Soligenix Inc. (NASDAQ: SNGX) Advances Solutions for Hard-to-Diagnose CTCL

• CTCL is recognized by clinicians as one of the most difficult cancers to diagnose accurately in its early stages.
• Delayed diagnosis has meaningful clinical consequences.
• Within this challenging diagnostic and treatment landscape, Soligenix is advancing a novel therapeutic approach for CTCL through its development of HyBryte(TM).

Cutaneous T-cell lymphoma, or CTCL, is a rare form of non-Hodgkin lymphoma that primarily affects the skin, often presenting with symptoms that closely resemble common dermatologic conditions such as eczema or psoriasis, leading to frequent misdiagnosis and delayed treatment. These diagnostic delays can allow the disease to progress silently for years, increasing patient suffering and complicating care. A late-stage biopharmaceutical company, Soligenix (NASDAQ: SNGX) is developing therapies aimed at addressing critical gaps in rare disease treatment, including CTCL.

CTCL is recognized by clinicians as one of the most difficult cancers to diagnose accurately in its early stages. According to specialists, patients often endure years of recurring rashes, itching and skin lesions before receiving a correct diagnosis because early CTCL lesions can be indistinguishable from benign inflammatory skin disorders on visual examination. This diagnostic uncertainty frequently results in repeated courses of topical steroids or other nonspecific treatments, delaying referral to specialists and definitive diagnosis.

Personalized Medicine in Oncology reports that CTCL patients commonly experience diagnostic delays of several years. The analysis noted that misdiagnosis is driven by low disease awareness, overlapping clinical features with common skin conditions and limitations in early diagnostic testing. The report noted that patients are often treated by multiple providers before CTCL is considered, underscoring a systemic challenge in recognizing the disease early.

Delayed diagnosis has meaningful clinical consequences. CTCL is typically indolent in early stages but can progress to more aggressive forms involving tumors, lymph nodes and internal organs. The Cutaneous Lymphoma Foundation notes that earlier-stage disease is generally associated with better outcomes and a wider range of skin-directed treatment options, whereas advanced disease often requires systemic therapies with greater toxicity and reduced effectiveness. As a result, improving awareness and treatment options is considered essential to improving long-term patient outcomes.

Epidemiological data further highlight the need for improved approaches. CTCL represents approximately 4% of all non-Hodgkin lymphomas, with mycosis fungoides being the most common subtype. According to the National Cancer Institute, incidence rates have remained relatively stable, but survival outcomes vary significantly depending on stage at diagnosis, reinforcing the importance of early detection and timely intervention.

Within this challenging diagnostic and treatment landscape, Soligenix is advancing a novel therapeutic approach for CTCL through its development of HyBryte(TM), also known as synthetic hypericin. HyBryte is a visible light-activated photodynamic therapy designed for the treatment of early-stage CTCL. Unlike traditional ultraviolet-based phototherapies, which can carry long-term safety risks with cumulative exposure, HyBryte is activated by visible light in the red-yellow spectrum, allowing targeted treatment of malignant T-cells in the skin while minimizing damage to surrounding healthy tissue.

Clinical data reported by Soligenix indicate that HyBryte has demonstrated statistically significant efficacy in reducing CTCL lesions in patients with early-stage disease. In several clinical trials, HyBryte met primary endpoints, achieving clinically meaningful response rates compared with placebo, while maintaining a favorable safety profile. The company has emphasized that the therapy’s localized mechanism of action may be particularly valuable for patients whose disease has been historically under-recognized or undertreated due to delayed diagnosis.

The relevance of HyBryte, is closely tied to the diagnostic realities of CTCL. Because many patients are diagnosed only after years of symptom progression, there is a strong need for treatments that are effective, well tolerated and suitable for long-term use in earlier disease stages. Soligenix has positioned HyBryte as a potential first-line option for patients who may not be candidates for systemic therapies or who seek alternatives to treatments associated with cumulative toxicity.

Beyond HyBryte, Soligenix’s broader focus on rare diseases and unmet medical needs reflects a strategic emphasis on conditions where delayed diagnosis and limited treatment options intersect. The company continues to engage with regulators and clinical experts to advance therapies that address both disease biology and real-world patient challenges, including the consequences of diagnostic delay.

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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