PRINCETON, N.J. - Soligenix, Inc. (NASDAQ:SNGX), a biopharmaceutical company, announced a partnership with Sterling Pharma Solutions to optimize the production of synthetic hypericin, a key ingredient in treatments for rare skin conditions. The collaboration aims to establish a scalable, cost-effective manufacturing process for hypericin, used in the drug formulations HyBryte™ for cutaneous T-cell lymphoma (CTCL) and SGX302 for psoriasis.
The partnership is currently focused on transferring and enhancing manufacturing processes to enable Good Manufacturing Practice (GMP) production for clinical trials. The long-term goal is to build a commercial manufacturing collaboration.
Christopher J. Schaber, PhD, President and CEO of Soligenix, expressed optimism about scaling up the manufacturing capabilities and reducing costs through this partnership. Adam Kujath, Site Head at Sterling Pharma Solutions, highlighted Sterling's expertise in active pharmaceutical ingredient manufacturing as beneficial to the program.
HyBryte™, which has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA), is a photodynamic therapy activated by visible light, offering a safer alternative to treatments that rely on DNA-damaging drugs and UV exposure. The therapy has shown promise in Phase 2 clinical studies, with significant improvements in CTCL lesions compared to placebo.
A confirmatory Phase 3 study, FLASH2, is expected to commence before the end of 2024, following a successful initial Phase 3 trial. The study design has been accepted by the European Medicines Agency (EMA), while discussions with the FDA on the study design continue.
The FDA has also awarded a grant to support the evaluation of HyBryte™ for expanded treatment in patients with early-stage CTCL, including home use.
Soligenix's announcement is based on a press release statement and reflects the company's current expectations for future results and opportunities. The forward-looking statements are subject to risks and uncertainties that could cause actual events or results to differ materially.
In other recent news, Soligenix has been granted a European patent for synthetic hypericin production, a key component in its photodynamic therapy, HyBryte™, used for treating cutaneous T-cell lymphoma (CTCL). This patent, set to expire in 2036, augments the firm's intellectual property portfolio. The HyBryte™ therapy has demonstrated significant efficacy in a Phase 3 trial and a second confirmatory Phase 3 trial is scheduled to commence in 2024.
The company has regained compliance with Nasdaq's Minimum Bid Price Rule, following a 1-for-16 reverse stock split. Additionally, Soligenix has secured potential funding of approximately $4.2 million through a warrant agreement.
In terms of its product development, the company's HyBryte™ therapy has shown promising results, with 60% of CTCL patients meeting success criteria in a clinical study. Furthermore, Soligenix's MarVax™ and SuVax™ vaccines have received orphan drug designations from the U.S. Food and Drug Administration.
These recent developments underscore Soligenix's ongoing efforts to advance its research and development projects.
InvestingPro Insights
Soligenix's recent partnership announcement comes at a crucial time for the company, as reflected in the latest financial data and market trends. According to InvestingPro, Soligenix has a market capitalization of $11.11 million, indicating its current small-cap status in the biopharmaceutical sector.
The company's financial position shows some interesting contrasts. An InvestingPro Tip reveals that Soligenix holds more cash than debt on its balance sheet, which could be beneficial as it moves forward with its manufacturing partnership and clinical trials. This solid cash position may provide the necessary financial flexibility to support the development of HyBryte™ and SGX302.
However, the company faces challenges. Another InvestingPro Tip notes that Soligenix was not profitable over the last twelve months, with a negative P/E ratio of -1.58. This aligns with the company's focus on research and development, which often requires significant investment before profitability is achieved in the biopharmaceutical industry.
Despite these financial hurdles, market sentiment towards Soligenix has shown recent positive trends. The stock has demonstrated a strong return over the last three months, with a price total return of 115.49%. This could indicate growing investor confidence in the company's strategic moves, including the partnership with Sterling Pharma Solutions.
It's worth noting that InvestingPro offers 12 additional tips for Soligenix, providing a more comprehensive analysis for investors interested in delving deeper into the company's prospects.
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