Accessibility StatementSkip Navigation PRINCETON, N.J., Nov. 19, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryteâ"¢ (sy ...

Core Insights - Biofrontera Inc. reported a strategic transformation in 2025, focusing on customer segmentation and data analysis to enhance sales effectiveness, resulting in increased sales volume and revenue growth [1][4] - The company has restructured its agreement with Biofrontera AG, acquiring all rights, approvals, and patents for Ameluz® and RhodoLED® in the U.S., which is expected to improve cost management and operational efficiency [1][4] - The company secured an $11 million investment, which, along with the restructuring and improved promotional strategies, has positioned it strongly for future growth [1] Financial Performance - Total revenues for Q2 2025 were $9.0 million, a 15% increase from $7.8 million in Q2 2024, driven by a 5% increase in unit sales price and a 9.5% increase in sales volume of Ameluz® [2][4] - For the first half of 2025, total revenues reached $17.7 million, a 12% increase from $15.8 million in the same period of 2024, attributed to higher unit sales prices and increased sales volume [4][9] - Cash and cash equivalents as of June 30, 2025, were $7.2 million, up from $5.9 million at the end of 2024 [4] Operating Expenses - Total operating expenses for Q2 2025 were $14.1 million, compared to $12.9 million in Q2 2024, with a significant decrease in cost of revenues by $1.7 million, or 41.8%, due to renegotiated terms with Biofrontera AG [3][10] - Selling, general, and administrative expenses increased to $10.5 million in Q2 2025 from $7.9 million in Q2 2024, primarily due to a $3.4 million rise in legal costs [5][11] Net Loss and Adjusted EBITDA - The net loss for Q2 2025 was $5.3 million, compared to a net loss of $0.3 million in the prior-year quarter, largely due to a $5.4 million non-cash fluctuation in the fair value of warrants [6][19] - Adjusted EBITDA for Q2 2025 was negative $5.1 million, slightly worse than negative $4.7 million in Q2 2024, reflecting higher legal costs despite lower cost of goods sold [7][22] Clinical Developments - The company announced the completion of patient enrollment in a Phase 3 study for Ameluz® targeting mild to moderate actinic keratosis (AK) on the entire body and a Phase 2b study for moderate to severe acne vulgaris [4][10] - A U.S. patent for a revised formulation of Ameluz® was granted, extending patent protection until December 2043 [4]

Core Insights - Soligenix, Inc. is advancing HyBryte™ (synthetic hypericin) as a potential new therapy for early-stage cutaneous T-cell lymphoma (CTCL), specifically targeting mycosis fungoides (MF), the most common form of CTCL [1][7] - The company emphasizes the urgent need for safer and more effective therapies for CTCL, as there has not been a new FDA-approved skin-directed therapy in over 10 years [3][4] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL and other therapeutic programs [7] - The company is also involved in vaccine development for biodefense and infectious diseases, supported by government funding [8] Clinical Development - Dr. Ellen Kim, the Lead Principal Investigator, highlighted the promising clinical results from ongoing Phase 3 FLASH studies, noting that participants have experienced positive outcomes with no serious adverse events leading to dropouts [3][4] - HyBryte™ operates through a unique mechanism that does not damage DNA, theoretically reducing the risk of skin cancer compared to traditional phototherapy [4] Research and Future Directions - Dr. Kim expressed excitement about the open enrollment in HyBryte™ clinical trials, emphasizing the critical role of patient participation in advancing new therapies [6] - The company aims to seek regulatory approvals for HyBryte™ following the successful completion of its second Phase 3 study [7]

Core Insights - The interim results from an FDA-funded study indicate that HyBryte™ shows a rapid response and strong safety profile in treating early-stage cutaneous T-cell lymphoma (CTCL), with 75% of patients achieving "Treatment Success" after 18 weeks of treatment [1][2][3] Company Overview - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, particularly in the area of CTCL [16][17] - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, which has received orphan drug and fast track designations from the FDA [5][11] Study Details - The ongoing open-label, investigator-initiated study (IIS) has enrolled nine patients, with six out of eight evaluable patients achieving a predefined "Treatment Success" [2][3] - The study is designed to evaluate the efficacy of HyBryte™ over a treatment period of up to 54 weeks, with a focus on the cumulative mCAILS score [4][12] Treatment Efficacy - In the first Phase 3 FLASH study, HyBryte™ demonstrated a 16% response rate for at least a 50% reduction in lesions compared to 4% in the placebo group, indicating significant efficacy [6][7] - The second open-label treatment cycle showed a 40% response rate among patients treated for 12 weeks, further supporting the efficacy of extended treatment [7][8] Safety Profile - HyBryte™ has been reported to have a benign safety profile, with no significant systemic absorption and a mechanism of action that avoids DNA damage, making it a safer alternative to current therapies [9][10] - The treatment has been well tolerated across multiple cycles, with 66% of patients opting to continue treatment in the optional safety cycle [8][9] Future Developments - A confirmatory Phase 3 study, FLASH2, is expected to begin before the end of 2024, aiming to replicate the successful design of the first FLASH study and enroll approximately 80 subjects [11][12] - The study will assess the efficacy of HyBryte™ over an extended 18-week treatment period, with ongoing discussions with the FDA regarding study design [11][12] Financial Support - The FDA has awarded a grant of up to $2.6 million to support the investigator-initiated study evaluating HyBryte™ for expanded treatment options, including home use [13]

Core Insights - Soligenix, Inc. is presenting findings on the efficacy of HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL) and psoriasis at two major dermatology conferences in March 2025 [1][4][6] Group 1: Clinical Findings - Recent supportive studies indicate that longer treatment times with HyBryte™ improve efficacy, with a study showing a 40% response rate in patients treated for 12 weeks compared to a 4% response in the placebo group [5][11] - The Phase 3 FLASH trial demonstrated that 16% of patients receiving HyBryte™ achieved at least a 50% reduction in lesions, significantly higher than the 4% in the placebo group [10] - HyBryte™ has shown a statistically significant improvement in treating both plaque and patch lesions of CTCL, with response rates of 42% and 37% respectively [11] Group 2: Safety and Regulatory Status - HyBryte™ has received orphan drug and fast track designations from the FDA, indicating its potential as a safe and effective treatment for CTCL [9] - The treatment mechanism of HyBryte™ is not associated with DNA damage, making it a safer alternative compared to current therapies that carry significant side effects [13] - The FDA awarded a $2.6 million Orphan Products Development grant to support the evaluation of HyBryte™ for expanded treatment in early-stage CTCL patients [17] Group 3: Market Potential - The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027, indicating significant commercial potential for HyBryte™ in treating psoriasis [23] - CTCL affects approximately 31,000 individuals in the U.S. and 38,000 in Europe, highlighting a substantial patient population for potential treatment [19] Group 4: Company Overview - Soligenix, Inc. focuses on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL and SGX302 for psoriasis [24]