Soligenix Reaches Enrollment Milestone in Phase 3 FLASH2 Trial for HyBryte

Soligenix Inc. (NASDAQ: SNGX) has reached a significant enrollment milestone in its ongoing confirmatory Phase 3 FLASH2 trial for HyBryte(TM), a treatment for cutaneous T-cell lymphoma. The company recently received updated analysis from Zacks Small-Cap Research following this announcement, with the overall blinded response rate standing at 48% for patients who have completed treatment. According to a research report published by Zacks Small-Cap Research on November 20, 2025, expert analysis indicated strong conviction about the 50-patient enrollment milestone and encouraging clinical results while noting puzzlement at the market's subdued response.

The Zacks report maintains a $25 per share valuation for Soligenix, based on a probability-adjusted discounted cash flow model that considers potential future revenues from the company's product pipeline, including HyBryte, SGX302 and SGX945. The report expresses confidence that the trial is trending in the right direction based on the 48% blinded response rate, stating that this update gives confidence that the trial is at the very least trending in the right direction. With no changes to the financial model following the enrollment milestone, the valuation remains at $25 per share, representing the report's view that the risk-reward profile remains attractive for investors willing to accept the inherent uncertainties of late-stage clinical development.

Looking ahead, the second quarter 2026 interim analysis represents the next major catalyst for Soligenix. The company's Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, the company's first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and in Behçet's disease.

The company's Public Health Solutions business segment includes development programs for RiVax(R), its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses and CiVax(TM), the company's vaccine candidate for the prevention of COVID-19. The development of Soligenix's vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax(R). This business segment has been supported with government grants and contract funding from the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency and the Biomedical Advanced Research and Development Authority. For further information, visit the company's website at https://www.Soligenix.com.

The latest news and updates relating to SNGX are available in the company's newsroom at https://ibn.fm/SNGX. The full article discussing the company's milestone can be viewed at https://ibn.fm/e9XQ5. MissionIR, which published the press release, is a specialized communications platform with a focus on assisting IR firms with syndicated content to enhance the visibility of private and public companies within the investment community. For more information, please visit https://www.MissionIR.com.