Soligenix's revenues for 2009 increase by 22%

Apr 1 2010

Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, today announced its financial results for 2009.

Soligenix's revenues for the year ended December 31, 2009 were $2,816,037 as compared to $2,310,265 for the prior year, representing an increase of $505,772, or 22%.  During 2009, Soligenix received a $1 million clinical milestone payment from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau), the Company's collaborative partner on the orBec® Phase 3 clinical trial in the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD). The increase in revenues generated by this one-time milestone payment was offset by decreases in grant revenues from the National Institutes of Health (NIH) as the Company reached the end of its earlier NIH grants before the work under newer grants had commenced.

Soligenix's net loss for the year ended December 31, 2009 was $6,034,453 as compared to a net loss of $3,422,027 for the prior year, representing an increase of $2,612,426, or 76%. This increase is primarily attributed to increased spending of $2,971,052 in research and development related to the preparation for and conduct of the Phase 3 orBec® study. For the year ended December 31, 2009, there was also an increase in general and administrative expenses of $339,532, which reflects staffing and other corporate costs in 2009.

"In 2009, we saw important advances for Soligenix," stated Christopher J. Schaber, Ph.D., President and CEO of Soligenix.  "Beginning with our partnership with Sigma-Tau in North America and the initiation of our confirmatory Phase 3 clinical trial of orBec® in the treatment of acute GI GVHD, we have demonstrated orBec®'s ability to draw partnerships and attract significant funding. orBec® is now poised to potentially be the first FDA-approved therapy for this unmet medical need. Additionally, we achieved significant non-dilutive financing for our RiVax™ program in biodefense through our receipt of a $9.4 million NIH grant. We are optimistic that we will be able to continue the growth that we achieved in all facets of Soligenix and maintain that positive momentum in 2010."

Soligenix's 2009 Highlights:  

• The initiation of a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral beclomethasone dipropionate (oral BDP), for the prevention of acute radiation enteritis.
• The initiation of enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec® for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD). The initiation of this trial also triggered a $1 million milestone payment from Soligenix's partner, Sigma-Tau.
• The award of a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH, for the development of formulation and manufacturing processes for vaccines, including RiVax™, that are stable at elevated temperatures.
• The award of a $500,000 NIH Small Business Innovation Research grant to support the conduct of a Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of oral BDP, for the prevention of acute radiation enteritis.
• The receipt of Orphan Drug Designation by the FDA's Office of Orphan Products Development for orBec® for the treatment of gastrointestinal symptoms associated with chronic GI GVHD.
• The receipt of European Medicines Evaluation Agency (EMEA) agreement on the design of its confirmatory Phase 3 clinical trial of orBec® in acute GI GVHD. 
• The completion of a potential $30 million partnering agreement with Sigma-Tau for the development and commercialization in North America of orBec® and oral BDP.
• Agreement with the FDA on the design of a confirmatory, pivotal Phase 3 clinical trial evaluating its lead product, orBec®, for the treatment of acute GI GVHD. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure.

SOURCE Soligenix, Inc.