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Interview to be webcast on November 29, 2022 at 11:00 am ET
New York, NY – 
To register for the webcast and access the replay of the interview please click: https://us06web.zoom.us/webinar/register/WN_bIGC3Z_OT5q8RVoQvlMfwg.
Soligenix President and Chief Executive Officer, Dr. Christopher J. Schaber, will discuss the significant milestones achieved by the company during 2022 and will take a look at what investors can expect to see in the coming quarter.
“Soligenix has had a transformational year in 2022, with more significant milestones anticipated before the end of Q4,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The results of our successful Phase 3 study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) were published in the prestigious JAMA Dermatology and the FDA awarded a $2.6 million grantfor an expanded study of HyBryte™. Soligenix was also invited to submit a contract proposal for vaccine development by the Biomedical Advanced Research and Development Authority (BARDA).
“We expect to submit our new drug application (NDA) application to the FDA for HyBryte™ during this quarter. Additionally, we are continuing our expansion into new disease indications with synthetic hypericin having received FDA investigational new drug (IND) clearance for a Phase 2a clinical trial in mild-to-moderate psoriasis, also expected to begin before year end.
“We look forward to participating in the PCG Advisory Fireside Chat and sharing some of the year’s highlights with investors.”
Soligenix was recently featured in an interview on New To The Street which was broadcast on FOX Business.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203).
Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company’s website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.
About PCG Advisory
PCG Advisory is a leading investor relations firm dedicated to the delivery of top-tier strategic services that encompass investor relations, capital markets navigation, and corporate communications for innovative and emerging companies from around the globe. PCG Advisory has extensive experience with life science, fintech and blockchain technology companies. PCG Advisory is part of PCG Holdings Inc., a holding company for a network of resources dedicated to the discovery and creation of value in the small and micro-cap equity market that was founded in 2008. All subsidiaries of PCG Holdings are geared toward helping investors identify value where it is not most obvious by facilitating a dynamic flow of information between its clients and the investment community. PCG Holdings operating subsidiaries also includes PCG Digital and PCG Video. PCG Digital owns, partners with and/or licenses innovative aggregation, distribution, and engagement platforms. PCG Digital reaches thousands of individual, retail and institutional investors and stakeholders through its proprietary and extensive distribution network as well as through the use of unique multimedia marketing and audience development techniques. PCG Video produces management interviews and highlight and informational clips to further enhance and showcase our client companies. Videos are filmed at robust production resources in PCG’s NYC office. For more information, please go to: www.pcgadvisory.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Notwithstanding the result in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 1/2 proof-of-concept clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
Investor Relations:
Kirin Smith, President
PCG Advisory, Inc.
ksmith@pcgadvisory.com
(646) 823-8656
www.pcgadvisory.com
View the original release on www.newmediawire.com
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