Soligenix, Inc., an established biopharma company specializing in products which offset the potentially fatal side effects of many oncology treatments and severe diseases in the gastrointestinal system, as well as vaccines tailored for counter-bioterrorism applications, announced FY 09 results today.
Revenue was up 22% ($506k) to $2.2M from 08 on strength of a $1M clinical milestone outlay from Sigma-Tau Pharmaceuticals Inc. (Sigma-Tau) in relation to a collaborative Phase 3 (randomized, double-blind, placebo-controlled) clinical trial of orBec® for gastrointestinal Graft-versus-Host disease (GI GVHD).
SNGX also completed a partnering agreement with Sigma-Tau regarding NA commercialization and deployment of orBec® and oral BDP worth an estimated $30M.
The European Medicines Evaluation Agency (EMEA) agreed to the design of a Phase 3 clinical trial for orBec® as well.
Declines in grant money from the National Institutes of Health (NIH), resulting from the typical end-of-cycle changeover between old grants and new ones, offset this $1M boon somewhat.
SNGX was awarded a $9.4M grant from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) division for its work on the stable-at-room-temp biodefense vaccine RiVax™, and a $500k Small Business Innovation Research grant relating to Phase1/2 clinical trialing of the Company’s time-release oral beclomethasone dipropionate (BDP) formulation for acute radiation enteritis.
Net Losses were up 76% ($2.6M) to $6M from 08 due to a massive $3M R&D push for Phase 3 trials of orBec® because of its potentially explosive potential to become the first ever FDA-approved treatment for GI GVHD, and the drug has also received the FDA’s Orphan Drug Designation (a designation indicating Top Priority).
General and Administrative Expenses saw a $340k uptick due to staffing and corporate costs.
President and CEO of SNGX Christopher J. Schaber, Ph.D., noted the breakaway character of FY 09 results: from the Partnership with Sigma-Tau in NA to the trialing of orBec®, which stands to be unchallenged in its market; to the achievement of “significant non-dilutive financing” for the RiVax™ program, which is also poised to generate substantial long-term ROI for the Company’s shareholders due to the amazing potential of the counter-bioterrorism market.
Schaber projects sustained momentum and therefore continued growth in 2010.