Soligenix Reports First Quarter 2014 Financial Results, and Highlights Recent
PRINCETON, N.J., May 12, 2014
PRINCETON, N.J., May 12, 2014 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a clinical stage biopharmaceutical company focused
on developing products to treat serious inflammatory diseases where there
remains an unmet medical need, as well as developing several biodefense
vaccines and therapeutics, announced today its financial results for the first
quarter ended March 31, 2014.
Soligenix's revenues for the quarter ended March 31, 2014 were $0.9 million as
compared to $0.9 million for the first quarter of 2013. Revenues included
contracts with the US Department of Health and Human Service's Biomedical
Advanced Research and Development Authority (BARDA) and the National Institute
of Allergy and Infectious Diseases (NIAID) in support of OrbeShield™ (oral
beclomethasone 17,21-dipropionate or BDP) development in the treatment of
gastrointestinal acute radiation syndrome (GI ARS).
Soligenix's net (loss) for March 31, 2014 was $3.3 million, or $(0.17) per
share, as compared to $1.1 million, or $(0.10) per share, for the first
quarter ended March 31, 2013. Included in the net loss for the quarter ended
March 31, 2014 is a non-cash charge of $1.7 million, or $0.09 per share, due
to the change in fair value of the warrant liability related to warrants
issued in connection with the Company's June, 2013 registered public offering.
Research and development expenses for the quarter ended March 31, 2014 were
$1.0 million as compared to $0.8 million for the same period in 2013. General
and administrative expenses for the quarter ended March 31, 2014 were $0.9
million as compared to $0.5 million for the same period in 2013. Overall
operating expenses increased by $0.6 million due to expenses related to the
Company's Phase 2 clinical trials with SGX942 in the treatment of oral
mucositis and orBec^® in the treatment of chronic gastrointestinal
Graft-versus-host disease (GI GVHD), as well as from increased headcount and
non-cash expenses for stock based compensation from stock options issued to
existing and newly hired employees.
For the quarter ended March 31, 2014, other net income/expense includes a $1.7
million, or $0.09 per share, non-cash charge related to the change in fair
value of the warrant liability related to warrants issued in connection with
the Company's June 2013 registered public offering.
As of March 31, 2014, the Company's cash position was $5.6 million.
Christopher J. Schaber, PhD, President and Chief Executive Officer of
Soligenix stated, "We continue to advance our multiple development programs
across our BioTherapeutics and Vaccine/BioDefense business segments, including
patient enrollment in the Phase 2 clinical studies with SGX942 in the
treatment of oral mucositis in head and neck cancer and orBec^® in the
treatment of chronic GI GVHD. We continued to effectively manage our cash
burn ending the quarter with $5.6 million. In addition, we were recently
awarded two Small Business Innovation Research (SBIR) grants totaling
$500,000. The receipt of these grants further validates the potential of our
development programs and continued ability to secure government funding to
support them. Within the past twelve months, we have received contract and
grant funding totaling up to approximately $33.0 million. I look forward to
providing updates throughout the balance of this year and into 2015."
Soligenix First Quarter Highlights:
oOn April 7, 2014, the Company announced the award by the National
Institute of Dental and Craniofacial Research (NIDCR) of a one year
$200,000 SBIR grant to support the conduct of its Phase 2 study evaluating
SGX942 as a treatment of oral mucositis in patients undergoing chemo
radiation therapy for head and neck cancer.
oOn February 14, 2014, the Company announced the award by NIAID of a one
year $300,000 SBIR grant to support further preclinical development of
SGX943 as a treatment for melioidosis. This award will allow the Company
to conduct studies in collaboration with Tulane University.
oOn January 16, 2014, the Company announced that it had received
approximately $750,000, net of transaction costs, in non-dilutive funding
via the State of New Jersey's Technology Business Tax Certificate Transfer
oOn January 15, 2014, the Company announced significant steps forward in
the development of ThermoVax™, its proprietary vaccine thermostabilization
platform technology. Recent studies have demonstrated the potential for
heat-sensitive vaccines formulated using this technology to withstand
temperatures exceeding 40 degrees Celsius (104 degrees Fahrenheit) for up
to one year. The underlying work has been conducted with the Company's
proprietary ricin toxin vaccine (RiVax™) as part of a continuing program
to evaluate the effectiveness of protein subunit vaccines to withstand
extremes of temperature and other environmental stress conditions. The
research and development of ThermoVax™ is currently being supported by a
$9.4 million NIAID grant for biodefense vaccines to prevent ricin toxin
and anthrax exposure.
oOn January 6, 2014, the Company announced that it had appointed Richard
Straube, MD, as its Senior Vice President and Chief Medical Officer. Dr.
