PRINCETON, N.J., April 19, 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 that it has received approximately $1.4 millionnet of transaction costs, in non-dilutive financing through several government tax programs.
“We received $1.2 million of the state of from New Jersey (NJ) Tax Certificate Transfer Program for Technology Companies and $0.2 million of from the United Kingdom (UK) Her Majesty’s Revenue & Customs (HMRC) Research and Development (R&D) Tax Credit Program,” said Christopher J. Schaber, PhD, President and CEO of Soligenix. “We continue to be extremely active in our pursuit of non-dilutive funding to offset operating expenses. This is the twelfth year we have received NJ Net Operating Loss (NOL) funding. this period, we received approximately $7.6 million in non-dilutive NOL financing. This has allowed us to advance our rare disease portfolio to where we are today, with multiple late-stage clinical assets and prepare to file a new drug application for HyBryte™ for the treatment of cutaneous lymphoma. to T cells later this year. We are grateful for the continued support of the NJ Economic Development Authority (NJEDA) to its biotechnology industry. This is also the third year we have received the HMRC tax credit, to date we have received $0.5 million to support our clinical trials in the UK.”
The NJEDA program allows approved technology and biotechnology companies to sell their unused NOL deferrals and unused R&D tax credits to unaffiliated, profitable taxpayers in the state of New Jersey. This allows companies with NOLs to turn their losses and tax credits into cash proceeds to fund additional R&D, purchase equipment and/or facilities, or cover other eligible expenses. The NJEDA determines program eligibility, the NJ Division of Taxation determines the value of available tax benefits (NOL and R&D Tax Credits), and the NJ Commission on Science and Technology assesses the technology and its viability. the New Jersey State was at the origin of this program and the first State to implement and fund it.
HMRC’s R&D Tax Credit scheme supports companies working on innovative science and technology projects in the UK. It can be claimed by a range of businesses looking to research or develop a breakthrough in their field.
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 toward 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 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 segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, and SGX943, our therapeutic candidate for emerging and antibiotic-resistant infectious diseases, as well as our vaccines 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 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).
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”, “aims”, “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 can be no assurance that marketing clearance from the FDA or 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 can be no assurance that RiVax® will qualify for a Biodefense Priority Review Voucher (PRV) or that past PRV sales will be indicative of a 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.