NASDAQ:SNGX
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Business Update
Phase 3 CTCL Trial to Initiate Before End of 2024
Soligenix, Inc. (NASDAQ:SNGX) is on track to initiate a confirmatory Phase 3 trial of HyBryte for the treatment of cutaneous T cell lymphoma (CTCL) before the end of 2024. The FLASH2 trial will be very similar in design to the Phase 3 FLASH trial, as shown in the following figure, which provides a comparison between the two studies. This similarity in design increases our confidence in a positive outcome for the FLASH2 trial. With the trial expected to begin enrollment prior to the end of 2024, we anticipate topline results in the second half of 2026. After reaching agreement with the European Medicines Agency (EMA) on the key design elements of the FLASH2 trial, the company is continuing discussions with the U.S. Food and Drug Administration (FDA) on an appropriate study design as the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial.
Results from Additional, Supportive Trials of HyBryte Presented at EORTC
On October 7, 2023, Soligenix announced that findings from recent additional, supportive trials with HyBryte in the treatment of CTCL were presented at the European Organization for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumor Group Annual Meeting. The presentations included:
• An oral presentation by Dr. Brian Poligone on results from two expanded treatment studies: HPN-CTCL-02 that showed a lack of significant systemic exposure to hypericin after topical application and HPN-CTCL-04 that showed HyBryte treatment was more effective than Valchlor® along with a more favorable safety profile.
• A poster presentation by Dr. Ellen Kim that presented results from an investigator-initiated study examining longer treatment times with hypericin in CTCL. Thus far, eight patients have enrolled and six are actively receiving treatment (two patients withdrew for logistical reasons). One patient completed 55 weeks, two completed at least 25 weeks, and three completed at least five weeks. Results show that 3/4 (75%) of patients who have received treatment for at least 18 weeks have achieved the primary endpoint of index lesion response rate, defined as ≥50% reduction in mCAILS score of index lesions from baseline to end of treatment. There have been no serious adverse events reported. Enrollment is continuing with the potential to include additional sites.
Partnership Agreement for Hypericin Production
On October 3, 2024, Soligenix announced a manufacturing partnership agreement with Sterling Pharma Solutions for a scalable production technology for synthetic hypericin, which is the active pharmaceutical ingredient in the topical drug product formulations for HyBryte and SGX302. The two companies are currently working to transfer and optimize the manufacturing processes to enable GMP manufacturing and establish a long-term collaboration. The ultimate goal is to reduce the overall cost of goods as the company pushes toward potential commercialization.
Financial Update
On November 9, 2024, Soligenix announced financial results for the third quarter of 2024. The company reported no revenues for the third quarter of 2024, compared to $0.1 million for the third quarter of 2023. The revenues are derived from government contracts and grants to support the development of SGX943 for treatment of emerging and/or antibiotic resistant infectious diseases, development of CiVax™, and evaluation of HyBryte for expanded treatment in patients with early-stage CTCL. R&D expenses for the third quarter of 2024 were $1.0 million, compared to $0.8 million for the third quarter of 2023. The increase was primarily due to the initiation of the Phase 2 trial in Behcet’s disease and the second Phase 3 CTCL trial. G&A expenses for the third quarter of 2024 were $0.9 million, compared to $1.0 million for the third quarter of 2023. The decrease was primarily due to a decrease in legal and professional fees.
Soligenix exited the third quarter of 2024 with approximately $9.8 million in cash and cash equivalents. As of November 1, 2024, Soligenix had approximately 2.5 million shares outstanding, and when factoring in stock options, warrants, and the potential convertible debt the fully diluted share count is approximately 4.4 million.
Conclusion
We look forward to the initiation of the confirmatory Phase 3 trial in CTCL for HyBryte and the Phase 2 trial in Behcet’s disease for SGX942 before the end of 2024. Looking ahead to next year, we anticipate data from the ongoing Phase 2 trial of SGX302 in mild-to-moderate psoriasis and the Phase 2 trial in Behcet’s disease to be available in the first half of 2025. With no changes to our model our valuation remains at $35 per share.
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