SNGX Soligenix Inc

 PRISM MarketView presents an in-depth interview with Dr. Christopher Schaber, President and Chief Executive Officer of Soligenix, Inc. (Nasdaq: SNGX). The late-stage biopharmaceutical company is advancing a broad pipeline of therapeutic and vaccine candidates across its two business segments, emphasizing its strategic focus on diversified drug development.

Soligenix has recently achieved success in its first Phase 3 clinical trial of HyBryte™ (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL), a rare and chronic cancer. The trial showed statistical significance in its primary endpoint, and a second confirmatory Phase 3 study is set to commence in 2024. HyBryte™ has received Orphan Drug Designations from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with Fast Track status from the FDA. These developments underscore a potentially de-risked path to regulatory approvals worldwide.

In addition to its robust biotherapeutics portfolio, which includes active clinical programs in psoriasis and Behçet’s disease, Soligenix has an established Public Health Solutions business. This segment is advancing heat-stable vaccines and therapeutics, notably with its proprietary ThermoVax® process, which enables lyophilization without compromising potency — a critical factor in areas lacking cold chain logistics.

Dr. Schaber shared insights into the recent publication of HyBryte results in the Journal of the European Academy of Dermatology & Venereology. The open-label study, involving nine patients, showed significant improvements in CTCL lesions, confirming the efficacy seen in the Phase 3 FLASH trial. "Our clinical studies have demonstrated HyBryte's strong and rapid efficacy and a benign safety profile. It's applicable across various lesion types, skin tones, and stages of disease," said Dr. Schaber.

Addressing the public health solutions segment, Dr. Schaber highlighted the advancement of vaccine candidates for ricin toxin, Sudan ebolavirus, Marburg marburgvirus, and COVID-19. Soligenix is particularly focused on pursuing FDA approval for RiVax® under the FDA's animal rule and expects to publish preclinical study results in the second half of 2024. The segment has already secured over $30 million in NIH funding and grants.

For 2024, Soligenix is poised to achieve several key milestones. "We will be enrolling the first patients in our 18-week Phase 3 placebo-controlled study evaluating HyBryte™ in CTCL across the US and Europe. We also anticipate reporting expanded results from our Phase 2a study of SGX302 in psoriasis and initiating a Phase 2a clinical study of SGX945 for aphthous mouth ulcers in Behçet's Disease," Dr. Schaber explained.

The full interview with Dr. Christopher Schaber can be found at: https://prismmarketview.com/soligenix-building-on-compelling-phase-3-data-with-accelerated-confirmatory-trial-and-key-catalysts-on-the-horizon/

About SoligenixSoligenix is a late-stage biopharmaceutical company that focuses on the development and commercialization of products to treat rare diseases with unmet medical needs. The Specialized BioTherapeutics business segment of the company is advancing HyBryte™ (SGX301 or synthetic hypericin sodium), a novel photodynamic therapy using safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). Following the successful completion of the second Phase 3 study, the company will seek regulatory approvals to support potential commercialization worldwide. The development programs in this segment also include the expansion of synthetic hypericin (SGX302) into psoriasis, the 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 (SGX945) for Behçet's Disease.

The Public Health Solutions business segment of Soligenix includes development programs for RiVax®, the ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, the vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of these vaccine programs incorporates the use of the company's proprietary heat stabilization platform technology, ThermoVax®. This business segment has received support from 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 more information about Soligenix, Inc., please visit the company's website at https://www.soligenix.com and follow the company on LinkedIn and Twitter at @Soligenix_Inc.

Forward-Looking StatementsThis 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, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering. 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 first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that the second HyBryte™ (SGX301) Phase 3 clinical trial will be successful or that a marketing authorization from the FDA or EMA will be granted. Additionally, although the EMA has agreed to the key design components of the second HyBryte™ (SGX301) Phase 3 clinical trial, no assurance can be given that the Company will be able to modify the development path to adequately address the FDA's concerns or that the FDA will not require a longer duration comparative study. Notwithstanding the result in the first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a 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. Despite the positive efficacy results demonstrated in the Phase 2 and 3 clinical studies of SGX942 for the treatment of oral mucositis due to chemoradiation therapy for head and neck cancer, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. 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 (the "SEC"), including, but not limited to, the Company's preliminary prospectus (Registration No. 333-271049) filed with the SEC on May 4, 2023, and 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.

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