- The report maintains $25 per share valuation for Soligenix, based on a probability-adjusted discounted cash flow model that considers potential future revenues.
- The centerpiece of the Zacks analysis focuses on what is characterized as a “very encouraging” 48% blinded response rate.
- With 50 patients now enrolled out of a planned 80-patient study, the company remains on track for the interim analysis to occur in the second quarter of 2026.
When a late-stage clinical trial reports response rates nearly double what researchers expected, yet the stock market barely reacts, seasoned analysts take notice and wonder if investors are missing something significant. Soligenix (NASDAQ: SNGX), a New Jersey-based biopharmaceutical company focused on developing products to treat rare diseases where there is an unmet medical need, recently received updated analysis from Zacks Small-Cap Research following its announcement that milestone enrollment had been reached in the ongoing confirmatory Phase 3 FLASH2 trial of HyBryte(TM) for the treatment of cutaneous T-cell lymphoma, with the overall blinded response rate standing at 48% for patients who have completed treatment (https://ibn.fm/Ol9Er).
In the Nov. 20, 2025, research report published by Zacks Small-Cap Research, expert analysis indicated strong conviction about the 50-patient enrollment milestone and encouraging clinical results while noting puzzlement at the market’s subdued response. The report maintains Zacks’ $25 per share valuation for Soligenix, based on a probability-adjusted discounted cash flow model that considers potential future revenues from the company’s product pipeline, including HyBryte, SGX302 and SGX945. This valuation represents substantial upside potential from the stock’s Nov. 20, 2025, closing price of $1.32, though the report acknowledges the model is dependent upon continued clinical success and will be adjusted accordingly based upon future results.
The centerpiece of the Zacks analysis focuses on what is characterized as a “very encouraging” 48% blinded response rate. To understand why this figure carries such weight, the report walks readers through the statistical assumptions that underpinned the FLASH2 study design. Soligenix powered the trial using an anticipated overall blinded study response rate of 25%, which incorporated conservative assumptions of a 40% response rate in the HyBryte treatment arm and a 10% response rate in the placebo arm through 18 weeks of treatment. The 25% blinded rate represents the average of these two figures, assuming roughly equal enrollment between treatment and placebo cohorts. While acknowledging that exact numbers may vary, the report emphasizes that the fundamental point remains compelling: for the blinded response rate to reach 48%, the active treatment arm is likely exhibiting a very robust response rate.
This mathematical analysis gains additional credibility when compared against ongoing independent research. Dr. Ellen Kim, director of the Penn Cutaneous Lymphoma Program and lead investigator of the FLASH2 study, has reported a 75% response rate after 18 weeks of treatment in an open-label, investigator-initiated study (“IIS”) currently being conducted at the University of Pennsylvania (https://ibn.fm/0wPtV). The Zacks report notes that if the blinded FLASH2 data were to suggest an 86% response rate in the active arm, this would actually exceed even Kim’s impressive 75% finding.
The report explicitly addresses what it calls a puzzling market reaction to the enrollment milestone announcement. Despite what the report views as highly encouraging clinical data, the stock price response was muted. The Zacks analysis concludes that “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%.” The report notes that “we were somewhat perplexed by the muted response by the stock” given what it views as very encouraging results.
The timing implications also receive significant attention in the Zacks report. With 50 patients now enrolled out of a planned 80-patient study, the company remains on track for the interim analysis to occur in the second quarter of 2026. This interim analysis, to be conducted by an independent Data Monitoring Committee, represents a critical inflection point for the program.
The valuation methodology employed by Zacks centers on a probability-adjusted discounted cash flow model that incorporates potential future revenues from three key pipeline assets: HyBryte for cutaneous T-cell lymphoma, SGX302 for psoriasis and SGX945 for Behçet’s disease. The commercial opportunity underlying the Zacks valuation becomes clearer when considering the patient population. Cutaneous T-cell lymphoma affects approximately 31,000 individuals in the United States with approximately 3,200 new cases annually. Currently, there is no FDA-approved first-line therapy specifically for early-stage CTCL, creating an opportunity for HyBryte to potentially become the first photodynamic therapy to receive such approval if the FLASH2 trial proves successful.
Looking ahead, the second quarter 2026 interim analysis represents the next major catalyst for Soligenix. The Zacks report expresses confidence that the trial is trending in the right direction based on the 48% blinded response rate, stating that “this update gives us a lot of confidence that the trial is at the very least trending in the right direction.” With no changes to the financial model following the enrollment milestone, the valuation remains at $25 per share, representing the report’s view that the risk-reward profile remains attractive for investors willing to accept the inherent uncertainties of late-stage clinical development.
For more information, visit www.Soligenix.com.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
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