Straube is a board-certified pediatrician with clinical research
experience in host-response modulation. He has had a long and
distinguished career of more than 35 years in both academia and industry,
most notably with Centocor, Ohmeda Pharmaceuticals, INO Therapeutics, and
Stealth Peptides, Inc. Dr. Straube will lead Soligenix's clinical research
with primary responsibility for the execution and completion of its
multiple clinical programs, including its Phase 2 study in oral mucositis
and its Phase 2/3 study in pediatric Crohn's disease.
About Soligenix, Inc.
Soligenix is a clinical stage biopharmaceutical company focused on developing
products to treat serious inflammatory diseases where there remains an unmet
medical need, as well as developing several biodefense vaccines and
therapeutics. Soligenix is developing proprietary formulations of oral BDP
(beclomethasone 17,21-dipropionate) for the prevention/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^®), as well as developing its novel
innate defense regulator (IDR) technology SGX942 for the treatment of oral
Through its BioDefense Division, Soligenix is developing countermeasures
pursuant to the Biomedical Advanced Research and Development Authority (BARDA)
Strategic Plan of 2011-2016 for inclusion in the US government's Strategic
National Stockpile. Soligenix's biodefense products in development are a
recombinant subunit vaccine called RiVax™, which is designed to protect
against the lethal effects of exposure to ricin toxin and VeloThrax™, a
vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated
and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both
RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National
Institute of Allergy and Infectious Diseases (NIAID) grant supporting
development of Soligenix's new vaccine heat stabilization technology known as
ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of
gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract
award valued up to $26.3 million and a NIAID contract award valued up to $6.4
million. OrbeShield™ has previously demonstrated statistically significant
preclinical survival results in a canine model of GI ARS funded by the NIAID.
Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon
Corporation (NYSE: XON) focused on the joint development of a treatment for
Melioidosis, a high priority biothreat and an area of unmet medical need.
For further information regarding Soligenix, Inc., please visit the Company's
website at www.soligenix.com.
This press release contains forward-looking statements that reflect Soligenix,
Inc.'s current expectations about its future results, performance, prospects
and opportunities, including but not limited to, potential market sizes,
patient populations and clinical trial enrollment. Statements that are not
historical facts, such as "anticipates," "estimates," "believes," "intends,"
"potential," or similar expressions, are forward-looking statements. These
statements are subject to a number of risks, uncertainties and other factors
that could cause actual events or results in future periods to differ
materially from what is expressed in, or implied by, these statements.
Soligenix cannot assure you that it will be able to successfully develop,
achieve regulatory approval for or commercialize products based on its
technologies, particularly in light of the significant uncertainty inherent in
developing vaccines against bioterror threats conducting preclinical and
clinical trials of vaccines, obtaining regulatory approvals and manufacturing
vaccines, that product development and commercialization efforts will not be
reduced or discontinued due to difficulties or delays in clinical trials or
due to lack of progress or positive results from research and development
efforts, that it will be able to successfully obtain any further funding to
support product development and commercialization efforts, including grants
and awards, maintain its existing grants which are subject to performance
requirements, enter into any biodefense procurement contracts with the US
Government or other countries, that it will be able to compete with larger and
better financed competitors in the biotechnology industry, that changes in
health care practice, third party reimbursement limitations and Federal and/or
state health care reform initiatives will not negatively affect its business,
or that the US Congress may not pass any legislation that would provide
additional funding for the Project BioShield program. These and other risk
factors are described from time to time in filings with the Securities and
Exchange Commission, including, but not limited to, Soligenix's reports on
Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation
to update or revise any forward-looking statements as a result of new
information or future events.
SOURCE Soligenix, Inc.
Contact: Joe Warusz, CPA, Acting Chief Financial Officer, (609) 538-8200 |
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