Soligenix (OTCBB:SNGX) said Tuesday that full year revenues rose by more than four times, as net loss narrowed.
development stage biopharmaceutical company posted revenues for the
year that ended December 31 of $7.7 million, way up from $1.9 million a
The sharp increased reflected a $5.0 million
non-refundable license fee from Sigma-Tau Pharmaceuticals, in connection
with the expansion of Soligenix's
existing North American commercialization rights to orBec and oral BDP
into European territory. Oral BDP is being tested to treat and prevent
acute radiation sickness and other gastrointestinal diseases.
has been marketed in the US and worldwide since the early 1970s as the
active pharmaceutical ingredient in inhalation products to treat
patients with allergic rhinitis and asthma.
net loss for the year was $2.4 million, or a 22-cent-loss per share, as
compared to a $7.4 million net loss, or 73-cent-loss per share in 2010.
The smaller loss is also attributable to the Sigma-Tau licensing agreement fee received in the third quarter, Soligenix said.
Research and development expenses for the full year were $6.3 million, up slightly from $6.0 million in the previous year.
increase was due to a $1.0 million cash and stock payment to the
company's orBec licensor in connection with the Sigma-Tau agreement,
offset by reduced spending resulting from the termination of a phase 3
clinical trial for orBec in the treatment of acute gastrointestinal
Graft-versus Host disease (GI GVHD).
"In 2011 we saw the
unfortunate stoppage of our Phase 3 trial of orBec in acute GI GVHD at
the recommendation of an independent Data Safety Monitoring Board," said
president and CEO, Christopher J. Schaber.
"As a result of this
event, we have restructured the organization by decreasing headcount
with a continued focus on cash management and research and development
"We remain committed to evaluating all
strategic options while we continue the development of our oral BDP
programs for pediatric Crohn's disease, acute radiation syndrome and
acute radiation enteritis as well as the development of our vaccine
programs including our novel thermostabilization technology, ThermoVax."
The company has announced a number of notable operational
achievements of late, including promising results from its preclinical
study of SGX202 (oral BDP), testing for the treatment of
gastrointestinal acute radiation syndrome in dogs.
The new study
results indicated that dogs treated with SGX202 starting 24 hours after
exposure to lethal doses of total body irradiation (TBI) demonstrated
"statistically significant" improvement in survival when compared to
The company said these results show that SGX202
has the potential to reduce the inflammatory storm induced by the
radiation-damaged GI tract.
Also earlier this year, the company
unveiled preliminary results from a phase 1/2 clinical trial of SGX201, a
time-release formulation of oral BDP for the prevention of acute
radiation enteritis. The study showed that oral administration of SGX201
was safe and well tolerated across all four dose groups.
radiation enteritis is caused by the radiation-induced death of cells in
the lining of the bowel. As bowel cells die and are not replaced, there
is a resulting inflammatory response to dead cells and bacteria, with
diarrhea, nausea, vomiting and pain being prominent symptoms.
addition of chemotherapy may exacerbate the intestinal symptoms, and
can result in the delay or interruption of the cancer treatment. There
are over 100,000 patients each year in the United States who receive
abdominal or pelvic external beam radiation treatment for cancer, and
these patients are at risk of developing radiation enteritis.
subjects with rectal cancer scheduled to undergo concurrent radiation
and chemotherapy prior to surgery were enrolled in one of four dose
groups in the study, with dosing administered throughout the duration of
radiation therapy plus one week.
The main goal of the study was
to evaluate the safety and tolerability of escalating doses of SGX201,
as well as to assess the preliminary efficacy of SGX201 for the
prevention of signs and symptoms of acute radiation enteritis.
addition, the incidence of diarrhea was lower than that seen in recent
published historical control data in this patient population, the
The company also announced positive results from
preclinical studies of its proprietary vaccine thermo-stabilization
technology, establishing proof-of-concept.
The company's technology allows vaccines that usually need to be refrigerated to maintain their efficacy at higher temperatures.
used its aluminum-adjuvant ricin toxin vaccine, RiVax, in the study.
RiVax was developed under lyophilization conditions, and uses an active
carrier to help maintain the protein structure of the ricin A chain,
which provides the immunogenic component of the drug.
lyophilization process is often employed to extend the shelf life of
drugs, by removing the water from the pharmaceutical preparation.
Vaccines that undergo this process often lose their potency, especially
if the vaccine is made with aluminum salt adjuvants, as most are.
this reason, many vaccines need to be refrigerated or frozen, and as a
result, the World Health Organization (WHO) estimates that about half of
all global vaccine doses are wasted.
aluminum-adjuvanted vaccines, RiVax usually requires temperatures at or
below eight degrees Celsius for storage and efficacy. However, using Soligenix's
tehcnology and the lyophilization process, the company found that the
vaccine provided strong, neutralizing antibodies, even in temperatures
as high as 40 degrees Celsius.
technology is especially valuable in biodefense or pandemic situations,
where drugs need to be stockpiled for a long period of time.
Under its biodefense unit, the company is also developing SGX204, a vaccine against anthrax exposure.
As at year-end 2011, the company's cash position was $6.0 million with working capital of $5.7 million.