Soligenix Inc - Company Profile

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Soligenix Inc: Segment Analysis

Business Description

Soligenix Inc (Soligenix) is a late-stage biopharmaceutical company that develops and commercializes products for the treatment of rare diseases and unmet medical needs. The company operates through two reportable business segments: Specialized BioTherapeutics and Public Health Solutions.

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R&D Overview

The company's dedicated research and development (R&D) endeavors empower it to create innovative therapeutics and vaccines. Its focus lies in developing drug candidates within the domains of inflammation, oncology, and biodefense. The company's pipeline encompasses specialized biotherapeutics designed to address various conditions, including cutaneous T-cell lymphoma, oral mucositis in head and neck cancer, mild to moderate psoriasis, acute radiation enteritis, and pediatric Crohn's disease. It spent US$7.9 million on research and development in FY2022.

Business Segments

Overview

Focuses on developing therapeutic candidates for antibiotic resistant and treating emerging infectious disease. Develops product candidates that are designed for the protection against effects of ricin toxin. The development of the company’s vaccine program is supported by ThermoVax, the heat stabilization technology. Product candidates include Rivax, Thermovax, CiVax and SGX943. Rivax, a vaccine for treating Ricin Toxin Poisoning, completed Phase 1a and 1b clinical trial, inducing antibodies in humans that neutralize the ricin toxin. ThermoVax is a novel method of thermostabilizing vaccines with aluminum salt and has potential to eliminate the need for transportation, cold-chain production, and storage by relieving the health care system under frozen conditions. SGX943, an IDR which is under pre-clinical development and being developed for emerging and antibiotic resistant infectious disease. CiVax is a vaccine adjuvant for the prevention of Covid-19, which is under pre-clinical development stage.

Performance

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Overview

Focuses on developing proprietary formulations of oral beclomethasone 17, 21-dipropionate (BDP) for the treatment of gastrointestinal (GI) disorders with indications of severe inflammation including, acute radiation enteritis and pediatric Crohn’s disease. The company is using its topical synthetic hypericin developing a novel photodynamic therapy HyBryte has completed Phase III clinical trials for treatment of cutaneous T-cell lymphoma (CTCL). The HyBryte has received both Orphan Drug designation and Fast Track designation from the FDA. It is also developing an innate defense regulator technology, Dusquetide (SGX942) for the treatment of oral mucositis. The company is investigating Dusquetide (SGX942) is in Phase III studies for the treatment of oral mucositis. Soligenix is developing SGX302, a potent photosensitizer. SGX302 has completed Phase I/II trial for treating mild-to-moderate psoriasis. It is sourcing from cutaneous T-cells apoptosis, albeit with help of UV light. Its SGX203 is an orally administered two tablet delivery system of BDP and has completed Phase I/II trial for Pediatric Crohn's disease. The company has received both Orphan Drug designation and Fast Track designation for SGX203 from the FDA.

Performance

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