• Q1 milestones are representative of Soligenix’s commitment to advance its pipeline of therapeutic candidates, focusing on areas with significant unmet medical needs.
• The company noted positive interim results from the ongoing open-label, investigator-initiated study (“IIS”) evaluating extended HyBryte(TM) treatment.
• Soligenix announced the release of a publication describing the preclinical efficacy of CiVax(TM), a thermostabilized subunit vaccine against SARS-CoV-2.

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company dedicated to developing and commercializing treatments for rare diseases, recently announced its financial results for the first quarter of 2025, alongside a summary of the company’s latest accomplishments (https://ibn.fm/OMQmM). These milestones are representative of Soligenix’s continued commitment to advance its pipeline of therapeutic candidates, focusing on areas with significant unmet medical needs.

“Our strategic focus remains on advancing our clinical programs, and we anticipate several significant development milestones,” said Soligenix CEO and president Christopher J. Schaber, PhD. “These include top-line results in 2026 from our actively enrolling phase 3 confirmatory study of HyBryte(TM) [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.”

Among its recent accomplishments, last month Soligenix announced positive interim results from the ongoing open-label, investigator-initiated study (“IIS”) evaluating extended HyBryte(TM) treatment (https://ibn.fm/KrWyY). The study followed patients with early-stage CTCL for up to 54 weeks. “Following 18 weeks of treatment, 75% of patients achieved treatment success, reinforcing HyBryte as a potentially safe and fast-acting therapy for this chronic and underserved cancer,” the company reported.

Earlier this year, Soligenix announced the release of a publication describing the preclinical efficacy of CiVax(TM), a thermostabilized subunit vaccine against SARS-CoV-2 (https://ibn.fm/hjvcX). According to the announcement, “using custom-developed immunoassays, the combination of a primary adenovirus vaccine (COVID-19 Vaccine AstraZeneca) coupled with a CiVax(TM) booster was shown to induce broader protection against COVID-19 variants in non-human primates than a two-shot mRNA series (such as the Moderna vaccine Spikevax(R) or the Pfizer vaccine Cominarty(R)) in humans.”

The report, entitled “Use of a Multiplex Immunoassay Platform to Investigate Multifaceted Antibody Responses in SARS-CoV-2 Vaccinees With and Without Prior Infection,“ was published in the COVID journal. It was released in collaboration with Dr. Axel Lehrer, a professor in the Department of Tropical Medicine, Medical Microbiology and Pharmacology at John A. Burns School of Medicine at the University of Hawaiʻi.

“The CiVax(TM) vaccine has demonstrated broad and robust immune responses in mice, which has been recapitulated in NHPs and further shown to yield protection against infection with COVID-19 variants of concern,” said Lehrer. “The rapid-onset, multivariant booster response with CiVax(TM) in a heterologous or mixed prime-boost approach further supports the broad-spectrum utility of our vaccine candidate.”

Regarding its financial report, 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 report noted that the decrease in revenue was primarily related to a decrease in revenue associated with the zero-margin grant for the HyBryte(TM) IIS.

As of March 31, 2025, the company’s cash position was approximately $7.3 million. “We are committed to allocating resources responsibly to achieve our strategic goals and near-term milestones,” stated Schaber. “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.”

For more information, visit 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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