New York, New York--(Newsfile Corp. - March 16, 2021) - PCG Digital -- The future is looking bright at Soligenix, Inc. In a corporate update released on February 24th, Dr. Christopher Schaber, Chairman, President and CEO, updated investors on the status of ongoing research projects. The report suggests that multiple milestones will be achieved this year and next.
One of the key corporate highlights is the completion of a Phase 3 FLASH ("Fluorescent Light Activated Synthetic Hypericin") study with SGX301 (synthetic hypericin), a treatment for cutaneous T-cell lymphoma (CTCL). Pending FDA clearance, the treatment will be marketed as HyBryte.
"Responses continued to improve through both 12-week and 18-week treatment cycles," the report states. "SGX301 also demonstrated significant responses in both patch and plaque lesions, highlighting the unique benefits of the visible light activation of hypericin."
"Current treatments for CTCL are generally less effective against plaques and deeper lesions," reported Dr. Brian Poligone, Lead Enrolling Investigator in the FLASH study. "The ability of SGX301 to target both patches and thicker plaques in CTCL is an important feature."
SGX301 is a rare early-stage first-line treatment option for CTCL, so Soligenix is expecting wide-spread adoption by dermatologists with potential FDA approval. The FLASH study results are an important step in proving the viability of the treatment to medical professionals.
Strategic Partnerships and Commercialization
Now that the FLASH study is successfully completed, Soligenix is prepared to submit a new drug application (NDA) to the FDA in the second quarter of 2021. SGX301 has already been designated as an "Orphan Drug" and will be placed on the fast track for approval.
According to a BIO (Biotechnology Industry Organization) report on clinical development success rates that was released last month, the probability of FDA approval after successfully completing Phase 3 trials and submitting an NDA, taking into account re-submissions, is 90.6%.
In January, as part of their preparation for commercialization, Soligenix formed a strategic partnership with Daavlin, the manufacturer of the companion light device for SGX301. They also held a webcast event to discuss commercialization efforts for the treatment.
"As CTCL is a highly specialized orphan market, it presents a tailor-made market opportunity for us," stated Dr. Schaber in his report. "The peak annual net sales in the U.S. are expected to exceed $90 million, with total 10-year U.S. revenues forecasted over $700 million."
The company currently has no plans to take on a partner for US commercialization, but they are having a number of international business (ex-US) discussions with potential partners that have a good reputation and expertise in CTCL therapeutics.
"We're maintaining 100% of SGX301's value in our US commercialization efforts," the report states. "The build and launch expenses are approximately $7 million, which we can fund with in-house resources. A partnership would mean retaining less than half of any revenue."
Public Health Solutions bring in Additional Grant Money
Soligenix has also entered the fray to combat Covid-19. Dr. Schaber also reported in the February update that the company has been awarded a Direct to Phase II Small Business Innovation Research grant to develop Covid-19 and Ebola virus vaccines.
"We've recently received a $1.5 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to manufacture, formulate, and characterize COVID-19 vaccine candidates," the report states.
The grant also covers thermostabilization of Covid-19 vaccines and the development of Ebola Virus Disease vaccines in conjunction with the company's CoVaccine HT™ adjuvant. Proof of concept data in non-human primates (NHPs) is expected by the end of Q2 this year.
Developing a heat stable vaccine solves a major problem that other manufacturers have been facing. Certain Covid-19 vaccines need to be cold stored and shipped in temperatures below -70 degrees Celsius. Soligenix tech can increase that ceiling to +40 degree Celsius.
"We've demonstrated the feasibility of developing heat stable subunit protein vaccine formulations for filovirus vaccines, including Ebola virus, Sudan virus, and Marburg virus," the report states. "Protective efficacy against all of them has been demonstrated in NHPs."
The same technology has been used by Soligenix to develop RiVax®, a heat stable ricin toxin vaccine candidate that has received Orphan Drug and Fast Track designation from the FDA. As a new chemical entity, it could also qualify for a biodefense Priority Review Voucher (PRV), which is transferable and can be sold to other companies seeking to gain an accelerated review for their NDA. A similar type of PRV recently sold for close to $100 million.
Balance Sheet and Financial Outlook for SNGX
Soligenix currently trades on Nasdaq under the ticker symbol SNGX. They're up 1.12% YTD and have a strong balance sheet with significant working capital. Cash reserves as of February 2021 are in excess of $30 million, not including non-dilutive government funding.
The liquidity is due to a strategic partnership with venture and debt fund Pontifax Medison, which gave Soligenix access to convertible debt (can be converted to common stock), and an ATM sales issuance agreement with B. Riley Securities, Inc.
The combination of these two financial vehicles provides significant cash runway through 2022, so there's a strong belief among investors that Soligenix will achieve their short and long-term goals. Keep an eye out for further updates as the year progresses.
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