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Soligenix Reports Year-End 2013 Financial Results and Highlights Recent Accomplishments

PRINCETON, N.J., March 26, 2014 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today its financial results for the year ended December 31, 2013.

Soligenix's revenues for the year ended were $3.2 million as compared to $3.1 million for the prior year. Revenues included the initiation of contracts with the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) during the fourth quarter of this year in support of OrbeShield™ (oral beclomethasone 17,21-dipropionate or BDP) development in the treatment of gastrointestinal acute radiation syndrome (GI ARS). 

Soligenix's net loss was $10.1 million, or $0.65 per share, as compared to $4.2 million, or $0.37 per share, for the year ended December 31, 2013 and 2012, respectively.  Included in the net loss for the year ended December 31, 2013 is a non-cash charge of $3.7 million, or $0.24 per share, due to the change in fair value of the liability related to warrants issued in the Company's June 25, 2013 registered public offering as well as a $1.5 million non-cash charge related to the exclusive worldwide collaboration with Intrexon Corporation.

Research and development expenses were $5.1 million as compared to $2.6 million for the year ended December 31, 2013 and 2012, respectively.  Included in the 2013 year end expenses is a $1.5 million non-cash charge related to the collaboration with Intrexon Corporation and costs related to a number of development programs including SGX942 in the treatment of oral mucositis, SGX203 in the treatment of pediatric Crohn's disease, and orBec® in the treatment of chronic gastrointestinal Graft-versus-Host disease (GI GVHD).

General and administrative expenses were $2.8 million as compared to $2.6 million for the year ended December 31, 2013 and 2012, respectively. This increase is primarily related to non-cash expenses for stock based compensation from stock options issued during the year. 

For the year ended December 31, 2013, other net income/expense includes a $3.7 million, or $0.24 per share, non-cash charge related to the change in fair value of the liability for warrants issued in the Company's June 25, 2013 registered public offering.

As of December 31, 2013, the Company's cash position was $5.9 million.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "During the year we have made significant progress in both our BioTherapeutics and Vaccine/BioDefense business segments while extending our cash runway through the completion of a common stock offering which attracted new institutional investors, including an affiliated fund of Third Security, LLC, as well as through multi-year government grant and contract awards totaling up to approximately $32 million. We have advanced our development pipeline with the initiation of two Phase 2 clinical trials.  The first with SGX942 in the treatment of oral mucositis in head and neck cancer, and the second with orBec® in the treatment of chronic GI GVHD.  We have also expanded our pipeline through a worldwide exclusive collaboration with Intrexon Corporation that will focus on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need."  

Dr. Schaber continued, "We are very pleased with our success during 2013 and are focused on  continuing to increase shareholder value through advancing our programs and pursuing opportunities in both of our business segments. I look forward to providing updates throughout the year and into 2015."

Soligenix's Key Highlights:

  • On February 14, 2014, the Company announced the award by NIAID of a one year $300,000 Small Business Innovation Research (SBIR) grant to support further preclinical development of SGX943 as a treatment for melioidosis. This award will allow the Company to conduct studies in collaboration with Tulane University.
  • On January 16, 2014, the Company announced it received approximately $750,000, net of transaction costs, in non-dilutive funding via the State of New Jersey's Technology Business Tax Certificate Transfer Program.
  • On January 15, 2014, the Company announced significant steps forward in the development of ThermoVax™, its proprietary vaccine thermostabilization platform technology. Recent studies have demonstrated the potential for heat-sensitive vaccines formulated using this technology to withstand temperatures exceeding 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. The underlying work has been conducted with the Company's proprietary ricin toxin vaccine (RiVax™) as part of a continuing program to evaluate the effectiveness of protein subunit vaccines to withstand extremes of temperature and other environmental stress conditions. These studies amplify and extend former evaluations that indicated retention of potency for at least six months at temperatures as high as 40 degrees Celsius, outside the range of typical vaccine storage conditions. The research and development of ThermoVax™ is currently being supported by a $9.4 million NIAID grant for biodefense vaccines to prevent ricin toxin and anthrax exposure.
  • On January 6, 2014, the Company announced that it had appointed Richard Straube, MD, as its Senior Vice President and Chief Medical Officer. Dr. Straube is a board-certified pediatrician with clinical research experience in host-response modulation. He has had a long and distinguished career of more than 35 years in both academia and industry, most notably with Centocor, Ohmeda Pharmaceuticals, INO Therapeutics, and Stealth Peptides, Inc. Dr. Straube will lead Soligenix's clinical research with primary responsibility for the execution and completion of its multiple clinical programs, including its Phase 2 study in oral mucositis and its Phase 2/3 study in pediatric Crohn's disease.
  • On December 5, 2013, the Company announced that it had initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating SGX942, a first-in-class innate defense regulator (IDR), as a treatment for oral mucositis in patients undergoing chemoradiation therapy for head and neck cancer. This Phase 2 study is a multicenter trial focused on patients with tumors of the mouth and oropharynx who often experience debilitating oral mucositis as a consequence of tumor treatment with intensity modulated radiation and chemotherapy. The primary efficacy will be assessed on the basis of the incidence and duration of both ulcerative and severe oral mucositis throughout the course of radiation treatment.
  • On December 2, 2013, the Company announced that it had initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating orBec® (oral BDP) as a treatment for the gastrointestinal (GI) manifestations of chronic Graft-versus-Host disease (GVHD). This Phase 2 study is a multicenter, pilot study enrolling patients that have received allogeneic hematopoietic cell transplantation at least 100 days earlier, have documented chronic GVHD in at least one organ outside the GI tract, and have a mucosal biopsy consistent with GI GVHD. The primary efficacy objective of the study is to estimate the proportion of subjects with chronic GVHD with GI involvement who achieve a complete response, partial response or minimal response of GI GVHD signs and symptoms when treated with orBec® for up to 16 weeks. The study is partially funded by a National Cancer Institute (NCI) SBIR grant award of approximately $300,000.
  • On November 21, 2013, the Company announced that it signed a stock purchase agreement with Lincoln Park Capital Fund, LLC, providing an initial investment in Soligenix of $600,000 and the availability of additional periodic investments at the Company's sole discretion of up to $10.0 million over a 36 month term.

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™.  Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains 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," "intends," "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.  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 vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing 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 US 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 US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  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.

SOURCE Soligenix, Inc.

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