Upcoming high-impact milestones include interim analysis in Q2 2026
and top-line results in H2 2026 from HyBryte trial
PRINCETON, N.J., March 31, 2026 /PRNewswire/ -- 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, announced today its recent accomplishments and financial results for the year ended December 31, 2025.
"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.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease.
Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.
This press release may contain forward-looking statements that reflect Soligenix's current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations, clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the first HyBryte (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma or any other studies (including the open-label, investigator-initiated study) and the overall blinded aggregate response rate observed in the second HyBryte (SGX301) Phase 3 clinical trial, there can be no assurance that the second HyBryte (SGX301) Phase 3 clinical trial will be successful or that a marketing authorization from the FDA or EMA will be granted. Additionally, although the EMA has agreed to the key design components of the second HyBryte (SGX301) Phase 3 clinical trial, no assurance can be given that the Company will be able to modify the development path to adequately address the FDA's concerns or that the FDA will not require a longer duration comparative study. Notwithstanding the result in the first HyBryte (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Additionally, despite the biologic activity observed in aphthous ulcers induced by chemotherapy and radiation, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
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