Soligenix Inc Stock Price, News & Analysis

Soligenix (NASDAQ:SNGX) reported its Q2 2025 financial results and recent accomplishments. The company posted a net loss of $2.7 million ($0.82 per share) compared to $1.6 million ($1.31 per share) in Q2 2024. The company held $5.1 million in cash as of June 30, 2025, plus $1.4 million received via ATM facility on July 1, providing runway through Q1 2026.

Key developments include completion of Phase 2a proof of concept study for SGX945 in Behçet's Disease, successful manufacturing transfer of synthetic hypericin to the US, and ongoing clinical trials. The company expects top-line results from Phase 2a psoriasis trial with SGX302 before year-end 2025, and anticipates Phase 3 HyBryte™ CTCL study results in 2026.

Soligenix (NASDAQ: SNGX) is advancing its HyBryte™ platform to address the growing need for effective treatments in cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer primarily affecting older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient.

The development comes amid increasing healthcare challenges related to rare diseases, which affect over 30 million Americans. The initiative aligns with the "Make America Healthy Again" program, which aims to improve treatment access and accelerate medical innovation, particularly for an aging population facing complex healthcare needs and often experiencing diagnostic delays.

Soligenix (NASDAQ: SNGX) is advancing its HyBryte™ platform to address the growing need for treatments in rare diseases, specifically targeting cutaneous T-cell lymphoma (CTCL), a rare skin cancer affecting primarily older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient.

This development aligns with healthcare initiatives aimed at improving treatment access and accelerating medical innovation, particularly relevant as over 30 million Americans live with rare diseases. The company's focus on CTCL represents a strategic move to address an underserved therapeutic area, especially significant given the aging American population and the challenges in diagnosing rare diseases in seniors.

Soligenix (NASDAQ: SNGX) has announced positive results from its Phase 2a clinical trial of SGX945 (dusquetide) for treating Behçet's Disease. The study demonstrated biological efficacy comparable to the approved drug apremilast (Otezla®), showing a 40% improvement in oral ulcers versus placebo after 4 weeks of treatment.

Key findings include sustained improvement even 4 weeks after treatment cessation, with 7 out of 8 patients reporting benefits. Unlike apremilast, which requires continuous administration and has side effects like diarrhea (41%), nausea (19%), and headache (14%), SGX945 showed no treatment-related adverse events. The company plans to reformulate SGX945 for subcutaneous home-based treatment and proceed with a placebo-controlled Phase 2 study.

Soligenix (Nasdaq: SNGX) provided a corporate update highlighting key developments and upcoming milestones. The company's late-stage rare disease pipeline includes HyBryte™ for cutaneous T-cell lymphoma (CTCL), with top-line results from the 80-patient Phase 3 FLASH2 trial expected in H2 2026. The trial has shown promising results with 75% treatment success after 18 weeks of continuous treatment.

Additional pipeline developments include SGX302 for psoriasis with Phase 2a results expected in Q4 2025, and SGX945 for Behçet's Disease with Phase 2a results anticipated in Q3 2025. The company projects potential peak annual U.S. sales of $90 million for HyBryte™, with a total addressable global market of over $2B across all programs. Soligenix reports approximately $7 million in cash, providing runway into Q1 2026.

Soligenix (Nasdaq: SNGX) has successfully completed the transfer of synthetic hypericin manufacturing from Europe to the United States through its partnership with Sterling Pharma Solutions. The manufacturing process transfer includes optimization and implementation of a commercially viable, scalable production process for the active ingredient used in HyBryte™ and SGX302 formulations.

The synthetic hypericin is being developed for treating cutaneous T-cell lymphoma (CTCL) and psoriasis. The companies have established cGMP manufacturing capabilities for clinical trials and are working towards a long-term commercial manufacturing collaboration. Sterling's expertise includes innovative solutions such as continuous flow chemistry for this product.

Soligenix (SNGX) highlights Dr. Ellen Kim's Q&A discussion regarding HyBryte™, their novel photodynamic therapy for treating cutaneous T-cell lymphoma (CTCL). Dr. Kim, Lead Principal Investigator for Phase 3 FLASH studies, emphasized the urgent need for safer CTCL treatments, noting no new FDA-approved skin-directed therapy in over 10 years. HyBryte™ shows promising clinical results with unique advantages: it's non-mutagenic, doesn't damage DNA, has no systemic absorption, and is well-tolerated. The therapy specifically targets mycosis fungoides, the most common form of CTCL, with no serious adverse events reported in trials. Dr. Kim, who serves as a professor at the University of Pennsylvania and Director of the Penn Cutaneous Lymphoma Program, expressed optimism about ongoing clinical trials and their potential impact on early-stage CTCL treatment.

Soligenix (SNGX) reported its Q1 2025 financial results and recent accomplishments. The company posted a net loss of $3.2 million ($1.06 per share), compared to $1.9 million ($2.91 per share) in Q1 2024. Research and development expenses increased to $2.2 million, up from $1.1 million in the previous year. The company reported no revenue for Q1 2025, down from $0.1 million in Q1 2024. As of March 31, 2025, Soligenix maintained a cash position of $7.3 million, which is expected to sustain operations through December 2025. The company anticipates key milestones including top-line results from its Phase 3 HyBryte™ study for CTCL in 2026 and Phase 2 results for SGX945 and SGX302 in H2 2025.

Soligenix (SNGX) announced positive interim results from an FDA-funded study evaluating extended HyBryte™ treatment for early-stage cutaneous T-cell lymphoma (CTCL). After 18 weeks of treatment, 75% of patients achieved Treatment Success, defined as ≥50% improvement in mCAILS score.

Of the eight evaluable patients through Week 18, four completed the 54-week treatment with an average maximum improvement of 85% in mCAILS score, three remain on treatment, and one dropped out due to logistical issues. The study, led by Dr. Ellen Kim at Penn Cutaneous Lymphoma Program, demonstrates HyBryte's™ rapid response compared to other CTCL therapies that typically take 6-12 months for meaningful results.

The ongoing open-label study aims to enroll approximately 20 patients, supported by an FDA Orphan Products Development Grant of up to $2.6 million. The results reinforce HyBryte's™ potential as a safe and fast-acting therapy for this rare cancer.