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Soligenix Reports Third Quarter 2011 Financial Results

PRINCETON, N.J., Nov. 14, 2011 /PRNewswire/ -- Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today its financial results for the third quarter of 2011.

Soligenix's revenues for the third quarter of 2011 were approximately $5,796,000 as compared to $861,000 for the third quarter of 2010. The increase in revenues was a result of a $5 million license fee from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) in connection with the expansion of its existing North American commercialization rights to orBec® and oral BDP into the European Territory (the Sigma-Tau Agreement).

Soligenix's net income for the third quarter of 2011 was approximately $2,205,000, or $0.01 per share, as compared to a (loss) of ($1,734,000), or $(0.01) per share for the third quarter of 2010. Recognition of income for the current quarter is attributable to the Sigma-Tau Agreement offset by R&D costs in connection with the conduct of the confirmatory Phase 3 clinical trial of orBec® in acute gastrointestinal Graft-versus-Host disease (GI GVHD).

Research and development expenses for the third quarter of 2011 were approximately $2,342,000 as compared to $1,277,000 for the third quarter of 2010.  This increase is primarily attributable to payment of approximately $1,000,000 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 third quarter of 2011 were approximately $595,000, compared to approximately $543,000 for the third quarter of 2010.

As of September 30, 2011, the Company's cash position was approximately $7,218,000 with working capital of approximately $6,257,000.  

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "The third quarter saw the unfortunate stoppage of our confirmatory Phase 3 trial of orBec® in acute GI GVHD at the recommendation of an independent Data Safety Monitoring Board.  While we continue to analyze the dataset from this trial, we remain committed to evaluating all strategic options to re-establish the value of Soligenix, including through the development of our oral BDP programs for pediatric Crohn's disease, acute radiation syndrome and acute radiation enteritis as well as through our vaccines/biodefense programs with our novel thermostability technology and ricin toxin vaccine. We look forward to making news in some of these areas in the not too distant future."

Soligenix's Third Quarter and Recent News:
  • On October 11, 2011, Soligenix announced the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance related to the development of SGX203 (oral beclomethasone dipropionate, or oral BDP) for the treatment of pediatric Crohn's disease.
  • On September 15, 2011, Soligenix announced the recommendation of an independent Data Safety Monitoring Board to stop its confirmatory Phase 3 clinical trial for orBec® in the treatment of acute GI GVHD for futility.
  • On July 28, 2011, Soligenix announced the expansion and amendment of its North American licensing partnership with Sigma -Tau for the development and commercialization of orBec® (oral beclomethasone dipropionate or Oral BDP) into the European territory. As part of the amended agreement, Sigma -Tau made a $5 million payment to Soligenix. 

About Soligenix, Inc.

Soligenix is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid that has been initially developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also conducting a National Cancer Institute (NCI)-supported Phase 1/2 clinical trial of SGX201 in the prevention of acute radiation enteritis. Additionally, Soligenix has a Lipid Polymer Micelle (LPM™) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

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