Wednesday, May 25 2022

PRINCETON, N.J., March 29, 2022 /PRNewswire/ — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today announced its recent achievements and financial results for the year ended December 31, 2021.

“This year will be a pivotal year for the Company as we plan to reach a number of transformational milestones,” said Christopher J. Schaber, PhD, President and CEO of Soligenix. “Most importantly, these steps include submitting the New Drug Application (NDA) to United States (United States) Food and Drug Administration (FDA) for the marketing authorization of HyBryte™ (SGX301 or synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), a rare form of cancer of the skin. Additionally, we plan to initiate a phase 2a clinical trial in mild to moderate psoriasis with SGX302 (synthetic hypericin), where we have already demonstrated positive proof of concept in a small phase 1/2 pilot study. As part of our Public Health Solutions business line, we continue to advance our thermostable vaccine platform technology, ThermoVax®in particular through the development of candidate vaccines against filoviruses (targeting Ebola, Sudanand Marburg viruses), a novel heat-stable COVID-19 vaccine candidate, CiVax™, and a ricin toxin vaccine, RiVax®where non-human primate (NHP) data for all three vaccination programs demonstrated significant efficacy.”

Dr. Schaber continued: “With approximately $23.3 million in cash, not including our non-dilutive government funding, we expect to have the capital necessary to achieve our near-term milestones, including the filing of NDAs and the expansion into psoriasis with the conduct of the phase clinical trial 2a. We continue to evaluate various strategic options, including but not limited to partnership and M&A opportunities.”

Recent Soligenix Achievements

  • At March 17, 2022, the company announced the results of a booster vaccination study using CiVax™ (thermally stable COVID-19 subunit vaccine program) in NHPs demonstrating rapid improvement in neutralizing antibody responses to SARS-CoV-2, including included against the Delta and Omicron variants. To view this press release, please click here.
  • At January 10, 2022the Company has released an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. To view this press release, please click here.
  • At January 4, 2022, the Company announced that dusquetide is effective in reducing tumor size in non-clinical xenograft models. To view this press release, please click here.
  • At December 2, 2021the company announced 100% protection for NHPs against Sudan challenge against ebolavirus using a heat stabilized bivalent vaccine formulated in a single vial, reconstituted only with water immediately before use. To view this press release, please click here.

Financial Results – Year Ended December 31, 2021

Soligenix revenue for the year ended December 31, 2021 were $0.8 million compared to $2.4 million for the year ended December 31, 2020. Revenues primarily include payments on grants received to support the development of: SGX943 for the treatment of emerging and/or antibiotic-resistant infectious diseases; Thermovax®, our thermostabilization platform technology; and CiVax™, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $12.6 millionWhere ($0.31) per share, for the year ended December 31, 2021compared to $17.7 millionWhere ($0.64) per share, for the year ended December 31, 2020. The decrease in net loss is mainly attributable to additional costs in 2020 related to the issuance of $5.0M shares of common stock fully acquired from Hy Biopharma, Inc. (“Hy Biopharma”) in connection with the completion of a development stage.

Research and development expenses were $8.4 million compared to $9.8 million for the years ended December 31, 2021 and 2020, respectively. The decline in research and development expenses for the year December 31, 2021 was related to the conclusion of the phase 3 studies in CTCL and oral mucositis.

General and administrative expenses were $4.8 million and $4.3 million for the years ended December 31, 2021 and 2020, respectively. This increase in general and administrative expenses is primarily due to an increase in legal fees associated with the Emergent Arbitration partially offset by a decrease in the company’s headcount.

From December 31, 2021the Company’s cash position was approximately $26.0 million.

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 line is growing and moving towards the potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) as a novel photodynamic therapy using safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study, regulatory approval is being sought and commercialization activities for this product candidate are initially progressing in the United States. Development programs in this business segment also include the expansion of synthetic hypericin (SGX302) in 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 conditions ( GI) disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).

Our Public Health Solutions business line includes active development programs for RiVax®, our vaccine candidate against ricin toxin, and SGX943, our therapeutic candidate for emerging and antibiotic-resistant infectious diseases, and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary thermal stabilization platform technology, known as ThermoVax®. To date, this line of business has been supported by government grants 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 us on LinkedIn and Twitter at @Soligenix_Inc.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations regarding its future results, performance, prospects and opportunities, including, but not limited to, potential market sizes, patient populations and clinical trial recruitment. Statements that are not historical facts, such as “expects”, “estimates”, “believes”, “hopes”, “intends”, “plans”, “expects”, “targets”, “may”, “suggest”, “will”, “potential” or similar expressions are forward-looking statements. Such statements are subject to a number of risks, uncertainties and other factors that could cause Actual events or results in future periods will differ materially from what is expressed or implied by such statements, as has been the case with the outbreak of COVID-19. Soligenix cannot assure you that it will be able to develop, obtain regulatory approval or successfully commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapies and vaccines against bioterrorism threats, conducting trials preclinical and clinical therapeutic products and vaccines, obtaining regulatory approvals, and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or interrupted 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 additional funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants that are subject to performance requirements, to enter into biodefense supply contracts with the US government or other countries, that it will be able to compete with larger and better-funded competitors in the biotechnology industry, as changes in healthcare practice, reimbursement limitations t by third parties and federal and/or state health care reform initiatives will not adversely affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. Further, there can be no guarantee as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result obtained in the Phase 3 clinical trial HyBryte™ (SGX301) for the treatment of cutaneous T-cell lymphoma, there is no guarantee that a marketing authorization from the FDA or the EMA will be successful. Notwithstanding the outcome of 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, nothing warrants that the timing or success of clinical trials of SGX302 for the treatment of psoriasis. Further, there is no guarantee that RiVax® will be eligible for a Biodefense Priority Review Voucher (PRV) or that past PRV sales will be indicative of any potential sale price for a PRV for RiVax®. Further, there can be no assurance 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 documents filed with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K . Except as required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCESoligenix, Inc.

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