Soligenix, Inc. issued a shareholder update letter detailing clinical progress across its pipeline, including the ongoing Phase 3 FLASH 2 trial for HyBryte™ and positive Phase 2a results for SGX945 and SGX302. The company reported having sufficient capital to meet goals through 2026 and continues to evaluate strategic options.
Key takeaways
The confirmatory Phase 3 FLASH 2 clinical trial for HyBryte™ has enrolled 66 patients as of February 10, 2026, with interim analysis expected in 2Q 2026.
Top-line results for the Phase 3 FLASH 2 trial are expected in the second half of 2026.
In an investigator-initiated study, 75% of evaluable patients achieved 'Treatment Success' following 18 weeks of HyBryte™ treatment.
The company reported approximately $10.5 million in cash as of September 30, 2025, providing sufficient capital through 2026.
The company expects peak annual net sales of HyBryte™ in the U.S. to exceed $90 million.
Soligenix continues to evaluate strategic options, including partnership and merger and acquisition opportunities.