Soligenix third quarter revenues increase to $861,000

Soligenix, Inc.Nov 12 2010

Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today its financial results for the third quarter of 2010.

Soligenix's revenues for the third quarter of 2010 were approximately $861,000 as compared to $767,000 for the third quarter of 2009. 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 initiated drawdowns under its FDA Orphan Products grant for the confirmatory Phase 3 trial of orBec® in acute gastrointestinal Graft-versus-Host disease (GI GVHD).

Soligenix's net loss for the third quarter of 2010 was approximately $1,734,000, or $(0.01) per share, as compared to $1,660,000, or $(0.01) per share for the third quarter of 2009.

Research and development expenses for the third quarter of 2010 were approximately $1,122,000, compared to $1,109,000 for the third quarter of 2009. General and administrative expenses for the third quarter of 2010 were approximately $356,000, compared to $618,000 for the third quarter of 2009. The decrease in G&A expenses results from decreases in compensation associated with severance, benefits, and board fees.  

"We are happy to have received new funding this year in various forms and have ended the third quarter with approximately $9 million in cash and an additional $9.9 million in grant funding commitments for our development programs," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Our confirmatory Phase 3 clinical trial of orBec® is actively enrolling and 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 high morbidity and mortality rates."

Third Quarter 2010 Highlights and Recent Developments:  

• On November 3, 2010, Soligenix announced that it had been awarded a maximum allowable cash grant per project totaling $244,479 under the U.S. Internal Revenue Service's Qualifying Therapeutic Discovery Project (QTDP) program. The awards are intended for projects designed to treat or prevent diseases by conducting studies for the purpose of securing approval from the U.S. Food and Drug Administration.
• On November 2, 2010, Soligenix announced that it had completed enrollment of its Phase 1B clinical trial of RiVax™, a ricin subunit vaccine, in healthy volunteers. Preliminary results indicate that RiVax™ appears safe at all doses tested in volunteers. This trial is designed to assess the duration of immune responses using an adjuvant formulation of RiVax™ over a period of more than one year after vaccination.
• On October 25, 2010, Soligenix reported preliminary results from its Phase 2 "proof-of-concept" exploratory clinical trial of orBec® for the prevention of acute Graft-versus-Host disease (GVHD). The preliminary results indicate that orBec® appears safe and well tolerated in this patient population, but did not achieve statistical significance in the primary endpoint, which was the proportion of subjects who developed acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation. However, the use of orBec® resulted in fewer cases of more severe acute GVHD grades IIb-IV (21% vs. 33% of patients receiving placebo).
• On September 27, 2010, Soligenix announced the election of Tamar D. Howson and Virgil D. Thompson to its Board, the results of its annual meeting of shareholders, as well as an adjustment to the expected timeline to completion for its confirmatory Phase 3 clinical trial of orBec® in acute gastrointestinal Graft-versus-Host disease into the second half of 2011.
• On September 2, 2010, Soligenix announced the publication of an article online in Vaccine.  The article describes the systematic identification of neutralizing and non-neutralizing B-cell epitopes on ricin toxin's enzymatic A subunit (RTA). An inactivated form of RTA is the primary component of RiVax™, the Company's proprietary vaccine against ricin toxin.
• On August 23, 2010, Soligenix announced that it had been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development of the U.S. Food and Drug Administration pursuant to its Orphan Products Development Program.