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PRINCETON, N.J. - Soligenix, Inc. (NASDAQ:SNGX), a micro-cap biotech company with a market capitalization of $4.28 million, announced Tuesday it has successfully completed the transfer of manufacturing for its synthetic hypericin active ingredient from Europe to the United States under its partnership with Sterling Pharma Solutions. The company maintains a healthy balance sheet with more cash than debt and a current ratio of 1.85.InvestingPro analysis reveals 13 additional key insights about Soligenix’s financial position and market performance.
The transfer included optimizing and implementing a commercially viable, scalable production process for the active ingredient used in HyBryte and SGX302, topical formulations being developed to treat cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively.
The companies have established current good manufacturing practice (cGMP) production capabilities for clinical trials with plans to create a long-term commercial manufacturing collaboration.
"We are pleased to have successfully produced larger quantities of cGMP synthetic hypericin, and look forward to continuing to work with Sterling to refine the process for process validation while further reducing our cost of goods," said Christopher J. Schaber, President and CEO of Soligenix.
Synthetic hypericin is a photosensitizer that is applied topically to skin lesions and activated by visible light approximately 24 hours later. The company’s lead product, HyBryte, has received orphan drug and fast track designations from the FDA and orphan designation from the European Medicines Agency.
Soligenix expects to initiate FLASH2, its second Phase 3 trial for HyBryte in early-stage CTCL, before the end of 2024. This confirmatory study will enroll approximately 80 subjects and feature an 18-week continuous treatment period, based on agreement with the EMA on key design components. The company’s stock, currently trading at $1.31, has seen significant volatility, trading well below its 52-week high of $14.83. According to InvestingPro Fair Value analysis, the stock appears undervalued at current levels.
According to the company’s press release statement, CTCL affects approximately 31,000 individuals in the U.S. and 38,000 in Europe, with about 3,200 and 3,800 new cases annually in those regions, respectively. While the company reported negative EBITDA of $10.63 million in the last twelve months, its focus on this significant market opportunity could present growth potential. Discover more detailed financial metrics and growth projections with InvestingPro.
In other recent news, Soligenix has reported promising results from its clinical trials for HyBryte™, a treatment for cutaneous T-cell lymphoma (CTCL). The company announced that 75% of patients experienced significant improvement after just 18 weeks of treatment, with three out of eight patients achieving a complete response. The U.S. Food and Drug Administration (FDA) has supported this study with a $2.6 million grant through its Orphan Products Development program. Soligenix is currently enrolling patients for the confirmatory Phase 3 FLASH2 trial, which could solidify HyBryte™ as a front-line treatment for CTCL. Analysts note that the therapy’s potential for at-home use could provide added convenience for patients. The market potential for HyBryte™ is significant, given the rarity of CTCL and limited existing treatment options. The disease affects approximately 3,000 new patients annually in the U.S., with a similar patient population in Europe. Investors are closely monitoring Soligenix’s progress, which could offer a safer and faster alternative to existing therapies.
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