Soligenix announced that it has reached the 50‑patient enrollment threshold in its 80‑patient, randomized, double‑blind, placebo‑controlled Phase 3 FLASH 2 study of HyBryte, a synthetic hypericin photodynamic therapy for cutaneous T‑cell lymphoma (CTCL). The milestone positions the company to conduct a pre‑specified blinded interim efficacy analysis in the first half of 2026, a key step toward regulatory submission.
The confirmatory FLASH 2 trial builds on the positive results of the earlier Phase 3 FLASH study, which demonstrated a statistically significant response after six weeks of treatment and increasing response rates at 12 and 18 weeks. FLASH 2 extends the treatment period to 18 weeks of continuous therapy, allowing a more robust assessment of durability and safety in a larger patient cohort.
Financially, Soligenix reported a net loss of $2.5 million ($0.58 per share) for the quarter ended September 30 2025, compared with a $1.7 million loss ($0.78 per share) in the same quarter of 2024. The company generated no revenue in either quarter but maintained approximately $10.5 million in cash, which management states provides sufficient operating runway through 2026 while it pursues strategic financing or partnership opportunities.
The CTCL market represents a substantial unmet need, with a global therapeutic market estimated at $995 million in 2024. HyBryte’s unique mechanism—activating synthetic hypericin with visible light to target malignant T‑cells without DNA damage—offers a potentially safer profile than existing therapies. The drug has received orphan drug and fast‑track designations from the FDA, positioning it for expedited review and market exclusivity if approved.
CEO Christopher J. Schaber emphasized that the enrollment pace is on track and that the interim analysis will provide early insight into HyBryte’s efficacy and safety. He also highlighted the company’s focus on allocating resources to hit strategic milestones and evaluating partnership or financing options to support the pipeline.
The 50‑patient milestone de‑risks the HyBryte program, strengthens Soligenix’s rare‑oncology portfolio, and brings the company closer to a potential regulatory submission. With a clear interim analysis schedule, a solid cash position, and a sizable market opportunity, Soligenix is positioned to advance HyBryte toward commercialization if the confirmatory data confirm the earlier positive signals.
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