Soligenix Inc. (NASDAQ: SNGX) Advances Phase 3 Replication Study for Early-Stage Cutaneous T-Cell Lymphoma Treatment

• Soligenix is enrolling patients in its FLASH2 study, with a formal interim analysis anticipated early in 2026.
• SNGX’s HyBryte is a novel photodynamic therapy using synthetic hypericin activated by safe visible light.
• The ongoing phase 3 replication study meets stringent requirements of regulatory agencies to strengthen the case for HyBryte as a commercially available treatment.

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company specializing in the development and commercialization of treatments for rare diseases and unmet medical needs, is making significant strides in its efforts to bring innovative therapies to patients with early-stage cutaneous T-cell lymphoma (“CTCL”). The company’s lead candidate, HyBryte(TM) (“SGX301”), has already demonstrated positive results in a prior phase 3 trial, and Soligenix is now conducting a phase 3 replication study to further validate its efficacy and safety (https://ibn.fm/zdRnQ). This development marks an important milestone in the company’s mission to address an urgent medical need in a condition with limited treatment options.

“We are pleased to be initiating patient enrollment into our FLASH2 study,” said Soligenix president and CEO Christopher J. Schaber (https://ibn.fm/LjfXu). “FLASH2 is expected to enroll patients in the United States and Europe, with a formal interim analysis anticipated early in 2026. Given the extensive engagement with the CTCL community, the esteemed Medical Advisory Boards in the U.S. and Europe, key patient advocacy groups like the Cutaneous Lymphoma Foundation, as well as our previous trial experience with this disease, accelerated enrollment in support of this study is anticipated. We look forward to providing periodic updates on the trial’s progress in 2025.”

CTCL is a rare and chronic form of non-Hodgkin’s lymphoma that primarily affects the skin, leading to symptoms such as red, scaly patches, growths and severe itching (https://ibn.fm/JXiDN). Patients with early-stage CTCL often struggle to find effective treatments that are both safe and well-tolerated over long periods. Current treatment options include corticosteroids, phototherapy and chemotherapy. These treatments often come with limitations, such as toxicity, inconsistent responses and adverse side effects.

HyBryte(TM) is a novel photodynamic therapy using synthetic hypericin activated by safe visible light. This revolutionary treatment offers a potentially game-changing approach by providing a noninvasive, well-tolerated alternative that targets malignant T-cells with precision.

The initial phase 3 trial (“FLASH”) of HyBryte(TM) showed strong efficacy, demonstrating a statistically significant response in patients compared to placebo. The study results indicated that HyBryte(TM) was not only effective in reducing lesion size and severity but also presented a favorable safety profile, making it a compelling option for long-term disease management. The positive data from this initial trial has led Soligenix to move forward with the FLASH2 replication study, which aims to confirm the results in a larger patient population and further establish HyBryte(TM) as a viable front-line treatment for early-stage CTCL.

The ongoing phase 3 replication study is designed to potentially meet the stringent requirements of regulatory agencies, in order to strengthen the case for HyBryte(TM) as a commercially available treatment. If successful, this study could pave the way for regulatory approval worldwide, bringing a much-needed new option to patients who have long been underserved by existing therapies. The ability of HyBryte(TM) to deliver effective results with minimal systemic exposure makes it particularly well-suited for chronic conditions such as CTCL, where long-term management is essential.

Soligenix is positioning itself as a leader in the rare disease space by focusing on therapies that address critical gaps in treatment. In addition to HyBryte(TM), the company has a diversified pipeline that includes other promising candidates targeting conditions such as oral mucositis, and Behcet’s Disease, as well as mild-to-moderate psoriasis. By leveraging its proprietary drug development expertise and commitment to scientific rigor, Soligenix is working to bring life-changing treatments to patients who have few, if any, safe and effective therapeutic alternatives.

The significance of Soligenix’s phase 3 replication study extends beyond just the CTCL community. Success in this trial could reinforce the company’s broader strategy of using innovative therapeutic approaches to tackle rare and difficult-to-treat diseases. The progress of HyBryte(TM) also highlights the importance of photodynamic therapy as a novel and effective modality that could potentially be applied to other dermatological and oncological conditions.

As Soligenix moves forward with its pivotal phase 3 replication study, industry observers, investors, and medical professionals will be closely monitoring the results. A positive outcome could not only validate HyBryte(TM) as a groundbreaking treatment for early-stage CTCL but also elevate Soligenix’s standing as a leader in the rare-disease treatment space. The company remains dedicated to advancing its research and bringing new hope to patients facing life-altering conditions with limited treatment options.

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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