PRINCETON, N.J. - Soligenix, Inc. (NASDAQ:SNGX), a biopharmaceutical company specializing in rare diseases, has secured a patent from the Hong Kong Patent Office for a novel method of producing synthetic hypericin. This active ingredient is central to the company's treatments for cutaneous T-cell lymphoma (CTCL) and psoriasis.
The patent, titled "Systems and Methods for Producing Synthetic Hypericin," covers a proprietary process for creating a highly purified form of synthetic hypericin. This compound is used in HyBryte™, a photodynamic therapy for CTCL, which is preparing to enter a confirmatory Phase 3 clinical trial, and in SGX302, a candidate for plaque psoriasis treatment.
HyBryte™ has demonstrated statistically significant efficacy in a Phase 3 trial and is distinguished by its use of visible light, which avoids the risks associated with ultraviolet exposure in other photodynamic therapies. The treatment has received orphan drug and fast track designations from the FDA and orphan designation from the EMA.
SGX302 is under investigation for mild to moderate plaque psoriasis, with ongoing studies suggesting its potential efficacy. Dr. Christopher J. Schaber, President and CEO of Soligenix, expressed optimism about the patent's role in strengthening the company's intellectual property and advancing its clinical studies.
The patent, part of a larger portfolio including related U.S. and European patents, is expected to expire in 2036. It adds to the company's global patent coverage, which also encompasses liquid formulations and methods of use.
As Soligenix continues its development efforts, the recent patent grant represents a strategic milestone in protecting its synthetic hypericin technology. Information in this article is based on a press release statement.
In other recent news, Soligenix, Inc. has been making significant strides in its financial strategy and research and development efforts. The biopharmaceutical company has amended its loan agreement with Pontifax Medison Finance, allowing it to satisfy remaining loan amounts with stock, a move aimed at improving liquidity. The company has also regained compliance with Nasdaq's Minimum Bid Price Rule, following a 1-for-16 reverse stock split, and secured potential funding of approximately $4.2 million through a warrant agreement.
In partnership with Sterling Pharma Solutions, Soligenix is working to optimize the production of synthetic hypericin, a key component in its drug formulations HyBryte™ and SGX302, used for treating rare skin conditions. The collaboration aims to establish a scalable, cost-effective manufacturing process for hypericin.
The company has also been granted a European patent for synthetic hypericin production, reinforcing its intellectual property portfolio. This patent supports the development of HyBryte™, which has shown promising results in Phase 2 clinical studies for cutaneous T-cell lymphoma (CTCL), with a confirmatory Phase 3 study, FLASH2, expected to commence before the end of 2024.
These recent developments underscore Soligenix's ongoing efforts to manage its capital and advance its research and development projects.
InvestingPro Insights
While Soligenix's recent patent grant in Hong Kong marks a significant milestone for its synthetic hypericin technology, investors should consider the company's financial performance and market position. According to InvestingPro data, Soligenix has a market capitalization of just $8.19 million, reflecting its status as a small-cap biopharmaceutical company.
The company's financial metrics reveal some challenges. InvestingPro Tips indicate that Soligenix suffers from weak gross profit margins, which is evident in the reported gross profit margin of 8.75% for the last twelve months as of Q2 2023. Additionally, the company's revenue growth has been negative, with a 50.35% decline over the same period.
Despite these financial hurdles, Soligenix maintains a strong balance sheet position. An InvestingPro Tip highlights that the company holds more cash than debt, which could provide some financial flexibility as it advances its clinical programs for HyBryte™ and SGX302.
Investors should note that analysts anticipate a sales decline in the current year, and the company is not expected to be profitable this year. This aligns with the typical profile of early-stage biopharmaceutical companies investing heavily in research and development.
For those interested in a deeper analysis, InvestingPro offers 7 additional tips for Soligenix, providing a more comprehensive view of the company's prospects and challenges.
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