Soligenix, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsSoligenix is a late-stage biopharmaceutical company developing HyBryte for cutaneous T-cell lymphoma and other rare disease therapeutics, with no approved products and recurring losses.
What they do
Soligenix operates two segments: Specialized BioTherapeutics (developing HyBryte/SGX301 for CTCL, SGX302 for psoriasis, and dusquetide-based SGX945/SGX942 for inflammatory diseases) and Public Health Solutions (vaccines and therapeutics, including RiVax, SGX943, filovirus vaccines, and CiVax, supported by U.S. government funding). It has no marketed products and generates minimal revenue, primarily from government grants and contracts.
Revenue drivers
- Government grants and contracts (Public Health Solutions) — Historically funded by NIAID, BARDA, and DTRA for vaccine and therapeutic programs; no product sales revenue.
- Specialized BioTherapeutics — No commercial revenue; potential future revenue depends on regulatory approval and commercialization of HyBryte and other candidates.
- Total revenue — Annual revenue has been declining, from $2.4M in 2020 to $119,371 in 2024, reflecting reduced grant activity.
Recent performance
For fiscal 2025, net loss was $11.1 million and diluted EPS was -$2.14, with operating cash flow of -$10.3 million. Revenue for 2024 was $119,371, down from $839,359 in 2023. As of June 30, 2026, cash and equivalents were $9.8 million, total assets $10.5 million, and total liabilities $3.9 million. The company has no long-term debt.
Strategy
Soligenix is prioritizing execution of the FLASH2 Phase 3 trial for HyBryte, with enrollment started in December 2024 and top-line results expected in the second half of 2026. It is also advancing SGX302 into a Phase 2a psoriasis trial and SGX945 into a Phase 2 BD trial, while seeking partners for SGX942 oral mucositis. The company continues to pursue government funding for its ThermoVax-based vaccine programs and explores business development and strategic alternatives, including M&A.
Risks
- Going concern risk — The audit report for FY2025 includes an explanatory paragraph about substantial doubt regarding the company's ability to continue as a going concern absent new financing.
- Clinical and regulatory risk — FLASH2 results are pending and regulatory approval is uncertain; FDA feedback may require modifications to the development path.
- Liquidity and funding risk — Recurring losses and negative cash flows may require additional equity or debt financing, which may not be available on favorable terms.
- Nasdaq delisting risk — The company received delisting notices or listing-rule failures in November 2025 and June 2026, indicating potential non-compliance with listing requirements.
Outlook
Management expects top-line results from the FLASH2 trial in the second half of 2026, which will be a key catalyst. They anticipate continued government funding for public health programs and are pursuing additional grants and contracts. The company's ability to continue operations depends on securing new financing within the next year.