Soligenix Reports $3.24 Million Net Loss in Q1 2025, Focuses on Clinical Trials

Soligenix, Inc. reported a net loss of $3.24 million for the first quarter of 2025, a significant increase from the $1.92 million loss recorded in the same period of 2024. This increase in net loss is attributed primarily to higher operating expenses, which rose to $3.31 million from $2.12 million year-over-year, driven by costs associated with ongoing clinical trials and a decrease in other income related to the fair value of convertible debt. The company did not generate any revenue during the quarter, a decline from $117,029 in grant revenue reported in the prior year.

The company's total assets decreased to $7.75 million as of March 31, 2025, down from $8.97 million at the end of 2024. Current assets also fell to $7.64 million, primarily due to a reduction in cash and cash equivalents, which stood at $7.30 million compared to $7.82 million at the end of the previous year. Current liabilities decreased to $4.13 million, down from $4.85 million, reflecting a reduction in accrued expenses and accounts payable. The accumulated deficit increased to $237.21 million, up from $233.97 million at the end of 2024.

Strategically, Soligenix is advancing its product pipeline, particularly focusing on its lead candidate, HyBryte™ (SGX301), for the treatment of cutaneous T-cell lymphoma (CTCL). The company has initiated patient enrollment for a second Phase 3 clinical trial, FLASH2, following positive results from the first Phase 3 study. The company anticipates top-line results from this trial in the second half of 2026. Additionally, Soligenix is expanding its research into other indications, including psoriasis and oral mucositis, with ongoing clinical trials for SGX302 and SGX942, respectively.

Operationally, Soligenix's research and development expenses surged to $2.23 million in Q1 2025, compared to $1.10 million in the same quarter of 2024, reflecting increased investment in clinical trials. The company is also exploring additional funding avenues, including public or private equity offerings and government grants, to support its operations and product development. As of the filing date, Soligenix had approximately $554,000 in active government grant funding available to support its research programs through May 2026.

Looking ahead, Soligenix faces substantial doubt regarding its ability to continue as a going concern, as it does not have sufficient cash to fund operations for the next 12 months. The company plans to secure additional capital and pursue strategic partnerships to alleviate these concerns. However, the success of these efforts remains uncertain, and the company acknowledges that failure to obtain adequate funding may necessitate delays or reductions in its business activities.