Soligenix Provides Updates on Recent Achievements and Q1 2025 Financial Performance

On May 9, 2025, Soligenix, Inc., a biopharmaceutical company traded on Nasdaq (SNGX), revealed its latest accomplishments and the financial outcomes for the first quarter of 2025, emphasizing its commitment to addressing rare diseases with significant unmet medical needs.

Soligenix’s President and CEO, Dr. Christopher J. Schaber, stated that the primary focus of the company is to push forward with its clinical programs, anticipating key milestones ahead. Notably, the company is actively enrolling patients for a Phase 3 confirmatory study on HyBryte™ (synthetic hypericin), aiming for early results to be released in 2026. Additionally, significant findings from ongoing Phase 2 studies involving SGX945 (dusquetide) for Behçet’s disease and SGX302 (synthetic hypericin) for psoriasis are expected in the latter half of this year.

As of March 31, 2025, Soligenix reported having approximately $7.3 million in cash, which facilitates continued operations into December 2025. Dr. Schaber emphasized the company’s intention to use its resources judiciously and explore strategic opportunities, which could include mergers and acquisitions, partnerships, government grants, or other financing options to enhance its late-stage pipeline.

Recent Accomplishments

Soligenix recorded two notable milestones recently:

1. Positive Interim Results for HyBryte™: On April 14, 2025, the company announced favorable interim results from an open-label investigator-initiated study examining HyBryte™ treatment, which has been administered to patients with early-stage cutaneous T-cell lymphoma (CTCL) for 18 weeks, with a planned extension to 54 weeks.

2. Publication on CiVax™ Efficacy: On March 25, 2025, Soligenix publicized the preclinical efficacy results of CiVax™, a thermostabilized subunit vaccine aimed at combating SARS-CoV-2.

Financial Highlights for Q1 2025

In terms of financial performance, Soligenix reported no revenue for the first quarter of 2025, a decline compared to $0.1 million from the same quarter last year. This change largely stems from a reduction in revenue linked to a zero-margin grant for the HyBryte™ study.

The company experienced a net loss of $3.2 million or $1.06 per share for this quarter, showing an increase from the previous year's $1.9 million (or $2.91 per share). This rise in net loss is attributed to higher operational costs stemming from ongoing clinical trials and a decline in other income linked to fluctuating debt valuations during the prior period.

Research and development expenditures for Q1 2025 were approximately $2.2 million, doubling the $1.1 million from Q1 2024, reflecting rising expenses due to the ongoing Phase 2 study for Behçet's disease and the second Phase 3 trial for CTCL treatments.

General and administrative costs were around $1.1 million, increasing slightly from $1.0 million in the previous year, primarily due to elevated professional fees and various taxes incurred.

Future Directions

Soligenix remains focused on its dual business segments. The Specialized BioTherapeutics division is working towards the potential commercialization of HyBryte™ as a new photodynamic therapy for treating CTCL. The success of this initiative depends on concluding the Phase 3 studies effectively and obtaining regulatory approvals that could allow for worldwide commercialization. Furthermore, the company is expanding its efforts in treating other conditions such as psoriasis and exploring the application of its first-in-class innate defense regulator technology.

In the Public Health Solutions division, projects targeting bioterror threats are in progress, including RiVax®, a vaccine for ricin toxin, alongside efforts concerning filoviruses and COVID-19. Funding from various government agencies has aided the development of these initiatives through grant mechanisms.

In summary, Soligenix is progressing with promising research in the biopharmaceutical sector, with proactive measures in financial and operational strategies aimed at fulfilling their mission of addressing critical healthcare needs in rare diseases and public health.