Soligenix Announces Recent Accomplishments; Continues Advancement of Rare Disease Pipeline

Late stage biopharmaceutical company, Soligenix, Inc. (Nasdaq: SNGX) has announced its recent accomplishments and financial results for the quarter ended March 31, 2024. The company recently raised $4.75 million through a public offering, which Soligenix says will be used to advance its rare disease pipeline.

Subsequent to quarter end, the company achieved a number of regulatory milestones, including receiving Orphan Drug Designation by the FDA for the active ingredient in SuVax™, the company’s vaccine candidate for Sudan ebolavirus, and Orphan Drug Designation for the active ingredient in MarVax™, Soligenix’s vaccine candidate for Marburg marburgvirus.

In April 2024, Soligenix received notice of intent to grant additional patents for its filovirus vaccines in the United Kingdom and South Africa. The company stated it has patents pending in other international jurisdictions.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, commented, “While we continue our ongoing discussions with the United States (U.S.) Food and Drug Administration (FDA), we shared that the European Medicines Agency (EMA) has agreed to the study design of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease. This study will enroll approximately 80 patients across the U.S. and Europe, starting before the end of 2024, with top-line results expected in the second half of 2026.

We also will be initiating a Phase 2 study with SGX945 (dusquetide) in Behçet’s disease later this year with top-line results expected in the first half of 2025, along with top-line results expected during the same timeframe from our ongoing SGX302 (synthetic hypericin) Phase 2 study in mild-to-moderate psoriasis.”

Financial Highlights

Soligenix’s revenues for the quarter ended March 31, 2024 were $0.1 million as compared to $0.3 million for the quarter ended March 31, 2023.

As of March 31, 2024, the Company’s cash position, exclusive of the approximate $4.3 million in net proceeds from its recent financing, was approximately $7.1 million.

“We have a clear vision for the future, and we are actively pursuing new opportunities to create long-term value for our shareholders including but not limited to, partnership and merger and acquisition opportunities,” said Dr. Schaber.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet’s Disease.

Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.