MissionIRNewsBreaks – Soligenix Inc. (NASDAQ: SNGX) Reaches Enrollment Milestone in Phase 3 FLASH2 Trial for HyBryte(TM)

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Yesterday at 5:53pm UTC

Soligenix (NASDAQ: SNGX) is a New Jersey-based biopharmaceutical company focused on developing products to treat rare diseases where there is an unmet medical need. The company recently received updated analysis from Zacks Small-Cap Research following its announcement that milestone enrollment had been reached in the ongoing confirmatory Phase 3 FLASH2 trial of HyBryte(TM). The study focuses on the treatment of cutaneous T-cell lymphoma, with the overall blinded response rate standing at 48% for patients who have completed treatment. “In the Nov. 20, 2025, research report published by Zacks Small-Cap Research, 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 report maintains Zacks’ $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,” reads an article discussing the company.

“Looking ahead, the second quarter 2026 interim analysis represents the next major catalyst for Soligenix. The Zacks report expresses confidence that the trial is trending in the right direction based on the 48% blinded response rate, stating that ‘this update gives us a lot of 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.”

To view the full article, visit https://ibn.fm/e9XQ5

About Soligenix Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (“SGX301” or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). 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 (“SGX302”) into psoriasis, the company’s first-in-class innate defense regulator (“IDR”) technology, dusquetide (“SGX942”) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (“SGX945”) 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 (such as Marburg and Ebola) and CiVax(TM), the company’s vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of Soligenix’s vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grants and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Defense Threat Reduction Agency (“DTRA”) and the Biomedical Advanced Research and Development Authority (“BARDA”).

For further information, visit the company’s website at www.Soligenix.com.

NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX

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