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
melioidosis therapeutic candidate. 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).
Announces Recent Accomplishments And Year-End 2016 Financial Results
Highlighted by Revenues of $10.4 Million
PRINCETON, N.J., March 27, 2017 /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, 2016.
Christopher J. Schaber, PhD, President and Chief Executive Officer of
Soligenix stated, "We are extremely pleased with the positive results
from the Phase 2 study of SGX942 (dusquetide) for the treatment of oral
mucositis in patients with head and neck cancer. We are encouraged by
the response received from the EMA that the proposed Phase 3 clinical
study, if positive, is sufficient to establish the efficacy and safety
of SGX942 in support of potential marketing authorization in Europe. We
believe that this positive Scientific Advice outcome represents a
significant step forward in our oral mucositis development program and
has the potential to accelerate the registration timetable in Europe.
Given the current timeline, we anticipate initiating this pivotal Phase
3 clinical trial in the first half of 2017."
Dr. Schaber continued, "We also continue to actively enroll patients in
our pivotal Phase 3 study in cutaneous T-cell lymphoma with SGX301
(synthetic hypericin), in which we expect data by the end of 2017. Our
Vaccines/BioDefense business segment achieved revenues of $10.4 million
through our government contracts as we continued to advance the
development of our heat stable ricin vaccine, RiVax™ and our
therapeutic for gastrointestinal acute radiation syndrome, OrbeShield®."
Soligenix Recent Accomplishments:
On February 22, 2017, the Company announced that its proprietary
formulation of synthetic hypericin had been granted a European patent
for the treatment of psoriasis. The issued patent, EP 2571507,
Formulations and methods of treatment of skin conditions, complements
the method of treatment claims covered by the previously issued US
patent 6001882, Photoactivated hypericin and the use thereof.
On February 2, 2017, the Company announced that SGX301 had been granted
Promising Innovative Medicine (PIM) designation in the United Kingdom
(UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA)
for the treatment of cutaneous T-cell lymphoma (CTCL). The PIM
designation is the first step towards inclusion in the Early Access to
Medicines Scheme which offers severely ill patients with
life-threatening and seriously debilitating conditions the lifeline of
trying ground-breaking new medicines much earlier than they would
normally be accessible.
On January 5, 2017, the Company announced it had received positive
Scientific Advice from the European Medicines Agency (EMA) for the
development of SGX942 as a treatment for oral mucositis in
patients with head and neck cancer receiving chemoradiation therapy
(CRT). The Scientific Advice from the EMA indicates that a
single, double-blind, placebo-controlled, multinational, Phase 3
pivotal study (IDR-OM-02), if successful, in conjunction with the Phase
2 dose-ranging study IDR-OM-01, is generally considered sufficient to
support a marketing authorization application (MAA) to the EMA for
potential licensure in Europe.
On December 16, 2016, the Company announced the completion of an
underwritten public offering of its common stock and warrants and the
simultaneous uplisting to the Nasdaq Capital Market. Gross proceeds
from this offering were approximately $5.3 million before deducting
underwriting discounts and commissions and other estimated offering
On December 12, 2016, the Company announced that SGX942 had been
granted PIM designation in the UK by the MHRA for the treatment of
severe oral mucositis in head and neck cancer patients receiving
On December 8, 2016, the Company announced the long-term follow-up data
from its Phase 2 clinical trial with SGX942, a first-in-class Innate
Defense Regulator (IDR), in the treatment of oral mucositis in head and
neck cancer patients undergoing CRT. The additional 12-month
safety data remains consistent with the preliminary positive safety and
efficacy findings from the Phase 2 study. The study met all of its
objectives including defining a clinically effective dose of SGX942 –
specifically the 1.5 mg/kg as seen in both the acute and long-term
follow-up phases of the trial. It also identified the most appropriate
clinical endpoint and patient population to use in the future Phase 3
pivotal study. The impact of the drug on the reported infection rates
as well as the trends in improved survival rates and complete tumor
responses at both one and 12 months following CRT confirmed the
long-term safety and tolerability of SGX942 in a sick patient
Financial Results – Year Ended December 31, 2016
Soligenix's revenues for the year ended December 31, 2016 were $10.4
million as compared to $8.8 million for the prior year. Revenues
included contracts with BARDA and NIAID in support of OrbeShield® (oral
beclomethasone 17,21-dipropionate) development in the treatment of
gastrointestinal acute radiation syndrome (GI ARS) and advanced
development of the Company's thermostabilization technology,
ThermoVax®, combined with its ricin toxin vaccine RiVax™, as a medical
countermeasure to prevent the effects of ricin exposure.
Soligenix's basic net loss was $3.2 million, or $0.93 per share, as
compared to $7.8 million for the prior year, or $3.00 per share, on a
split adjusted basis. Included in the net loss for years ended December
31, 2016 and 2015 is non-cash income of $1.5 million and a non-cash
expense of ($1.2) million, respectively. 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 is included
in other income (expense).
Research and development expenses were $4.3 million as compared to $5.4
million for the years ended December 31, 2016 and 2015, respectively.
The decrease is primarily a result of the completion of patient
enrollment during 2015 in the Phase 2 trial of SGX942 for the treatment
of oral mucositis in head and neck cancer patients.
General and administrative expenses were $3.4 million as compared to
$3.6 million for the years ended December 31, 2016 and 2015,
respectively. This decrease is primarily a result of a decrease in
As of December 31, 2016, the Company's cash position was $8.8 million.
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
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 the 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 and the Phase 3
clinical trial of SGX301 (synthetic hypericin) for the treatment of
cutaneous T-cell lymphoma. 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: Company Contact: Karen Krumeich, Chief Financial Officer,
(609) 538-8200; Investor Contacts: LHA, Kim Sutton Golodetz, (212)
838-3777, email@example.com orBruce Voss, (310) 691-7100,