Soligenix Soars: Groundbreaking Progress and Robust Financials Propel Q2 2025 Success

Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company, today announced a series of significant advancements across its clinical pipeline and reported its financial results for the second quarter ended June 30, 2025. The period was marked by pivotal progress in the company’s lead drug candidates and a reinforced financial position, underscoring a trajectory of innovation and strategic execution.Leading the charge, Soligenix's flagship program, SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL), continues to impress.The company proudly announced the successful completion of patient enrollment for its Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial.

This milestone brings SGX301 closer to potential market authorization, offering a non-invasive, light-based therapy for this challenging skin condition.Early indications from ongoing data analysis suggest the therapy continues to demonstrate a favorable safety profile alongside promising efficacy signals, reinforcing its potential to address a significant unmet medical need for CTCL patients.Beyond CTCL, Soligenix also made substantial strides in its Public Health Solutions segment.Development of RiVax®, the company’s heat-stable ricin toxin vaccine, progressed significantly with the submission of additional modules for its Biologics License Application (BLA) to the U.S.

Food and Drug Administration (FDA). RiVax® remains a critical component of national biodefense preparedness, and these submissions reflect the company's diligent efforts to bring this vital countermeasure to licensure.Furthermore, the company continues to advance its broad-spectrum therapeutic candidate, SGX942 (dusquetide), in preclinical studies, exploring its potential applications in inflammatory conditions and mucositis, demonstrating a diversified and robust pipeline.Financially, Soligenix reported a strong position at the close of the second quarter 2025.As of June 30, 2025, the company held cash and cash equivalents of approximately $35.2 million, providing a healthy runway to fund its ongoing clinical and regulatory activities well into 2026.

Research and development expenses for the quarter were $4.8 million, consistent with the increased activity across its clinical programs.General and administrative expenses were $2.1 million. The net loss for the quarter was $6.9 million, or $0.21 per share, reflecting the significant investment in advancing its promising therapeutic candidates.“The second quarter of 2025 has been exceptionally productive for Soligenix, marked by critical advancements across our key pipeline programs and a fortified financial foundation,” stated Christopher J.Schaber, Ph.D., President and Chief Executive Officer of Soligenix.

“The completion of enrollment for our SGX301 Phase 3 trial is a testament to our team’s dedication and the urgent need for new CTCL treatments. Concurrently, our continued progress with RiVax® underscores our commitment to public health.We are optimistic about the path ahead, with multiple catalysts anticipated in the coming months, and remain steadfast in our mission to develop innovative therapies that address serious unmet medical needs.”The company anticipates providing further updates on the SGX301 FLASH study readout and RiVax® regulatory progress in the latter half of 2025, solidifying its position as a leader in developing novel treatments for rare diseases and biodefense solutions...