On March 31, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the year ended December 31, 2025.
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"We are entering a pivotal year with several high-impact clinical and regulatory milestones across our rare disease pipeline," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Key among these milestones is the interim analysis from the confirmatory Phase 3 FLASH2 (Fluorescent Light And Synthetic Hypericin 2) clinical trial of HyBryte (SGX301 or synthetic hypericin) for the treatment of early-stage cutaneous T-cell lymphoma (CTCL) slated for the second quarter and the release of top-line results from this trial expected in the second half of 2026. The overall blinded aggregate response rate in this trial remains consistent with what was previously reported and is higher than the estimated overall response rate used to design the study, increasing our confidence in the interim analysis and final study results. Additionally, we are advancing our inflammatory disease programs, with plans to initiate a placebo-controlled Phase 2 study of SGX945 (dusquetide) for Behçet’s Disease once formulation work for home-use administration is complete in the second half of 2026. We recently reported top-line results for the last cohort of four patients in the Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin), where SGX302 gel therapy demonstrated clincial benefit in improving psoriasis lesions and was well tolerated by all patients with no drug related adverse events identified."
Dr. Schaber continued, "Ending 2025 with approximately $7.9 million in cash, we remain focused on disciplined capital management to drive our strategic objectives. While our current cash balance provides operating runway into Q4 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."
Soligenix Recent Accomplishments
On March 26, 2026, the Company announced that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), granted orphan drug designation to dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet’s Disease. To view this press release, please click here.
On March 23, 2026, the Company announced that findings from recent supportive trials with HyBryte in the treatment of CTCL are being presented at the United States Cutaneous Lymphoma Consortium Workshop. To view this press release, please click here.
On March 19, 2026, the Company announced that a summary of clinical trials completed to date evaluating HyBryte as a treatment for CTCL has been published in the peer-reviewed medical journal Expert Opinion on Investigational Drugs. To view the publication, please click here. To view this press release, please click here.
On March 10, 2026, the Company announced that SGX945 has been granted Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of Behçet’s Disease. To view this press release, please click here.
On February 26, 2026, the Company announced that the EMA COMP provided a positive recommendation on the Company’s request for orphan drug designation for dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet’s Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease. To view this press release, please click here.
On February 12, 2026, the Company issued an update letter detailing recent progress and upcoming milestones. To view this press release, please click here.
On December 18, 2025, the Company announced that the results from its Phase 2a proof of concept study evaluating SGX945 in the treatment of Behçet’s Disease have been published in Rheumatology (Oxford), in an article entitled "Results from a Pilot Study of Dusquetide for the Treatment of Aphthous Ulcers Associated with Behçet Syndrome". To view this press release, please click here.
On December 17, 2025, the Company announced extended results of its ongoing Phase 2a trial of SGX302 for the treatment of mild-to-moderate psoriasis. To view this press release, please click here.
On November 19, 2025, the Company announced it had completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryte in the treatment of CTCL. To view this press release, please click here.
Financial Results – Quarter Ended December 31, 2025
Soligenix reported no revenues for the year ended December 31, 2025, compared to $0.1 million for the prior year. The decrease in revenues was primarily a result of the conclusion of the zero-margin grant for the HyBryte investigator-initiated study.
Soligenix’s net loss was $11.1 million, or ($2.14) per share, for the year ended December 31, 2025, compared to $8.3 million, or ($4.98) per share, for the prior year. The increase in net loss is primarily attributed to increases in research and development costs associated with the Phase 2 study in Behçet’s Disease, the ongoing second confirmatory Phase 3 CTCL study; a decrease in other income relating to tax credits; and the change in the fair value of debt.
Research and development expenses were $7.5 million as compared to $5.2 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily related to costs associated with the Phase 2 study in Behçet’s Disease and the ongoing second confirmatory Phase 3 CTCL study.
General and administrative expenses were $4.4 million and $4.2 million for the years ended December 31, 2025 and 2024, respectively. This increase is primarily attributable to increases in various taxes and stock related expenses offset by a decrease in professional fees.
As of December 31, 2025, the Company’s cash position was approximately $7.9 million.
(Press release, Soligenix, MAR 31, 2026, View Source [SID1234664085])