FAQ on Soligenix Inc.'s HyBryte(TM) and Its Phase 3 FLASH2 Study

What is HyBryte(TM) and what is it used for?

HyBryte(TM) is a novel photodynamic therapy developed by Soligenix Inc., designed to treat early-stage cutaneous T-cell lymphoma (CTCL) by using synthetic hypericin activated by safe visible light to target malignant T-cells with precision.

Why is the phase 3 FLASH2 study significant?

The phase 3 FLASH2 study is significant because it aims to replicate the success of a prior phase 3 trial, potentially meeting stringent regulatory requirements to make HyBryte(TM) a commercially available treatment for CTCL.

How does HyBryte(TM) compare to other treatments for CTCL?

HyBryte(TM) offers a noninvasive, well-tolerated alternative to traditional treatments, targeting malignant T-cells with precision, which could represent a game-changing approach for CTCL patients.

When is the interim analysis for the FLASH2 study expected?

The interim analysis for the FLASH2 study is expected in early 2026, with patient enrollment currently underway.

What other conditions could HyBryte(TM) potentially treat?

Beyond CTCL, HyBryte(TM) could potentially be applied to other dermatological and oncological conditions, showcasing the versatility of photodynamic therapy.

What is Soligenix Inc.’s broader strategy?

Soligenix Inc. focuses on developing and commercializing innovative therapeutic approaches to tackle rare and difficult-to-treat diseases, with HyBryte(TM) being a key part of this strategy.

Where can I find more information about Soligenix Inc. and HyBryte(TM)?

For more information, visit Soligenix’s website at www.Soligenix.com or the company’s newsroom at https://ibn.fm/SNGX.

What are the implications of HyBryte(TM) for patients with CTCL?

HyBryte(TM) could provide CTCL patients with a safer, more effective treatment option, improving quality of life and outcomes for those with this rare and difficult-to-treat disease.