-End 2025 Financial Results and Strategic Milestones Ahead

On March 31, 2026, Soligenix, Inc., a biopharmaceutical company listed on Nasdaq under the ticker SNGX, announced its recent accomplishments along with its financial results for the year ending December 31, 2025. This report signifies a crucial period for the company as it steers through an impactful year marked by key clinical and regulatory milestones across its pipeline focusing on rare diseases.

Christopher J. Schaber, PhD, President and CEO of Soligenix, stated, "We are entering a pivotal year with several high-impact clinical and regulatory milestones across our rare disease pipeline." He emphasized the imminent interim analysis from its pivotal Phase 3 FLASH2 trial for HyBryte™ (SGX301 or synthetic hypericin), which targets early-stage cutaneous T-cell lymphoma (CTCL), expected in Q2 2026. Notably, the top-line results from this trial are anticipated in the latter half of 2026.

The company's optimism is buoyed by consistently favorable aggregate response rates observed in the trial, which strengthen confidence leading into interim analysis and eventual study conclusions. Furthermore, Soligenix is advancing its programs aimed at inflammatory diseases, highlighting plans to initiate a Phase 2 study of SGX945 (dusquetide) for Behçet's disease once formulation work for home-use administration is finalized.

Recently, therapeutic SGX302 (also utilizing synthetic hypericin) demonstrated promising results in its Phase 2a study targeting mild-to-moderate psoriasis, with all participants reporting clinical benefits and no drug-related adverse effects.

Breakdown of Recent Accomplishments

A series of significant achievements were reported by Soligenix in the past months leading up to the year-end results:

• - On March 26, 2026, the European Commission granted orphan drug designation to SGX945 for Behçet's disease based on a positive recommendation from the EMA, opening new avenues for potentially crucial support in development.
• - Presentations showcasing recent trial findings on HyBryte™ in the treatment of CTCL have made waves at influential medical workshops, enhancing visibility for the promising treatment options.
• - Research published in the peer-reviewed journal, Expert Opinion on Investigational Drugs, sheds light on HyBryte™'s clinical trial results, marking an essential step in validation from the broader scientific community.
• - SGX945 received Promising Innovative Medicine designation in the UK, emphasizing its potential impact.

The company is very aware of its cash reserves, ending 2025 with approximately $7.9 million. "While our current cash balance provides operating runway into Q4 2026, we are actively considering various strategic pathways, including partnerships, mergers and acquisitions, government grants, and financing opportunities to enhance our late-stage pipeline," Schaber explained.

Financially, Soligenix reported no revenues for 2025, a decrease attributed to the end of a zero-margin grant linked to HyBryte™. The company faced a net loss of $11.1 million for the year, up from $8.3 million in 2024, with increased expenses associated with ongoing research and development activities in both Behçet's disease and CTCL studies. Specifically, research and development costs surged to $7.5 million, reflecting a surge in Phase 2 and Phase 3 studies.

Despite these financial challenges, Soligenix is showing relentless vigilance in managing its resources while remaining devoted to progressing in the competitive landscape of biopharmaceuticals focused on rare diseases. With numerous regulatory interactions and upcoming trial results on the horizon, eyes will remain keenly fixed on Soligenix as it navigates its ambitious goals in the coming months.

About Soligenix, Inc.

Soligenix, Inc. is a biopharmaceutical company specializing in the development and commercialization of products aimed at treating rare diseases with unmet medical needs. The company’s endeavors extend into crucial medical fields, with cutting-edge biotherapeutics in both oncology and public health sectors. For more information, visit Soligenix's website.