NASDAQ:SNGX
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Business Update
Phase 3 CTCL Trial Continues
Soligenix, Inc. (NASDAQ:SNGX) is currently conducting the Phase 3 FLASH2 trial of HyBryte™ in patients with CTCL. The FLASH2 trial is very similar in design to the successful Phase 3 FLASH trial, as shown in the following figure, which provides a comparison between the two studies. One key difference between the trials is that in the FLASH trial patients were treated for three cycles of six-weeks each, with a two-week break in between cycles and the primary efficacy endpoint was measured after the first treatment cycle, while in the FLASH2 trial patients will be treated for 18 consecutive weeks before the primary efficacy endpoint is assessed. Based on the results from the FLASH trial, we believe the FLASH2 trial has a high probability of success and we anticipate topline results in 2026.
Interim Data from IIS Study Shows 75% Response Rate and Three Complete Responses
In April 2025, Soligenix announced interim data from the ongoing, open label, investigator-initiated study (IIS) of HyBryte™ (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T cell lymphoma (CTCL). Thus far, eight patients could be evaluated through Week 18. The results show that six (75%) achieved ‘treatment success’, which is defined as a ≥50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to baseline. In addition, four patients have completed the 54-week treatment period and showed an average maximum improvement in mCAILS score of 85%. Three other patients are still on treatment and one patient dropped out of the trial due to a logistical issue. In addition to the 75% treatment success rate, thus far three patients have achieved a complete response. Lastly, HyBryte continues to appear to be safe and well tolerated in all patients.
The 75% treatment success rate at 18 weeks in the IIS is particularly important in regards to the ongoing FLASH2 trial, which as indicated above is evaluating the primary endpoint of treatment success after 18 weeks of therapy. The robust results from the IIS adds to our confidence that the FLASH2 trial will ultimately be a success, and with many other CTCL therapies taking six to 12 months to generate a clinically meaningful response, we believe results like these for HyBryte support its eventual commercial success, if approved.
Financial Update
On May 9, 2024, Soligenix announced financial results for the first quarter of 2025. The company reported no revenue for the first quarter of 2025, compared to $0.1 million for the first quarter of 2024. The decrease was primarily related to a decrease in revenue associated with the zero-margin grant for the HyBryte IIS. R&D expenses for the first quarter of 2025 were $2.2 million, compared to $1.1 million for the first quarter of 2024. The increase was primarily due to costs associated with the Phase 2 study in Behcet’s Disease and the confirmatory Phase 3 CTCL trial along with third-party manufacturing costs. G&A expenses for the first quarter of 2025 were $1.1 million, compared to $1.0 million for the first quarter of 2024. The increase was primarily due to an increase in professional expenses and various taxes.
Soligenix exited the first quarter of 2025 with approximately $7.3 million in cash and cash equivalents. We estimate this is sufficient to fund operations through the end of 2025. As of May 2, 2025, Soligenix had approximately 3.3 million shares outstanding, and when factoring in stock options and warrants, a fully diluted share count of approximately 5.0 million.
Conclusion
We expect an enrollment status update for the ongoing confirmatory Phase 3 trial of HyBryte in CTCL in the second half of 2025 and topline results to be reported in 2026. Based on the data from the IIS we are very confident that the confirmatory Phase 3 trial will be successful. In addition to the update for the HyBryte Phase 3 trial, we also anticipate topline results from the Phase 2 trial of SGX945 in Behcet’s Disease and SGX302 in mild-to-moderate psoriasis in the second half of 2025. With no changes to our model, our valuation remains at $35 per share.
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