Soligenix posts $11.1M net loss, Q2 2026 interim Phase 3 analysis planned
Soligenix reported a net loss of $11.1 million for 2025 and ended the year with $7.9 million in cash, providing operating runway into Q4 2026. The company expects interim Phase 3 FLASH2 analysis of HyBryte™ in early-stage CTCL in Q2 2026 and top-line results in H2 2026.
1. Financial Overview
Soligenix reported no revenues for 2025 and a net loss of $11.1 million, compared to an $8.3 million loss the prior year. Research and development expenses rose to $7.5 million driven by its Behçet’s Disease and CTCL programs, while general and administrative costs totaled $4.4 million.
2. Upcoming Clinical Milestones
The company plans an interim analysis from its Phase 3 FLASH2 trial of HyBryte™ in early-stage CTCL in Q2 2026, followed by top-line results in H2 2026. It also aims to initiate a placebo-controlled Phase 2 study of SGX945 for Behçet’s Disease in the second half of 2026 upon completion of home-use formulation.
3. Regulatory Designations and Pipeline
Soligenix secured orphan drug designation for SGX945 in Behçet’s Disease from the European Commission and Promising Innovative Medicine status in the UK. Recent supportive data presentations and publications indicate response rates exceeding trial design estimates, reinforcing confidence ahead of pivotal readouts.