Soligenix's (OTCQB: SNGX) stock was flat Tuesday after the company announced its full year results for 2012, which was largely spent advancing its programs and expanding its drug pipeline.
For the year that ended December 31, 2012, net loss was $4.2 million, or 37 cents per share, compared to $2.4 million, or 22 cents per share, in the year-ago period, with the increase due mainly to a receipt of $5.0 million from Sigma-Tau in 2011 for the rights to orBec in Europe.
This was partially offset by lower research and development expenses related to the company's discontinued phase 3 trial of orBec for Graft-versus-Host disease, for which Soligenixsuffered in 2011 due to the study's failure.
Revenues for the latest year were $3.1 million, down from $7.6 million in the previous year, also a result of the $5.0 million payment from Sigma Tau in 2011.
The New Jersey-based company focuses on drugs for cancer-supportive care, gastrointestinal disease, and biodefense, and has seen its stock more than quadruple in the last six months as investors become more bullish on its developing assets.
Its lead compound, SGX942, is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. Mucositis is the clinical term for damage done to the mucosa by anti-cancer therapies like radiation and chemotherapy.
Soligenix's SGX942 is a key investment catalyst for the company, with a product launch anticipated in early 2017. In phase 1 trials, it was shown to reduce the severity and duration of oral mucositis and induce anti-inflammatory activity.
The drug maker is also developing SGX203, an oral BDP for pediatric Crohn’s disease. The phase 1/2 trial of SGX203 should begin in the first half of this year.
Beyond these two drugs, the company expects to receive additional government grants to pursue other indications of oral BDP and several biodefense therapeutics and vaccines.
Oral BDP is a topically active corticosteroid that has a local effect on inflamed tissue and is the active ingredient in four of its different product candidates.
Specifically, it is also being used for the development of OrbeShield for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.
In January, the company received an invitation from the Biomedical Advanced Research and Development Authority to submit a contract proposal for the development of OrbeShield, which was submitted in February.
The submission supports a potential multi-year, multi-million dollar contract to develop OrbeShield for the treatment of GI ARS.
"Throughout the year, we continued to make progress in advancing a number of our programs utilizing oral BDP, in both our BioTherapeutics and Vaccine/BioDefense business segments, as well as expanding our pipeline with acquired technology," said president and CEO, Christopher Schaber.
"In December 2012, we were successful in regaining North American and European commercial rights to oral BDP from Sigma-Tau and we expanded our pipeline with the acquisition of a novel innate defense regulator technology known as SGX94.
"We believe SGX94 is highly synergistic with our existing development pipeline in cancer supportive care and biodefense, and we anticipate the potential for a number of grant funding opportunities for SGX94 across both business segments."
Schaber said he is also pleased with the momentum the company has built entering 2013, and is "excited" about the opportunities he sees in both of Soligenix's business units.
At the end of 2012, the company's cash position was $3.4 million, with working capital of $2.7 million.
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