On July 9, 2024, Soligenix, Inc. (SNGX) announced positive interim results for HyBryte in an open-label, investigator-initiated study in patients with early-stage cutaneous T cell lymphoma (CTCL). Of the patients that have completed 12 weeks of therapy, 3 of 4 (75%) have achieved "Treatment Success", which is defined as =50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity). Two patients have not reached their first efficacy evaluation visit (i.e., at Week 6) and the last patient had a substantial improvement documented by Week 18 but had not yet achieved the success threshold. In addition, the company announced positive results from a comparator trial of HyBryte and Valchlor , in which HyBryte showed better tolerability and a more robust treatment response. Both of these results increase our confidence in a positive outcome to the upcoming Phase3 FLASH2 trial of HyBryte in CTCL and our valuation has increased to $35.
