Soligenix Announces Recent Accomplishments And 3rd Quarter 2022 Financial Results.

PRINCETON, N.J: Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2022.

"We have continued to achieve significant milestones across our development pipeline in 2022. The most important is still to come this quarter with the filing of our new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We were also pleased with the FDA Orphan Products Development grant award of a $2.6 million over 4 years to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home setting. Additionally, we are advancing synthetic hypericin development into other disease indications, such as psoriasis, where we plan to work in conjunction with our recently established Medical Advisory Board (MAB) to initiate a Phase 2a clinical study for the treatment of mild-to-moderate psoriasis in December.

Supported by funding from the National Institute of Allergy and Infectious Diseases, we were able to demonstrate 100% protection of non-human primates against both lethal Sudan ebolavirus and Marburg marburgvirus challenge with our SuVax and MarVax vaccines, respectively. With the achievement of these important milestones, we were fortunate to receive an invitation by the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures to submit a full contract proposal for the further development of these novel vaccine candidates as medical countermeasures for use in the event of a Sudan ebolavirus or Marburg marburgvirus outbreak. While an invitation to submit a contract proposal is not a guarantee of funding, we believe that we are well-positioned to receive BARDA development support for this indication allowing us to further demonstrate the growing body of compelling scientific evidence supporting our heat stable filovirus vaccine platform, including vaccine candidates directed towards Sudan ebolavirus and Marburg marburgvirus."

Dr. Schaber continued, "With approximately $16.9...