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8-K - FORM 8-K - SOLIGENIX, INC. | f8k040110_soligenix.htm |
Exhibit
99.1
Soligenix
Reports Year-End 2009 Financial Results and
Reviews
Accomplishments
Princeton, NJ – April 1, 2010
– Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a late-stage
biopharmaceutical company, today announced its financial results for
2009.
Soligenix’s
revenues for the year ended December 31, 2009 were $2,816,037 as compared to
$2,310,265 for the prior year, representing an increase of $505,772, or
22%. During 2009, Soligenix received a $1 million clinical milestone
payment from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau), the Company’s
collaborative partner on the orBec® Phase
3 clinical trial in the treatment of acute gastrointestinal Graft-versus-Host
disease (GI GVHD). The increase in revenues generated by this one-time milestone
payment was offset by decreases in grant revenues from the National Institutes
of Health (NIH) as the Company reached the end of its earlier NIH grants before
the work under newer grants had commenced.
Soligenix’s
net loss for the year ended December 31, 2009 was $6,034,453 as compared to a
net loss of $3,422,027 for the prior year, representing an increase of
$2,612,426, or 76%. This increase is primarily attributed to increased spending
of $2,971,052 in research and development related to the preparation for and
conduct of the Phase 3 orBec®
study. For the year ended December 31, 2009, there was also an increase in
general and administrative expenses of $339,532, which reflects staffing and
other corporate costs in 2009.
“In 2009,
we saw important advances for Soligenix,” stated Christopher J. Schaber, PhD,
President and CEO of Soligenix. “Beginning with our partnership with
Sigma-Tau in North America and the initiation of our confirmatory Phase 3
clinical trial of orBec® in
the treatment of acute GI GVHD, we have demonstrated orBec®’s
ability to draw partnerships and attract significant funding. orBec® is
now poised to potentially be the first FDA-approved therapy for this unmet
medical need. Additionally, we achieved significant non-dilutive financing for
our RiVaxTM
program in biodefense through our receipt of a $9.4 million NIH grant. We are
optimistic that we will be able to continue the growth that we achieved in all
facets of Soligenix and maintain that positive momentum in 2010.”
Soligenix’s
2009 Highlights:
·
|
The initiation of a
Phase 1/2 clinical trial evaluating SGX201, a time-release formulation of
oral beclomethasone dipropionate (oral BDP), for the prevention of acute
radiation enteritis.
|
·
|
The
initiation of enrollment in its confirmatory Phase 3 randomized,
double-blind, placebo-controlled, multicenter clinical trial evaluating
orBec®
for the treatment of acute gastrointestinal Graft-versus-Host disease (GI
GVHD). The initiation of this trial also triggered a $1 million milestone
payment from Soligenix’s partner,
Sigma-Tau.
|
·
|
The
award of a $9.4 million grant from the National Institute of Allergy and
Infectious Diseases (NIAID), a division of the NIH, for the development of
formulation and manufacturing processes for vaccines, including RiVaxTM,
that are stable at elevated
temperatures.
|
·
|
The
award of a $500,000 NIH Small Business Innovation Research grant to
support the conduct of a Phase 1/2 clinical trial evaluating SGX201, a
time-release formulation of oral BDP, for the prevention of acute
radiation enteritis.
|
·
|
The
receipt of Orphan Drug Designation by the FDA’s Office of Orphan Products
Development for orBec®
for the treatment of gastrointestinal symptoms associated with chronic GI
GVHD.
|
·
|
The
receipt of European Medicines Evaluation Agency (EMEA) agreement on the
design of its confirmatory Phase 3 clinical trial of orBec®
in acute GI GVHD.
|
·
|
The
completion of a potential $30 million partnering agreement with Sigma-Tau
for the development and commercialization in North America of orBec®
and oral BDP.
|
·
|
Agreement
with the FDA on the design of a confirmatory, pivotal Phase 3 clinical
trial evaluating its lead product, orBec®,
for the treatment of acute GI GVHD. The agreement was made under the FDA's
Special Protocol Assessment (SPA)
procedure.
|
About
Soligenix, Inc.
Soligenix,
Inc. (Soligenix) is a late-stage biopharmaceutical company developing products
to treat life-threatening side effects of cancer treatments and serious
gastrointestinal diseases, and vaccines for certain bioterrorism agents.
Soligenix’s lead product, orBec® (oral
beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid
being developed for the treatment of acute gastrointestinal
Graft-versus-Host-Disease (GI GVHD), a common and potentially life-threatening
complication of hematopoietic cell transplantation. orBec® is
currently the subject of a confirmatory Phase 3 clinical trial for the treatment
of acute GI GVHD and an NIH-supported, Phase 2, randomized, double-blind,
placebo-controlled trial in the prevention of acute GVHD. Both of these trials
are actively enrolling patients. Soligenix has also recently initiated an
NIH-supported Phase 1/2 clinical trial of SGX201 in the prevention of acute
radiation enteritis. Additionally, Soligenix has a Lipid Polymer Micelle (LPM™)
drug delivery technology for the oral delivery of leuprolide for the treatment
of prostate cancer and endometriosis.
Through
its Biodefense Division, Soligenix is developing biomedical countermeasures
pursuant to the Project BioShield Act of 2004. Soligenix’s lead biodefense
product in development is a recombinant subunit vaccine called RiVax™, which is
designed to protect against the lethal effects of exposure to ricin toxin.
RiVax™ has been shown to be well tolerated and immunogenic in a Phase 1 clinical
trial in normal volunteers. RiVaxTM is
also the subject of a recent $9.4 million NIH grant received by the Company
supporting development of new heat stable vaccines.
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. Statements that are not historical facts, such as "anticipates,"
"believes," "intends," 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 or commercialize
products based on its technology, including orBec®,
SGX201, RiVax™, and LPMTM,
particularly in light of the significant uncertainty inherent in developing
vaccines against bioterror threats, manufacturing and conducting preclinical and
clinical trials of vaccines, and obtaining regulatory approvals, that its cash
expenditures will not exceed projected levels, 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 grants and awards, maintain its existing grants
which are subject to performance, enter into any biodefense procurement
contracts with the US Government or other countries, that the US Congress may
not pass any legislation that would provide additional funding for the Project
BioShield program, that it will be able to patent, register or protect its
technology from challenge and products from competition or maintain or expand
its license agreements with its current licensors, or that its business strategy
will be successful. Important factors which may affect the future use of
orBec® for
gastrointestinal GVHD include the risks that: positive results from the ongoing
Phase 3 clinic trial for orBec® cannot be assumed and the FDA could require
Soligenix to conduct additional clinical trials to demonstrate the safety and
efficacy of orBec®, which would take
a significant amount of time and money to complete; Soligenix is dependent on
the expertise, effort, priorities and contractual obligations of third parties
in the clinical trials, manufacturing, marketing, sales and distribution of its
products; orBec® may
not gain market acceptance if it is eventually approved by the FDA; and others
may develop technologies or products superior to orBec®.
Factors affecting the development and use of SGX201 and LPMTM are
similar to those affecting orBec®.
These and other 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.
Company Contact:
Evan
Myrianthopoulos
Chief
Financial Officer
(609)
538-8200
Soligenix,
Inc.
29 Emmons
Drive, Suite C-10
Princeton,
NJ 08540
www.soligenix.com