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Soligenix Reports First Quarter 2011 Financial Results and Reviews Accomplishments

PRINCETON, N.J., May 13, 2011 /PRNewswire/ -- Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today its financial results for the first quarter of 2011.

Soligenix's revenues for the first quarter of 2011 were approximately $808,000 as compared to $336,000 for the first quarter of 2010. The increased revenues were primarily a result of increases in National Institutes of Health (NIH) grant revenues as the Company increased research efforts under its thermostable vaccine development program and under its FDA Orphan Products grant for the confirmatory Phase 3 clinical trial of orBec® in acute gastrointestinal Graft-versus-Host disease (GI GVHD).

Soligenix's net loss for the first quarter of 2011 was approximately $1,720,000, or $(0.01) per share, as compared to $2,136,000, or $(0.01) per share for the first quarter of 2010.

Research and development expenses for the first quarter of 2011 were approximately $1,256,000, compared to $1,598,000 for the first quarter of 2010. General and administrative expenses for the first quarter of 2011 were approximately $564,000, compared to approximately $538,000 for the first quarter of 2010.

"While the first quarter of 2011 was quite eventful for us, our primary focus continues to be the conduct of our confirmatory Phase 3 orBec® clinical trial," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We remain committed to our goal of having orBec® become the first FDA-approved therapy to treat GI GVHD, an area of unmet medical need associated with high morbidity and mortality rates. On the biodefense and vaccine side of our business, we received Orphan Drug designation for RiVax™ and also executed a license on new technology that will potentially enable us to develop vaccines that are stable at elevated temperatures. We also achieved positive results of SGX202 in a canine model of radiation injury."  

Soligenix's First Quarter 2011 Highlights:  

  • On February 1, 2011, Soligenix announced that it had appointed Kevin Horgan, MD, as its Senior Vice President and Chief Medical Officer.

  • On January 27, 2011, Soligenix announced that it had entered into a definitive license agreement with the University of Colorado for novel technology for use in the development of subunit vaccines with long-term stability, including stability at elevated temperatures.

  • On January 20, 2011, Soligenix announced that the US Food and Drug Administration had granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication.

  • On January 18, 2011, Soligenix announced positive preliminary results from a preclinical study of SGX202 (oral beclomethasone dipropionate or BDP) in a canine gastrointestinal acute radiation syndrome model. The results indicate that dogs treated with SGX202 demonstrated statistically significant (p=0.04) improvement in median survival after exposure to lethal doses of total body irradiation when compared to control dogs.

About Soligenix, Inc.

Soligenix is a late-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 being developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. orBec® is currently the subject of a $1.2 million FDA Orphan Products Grant-supported confirmatory Phase 3 clinical trial for the treatment of acute GI GVHD. 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 biomedical 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 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, 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 risks that: the FDA's requirement that Soligenix conduct additional clinical trials to demonstrate the safety and efficacy of orBec® 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 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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