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DETROIT - Soligenix, Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company with a market capitalization of $6.72 million, has announced promising results from a clinical trial of its product candidate, HyBryte™, for the treatment of cutaneous T-cell lymphoma (CTCL). According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it faces financial challenges with an EBITDA of -$9.43 million in the last twelve months. The trial data indicates that 75% of patients experienced significant improvement after 18 weeks of treatment with HyBryte™, which uses visible light instead of harmful UV radiation.
In a study involving eight patients, six showed major improvements in their skin lesions, and three patients achieved a complete response, with their lesions essentially disappearing. For those who completed the full 54-week treatment, the average improvement was 85%. These clinical achievements come as the company’s stock has experienced significant volatility, with InvestingPro showing a 66% decline in share price over the past year. The findings suggest that HyBryte™ could be a faster-acting and safer alternative to existing treatments, which typically take 6-12 months to show results and often have serious side effects.
Dr. Ellen Kim of the University of Pennsylvania, who is leading the study, has expressed optimism about the consistent results and safety profile seen across multiple clinical trials. The U.S. Food and Drug Administration (FDA) is also funding the study with a $2.6 million grant through its Orphan Products Development program, highlighting the potential of HyBryte™.
Soligenix is currently enrolling patients for its confirmatory Phase 3 FLASH2 trial. If the results continue to support HyBryte™ as a safe, front-line treatment for CTCL, the therapy could eventually be used at home, offering greater convenience for patients.
CTCL is a rare, chronic, and incurable disease with approximately 3,000 new cases reported annually in the U.S., and 20,000-30,000 patients living with the condition. The disease is more common in men and individuals over 50 years old. With an additional 38,000 patients affected in Europe and limited effective treatment options available, HyBryte™ has the potential to capture a significant market share if approved. Despite this market opportunity, InvestingPro analysis indicates the company faces profitability challenges, with revenue declining by 85.78% and analysts not expecting profitability this year. Subscribers can access 5 additional ProTips and comprehensive financial metrics to better evaluate the investment potential.
Investors are watching Soligenix as the company progresses towards potentially bringing a safer, more effective treatment to an underserved patient population. The information reported is based on a press release statement.
In other recent news, Soligenix, Inc. has announced its financial results for the year ending December 31, 2024, reporting revenues of $0.1 million, a decrease from $0.8 million in the previous year. The net loss for the year was $8.3 million, primarily due to lower revenue and increased research and development expenses. The company also highlighted progress in its clinical trials, with top-line results from its HyBryte™ Phase 3 study expected in 2026. Additionally, Soligenix has settled its debt with Pontifax Medison Finance, terminating its Loan and Security Agreement and releasing the company from related obligations. This move marks a significant financial milestone as Soligenix continues to explore strategic options, including partnerships and acquisitions. In research developments, Soligenix’s CiVax™ vaccine booster has shown broader protection against COVID-19 variants in non-human primates. The CiVax™ booster, developed with the University of Hawaiʻi, could offer a more comprehensive immune response when used after an adenovirus vaccine. These recent developments reflect Soligenix’s ongoing efforts in advancing its pipeline and financial strategy.
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