Soligenix, Inc. reported a net loss of $8.3 million for the fiscal year ended December 31, 2024, an increase of 35% compared to a net loss of $6.1 million in the previous year. The company's revenues significantly decreased by 86%, from $839,359 in 2023 to $119,371 in 2024, primarily due to the conclusion of higher-margin grants related to the development of its product candidates. The gross profit for the year was reported at zero, a decline from $97,311 in the prior year, reflecting the end of grant funding for certain projects. Research and development expenses rose by 58% to $5.2 million, driven by costs associated with the initiation of new clinical trials, while general and administrative expenses decreased slightly.
In terms of strategic developments, Soligenix is advancing its product pipeline, particularly focusing on HyBryte™, a photodynamic therapy for cutaneous T-cell lymphoma (CTCL). Following the successful completion of a Phase 3 study, the company has begun patient enrollment for a second Phase 3 trial, FLASH2, with top-line results expected in the second half of 2026. Additionally, the company is expanding its research into psoriasis with SGX302 and is developing dusquetide (SGX942 and SGX945) for inflammatory diseases, including oral mucositis and Behçet’s Disease. The Public Health Solutions segment includes ongoing vaccine development programs for ricin toxin and filoviruses, supported by government grants.
Operationally, Soligenix employed 16 individuals as of December 31, 2024, including two part-time employees. The company has been actively pursuing additional government funding and strategic partnerships to support its research and development efforts. However, it faces significant challenges, including reliance on government contracts and grants, which are subject to budgetary constraints and may be terminated at any time. The company has also indicated that it may need to secure additional capital through equity offerings or strategic transactions to continue operations beyond 2025.
Looking ahead, Soligenix's management has expressed substantial doubt about the company's ability to continue as a going concern without securing additional funding. The company plans to explore various avenues for capital, including public or private equity offerings and government grants. The financial condition remains precarious, with cash and cash equivalents of approximately $7.8 million as of December 31, 2024, which may not be sufficient to support operations for the next 12 months. The company is also navigating the complexities of regulatory approvals and market acceptance for its product candidates, which could significantly impact its future revenue generation and overall viability.
About SOLIGENIX, INC.
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