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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.

Through its Biodefense Division, Soligenix is developing countermeasures pursuant to the Project BioShield Act of 2004. Soligenix's lead biodefense product in development is a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin. RiVax™ has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax™ is currently the subject of a $9.4 million National Institute of Allergy and Infectious Disease (NIAID) grant supporting development of new heat stable vaccines. Soligenix is also developing SGX202 for the treatment of radiation injury and has recently released positive preliminary preclinical results in a canine gastrointestinal acute radiation syndrome model.

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

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, including orBec®, SGX201, SGX202, SGX203, RiVax™, and LPM™, 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 its cash expenditures will not exceed projected levels, 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, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the DSMB's recent determination disclosed in our Form 8-K dated September 15, 2011 recommending that Soligenix stop its confirmatory Phase 3 clinical trial of orBec® in acute GI GVHD and the likelihood that: the FDA will  require that Soligenix conduct additional clinical trials to demonstrate the safety and efficacy of orBec® which will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; Soligenix is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec® may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec®. Factors affecting the development and use of SGX201, SGX202, SGX203, RiVax™ and LPM™ are similar to those affecting orBec®. These and other 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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