Soligenix (OTCQB:SNGX) reported Wednesday third quarter results that were impacted by license revenue in the year-earlier period, but it said it continued to make "steady progress" in advancing a number of its programs using oral BDP in both its biotherapeutics and biodefense businesses.
Indeed, last week, the company's shares surged as it announced that its program for SGX203, or the oral form of beclomethasone 17,21-dipropionate (BDP), as a treatment for mild-to-moderate pediatric Crohn's disease received fast track designation from the US FDA.
The development-stage biopharmaceutical company had previously received orphan drug designation for this indication of SGX203.
Soligenix will now be eligible to submit a new drug application for SGX203 on a rolling basis, permitting the FDA to review sections of the application prior to receiving the complete submission. Under the fast track program, new drug applications are typically eligible for priority review, which implies a shorter review period of six months.
In September, the company received a green light from the US FDA to start a clinical program for the drug. The clearance allows it to start a phase 1/2 study of the drug in healthy adolescents and young adults.
"In the third quarter of 2012 we continued to make steady progress in advancing a number of our programs utilizing oral BDP, in both our BioTherapeutics and Vaccine/BioDefense business segments," said president and CEO, Christopher J. Schaber.
"We were pleased to receive Investigational New Drug (IND) clearance and Fast Track designation for SGX203 from the U.S. Food and Drug Administration (FDA).
"We remain committed to enhancing our development pipeline through internal efforts and external strategic alliances. We look forward to reporting on further progress on all programs during the remainder of this year."
Soligenix's SGX203 contains BDP, a potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed globally since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma.
SGX203 is a two tablet delivery system of BDP, specifically designed for oral use that allows for the delivery of the drug throughout the small bowel and the colon.
Soligenix is developing proprietary formulations of oral BDP for the prevention and treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec).
Meanwhile, through its biodefense division, the company is developing vaccines including RiVax, designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax, a vaccine against anthrax exposure.
In August, the company said that phase 1B clinical trials of the aluminum hydroxide adjuvanted formulation of RiVax - designed to improve the immunogenicity of the vaccine - indicated that the adjuvanted vaccine is safe, well tolerated and induces greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax.
The company also recently formed a scientific advisory board to help in the development of its OrbeShield radiation drug for the treatment of gastrointestinal acute radiation syndrome (GI-ARS).
For the third quarter, revenue amounted to $931,627, compared to $5.8 million a year earlier, when its top line was boosted by license revenue of $5.0 million from Sigma-Tau Pharmaceuticals for rights to orBec in Europe.
Soligenix said grant revenue actually increased by $135,765 year-over-year, primarily related to increased reimbursable costs from its ThermoVax thermostability grant, which is focused on a new method for rendering aluminum salt adjuvanted vaccines stable at elevated temperatures.
Net loss for the quarter was $758,966, or 7 cents per share, compared to a profit of $2.2 million, or 20 cents per share, a year ago. This decline was also due to the license revenue seen in the third quarter of 2011.
Research and development expenses declined sharply, due to a $1.0 million payment in cash and company stock in connection with the Sigma-Tau agreement, and the discontinuation of the phase 3 clinical trial of orBec for Graft-versus-Host disease.
At the end of the period, Soligenix had $3.7 million in cash, with working capital of $3.1 million.
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