Soligenix, Inc. announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte? treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). In U.S. Food and Drug Administration (FDA)-funded study, initial results evaluating the expanded use of HyBryte?

in a 'real world' treatment setting are promising, further supporting and extending results from the previous positive Phase 2 and 3 clinical trials. The clinical study RW-HPN-MF-01, "Assessment of Treatment with Visible Light Activated Synthetic Hypericin Ointment in Mycosis Fungoides Patients" is designed as an open-label, multicenter clinical trial enrolling up to 50 patients at select U.S. clinical centers. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.

HyBryte? has received orphan drug and fast track designations from the U.S. Food and drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA). Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successful obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into anyiodefense procurement contracts with the U.S. Government or other countries, that it will be ability to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program.

In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the first HyBryte? (SGX301) Phase 3 clinical trial will be successful or that a marketing authorization from the FDA or EMA will be granted.

Additionally, although the EMA has agreed to the key design components of the second HyBryte? ("SGX301) Phase 3clinical trial, no assurance can be given that the Company will be able to modify the development path to adequately address the FDA's concerns or that the FDA will not require a longer duration comparative study. Notwithstanding the result in the first HyBryTE?

(SGX301") Phase 3 clinical trial, the company will not require a longer duration comparison study.