PRINCETON, N.J., Nov. 12, 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 quarter ended September 30,
2019.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "We are
now approaching data read-out in two Phase 3 clinical programs. We
anticipate completing patient enrollment before the end of the year
with final top-line results in the first quarter of 2020 for our
pivotal double-blind, placebo-controlled Phase 3 study for the
treatment of cutaneous T-cell lymphoma (CTCL) with SGX301
(synthetic hypericin). Following the recent positive
recommendation received from the independent Data Monitoring
Committee (DMC), we continue to enroll 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 (HNC) receiving chemoradiation therapy. The
study remains on target to complete enrollment and provide topline
results in the second quarter of 2020."
Dr. Schaber continued, "Additionally, we continue to advance our
heat stable ricin vaccine, RiVax®, with the support of a
National Institute of Allergy and Infectious Disease contract award
of up to $24.7 million."
Soligenix Recent Accomplishments:
- On October 24, 2019, the
Company announced that the United States Patent Office
had allowed the divisional patent application titled "Systems and
Methods for Producing Synthetic Hypericin". The allowed
claims are directed to unique, proprietary methods to produce a
novel, highly purified form of synthetic hypericin. Synthetic
hypericin is the active pharmaceutical ingredient in SGX301, the
Company's photodynamic therapy for the treatment of CTCL. To view
this press release, please click here.
- On September 16, 2019, the
Company announced that it had appointed Daniel P. Ring as Vice President of Business
Development and Strategic Planning. Mr. Ring has over 22
years of business development and commercial experience in the
biopharmaceutical industry. In this new role, Mr. Ring will
oversee the Company's global business development function, which
will include balanced and disciplined management of any current or
new strategic business opportunities, initiatives, mergers,
acquisitions, partnerships, alliances, and/or licensing agreements.
To view this press release, please click here.
- On September 11, 2019, the
Company announced that it had appointed Jonathan Guarino, CPA, CGMA, as its Senior Vice
President and Chief Financial Officer. Mr. Guarino has over 20
years of diverse experience in the financial and strategic
management of emerging growth and commercial companies, including
in the life sciences industry. He has a proven track record and
expertise in corporate financial operations, partnerships, as well
as growth financings. To view this press release, please click
here.
- On August 28, 2019, the Company
announced it had received a positive recommendation from the
independent DMC to continue enrolling into the company's pivotal
Phase 3 "DOM–INNATE" study (Dusquetide treatment in Oral
Mucositis – by modulating INNATE immunity) for SGX942
(dusquetide) in the treatment of oral mucositis in patients with
HNC. To view this press release, please click here.
- On August 15, 2019, the Company
announced that the National Institute of Dental and Craniofacial
Research (NIDCR), part of the National Institutes of Health (NIH),
had awarded Soligenix a Phase I Small Business Innovation Research
(SBIR) of approximately $150,000 to
support the evaluation of SGX942 (dusquetide) in pediatric
indications. This award will facilitate the assessment of SGX942
safety in juvenile animals, supporting future studies in pediatric
populations, including oral mucositis indications in pediatric
patients undergoing stem cell transplants and treatments for HNC.
To view this press release, please click here.
Financial Results – Third Quarter Ended September 30, 2019
Soligenix's revenues for the quarter ended September 30, 2019 were $1.3 million as compared to $1.4 million for the quarter ended September 30, 2018. 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
HNC.
Soligenix's basic net loss was $2.7
million, or ($0.14) per share,
for the quarter ended September 30,
2019, as compared to $1.9
million, or ($0.11) per share,
for the quarter ended September 30,
2018.
Research and development expenses were $2.3 million as compared to $1.4 million for the quarters ended September 30, 2019 and 2018, respectively. The
increase in research and development spending for the three months
ended September 30, 2019 was
primarily attributable to higher clinical trial expenditures
relating to the two pivotal Phase 3 studies for SGX301 and SGX942,
compared to the same period in 2018.
General and administrative expenses were $0.8 million as compared to $0.7 million for the quarters ended September 30, 2019 and 2018, respectively.
As of September 30, 2019, the
Company's cash position was approximately $6.6 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 Specialized
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 Public Health Solutions 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), the
Defense Threat Reduction Agents (DTRA) 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 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 or the Phase 3 clinical trial of SGX301
(synthetic hypericin) for the treatment of cutaneous T-cell
lymphoma, or any of our other clinical/preclinical trials. 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®. Also, no assurance can be provided that the
Company will receive or continue to receive non-dilutive government
funding from grants and contracts that have been or may be awarded
or for which the Company will apply in the future. 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.