aibioSoligenix FLASH 2 trial recommended to halt for futility
Tickers SNGX
After an interim efficacy analysis, the Data Monitoring Committee recommended stopping the Phase 3 HyBryte trial for futility, and Soligenix says it has approximately $5.9 million of cash.
Key facts
- Company
- Soligenix, Inc. (NASDAQ: SNGX)
- News type
- Company Updates
- Primary source
- Soligenix, Inc. 8-K (2026-04-28)
Soligenix, Inc. said on April 28, 2026 that the Data Monitoring Committee completed the interim efficacy analysis of its pivotal Phase 3 FLASH 2 trial of HyBryte, synthetic hypericin, in cutaneous T-cell lymphoma, and recommended that the study halt for futility. The company announced the outcome in a press release furnished with a Form 8-K. The company also said it has approximately $5.9 million of cash.
Christopher J. Schaber, PhD, President and Chief Executive Officer, said in the release: "We are obviously very disappointed with the unanticipated outcome of the study." He added that although HyBryte showed statistically significant reductions in CTCL lesions after six weeks of treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in FLASH 2.
What the company said it will do
Schaber said the company will analyze the data over the coming weeks to understand why the study did not meet expectations. If that work produces clarity, especially on subsets of patients who may benefit, the company intends to communicate its findings and explore follow-up discussions with the European Medicines Agency and the U.S. Food and Drug Administration.
The release says the company will assess potential next steps, if any, for HyBryte and will evaluate all strategic options, including merger and acquisition opportunities, as well as advancing dusquetide for Behcet's Disease, which the company says showed promising biological efficacy in a Phase 2 study last year using the intravenous formulation. The release notes that dusquetide has received orphan drug designation most recently from the EMA.
The trial design
The release describes the FLASH 2 trial as a randomized, double-blind, placebo-controlled, multicenter study. It replicates the design of the first FLASH study but extends the double-blind assessment to 18 weeks of continuous treatment, with the primary endpoint assessed at 18 weeks. The company says the trial had a good safety profile in pre-specified safety evaluations by the Data Monitoring Committee.
The release recaps the first FLASH trial, which enrolled 169 patients, 166 of them evaluable, with Stage IA, IB or IIA CTCL. In the first double-blind cycle, 16% of patients receiving HyBryte achieved at least a 50% reduction in their lesions at eight weeks, compared with 4% in the placebo group. The company describes this as the primary endpoint of that study.
What the company does
In its annual report on Form 10-K filed March 31, 2026, Soligenix describes itself as a late-stage biopharmaceutical company focused on rare diseases. It has two segments. The Specialized BioTherapeutics segment includes HyBryte, a photodynamic therapy, and dusquetide, an Innate Defense Regulator technology. The Public Health Solutions segment includes RiVax, a ricin toxin vaccine candidate, and vaccine programs against filoviruses and COVID-19.
Before the April 28 release, the annual report said the company anticipated top-line FLASH 2 results in the second half of 2026. The annual report also lists a planned Phase 2a trial of synthetic hypericin in psoriasis.
Financial position
The company's reported figures show research and development expense of $7.5 million for the fiscal year ended December 31, 2025, compared with $5.2 million for 2024. The net loss was $11.1 million for 2025 and $8.3 million for 2024. Cash from operations was negative $10.3 million for 2025 and negative $8.4 million for 2024. Revenue was $119,371 for 2024. These figures come from the annual report filed March 31, 2026.
What comes next
The release says the FDA and the EMA had indicated they would require a second successful Phase 3 trial to support marketing approval, and that trial was recommended to halt for futility. The release gives no p-values or response rates for FLASH 2. The 16% versus 4% result in the first study, at a p-value of 0.04, is the only controlled efficacy figure it offers.
The company's roughly $5.9 million of cash compares with negative $10.3 million of cash from operations for 2025. The release gives no date for the results of the strategic review.