Soligenix Reports Year-End 2011 Financial Results and Highlights Recent Accomplishments

PRINCETON, N.J., March 27, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today its financial results for the year ended December 31, 2011.

Soligenix's revenues for the year ended December 31, 2011 were $7.7 million as compared to $1.9 million for the prior year. The increase in revenues was a result of a $5.0 million non-refundable license fee from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) in connection with the expansion of Soligenix's existing North American commercialization rights to orBec® and oral beclomethasone dipropionate (oral BDP) into the European Territory (the Sigma-Tau Agreement).

Soligenix's net loss for the year ended December 31, 2011 was $2.4 million, or $(0.22) per share, as compared to $7.4 million, or $(0.73) per share for the year ended December 31, 2010, representing a decreased loss of $5.0 million. This decreased loss is primarily attributable to the Sigma-Tau Agreement license fee received in the third quarter of 2011.

Research and development expenses for the full year 2011 were $6.3 million as compared to $6.0 million for the full year 2010. This increase is primarily attributable to 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 offset by reduced spending resulting from the stoppage of our Phase 3 clinical trial of orBec® in the treatment of acute gastrointestinal Graft-versus Host disease (GI GVHD). General and administrative expenses for the full year 2011 were $2.2 million, compared to $2.2 for the full year 2010.

As of December 31, 2011, the Company's cash position was $6.0 million with working capital of $5.7 million.   

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "In 2011 we saw the unfortunate stoppage of our Phase 3 trial of orBec® in acute GI GVHD at the recommendation of an independent Data Safety Monitoring Board. As a result of this event, we have restructured the organization by decreasing headcount with a continued focus on cash management and research and development program expenditures. We remain committed to evaluating all strategic options while we continue the development of our oral BDP programs for pediatric Crohn's disease, acute radiation syndrome and acute radiation enteritis as well as the development of our vaccine programs including our novel thermostabilization technology, ThermoVax™."

Soligenix's Recent Highlights:

  • On February 21, 2012, the Company announced further promising results from its continuing preclinical study of SGX202 (oral BDP) in a canine gastrointestinal acute radiation syndrome (GI ARS) model. The new study results indicate that dogs treated with SGX202 starting 24 hours after exposure to lethal doses of total body irradiation (TBI) demonstrated statistically significant (p=0.04) improvement in survival when compared to control dogs. This study builds upon the previous results which showed statistically significant survival in dogs when dosing of SGX202 was initiated two hours after lethal doses of TBI. These results demonstrate that SGX202 has the potential to reduce the inflammatory cytokine storm induced by the radiation damaged GI tract.
  • On February 10, 2012, the Company announced preliminary results from its Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral BDP for the prevention of acute radiation enteritis. The Phase 1/2 protocol BDP-ENT-01 was designed as an open label, randomized, dose-finding study at five centers.  Sixteen subjects with rectal cancer scheduled to undergo concurrent radiation and chemotherapy prior to surgery were enrolled in one of four dose groups, with dosing administered throughout the duration of radiation therapy plus one week. The primary objective of the study was to evaluate the safety and tolerability of escalating doses of SGX201, as well as to assess the preliminary efficacy of SGX201 for prevention of signs and symptoms of acute radiation enteritis. This study demonstrated that oral administration of SGX201 was safe and well tolerated across all four dose groups.  There was also evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis according to NCI Common Terminology Criteria for Adverse Events for selected gastrointestinal events. In addition, the incidence of diarrhea was lower than that seen in recent published historical control data in this patient population.
  • On February 6, 2012, the Company announced results from preclinical studies of its proprietary vaccine thermostabilization technology, ThermoVax™, indicating its ability to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with Soligenix's aluminum-adjuvanted ricin toxin vaccine, RiVax™, made under precise lyophilization conditions using excipients that aid in maintaining native protein structure of the ricin A chain, the immunogenic compound of the vaccine. When RiVax™ was kept at 40 degrees Celsius for over one month, all of the animals vaccinated with the lyophilized RiVax™ vaccine developed potent and high titer neutralizing antibodies. In contrast, animals that were vaccinated with the liquid RiVax™ vaccine kept at 40 degrees Celsius did not develop neutralizing antibodies and were not protected against ricin exposure. The ricin A chain is extremely sensitive to temperature and rapidly loses the ability to induce neutralizing antibodies when exposed to temperatures higher than 8 degrees Celsius.  
  • On January 31, 2012, the Company implemented a one-for-twenty reverse split of its common stock effective February 1, 2012.
  • On January 26, 2012, the Company announced the receipt of approximately $574,000, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax Certificate Transfer Program.
  • On January 18, 2012, the Company announced results from long-term stability studies of its proprietary DNI (dominant negative inhibitor) anthrax rPA (recombinant protective antigen) subunit protein vaccine, known as SGX204. SGX204 is a hyperimmunogenic derivative of PA and is being developed as a vaccine to protect against anthrax disease either as a pre-exposure prophylactic vaccine or post-exposure vaccine. Positive stability was demonstrated when DNI rPA was subjected to temperatures as high as 70 degrees Celsius for one month.  In this case, DNI rPA retained native configuration with no evidence of denaturation that typically occurs in water buffers under the same thermal conditions. Redundant methods to determine protein structure each yielded results that indicated that the thermally stressed DNI protein retained completely native conformation after exposure to 70 degrees Celsius. The water free DNI protein was formulated with common excipients that allow for preservation of protein structure in the dried state. Long-term stability of DNI rPA was also demonstrated after refrigerated storage for more than 7 years. More importantly, when DNI rPA was combined with a potent adjuvant formulation, animals vaccinated with the combination developed high titer neutralizing antibodies that confer protection against anthrax disease. 
  • On December 12, 2011, the Company announced the publication of results from an investigator-initiated Phase 2 "proof-of-concept" exploratory clinical trial of orBec® for the prevention of acute Graft-versus-Host disease (GVHD) in patients undergoing myeloablative conditioning regimens with initiation of dosing prior to hematopoietic cell transplantation (HCT) and continuing through the post-transplantation period. The article is entitled "Evaluation of Oral Beclomethasone Dipropionate for the Prevention of Acute Graft-versus-Host Disease" and was posted online in Biology of Blood and Marrow Transplantation.

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 developing oral BDP for the prevention/treatment of other gastrointestinal disorders characterized by severe inflammation, including acute radiation enteritis (SGX201), which is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial and pediatric Crohn's disease (SGX203).

Through its Biodefense Division, Soligenix is developing countermeasures pursuant to the Project BioShield Act of 2004. 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 SGX204, a vaccine against anthrax exposure.  RiVax™ has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. Both RiVax™ and SGX204 are currently the subject of a $9.4 million National Institute of Allergy and Infectious Disease (NIAID) grant supporting development of new vaccine technology known as ThermoVax™. Soligenix is also developing SGX202 for the treatment of gastrointestinal acute radiation syndrome (GI ARS) and has demonstrated statistically significant preclinical survival results in a canine GI ARS model.

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.



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