Soligenix Reports Q3 2024 Financial Results and Recent Achievements

PRINCETON, N.J., Nov. 8, 2024 – Soligenix, Inc. (Nasdaq: SNGX), a biopharmaceutical company, has shared recent achievements and financial outcomes for the quarter ending September 30, 2024. The company is dedicated to developing treatments for rare diseases with unmet medical needs.

Christopher J. Schaber, PhD, President and CEO of Soligenix, stated that the company remains committed to multiple clinical endeavors and key milestones. Among these is the commencement of a Phase 3 placebo-controlled trial for HyBryte™ (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (CTCL) by the end of this year. Additionally, Soligenix plans to start a Phase 2 study for SGX945 (dusquetide) in Behçet's disease soon, with initial results anticipated in the first half of 2025. This will coincide with data from their ongoing Phase 2 study of SGX302 (synthetic hypericin) in mild-to-moderate psoriasis.

Dr. Schaber further highlighted that with approximately $9.8 million in cash as of September 30, 2024, the company is managing its resources to meet its objectives. They are also exploring strategic partnerships and mergers and acquisitions to enhance long-term shareholder value.

Recent Accomplishments:
- On October 22, 2024, Soligenix announced that the Hong Kong Patent Office granted a patent for a novel process of producing highly purified synthetic hypericin.
- On October 7, 2024, the company shared that lead investigators from the University of Pennsylvania and the Rochester Skin Lymphoma Medical Group would present findings on HyBryte™ for CTCL treatment at the European Organisation for Research and Treatment of Cancer.
- On October 3, 2024, Soligenix entered a partnership with Sterling Pharma Solutions to develop a scalable production technology for synthetic hypericin.
- On September 3, 2024, the European Patent Office granted a similar patent for producing synthetic hypericin.

Financial Results:
For the quarter ended September 30, 2024, Soligenix reported no revenue, compared to $0.1 million in the same period in 2023. Revenues were primarily related to government contracts and grants supporting the development of SGX943, CiVax™ (a COVID-19 vaccine candidate), and HyBryte™ for CTCL. The net loss for the quarters ended September 30, 2024, and 2023 was $1.7 million, or ($0.78) per share and ($2.56) per share, respectively. The increase in net loss was due to reduced gross profit and tax credits, and higher operating expenses, offset by increased interest income and changes in the fair value of debt.

Research and development expenses rose to $1.0 million from $0.8 million in the previous year, mainly due to costs related to the Phase 2 study in Behçet's disease and the second Phase 3 CTCL trial. General and administrative expenses decreased to $0.9 million from $1.0 million, attributed to lower legal and professional fees.

As of September 30, 2024, the company's cash position stood at approximately $9.8 million. Soligenix is focused on developing and commercializing products for rare diseases. Their Specialized BioTherapeutics segment is progressing with HyBryte™ for CTCL, with plans for global commercialization upon regulatory approval. Other development programs include expanding synthetic hypericin into psoriasis and using dusquetide for inflammatory diseases like Behçet's Disease.

The Public Health Solutions segment includes developing RiVax®, a ricin toxin vaccine, and vaccines for filoviruses and COVID-19, using the proprietary ThermoVax® technology. These initiatives have been supported by funding from various government agencies, including NIAID, DTRA, and BARDA.

Soligenix remains focused on advancing its clinical programs and exploring opportunities to enhance shareholder value through strategic initiatives.