Soligenix Inc. (NASDAQ: SNGX) Reports Strong Results in ‘Real-World’ Trial

• Recent data indicates Soligenix’s HyBryte(TM) is showing promising treatment success in early-stage cutaneous T-cell lymphoma.
• “With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments,” leading investigator states.
• No new FDA-approved, skin-directed therapies have been introduced in more than a decade, and conventional options carry risks.

Soligenix (NASDAQ: SNGX) is reporting encouraging interim outcomes from the ongoing investigator-initiated study (“IIS”) of its HyBryte(TM) (synthetic hypericin) program, under the direction of Ellen Kim, MD, director of the Penn Cutaneous Lymphoma Program. Kim is a leading enroller in Soligenix’s phase 3 FLASH study and serves as principal investigator for the confirmatory phase 3 FLASH2 trial, which recent data from the IIS indicates is delivering promising treatment success in early-stage cutaneous T-cell lymphoma (“CTCL”).

Soligenix and the Cutaneous Lymphoma Foundation recently released interim results from the open-label IIS evaluating extended HyBryte(TM) therapy administered twice weekly for up to 54 weeks in patients with early-stage mycosis fungoides (https://ibn.fm/IUoEe). At the 18-week evaluation point, six out of eight evaluable patients — 75% — achieved “treatment success,” defined as a ≥50% reduction in modified Composite Assessment of Index Lesion Severity (“mCAILS”) from baseline. This aligns with the efficacy observed in the phase 3 FLASH study, in which the response rate reached 49% (p < 0.0001 vs. placebo) after 18 weeks (https://ibn.fm/HfwFF).

Further highlighting the treatment’s speed and durability, four of the responding patients in the IIS continued on treatment through 54 weeks, achieving an average maximum mCAILS improvement of 85%, while three remained on therapy. The tolerability profile has been similarly strong: HyBryte(TM) is non-mutagenic, does not damage DNA and is not systemically absorbed; in addition, no serious adverse events or patient dropouts have been reported.

“The complete response rates observed, including three patients achieving a complete response on this study to date, as well as the consistent treatment response and safety profile across multiple HyBryte(TM) clinical studies, has been exciting to see,” said Kim. “In the first phase 3 FLASH study, HyBryte(TM) was shown to be efficacious with a benign safety profile compared to the current therapies of steroids, chemotherapeutics and ultraviolet light in this chronic orphan disease.

“With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments,” Kim continued. “In our study funded by the U.S. Food and Drug Administration (“FDA”), initial results evaluating the expanded use of HyBryte(TM) in a ‘real-world’ treatment setting remain very promising, further supporting and extending results from the previous positive phase 2 and 3 clinical trials. It also provides further confidence to the potential responses we can expect to see in the confirmatory phase 3 placebo-controlled FLASH2 study.”

The FLASH2 trial, a randomized, double-blind, placebo-controlled phase 3 study enrolling approximately 80 early-stage CTCL patients across the United States and Europe, began enrolling in December 2024. It extends treatment in a single continuous 18-week cycle, compared to the 6-week cycle in the original FLASH protocol, with primary efficacy assessed at week 18. Soligenix anticipates an interim analysis in early 2026.

The urgency for innovation in CTCL is clear: no new FDA-approved, skin-directed therapies have been introduced in more than a decade, and conventional options carry risks such as contact dermatitis, UV-induced skin damage and long-term carcinogenic potential (https://ibn.fm/05o9S). “CTCL patients are often searching for alternative treatment,” Kim noted. “HyBryte(TM) offers a distinct treatment option, which patients found extremely useful and continue to specifically request” (https://ibn.fm/XqgT0).

Soligenix anticipates submitting a New Drug Application (“NDA”) to the FDA following successful FLASH2 results. Kim’s leadership, combined with her pivotal role in both enrolment and oversight of these trials, positions HyBryte(TM) as a leading candidate in addressing a significant unmet need in early-stage CTCL. With FLASH2 well underway and key milestones expected in 2026, HyBryte(TM) may soon redefine treatment standards for mycosis fungoides, offering new hope to patients and investors alike.

For more information, visit www.Soligenix.com.

NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX

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