PRISM Q&A CORNER

New York, May 21, 2024 - PRISM MarketView - Late-stage biopharmaceutical company, Soligenix Inc (Nasdaq: SNGX) is advancing a broad pipeline of therapeutic and vaccine candidates across its two business segments, offering a diversified approach to drug development, and an attractive value proposition for investors

Following success in its first Phase 3 clinical trial, which demonstrated statistical significance in its primary endpoint, the company’s lead product candidate, HyBryte™ (synthetic hypericin), will initiate a second confirmatory Phase 3 study in 2024 to replicate its findings from the first trial. HyBryte™, a promising treatment for cutaneous T-cell lymphoma (CTCL), a rare and chronic cancer, has been granted Orphan Drug Designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).  The FDA also has granted HyBryte™ Fast Track status.  The development progress to date, including the positive results in the first Phase 3 study, referred to as the FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, potentially provides for a significantly de-risked path to regulatory approvals worldwide.

Alongside its strong biotherapeutics portfolio that includes two other active programs in psoriasis and Behçet’s disease, Soligenix has diversified its investment proposition with an established Public Health Solutions business. This segment of the company develops heat stable vaccines and therapeutics for military and civilian populations, using ThermoVaxⓇ, its proprietary thermostabilization process which allows vaccines to be lyophilized (freeze-dried) while maintaining optimal potency – an important consideration in many locations around the world where cold chain logistics are not available.

Soligenix is addressing multiple attractive markets with the product candidates across its robust pipeline targeting potential commercial returns of ~$2B in global annual sales, another key value driver for investors.

PRISM MarketView spoke with Soligenix’s President and Chief Executive Officer, Dr. Christopher Schaber, to find out more about what investors can expect to see in 2024 and beyond.

"We are very proud to have our study published in the Journal of the European Academy of Dermatology & Venereology (JEADV). The study was an open-label study, which enrolled nine patients to receive HyBryte™ treatment of their cancerous lesions over an eight-week period. Results in individual lesions showed that 7 of the 27 index lesions (25.9%) had at least a 50% improvement in their modified Composite Assessment of Index Lesion Severity (mCAILS) score and 4 of the 27 index lesions (14.8%) were completely resolved after as little as 8 weeks of twice a week HyBryte™ treatment. The treatment response results confirm the results of Soligenix’s Phase 3 FLASH trial, which was published in the Journal of the American Medical Association (JAMA) Dermatology."

"Our clinical studies with HyBryte™ have demonstrated strong and rapid efficacy and a benign safety profile, and it has broad applicability across lesion types, skin tones and stages of disease. The clinicians that have been part of our clinical trials have described the data generated to date as being extremely compelling. Our confirmatory Phase 3 study, called FLASH2, that will enroll approximately 80 patients in the US and Europe, will not only build on the robust data to date, it will enable clinicians to treat patients’ cancer more aggressively, as they would in a ‘real world’ setting. It is a testament to the product and its efficacy that these experts are eager to see HyBryte™ continue its journey towards regulatory approval and its potential use as a front-line treatment in a difficult to treat disease like CTCL."

"CTCL is a rare and chronic cancer with no cure in urgent need of additional treatment options that are well-tolerated and safe over the long term. Most current treatment options for CTCL are associated with significant safety concerns, including black-box warnings, and are unsuitable for long-term use. The disease affects approximately 30,000 people in the US and a similar number in Europe and Asia, and we are addressing an attractive estimated global market of more than $250 million."

"Our Public Health Solutions segment is advancing vaccine candidates addressing ricin toxin exposure with RiVax®, Sudan ebolavirus with SuVax™, Marburg marburgvirus with MarVax™ and COVID 19 exposure with CiVax™. We are currently pursuing regulatory approval for RiVax under the FDA’s animal rule, which allows the regulator to grant approval in certain cases based on well-controlled animal studies. We expect to publish results from preclinical studies in this business segment in the second half of 2024. To date, we have received more than $30 million in funding and grants from the National Institutes of Health (NIH)."

"We are expecting to achieve a number of key milestones in 2024, including enrolling the first patients in our confirmatory 18-week Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in CTCL. The study will enroll approximately 80 patients at centers across the US and Europe, and since this is a chronic cancer, there is the potential to enroll patients from the first Phase 3 FLASH study, which should accelerate the timeline to topline results. Additionally, in the first half of 2025 we anticipate reporting expanded study results from our Phase 2a study of SGX302 in psoriasis after we announced positive preliminary topline results earlier this year, and we expect to initiate a Phase 2a clinical study of SGX945 (dusquetide) for the treatment of aphthous ulcers in Behçet’s Disease, which will report topline results in the first half of 2025 as well.  So, there are a number of important clinical milestones on the horizon, which is very exciting."

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