New York, New York–(Newsfile Corp. – January 25, 2021) – PCG Digital: Advancing health care innovation is a cornerstone of thorough public health policy. Researching and developing new treatments for unmet medical needs has become increasingly important as the world continues to battle through the worst pandemic in our lifetime. While the news and focus of health innovation continues to be largely on COVID-19, medical breakthroughs continue to progress across the board.

Soligenix, Inc. (NASDAQ: SNGX) is one such biopharmaceutical company that has made big strides against unmet medical needs. Recently, the company released data from the Phase 3 FLASH clinical trial of its SGX301 candidate for the treatment of cutaneous T-cell lymphoma (CTCL), which showed strong positive effects.

What is CTCL?

Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin’s lymphoma, which impacts a vital part of the immune system: white blood cells or T-cells. Patients with CTCL develop abnormalities within their T-cells, which makes the cells attack the skin. This leads to visible skin rashes, which feature redness and can be slightly raised, feature scaliness, and even form tumors.

There are two main types of CTCL: Mycosis fungoides (MF) and Sezary syndrome (SS). MF is the early-stage and most common version of CTCL, which features an 88% 5-year survival rate. On the other hand, SS is the more serious and advanced stage version of CTCL, which sees its 5-year survival rate plummet to 24%.

Over 40,000 non-Hodgkin’s lymphoma patients around the world currently suffer from some form of CTCL and there are no approved cures. According to the Cutaneous Lymphoma Foundation, there is an average of 3,000 new cases of CTCL reported in the U.S. every year and roughly 16,000-20,000 Americans currently suffer from mycosis fungoides. Soligenix notes that the total addressable global market for CTCL is around $250 million, with an estimated > $75 million coming from the United States.

SGX301 Phase 3 Data Shows Strong Efficacy

Soligenix’s SGX301 is a novel first-in-class photodynamic therapy for early-stage CTCL, known as mycosis fungoides. Synthetic hypericin is the key active ingredient in SGX301, which is a powerful photosensitizer that can be topically applied to areas on the skin impacted by CTCL. After the topical is absorbed by the impacted T-cells for 16-to-24 hours, it is activated by safe, visible fluorescent light.

Fluorescent lighting is used instead of ultraviolet for a couple of reasons. First, the visible light emitted by fluorescent can penetrate deeper into the skin compared to ultraviolet. Secondly, ultraviolet lighting has carcinogenic properties that can cause other more deadly skin cancers, such as melanoma.

During Soligenix’s Phase 3 FLASH trial for SGX301, a total of 169 patients with either Stage IA, IB, or IIA CTCL were enrolled in the clinical trial. The Phase 3 trial was a randomized, double-blind, and placebo-controlled study, which featured three treatment cycles. Treatments were delivered twice a week for the first six weeks of the trial, with a treatment response determination at the end of week eight of the trial.

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After the first six weeks and completion of Cycle 1, SGX301 showed a statistically significant treatment response (p=0.04) compared to the patients that were administered the placebo. Thus, the Cycle 1 process reached its primary endpoint.

Soligenix noted that positive treatment responses only continued to show significant improvement during Cycle 2’s open-label treatment cycle after 12 weeks. It is important to note that SGX301 proved to be statistically significant through Cycle 2 in both patch and deeper plaque lesions. This further supports fluorescent lighting and its ability to deeply penetrate the skin. The same statistically significant improvements continued into the 18^th week, which marked the completion of the optional Cycle 3 treatment.

Unlike other forms of phototherapies that use ultraviolet light, SGX301’s Phase 3 FLASH trial showed no mutagenic risks. This truly makes Soligenix’s SGX301 candidate a significant step in treating early-stage CTCL. Not only did the trial show a very clear and meaningful statistical benefit in treating CTCL, but its safety profile far exceeds second-line and off-label treatments.

SGX301 Commercialization: Daavlin-Soligenix Strategic Partnership

Now that SGX301 has shown to be a major potential gamechanger in the treatment against CTCL, Soligenix is preparing its US commercialization plans. On January 7, 2021, Soligenix made one of its biggest steps towards SGX301 commercialization after entering into a strategic partnership with Daavlin.

Daavlin is a 40-year-old, Bryan, Ohio-based company with a rich history of innovation and development within phototherapy. The company provides a rather extensive line of products and services to healthcare providers around the globe.

Under the terms of the agreement, Soligenix and Daavlin secured a long-term supply and distribution agreement of a commercially-ready light device that is critical to SGX301’s success in treating CTCL.

Once the U.S. FDA has approved SGX301, Soligenix will focus on promoting its SGX301 treatment and the Daavlin-supplied companion light device. Daavlin will exclusively sell the lighting device to Soligenix, physicians, and patients.

“Daavlin brings technical, manufacturing, and commercial capabilities in both the US and Europe that will assist us in rapidly and efficiently distributing the SGX301 companion light device upon approval by FDA,” stated Christopher J. Schaber, Ph.D., President, and Chief Executive Officer of Soligenix. “Seamless integration of the drug product and companion light device for physicians and patients is critical to the commercial success of SGX301 and working with Daavlin will help us achieve that operational excellence.”

SGX301 Commercialization Funding: Pontifax Financing Deal

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Aside from qualified strategic partnerships, ample funding and capital allocation are required to successfully launch a new treatment. In December 2020, Soligenix announced a $20 million strategic convertible debt financing agreement with Pontifax Medison Debt Financing, a healthcare-focused venture, and debt fund.

Under the terms of the financing, Soligenix will have the ability to access up to $20 million in convertible debt financing broken up into three tranches. The funding is set to mature over a four-and-a-half-year period and will carry an interest-only period for the first two years of the deal.

Soligenix has accessed the first tranche of $10 million and will have the option to draw an additional $5 million in a second tranche any time over the next twelve months. The third tranche will also carry $5 million in funding and will be available upon the filing of the SGX301 new drug application (subject to conditions).

Pontifax has the option to convert outstanding drawn funds from the first two tranches into common shares of Soligenix at a conversion price of $4.10 per share. If certain conditions are met, Soligenix will have the ability to force the conversion at a price of $4.92 per share.

“The access to less dilutive capital provided by this facility is designed to increase our financial flexibility as we continue to advance our rare disease pipeline, and build toward commercialization in the United States with SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL) and SGX942 for the treatment of oral mucositis in head and neck cancer patients,” stated Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix.

Overall, Soligenix is continuing to show its expertise in the research and development of treatments for unmet medical needs. The company’s SGX301 candidate to treat early-stage CTCL is a gamechanger, as it provides several very clear advantages over the second-tier treatments available today. With primary endpoints being met throughout its successful Phase 3 FLASH trial, Soligenix has made the case for the FDA to approve SGX301. Considering the funding and strategic partnership deals with Pontifax and Daavlin respectively, Soligenix has established an ecosystem to successfully roll out SGX301 to the $75 million addressable US CCTL market.

Join the Soligenix investor webcast event scheduled for Tuesday, January 26, 2021 from 2:30-4:00 PM Eastern Standard Time (EST). Management plans to detail further information about their commercialization plans, and an opportunity for investors’ Q&A after the presentation. Check the link below to be a part of the investor webcast on Tuesday.

Live Event: https://sqps.onstreamsecure.com/origin/enliven/players/Soligenix.html

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