Core Viewpoint - Soligenix, Inc. is expanding its European Medical Advisory Board to enhance strategic guidance for the Phase 3 study of HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), with top-line results expected in the second half of 2026 [1][2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, particularly through its Specialized BioTherapeutics segment [20]. - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, aimed at treating CTCL [20]. Clinical Study Details - The confirmatory Phase 3 study, named FLASH2, will enroll approximately 80 patients and is designed to replicate the successful elements of the previous Phase 3 FLASH trial, which showed a 49% treatment response rate [15]. - The FLASH2 study will extend the double-blind, placebo-controlled assessment to 18 weeks, with the primary endpoint assessed at the end of this period [15]. Advisory Board Expansion - The European Medical Advisory Board now includes five esteemed dermatologists, enhancing the company's expertise in clinical strategies and regulatory interactions [2][3][4][7][8]. - The board members are recognized leaders in the field of dermatology and CTCL, contributing valuable insights for the upcoming clinical study [2][3][4][7][8]. Treatment Mechanism and Efficacy - HyBryte™ employs synthetic hypericin activated by visible light, which penetrates deeper into the skin compared to ultraviolet light, potentially treating more severe skin conditions [9]. - In previous studies, HyBryte™ demonstrated a statistically significant improvement in lesion reduction compared to placebo, with a 16% response rate in the first treatment cycle [10]. Safety Profile - HyBryte™ is noted for its safety, with no systemic absorption and a mechanism of action that does not involve DNA damage, making it a safer alternative to existing therapies [14]. - The treatment has been well tolerated across multiple cycles, with a significant portion of patients opting to continue treatment in the optional safety cycle [13]. Market Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [19][18]. - The company aims to address the significant safety risks associated with existing treatments, positioning HyBryte™ as a potentially safer and effective option for patients [14].

Core Insights - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, reporting recent accomplishments and financial results for Q2 2025 [1][10] Recent Accomplishments - The company is confident in its late-stage rare disease pipeline, with key milestones expected, including top-line results from a Phase 2a clinical trial for mild-to-moderate psoriasis with SGX302 by year-end [2] - Successful completion of a Phase 2a proof of concept study for SGX945 in Behçet's Disease, demonstrating biological efficacy [2][9] - Ongoing clinical updates for the extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL) and plans for a Phase 3 study [2] Financial Results - No revenue was reported for Q2 2025, consistent with minimal revenue in Q2 2024 [4] - Net loss for Q2 2025 was $2.7 million, or ($0.82) per share, compared to a net loss of $1.6 million, or ($1.31) per share in Q2 2024, primarily due to increased operating expenses [5] - Research and development expenses rose to $1.7 million in Q2 2025 from $0.5 million in Q2 2024, driven by costs related to clinical trials [6] - General and administrative expenses decreased to $1.1 million in Q2 2025 from $1.2 million in Q2 2024 [7] - Cash position as of June 30, 2025, was approximately $5.1 million, excluding $1.4 million received via the ATM facility on July 1, 2025 [7] Strategic Focus - The company is evaluating strategic options, including partnerships, mergers, acquisitions, government grants, and financing opportunities to advance its late-stage pipeline [2]