On May 9, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2025 (Press release, Soligenix, MAY 9, 2025, View Source [SID1234652827]).
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"Our strategic focus remains on advancing our clinical programs, and we anticipate several significant development milestones. These include top-line results in 2026 from our actively enrolling Phase 3 confirmatory study of HyBryte (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (CTCL). Furthermore, we expect to report top-line results in the second half of this year from our ongoing Phase 2 studies of SGX945 (dusquetide) in Behçet’s disease and SGX302 (synthetic hypericin) in mild-to-moderate psoriasis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
Dr. Schaber continued, "With approximately $7.3 million in cash at March 31, 2025, we are committed to allocating resources responsibly to achieve our strategic goals and near-term milestones. While this cash balance provides sufficient operating runway through December 2025, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."
Soligenix Recent Accomplishments
On April 14, 2025, the Company announced positive interim results following 18 weeks of treatment from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte treatment for up to 54 weeks in patients with early-stage CTCL. To view this press release, please click here.
On March 25, 2025, the Company announced a publication describing the preclinical efficacy of CiVax, a thermostabilized subunit vaccine against SARS-CoV-2. To view the publication, please click here. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2025
Soligenix reported no revenue for the quarter ended March 31, 2025, compared to $0.1 million for the prior quarter ended March 31, 2024. The decrease was primarily related to a decrease in revenue associated with the zero-margin grant for the HyBryte IIS.
Soligenix’s net loss was $3.2 million, or ($1.06) per share, for the quarter ended March 31, 2025, compared to $1.9 million, or ($2.91) per share, for the quarter ended March 31, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in other income attributable to the change in the fair value of debt during the three months ended March 31, 2024 with no corresponding change in fair value during the three months ended March 31, 2025.
Research and development expenses were $2.2 million for the quarter ended March 31, 2025 as compared to $1.1 million for the same period in 2024. The increase was primarily due to costs associated with our Phase 2 study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial as well as increases in third party manufacturing.
General and administrative expenses were $1.1 million for the quarter ended March 31, 2025 as compared to $1.0 million for the same period in 2024. The increase was primarily attributable to increases in professional expenses and various taxes.
As of March 31, 2025, the Company’s cash position was approximately $7.3 million.