Soligenix is Ready for Commercialization of SGX301 (HyBryte(TM)); FDA Has Approval Process on Fast Track


New York, New York–(Newsfile Corp. – February 23, 2021) – PCG Digital — Operational efficiency and sound financial management lead to positive results. That statement sums up why Soligenix (NASDAQ: SNGX) is fast approaching a new drug application (NDA) submission and potential FDA approval for SGX301 (synthetic hypericin), a photodynamic treatment option to battle the debilitating effects of cutaneous T-Cell lymphoma (CTCL).

The most recent treatment option in their rare disease pipeline, SGX301, will potentially be known as HyBryte following an FDA approval. Soligenix already has the key management and marketing plan in place for seamless commercialization, a rarity in the pharmaceutical world.

According to Soligenix CEO Dr. Christopher Schaber, the company is not looking to partner with other biopharmaceutical companies to market and distribute the new product in the U.S. SNGX has the cash reserves and resources to commercialize the product on its own.

Due to its orphan market status and that the product addresses an area of unmet medical need, SGX301 has received fast-track designation by the FDA to accelerate potential approval, which means it could be commercially available for clinical use as soon as the latter part of next year. As a rare early-stage first-line treatment option, Soligenix is expecting significant adoption by dermatologists treating this chronic cancer.

Peak US Sales for SGX301 are Estimated at $90 Million

Pre-launch costs are projected at approximately $7 million with annual sales and marketing costs coming in around $10 million. Soligenix can float that in cash if they need to. They have over $20 million in the bank. They also have an ATM with B. Riley worth another $20 million.

With US peak sales estimated to exceed $90 million and a CTCL market desperate for new treatment options, SGX301 looks like a home run. The product, which is a topical ointment activated by visible fluorescent light, appears to be effective, safe, and has the potential to be self-administered at home by the patient in the future.

CTCL is a rare form of Non-Hodgkin Lymphoma (NHL) that manifests itself in patches, tumors and plaque lesions. Roughly 25,000 Americans are currently suffering from the disease. It can be fatal in later stages, but SGX301 was developed to be used for early stage, which makes up almost 90% of the CTCL population, to potentially slow the disease progression.

There’s a need for the product and positive Phase 3 data to support SGX301 approval. CTCL affects over 40,000 NHL patients worldwide and there’s currently no cure available. Advanced stage patients develop a condition called Sezary syndrome (SS), which has a five-year survival rate of 24%. Early stage CTCL, aka Mycosis fungoides (MF), has a 5-year survival rate of 88%.

Promising Biotherapeutics and Vaccine Candidates in the SNGX Pipeline

Unlike many of their competitors, Soligenix isn’t going “all-in” on one product launch. Their biotherapeutics pipeline includes treatments for a number of inflammatory diseases, such as pediatric Crohn’s Disease, and radiation enteritis, all in various stages of clinical trials. Here’s what to look forward to:

  • SGX203 (for Pediatric Crohn’s disease): Another first of its kind treatment in an orphan market, SGX203 is an oral steroid formulation that coats the gastrointestinal tract to reduce inflammation, but it isn’t likely to circulate in the blood. This eliminates many of the systemic side effects of existing steroid treatments for pediatric Crohn’s disease.

  • SGX201 (for Radiation Enteritis): SGX201 is used to combat the negative side effects of chemotherapy, in this case in the bowels. Chemo causes damage to the abdominal and pelvic areas, causing inflammation of the bowels. SGX201 is an oral, topical anti-inflammatory steroid for treatment of that condition.

An important point to note, and one that the staff at Soligenix emphasizes repeatedly, is that these products above are biotherapeutics, not cures. They’re designed to ease the patients’ suffering in the safest way possible, which is a core goal for the company.

For the public health sector, Soligenix has made great strides in treatments for ricin exposure, emerging and antibiotic-resistant infectious diseases, and viral disease including Ebola and Marburg. They also have a Covid-19 vaccine currently in early-stage development.

RiVax®, a heat-stable Ricin toxin vaccine candidate, provided 100% protection in a non-human aerosol challenge model and has demonstrated safety in Phase 1 human studies. The total addressable global market for RiVax® is estimated at $200 million.

In a recent presentation at the 2021 BIO CEO & Investor Digital Conference, Dr. Schaber described the pipeline configuration at SNGX as the ability to take “multiple shots on goal to mitigate risk” with a diverse customer base, including the US government as a primary buyer.

From an investment perspective, Soligenix (NASDAQ: SNGX) looks like a solid buy with a promising upside. To learn more about the company and specifically the commercialization of SGX301, watch Dr. Christopher Schaber’s recent presentation. It’s available on YouTube here.


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