Soligenix Reports Q3 2025 Financial Results and Major Developments in Clinical Trials

Soligenix’s Recent Progress and Financial Overview

Soligenix, Inc. (Nasdaq: SNGX) is a biopharmaceutical company that is dedicated to developing treatments for rare diseases with unmet medical needs. As of November 7, 2025, the company shared significant achievements and financial results for the third quarter of 2025, emphasizing their focus on ongoing clinical trials and strategic goals.

Highlights from Recent Accomplishments

In their recent update, Soligenix expressed optimism about multiple milestones slated for completion before the end of the year. These include the anticipated top-line results of their Phase 2a clinical trial for mild-to-moderate psoriasis using SGX302 (synthetic hypericin) and enrollment updates for the confirmatory Phase 3 study of HyBryte™ (synthetic hypericin) targeting cutaneous T-cell lymphoma (CTCL).

Christopher J. Schaber, PhD, the President and CEO of Soligenix, conveyed satisfaction regarding the conclusion of the first Data Monitoring Committee (DMC) meeting for HyBryte™, reporting no safety concerns and affirming the therapy's acceptable safety profile, consistent with previous studies. Looking ahead, he confirmed that enrollment for the Phase 3 study is on track and expects top-line results to be released in the second half of 2026.

Among the notable accomplishments in the past quarter:
1. Medical Advisory Board Updates: On October 14, 2025, the company updated its U.S. Medical Advisory Board for CTCL to ensure targeted guidance as it progresses in the clinical development of HyBryte™.

2. DMC Meeting Outcomes: Announced on October 7, 2025, the DMC meeting for the Phase 3 study confirmed the therapeutic's safety, paving the way for further clinical advancement.

3. European Advisory Board Expansion: On September 30, the company expanded its European advisory board for enhanced strategic direction in advancing HyBryte™ studies.

4. Public Offering Completion: Soligenix completed a public offering on September 29, 2025, involving both existing and new healthcare-focused institutional investors.

5. Strategic Advisor Appointment: On September 23, 2025, Tomas J. Philipson, PhD was appointed as a Strategic Advisor. His extensive government relationships, especially with the FDA, promise valuable insights for the company.

6. Ebola Vaccine Progress: The company published results related to the extended stability of their Ebola vaccine using the ThermoVax® platform on September 4, 2025.

7. Orphan Drug Designation: Dusquetide, an active ingredient in SGX945, received orphan drug designation from the FDA for Behçet's Disease treatment following positive Phase 2a results.

Financial Performance Overview

Financially, Soligenix reported no revenue for the third quarter of 2025 or 2024. A net loss of $2.5 million, equating to ($0.58) per share, was recorded, which marks an increase from a $1.7 million loss ($0.78 per share) in the same quarter of the previous year. This increase is attributed chiefly to higher operating expenses tied to clinical trials and a reduction in interest income combined with the absence of an employee retention credit that was available in the preceding year.

Research and development expenses rose to $1.6 million from $1.0 million in the same period last year, largely due to expenses related to the Phase 3 CTCL trial and heightened contract manufacturing costs. Administrative costs amounted to $1.0 million, slightly up from $0.9 million in 2024, primarily due to professional service expense increases.

As of September 30, 2025, the company reported having approximately $10.5 million on hand, highlighted by a careful strategy to optimize this resource for supporting upcoming objectives and milestones through 2026.

Future Outlook

Soligenix is concentrated on navigating its strategic pathways, including the exploration of partnerships, potential mergers or acquisitions, and government grants to bolstered capabilities for advancing its clinical pipeline. As they gear up for crucial upcoming results and developments, the biopharmaceutical landscape is undoubtedly poised for further advancements in innovative treatments for rare diseases. For more information about Soligenix, you can visit their official website or follow them on LinkedIn and Twitter.