PRINCETON, N.J., March 26, 2019 /PRNewswire/ -- Soligenix,
Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage
biopharmaceutical company focused on developing and commercializing
products to treat rare diseases where there is an unmet medical
need, announced today its recent accomplishments and financial
results for the year ended December 31,
2018.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "We are
actively enrolling patients in our pivotal double-blind,
placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide)
for the treatment of oral mucositis in patients with head and neck
cancer receiving chemoradiation therapy. We anticipate completion
of patient enrollment for the planned interim analysis in the first
half of 2019, with the results of the interim analysis expected in
the third quarter of 2019."
Dr. Schaber continued, "Following the positive recommendation
received from the independent Data Monitoring Committee (DMC), we
continue to enroll patients in our double-blind, placebo-controlled
Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL)
with SGX301 (synthetic hypericin), for which we expect final
results in the first quarter of 2020."
Soligenix Recent Accomplishments:
- On February 11, 2019, the Company
announced the allowance of a new United
States (US) patent protecting its ricin toxin vaccine,
RiVax®. The patent, titled "Multivalent Stable Vaccine
Composition and Methods of making same", supports combination
vaccines protecting against ricin intoxication as well as other
toxins, such as those associated with anthrax. To view this press
release, please click here.
- On February 7, 2019, the Company
announced publication of a scientific article demonstrating the
successful thermostabilization of an Ebola subunit vaccine
candidate. The article titled, "Thermostable Ebola virus vaccine
formulations lyophilized in the presence of aluminum hydroxide", is
published in the European Journal of Pharmaceutics and
Biopharmaceutics online. To view this press release, please click
here.
- On January 23, 2019, the Company
announced that the European Patent Office had granted the patent
entitled "Novel Peptides for Treating and Preventing Immune-Related
Disorders, Including Treating and Preventing Infection by
Modulating Innate Immunity." The newly issued patent claims
composition of matter of innate defense regulator (IDR) analogs,
expanding patent protection around the Company's lead IDR,
dusquetide. Similar claims have been previously allowed in the US
and are being pursued in other worldwide jurisdictions. To view
this press release, please click here.
- On December 5, 2018, the Company
announced the publication of a review article discussing the
therapeutic applications of its innate immune modulator technology,
including dusquetide (the active ingredient in SGX942), its lead
clinical IDR. The article entitled, "Targeting Innate Immunity to
Treat Disease: Potential Therapeutic Applications", was published
in the journal Drug Target Review online. To view this press
release, please click here.
Financial Results – Year Ended December 31, 2018
Soligenix's revenues for the year ended December 31, 2018 were $5.2 million as compared to $5.4 million for the prior year. Revenues
included payments on a contract in support of RiVax®, in
addition to the grants received to support the development of
SGX301 for the treatment of CTCL and SGX942 for the treatment of
oral mucositis in head and neck cancer, as well as the subaward
from the Ebola collaboration with the University of Hawai'i at
Mānoa.
Soligenix's basic net loss was $8.9
million, or ($0.68) per share
for the year ended December 31, 2018,
as compared to $7.1 million for the
prior year, or ($1.16) per share.
Research and development expenses were $6.8 million as compared to $5.5 million for the years ended December 31, 2018 and 2017, respectively. The
increase is primarily related to expenditures incurred in the
expansion of the Phase 3 clinical trial of SGX942 as well as the
ongoing Phase 3 clinical trial of SGX301.
General and administrative expenses were $3.0 million as compared to $3.2 million for the years ended December 31, 2017 and 2016, respectively. This
decrease was primarily a result of a decrease in professional fees
and employee compensation expenses.
As of December 31, 2018, the
Company's cash position was approximately $9.0 million.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on
developing and commercializing products to treat rare diseases
where there is an unmet medical need. Our BioTherapeutics business
segment is developing SGX301 as a novel photodynamic therapy
utilizing safe visible light for the treatment of cutaneous T-cell
lymphoma, our first-in-class innate defense regulator (IDR)
technology, dusquetide (SGX942) for the treatment of oral mucositis
in head and neck cancer, and proprietary formulations of oral
beclomethasone 17,21-dipropionate (BDP) for the
prevention/treatment of gastrointestinal (GI) disorders
characterized by severe inflammation including pediatric Crohn's
disease (SGX203) and acute radiation enteritis (SGX201).
Our Vaccines/BioDefense business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate and SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease. The development of our
vaccine programs incorporates the use of our proprietary heat
stabilization platform technology, known as
ThermoVax®. To date, this business segment has
been supported with government grant and contract funding from the
National Institute of Allergy and Infectious Diseases (NIAID) and
the Biomedical Advanced Research and Development Authority
(BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at https://www.soligenix.com.
This press release may contain 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," "hopes,"
"intends," "plans," "expects," "goal," "may," "suggest," "will,"
"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 therapeutics and vaccines
against bioterror threats, conducting preclinical and clinical
trials of therapeutics and vaccines, obtaining regulatory approvals
and manufacturing therapeutics and 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 U.S.
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 U.S. Congress may not pass any legislation that would provide
additional funding for the Project BioShield program. In addition,
there can be no assurance as to timing or success of the Phase 3
clinical trial of SGX942 (dusquetide) as a treatment for oral
mucositis in patients with head and neck cancer receiving
chemoradiation therapy or the Phase 3 clinical trial of SGX301
(synthetic hypericin) for the treatment of cutaneous T-cell
lymphoma. There also can be no assurance as to timing or
success of the preclinical/clinical trials
of RiVaxÒ, that RiVaxÒ will be
approved for the PRV program or the amount for which a PRV
for RiVaxÒ can be sold. 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.
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SOURCE Soligenix, Inc.