Company Connecting the Dots for Final FDA Approval

New York, NY - (NewMediaWire) - June 03, 2021 - PCG Digital -- When Soligenix (NASDAQ: SNGX) updated its NDA rollout plan, the market quickly reacted. While the timeline was adjusted, the big picture and ultimate end game remain the same. With conditional acceptance of the HyBryte^TM name by the FDA and positive news in Japan and the UK, Soligenix continues to move forward in its aim to treat cutaneous T cell lymphoma.

Soligenix is developing SGX301 (recently branded HyBryte^TM) for the treatment of cutaneous T cell lymphoma (CTCL) and has successfully completed its Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial and a rolling NDA was expected to start this quarter. 

On May 7^th, the company announced that due to manufacturing issues caused in part by the ongoing pandemic and following FDA discussions, it would not pursue a “rolling” NDA at this time, but would instead submit it in the first half of 2022 with corresponding potential FDA approval adjusted to the first half of 2023. At first glance, this may appear as a major delay, however even with a rolling NDA the final module would not have been submitted until the first half of 2022 with FDA approval in late 2022.  In reality, the potential delay is likely to be brief with FDA approval now expected in the first half of 2023 instead of late 2022.

HyBryte^TM, the commercial name for SGX301 (synthetic hypericin), was recently recognized by the American Academy of Dermatology as “Top 12 Late-Breaking Research.” Clinical studies have indicated it will be an effective therapy for early stage cutaneous T-cell lymphoma (CTCL), which makes up the vast majority of the patient population living with this disease.

HyBryte^TMBrand Name Conditionally Accepted by FDA   

On an even more positive note, Soligenix is already planning for the commercialization of HyBryte^TM. According to the Company’s recent release, HyBryte^TMis now locked in as the brand name for SGX301.  

“We received U.S. Food and Drug Administration (FDA) conditional acceptance of HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin),” CEO Dr. Christopher J. Schaber reported. “We continue to prepare for a new drug application (NDA) submission.” 

There are roughly three thousand new cases of CTCL in the U.S. each year and another approximate 20,000 patients living with CTCL in the U.S. It’s a rare form of non-Hodgkin’s lymphoma, allowing the FDA to classify HyBryte^TMas an orphan drug, putting it on the fast track for approval when the time comes. 

Soligenix has the available cash and resources to market HyBryte^TMin the US without the assistance of outside partners, so there’s no danger of losing funding by delaying the rolling NDA. Marketing and sales processes are already underway for when FDA approval is granted. 

"With approximately $30 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing and U.S. commercialization of HyBryte™ in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million," Dr. Schaber added.

Patented in Japan and Awarded an “Innovation Passport” in the UK 

To further solidify the marketability of HyBryte^TM, Soligenix was recently approved for a patent in Japan titled “Systems and Methods for Producing Synthetic Hypericin.” Synthetic hypericin is the active pharmaceutical ingredient in HyBryte^TM.  

One week prior to that patent approval, the company was awarded an “innovation passport” in the United Kingdom to treat early stage CTCL patients who fall under their Innovative Licensing and Access Pathway (ILAP) program. ILAP was launched earlier in 2021.

Combine these two events with the positive results from the recent FLASH (fluorescent light activated synthetic hypericin) trial, and the table is set for potential success in the next year and a half. Peak US annual net sales are estimated to exceed $90 million. 

Zack’s Issues Updated Valuation for Soligenix (SNGX)

On May 24^th, Dr. David Bautz at Zack’s Small-Cap Research, issued an updated SNGX valuation which was positively received by investors, with the stock opening up higher on increasing volume. 

Here is a link to Dr. Bautz’s report: https://finance.yahoo.com/news/sngx-hybryte-conditionally-accepted-proprietary-115000575.html

“Soligenix has a strong balance sheet and there will be little to no budgetary impact caused by the change of the NDA submission,” Dr. Bautz stated in the report. “We were surprised at the change in timeline, but it does not appear there will be too much of a delay in FDA approval.” 

A Potentially Bright Future for Soligenix’s HyBryte

This Zacks valuation update is noticeable. Investors may recall that the company’s pre-pandemic share price peaked at $3.16 and over the past 12 months, Soligenix has made great strides and is now equipped with a strong war chest of over $30 million to push forward on multiple fronts. The future is bright.

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