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Soligenix Reports Third Quarter 2012 Financial Results And Highlights Recent Accomplishments

Stocks in this article: SNGX

PRINCETON, N.J., Nov. 14, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today its financial results for the third quarter ended September 30, 2012.

Soligenix's revenues for the quarter ended September 30, 2012 were $931,627 as compared to $5,795,862 for the third quarter of 2011. Revenues for the third quarter of 2011 included grant revenues of $795,862 and license revenue of $5,000,000 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 $135,765 and was primarily related to increased reimbursable costs from the Company's ThermoVax™, Thermostability Technology Grant focused on a novel method of rendering aluminum salt adjuvanted vaccines stable at elevated temperatures. 

Soligenix's net (loss) for the quarter ended September 30, 2012 was $758,966 or $(0.07) per share, as compared to a net income of $2,204,874 or $0.20 per share for the quarter ended September 30, 2011, representing an increased loss of $2,963,840. The increased loss is primarily related to the execution of the license with Sigma-Tau for rights to the European territory in the third quarter of 2011.    

Research and development expenses for the quarter ended September 30, 2012 were $371,338 as compared to $2,342,253 for the quarter ended September 30, 2011. The significant decrease of $1,970,915 is attributable to payment of approximately $1,000,000 in the form of cash and company stock in connection with the Sigma-Tau European territory license agreement and decreased spending associated with the discontinuation of the confirmatory Phase 3 clinical trial of orBec ® for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).  General and administrative expenses for the quarter ended September 30, 2012 decreased by $36,144 to $558,877, compared to $595,021 for the quarter ended September 30, 2011.

As of September 30, 2012, the Company's cash position was approximately $3,700,000 with working capital of approximately $3,100,000.  

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "In the third quarter of 2012 we continued to make steady progress in advancing a number of our programs utilizing oral BDP, in both our BioTherapeutics and Vaccine/BioDefense business segments. We were pleased to receive Investigational New Drug (IND) clearance and Fast Track designation for SGX203 from the U.S. Food and Drug Administration (FDA). We remain committed to enhancing our development pipeline through internal efforts and external strategic alliances. We look forward to reporting on further progress on all programs during the remainder of this year."

Soligenix's Recent Highlight:

  • On November 8, 2012, the Company announced that its SGX203 program in pediatric Crohn's disease received "Fast Track" designation from the FDA. The Company has also previously received Orphan Drug Designation from the FDA for oral BDP as a treatment for pediatric Crohn's Disease.
  • On October 3, 2012, the Company announced the formation of a Scientific Advisory Board (SAB) to provide strategic guidance to the Company as it relates to the development of OrbeShield™ (oral BDP) for the treatment of gastrointestinal acute radiation syndrome (GI-ARS).
  • On September 28, 2012, the Company announced that results of a study in a canine model of OrbeShield™ was being presented at a poster session entitled, "Post-exposure oral BDP improves survival in a canine GI ARS model." The presentation was made during the 58th Annual Meeting of the Radiation Research Society held in San Juan, Puerto Rico on September 30 through October 3, 2012.
  • On September 13, 2012, the Company announced that the U.S. Patent Office granted patent 8,263,582 entitled "Method of Treating Inflammatory Disorders of the Gastrointestinal Tract using Topically Active Corticosteroids." The new patent's main claims cover the use of BDP in orally administered dosage forms that act concurrently in both the upper and lower gastrointestinal tract. These dosage forms include the Company's oral formulation of BDP currently in development for pediatric Crohn's disease, acute radiation enteritis, and GI GVHD.
  • On September 6, 2012, the Company announced that the FDA had completed its review and cleared the IND application for SGX203 for the induction treatment of pediatric Crohn's disease. Clearance of the IND allows Soligenix to initiate a Phase 1/2 pharmacokinetic /pharmacodynamic study of SGX203 in healthy adolescents and young adults. 
  • On September 4, 2012, the Company announced that the National Cancer Institute (NCI) awarded Soligenix a Small Business Innovation Research (SBIR) grant to support the conduct of a Phase 2 clinical trial with orBec®  in the treatment chronic GI GVHD. The award provides Soligenix with approximately $300,000 over a two-year period.
  • On August 30, 2012, the Company announced the results of a Phase 1B clinical trial of an aluminum hydroxide (Alum) adjuvanted formulation of RiVax™, designed to improve the immunogenicity of the vaccine. The results of the Phase 1B study indicate that Alum adjuvanted RiVax™ is safe and well tolerated, and induces greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™.

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 a 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 ®) .

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 TM has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the National Institutes of Health.

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.

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