PRINCETON, N.J., March 15, 2018 /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,
2017.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "In the
third quarter of 2017, we initiated a 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 are actively enrolling
patients in this study and expect final results in the second half
of 2019. We also continue to actively enroll patients in our
pivotal Phase 3 study in cutaneous T-cell lymphoma (CTCL) with
SGX301 (synthetic hypericin), for which we expect results in the
first half of 2019."
Dr. Schaber continued, "Throughout 2017, we were awarded in
excess of $8.6 million in
non-dilutive funding from various government sources across our
entire biodefense and biotherapeutics pipeline in order to advance
multiple development programs, which support we greatly appreciate.
Our combined revenues from both our business segments were
$5.4 million through our government
contracts and grants as we continued to advance the development of
our heat stable ricin vaccine, RiVax®, and
our therapeutics, SGX301 and SGX942."
Soligenix Recent Accomplishments:
- On January 25, 2018, the Company
issued an update letter from Dr. Schaber. This letter summarized
progress and accomplishments during 2017 as well as provided
further guidance on the development programs for 2018.
- On January 2, 2018, the Company
announced that the United States
(US) Patent and Trademark Office had granted the patent titled
"Novel Peptides and Analogs for Use in the Treatment of Oral
Mucositis." The newly issued patent claims therapeutic use of
dusquetide (active ingredient in SGX942) and related innate defense
regulator analogs, and adds to composition of matter claims for
dusquetide and related analogs that have been granted in the US and
worldwide. Dusquetide previously demonstrated positive results in a
Phase 2 oral mucositis clinical trial and a pivotal Phase 3 study
was initiated in 2017.
- On December 21, 2017, the Company
announced that biomarkers for its ricin toxin vaccine
(RiVax®) testing had been successfully
identified, facilitating potential approval under the FDA "Animal
Rule". The FDA Animal Rule is applied to products where testing in
clinical trials would be unethical. In the case of a ricin toxin
vaccine, clinical efficacy testing of the vaccine is unethical
since exposing unvaccinated humans (i.e., placebo-control group) to
ricin toxin would be fatal. The Animal Rule combines safety studies
in humans and efficacy testing in animals, typically non-human
primates, to facilitate approval and is generally associated with
the approval of medical countermeasures for biodefense purposes.
Key to the application of the Animal Rule is the requirement to
establish a correlation between the response observed in clinical
trials in healthy volunteers with the response demonstrated in
animal efficacy studies. Identification of a biomarker to
facilitate demonstrating the correlation between animal and human
studies is a significant accomplishment in the
RiVax® development program.
- On November 30, 2017, the Company
announced that it had received preliminary approval for a tax
credit from the New Jersey Economic Development Authority's New
Jersey Technology Business Tax Certificate Transfer program. As a
result, the Company transferred this credit and received
approximately $417,000 in net
proceeds in January 2018.
Financial Results – Year Ended December 31, 2017
Soligenix's revenues for the year ended December 31, 2017 were $5.4 million as compared to $10.4 million for the prior year. Revenues
included contracts in support of
OrbeShield® (oral beclomethasone
17,21-dipropionate) development for the treatment of
gastrointestinal acute radiation syndrome and
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.
Soligenix's basic net loss was $7.1
million, or ($1.16) per share,
as compared to $3.2 million for the
prior year, or ($0.93) per share, on
a split adjusted basis. Included in the net loss for the year ended
December 31, 2016 is non-cash income
of $1.5 million. This non-cash
item reflects the change in fair value of the liability related to
warrants issued in the Company's June 25,
2013 registered public offering and was included in total
other income of $1.9 million.
Research and development expenses were $5.5 million as compared to $4.3 million for the years ended December 31, 2017 and 2016, respectively. The
increase is primarily related to expenditures incurred in the
preparation and initiation of the Phase 3 clinical trial of SGX942
as well as the ongoing Phase 3 clinical trial of SGX301.
General and administrative expenses were $3.2 million as compared to $3.4 million for the years ended December 31, 2017 and 2016, respectively. This
decrease was primarily a result of a decrease in professional
fees.
As of December 31, 2017, the
Company's cash position was $7.8
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, OrbeShield®, our
GI acute radiation syndrome therapeutic 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 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 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. 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. Further, there can be no assurance that
RiVax® will qualify for a biodefense
Priority Review Voucher (PRV) or that the prior sales of PRVs will
be indicative of any potential sales price for a PRV for
RiVax®. 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.