By David Bautz, PhD
NASDAQ:SNGX
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Business Update
Enrollment in FLASH2 Trial Reaches 50; Interim Analysis in 2Q26
On November 19, 2025, Soligenix, Inc. (NASDAQ:SNGX) announced that enrollment in the FLASH2 trial of HyBryte™ for the treatment of cutaneous T cell lymphoma (CTCL) has reached 50 participants out of a scheduled 80. Now that 50 patients are enrolled, the planned interim analysis will take place in the second quarter of 2026. The company also revealed that the overall blinded study response rate for participants that have completed treatment thus far is 48%. We believe this is indicative of a very high response rate in treated patients.
Soligenix powered the FLASH2 trial using an anticipated overall blinded study response rate of 25%, which included a very conservative 40% response rate in the HyBryte arm and a 10% response rate in the placebo arm through 18 weeks. Assuming an even number of patients were enrolled into each cohort, the 25% is calculated by combining the two response rates ((40%+10%)/2). Thus, in order for the blinded response rate to be 48%, we believe the treated cohort would need to be far exceeding the powering assumptions, so long as the placebo response rate is not unusually high.
If the two cohorts in the blinded response rate analysis were equal, and the placebo response rate was 10% (the same that was used in the powering assumptions for the trial), that would mean the active response rate would be 86% ((86%+10%)/2=48%)! Thus far, Dr. Ellen Kim has seen a response rate of 75% after 18 weeks of treatment in the open-label, investigator-initiated study currently being conducted at the University of Pennsylvania, so 86% would even far exceed that. While the numbers may not be exact, the point of this exercise is to show that for the blinded response rate to be 48%, assuming there have been a relatively equal number of patients that have finished treatment from each cohort, and unless the placebo response is drastically higher than previously seen, the active arm is likely exhibiting a very robust response rate. Of course, we will not know the details until the data are unblinded; however, this update gives us a lot of confidence that the trial is at the very least trending in the right direction.
Conclusion
We believe the 48% blinded response rate is very encouraging, and we were somewhat perplexed by the muted response by the stock. While we need to wait for the data to be unblinded to know for sure, unless there is an unprecedented response rate among placebo-treated patients, we estimate that the response rate in the HyBryte cohort is likely similar to that seen in the ongoing IIS of 75%. We look forward to the results of the interim analysis, and with no changes to our model, our valuation remains at $25 per share.
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