Soligenix Reports Year-End 2012 Financial Results and Highlights Recent Accomplishments

PRINCETON, N.J., Feb. 26, 2013 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today its financial results for the year ended December 31, 2012.

Soligenix's revenues for the year ended December 31, 2012 were $3.1 million as compared to $7.6 million for the prior year. The decrease in revenues was a result of $5.0 million received in 2011 from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) for rights to orBec^® (oral beclomethasone 17,21-dipropionate or BDP) in the European territory. Grant revenue increased by $0.5 million primarily related to increased reimbursable costs from the Company's four active government funded programs most notably our ThermoVax™ thermostability technology grant focused on a novel method of rendering aluminum salt adjuvanted vaccines stable at elevated temperatures. 

Soligenix's net (loss) for December 31, 2012 was $4.2 million, or $(0.37) per share, as compared to $2.4 million, or $(0.22) per share, for the year ended December 31, 2011, representing an increased loss of $1.8 million. This increased loss is primarily related to the receipt of $5.0 million from Sigma-Tau in 2011 for the rights to orBec^® in the European territory offset by decreased expenses in research and development related to the conduct of our Phase 3 trial of orBec^® in the treatment of acute gastrointestinal Graft versus Host disease (GI GVHD). 

Research and development expenses for the full year 2012 were $2.6 million as compared to $6.3 million for the full year 2011. This significant decrease is primarily attributable to the discontinued Phase 3 trial of orBec^® and the payment of approximately $1.0 million in the form of cash and company stock to our orBec^® licensor in connection with the Sigma-Tau Agreement.  General and administrative expenses for the full year 2012 were $2.6 million, compared to $2.2 million for the full year 2011. This increase is related to professional fees and non-cash expenses for replacing previously issued warrants to Sigma-Tau upon reacquiring the rights to orBec^® and accelerating the vesting of certain stock options issued to a former employee.

As of December 31, 2012, the Company's cash position was $3.4 million with working capital of $2.7 million.  

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "Throughout the year, we continued to make progress in advancing a number of our programs utilizing oral BDP, in both our BioTherapeutics and Vaccine/BioDefense business segments, as well as expanding our pipeline with acquired technology. In December 2012, we were successful in regaining North American and European commercial rights to oral BDP from Sigma-Tau and we expanded our pipeline with the acquisition of a novel innate defense regulator technology known as SGX94. We believe SGX94 is highly synergistic with our existing development pipeline in cancer supportive care and biodefense, and we anticipate the potential for a number of grant funding opportunities for SGX94 across both business segments."

Schaber continued, "In January, we were pleased to receive an invitation from the Biomedical Advanced Research and Development Authority (BARDA) to submit a contract proposal for the development of OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which was submitted in February.  We are also pleased with the momentum we have built entering 2013, and are excited about the opportunities we see in both of our business segments. I look forward to reporting on our progress on all programs throughout the coming year."

Soligenix's Recent Highlights:

• On February 20, 2013, the Company announced the submission of a full contract proposal to BARDA, Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures. This submission supports a potential multi-year, multi-million dollar contract to develop OrbeShield™ as a medical countermeasure (MCM) for the treatment of GI ARS.
• On January 29, 2013, the Company announced that its OrbeShield™ development program for the treatment of GI ARS received "Fast Track" designation from the FDA.
• On January 4, 2013, the Company announced that the FDA completed its review and cleared its IND application for OrbeShield™ for the mitigation of morbidity and mortality associated with GI ARS.
• On January 2, 2013, the Company announced that the Office of Orphan Products Development of the FDA granted orphan drug designation to OrbeShield™ for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.
• On December 28, 2012, the Company announced that it received approximately $521,000, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax Certificate Transfer Program.
• On December 27, 2012, the Company announced it regained the North American and European commercial rights to oral BDP through an amendment of its Collaboration and Supply Agreement with Sigma-Tau. The Company is now free to commercialize or enter into commercialization agreements for its oral BDP suite of products with other parties without limitation.
• On December 18, 2012, the Company announced the acquisition of a novel drug technology, known as SGX94, representing a unique approach to modulation of the innate immune system.  As part of the acquisition, the Company acquired all rights, including composition of matter patents, preclinical and Phase 1 clinical study datasets for SGX94, which is poised to enter Phase 2 clinical testing in humans.

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat serious gastrointestinal 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 for the treatment of oral Mucositis (SGX942).     

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 lead 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 $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

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. Statements that are not historical facts, such as "anticipates," "believes," "intends," 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 or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, 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 grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, 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.