Soligenix Updates on Pipeline Progress and Future Directions

Key Highlights of Soligenix

Welcome, dear shareholders and friends! At Soligenix, Inc. (NASDAQ: SNGX), we are excited to share our progress as we navigate the landscape of rare disease treatments. Our commitment to developing innovative therapies for those with great medical needs continues to drive our efforts. In this update, we will outline our milestones, financial strategies, and the promising pathways we foresee as we look ahead.

Clinical Milestones on the Horizon

As we usher in the future, we are particularly thrilled about our late-stage clinical trials, especially focused on HyBryte™ for cutaneous T-cell lymphoma (CTCL). The confirmatory Phase 3 FLASH2 trial is currently enrolling for 80 patients, with results expected in the not-so-distant future. This trial aims to assess the effectiveness of our synthetic hypericin therapy over an extended treatment period.

Details on the FLASH2 Clinical Trial

The FLASH2 study marks an important replication of our initial FLASH study, with adjustments that enhance our data's reliability. Significantly, we are transitioning the primary endpoint assessment to allow a longer evaluation period of 18 weeks instead of 6 weeks, aligning with positive trends observed in prior studies. We anticipate delivering preliminary results that can further validate HyBryte’s therapeutic potential, improving the lives of CTCL patients.

Ongoing Investigations and New Opportunities

In conjunction with our CTCL research, we also remain dedicated to exploring other rare diseases, including mild-to-moderate psoriasis and Behçet's Disease with our compounds SGX302 and SGX945. Results from ongoing Phase 2a trials in these areas are expected, providing us a glimpse into the possible effectiveness of our therapies in treating these challenging conditions.

Pioneering Psoriasis Treatment

Our focus on psoriasis is particularly significant as it affects millions globally. With an estimated market valuation projected to rise dramatically over the next few years, SGX302 could be a game-changer. This treatment employs a novel approach by utilizing visible light for its therapeutic effects, setting it apart from conventional UV light therapies that come with significant long-term risks.

Financial Health and Strategic Planning

To support our ambitious clinical pipeline, we are executing well-planned financing strategies to ensure adequate funding through 2026. Anticipated peak sales for HyBryte™ in the American market alone could surpass $90 million, contributing to a potentially lucrative opportunity as we eye a $1 billion market in psoriasis treatments alone. With these financial backing and market assessments, we are poised for growth.

Market Potential for New Treatments

Beyond our existing treatments, we are also evaluating the business potential surrounding our other therapeutic options, including dusquetide for Behçet's Disease. The scope for development in this area is promising, considering the need for effective management strategies for patients suffering from this painful condition.

Commitment to Partnership and Expansion

Firmly, we are continuing our discussions with potential partners to expand our reach beyond the U.S. market. Our focus remains on collaborations that can complement our expertise in rare disease therapeutics, ensuring we can propel our programs toward successful commercialization.

Manufacturing Capabilities for the Future

Supporting our clinical advancements, we have successfully transitioned the manufacturing of synthetic hypericin to a local facility, enhancing our capacity to meet future demand as we aim for larger batch productions. This step positions us well for the upcoming phases of regulatory submissions.

Looking Ahead

As we approach the latter half of this year and move into 2026, we are filled with optimism regarding our developmental prospects across various indications. With significant catalysts on the horizon, we are excited about the potential impact our innovations can have on patient care globally.

Frequently Asked Questions

What is Soligenix focused on currently?

Soligenix is currently focused on advancing its late-stage clinical trials for treatments in rare diseases, notably involving HyBryte™ for CTCL.

When can we expect results from the FLASH2 trial?

Preliminary results from the FLASH2 trial are expected in the second half of 2026, assessing the efficacy of HyBryte™ over 18 weeks of treatment.

How does SGX302 differ from traditional treatments for psoriasis?

SGX302 utilizes safe visible light rather than UV light, which can lead to fewer long-term risks typically associated with standard psoriasis treatments.

What are the anticipated financial outcomes for HyBryte™?

We anticipate peak annual net sales for HyBryte™ in the U.S. could exceed $90 million, contributing to substantial revenue streams.

Are there plans for partnerships to aid market expansion?

Yes, we are actively pursuing strategic partnerships with companies that have expertise in rare diseases to enhance our market reach and capabilities.

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