Soligenix Inc. (NASDAQ: SNGX) Advances CTCL Research with Interim Analysis, Comparative Study Results

• Soligenix reports clinical update centered on cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin lymphoma that primarily affects the skin.
• The interim update highlighted that the overall blinded aggregate response rate observed in patients who have completed treatment remains consistent with prior reporting.
• In addition, the company reported positive results from a study evaluating HyBryte(TM) against Valchlor(R), an existing treatment option for cutaneous T-cell lymphoma.

Advancing clinical research while generating positive data is a critical combination in biotechnology, particularly when addressing diseases with limited treatment options. Soligenix (NASDAQ: SNGX) is demonstrating that momentum as it provides  both an encouraging clinical update from its phase 3 FLASH2 study and positive comparative clinical results for its HyBryte therapy, reinforcing the company’s focus on developing innovative treatments for serious conditions.

The research highlighted in these announcements centers on cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin lymphoma that primarily affects the skin. According to the National Cancer Institute, CTCL can cause persistent skin lesions, plaques and tumors, often leading to significant discomfort and reduced quality of life. The disease is typically chronic and may require long-term treatment, making the development of effective and well-tolerated therapies particularly important.

Treatment options for CTCL remain limited, especially in early-stage disease where therapies are often used off-label or associated with notable side effects. The American Cancer Society notes that treatments such as phototherapy, topical therapies and systemic approaches are commonly used to manage symptoms of CTCL, although their effectiveness can vary and may not provide durable responses for all patients. In addition, some of these therapies carry risks with prolonged use, including skin irritation, damage and an increased risk of secondary skin cancers, underscoring the need for safer and more targeted treatment options.

The burden of the disease extends beyond physical symptoms. Chronic skin involvement, visible lesions and recurring flares can have a meaningful impact on quality of life, affecting both physical comfort and emotional well-being. As a result, ongoing research into therapies that can provide sustained efficacy with improved tolerability is considered a priority within the oncology and dermatology communities.

Against this backdrop, Soligenix has reported progress across two recent developments involving HyBryte, its investigational photodynamic therapy for CTCL. The company is continuing its phase 3 FLASH2 clinical trial, with an interim analysis expected in the second quarter of 2026 and topline results anticipated in the second half of the year. This late-stage study is designed to further evaluate the safety and efficacy of HyBryte following earlier clinical success.

The clinical update also highlighted that the overall blinded aggregate response rate observed in patients who have completed treatment remains consistent with prior reporting at approximately 48%, compared to a 25% response rate used to design the study. This difference is significant because it suggests that the therapy may be performing above initial expectations; final conclusions will depend on the unblinded data and full study results.

In addition, Soligenix reported positive results from a comparative study evaluating HyBryte against Valchlor, an existing treatment option for CTCL. The study measured outcomes over a 12-week treatment period and focused on defined improvements in disease severity.

According to the reported data, 60% of patients treated with HyBryte achieved the defined level of treatment success, compared to 20% of patients treated with Valchlor. The average cumulative improvement in disease severity scores was 52.5% in the HyBryte group compared to 34.7% in the Valchlor group, indicating a potentially stronger treatment effect.

The safety profile observed in the study further differentiates the therapy. HyBryte was reported to be well tolerated among treated patients, while a portion of patients receiving Valchlor experienced treatment-related adverse events, including skin reactions such as dermatitis and sensitivity at the application site. These findings are important because tolerability is a key consideration in chronic conditions that require ongoing treatment.

HyBryte is based on a photodynamic therapy approach that combines a light-activated compound with controlled exposure to visible light. This mechanism allows for targeted treatment of affected skin areas while minimizing systemic exposure, which may contribute to its favorable safety profile.

Together, the Phase 3 clinical update and comparative study results provide a clearer picture of HyBryte’s potential role in the treatment landscape for CTCL. The combination of encouraging efficacy signals and a favorable tolerability profile suggests that the therapy could address some of the limitations associated with existing treatments, particularly if these findings are confirmed in larger studies.

As Soligenix continues to advance its clinical programs, the data emerging from these studies highlight the importance of sustained research and innovation in rare and challenging diseases. With additional clinical milestones expected in 2026, the company’s progress reflects both the complexity of drug development and the potential impact of new therapeutic approaches on patient care.

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://nnw.fm/SNGX

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