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, issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.

Dear Friends and Shareholders,

I would like to start by thanking you for your continued support, and hope that you and your families had a healthy and happy holiday season. As we look ahead to 2022, we remain energized by the promise of our development pipeline as we continue to evaluate potential strategic options, including, but not limited to, partnership and merger and acquisition opportunities. The previously publicly disclosed upcoming key events and milestones for the year can be summarized as follows: submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing authorization of HyBryte (SGX301 or synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL); initiation of a Phase 2 clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin), where we have already validated the biologic activity of synthetic hypericin in CTCL and previously demonstrated positive proof of concept (PoC) in a small Phase 1/2 pilot study in psoriasis; pursuit of potential opportunities with dusquetide, the active ingredient in SGX942 that demonstrated biological efficacy in the per protocol population in our Phase 3 clinical study in oral mucositis in head and neck cancer (HNC), and potential anti-tumor efficacy in multiple preclinical xenograft studies; advancing our heat stable vaccine platform technology, including development of filovirus vaccine candidates (targeting Ebola, Sudan, and Marburg Viruses), a novel heat stable COVID-19 (Coronavirus Disease 2019) vaccine candidate, CiVax, and a ricin toxin vaccine, RiVax, where non-human primate (NHP) data for all three vaccine programs has demonstrated significant efficacy; and a final decision rendered from our arbitration with Emergent BioSolutions, Inc. and certain of its subsidiaries, where we are seeking to recover damages from Emergent regarding alleged issues experienced with the manufacture of the RiVax active ingredient at their contract facilities.

Additionally, we continue to follow through on our financing strategies, providing us with sufficient capital and cash runway to meet our goals into 2023 as we move towards U.S. commercialization of HyBryte in CTCL. We expect peak annual net sales of HyBryte in the U.S. to exceed $90 million, with the total addressable worldwide CTCL market estimated at approximately $250 million annually. Preliminary analysis of the total addressable worldwide psoriasis market opportunity with SGX302, which uses the same active ingredient as HyBryte, is significant and estimated to exceed $1 billion annually. Overall, we are excited about our near-term and future upcoming catalytic milestones.

Corporate Highlights

Since our last update, we have continued to advance our development programs across both the Specialized BioTherapeutics and Public Health Solutions business segments of our rare disease pipeline, where we currently anticipate achieving multiple important and potentially transformational milestones through 2023. We also continue to evaluate strategic options before us to better position the company for potential success. A more detailed review of the business is provided below.

Specialized Biotherapeutics Business Segment

At the end of 2020, we were very happy to announce completion of our pivotal Phase 3 FLASH ('Fluorescent Light Activated Synthetic Hypericin') study with HyBryte and share the continued positive benefits for our CTCL patients. Compared to the currently approved CTCL therapies for early disease, the treatment response to HyBryte was very rapid, being detected in as little as 6 weeks of treatment (Cycle 1, p=0.04). Responses continued to improve through 12 weeks of treatment (Cycle 2, p

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