PRINCETON, N.J., Aug. 13, 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 June 30,
2019.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "It is
an exciting time for Soligenix. We are now approaching data
read-out in two Phase 3 clinical programs. We have completed the
approximate 90 subject enrollment necessary to support the interim
efficacy analysis of 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. This interim analysis, to be conducted by
the independent Data Monitoring Committee (DMC) for the trial, is
anticipated to occur in September
2019. We expect completion of full enrollment in the study
in the second half of 2019, with final top-line results anticipated
in the first half of 2020, pending the DMC recommendation."
Dr. Schaber continued, "Following the positive recommendation
received from the independent DMC for our pivotal double-blind,
placebo-controlled Phase 3 study for the treatment of cutaneous
T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin), we
continue to enroll patients and anticipate completing study
enrollment in the second half of 2019, with final top-line results
in the first quarter of 2020."
Soligenix Recent Accomplishments:
- On July 29, 2019, the Company
announced that the European Patent Office had issued two patents,
both titled "Topically Active Steroids for use in Radiation and
Chemotherapeutics Injury". The new patents (#2,373,160 and
#2,902,031) claim use of oral beclomethasone 17,21-dipropionate for
treatment of damage to the gastrointestinal tract as a result of
acute radiation injury, including total body irradiation in an
accidental or biodefense context. To view this press release,
please click here.
- On July 8, 2019, the Company
announced the appointment of Ms. Diane L.
Parks, an accomplished businesswoman and commercial
executive with an extensive record of driving profitable growth for
large pharmaceutical and biotech companies, to its Board of
Directors. To view this press release, please click here.
- On May 28, 2019, the Company
announced that it would be participating in a biodefense contract
for the development of medical countermeasures against bacterial
threat agents, with Soligenix awarded a subcontract of
approximately $600,000 over 3 years.
To view this press release, please click here.
- On April 23, 2019, the Company
issued an update letter from Dr. Schaber. This letter provided an
update as well as further guidance on the development programs for
2019. To view this press release, please click here.
- On April 18, 2019, the Company
announced it had reached a significant milestone in the Phase 3
clinical study (the "DOM-INNATE" study) for SGX942 (dusquetide) in
the treatment of oral mucositis in patients with head and neck
cancer. Patient enrollment was sufficient to support the interim
efficacy analysis by the independent DMC. In accordance with the
clinical protocol, approximately 90 subjects had been enrolled into
the study as required for the planned interim efficacy analysis. To
view this press release, please click here.
Financial Results – Second Quarter Ended June 30, 2019
Soligenix's revenues for the quarter ended June 30, 2019 were $1.5
million as compared to $1.7
million for the quarter ended June
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 head and neck
cancer.
Soligenix's basic net loss was $2.1
million, or ($0.12) per share,
for the quarter ended June 30, 2019,
as compared to $1.6 million, or
($0.18) per share, for the quarter
ended June 30, 2018.
Research and development expenses were $1.9 million as compared to $1.2 million for the quarters ended June 30, 2019 and 2018, respectively. The
increase in research and development spending for the three months
ended June 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 June 30, 2019 and 2018, respectively.
As of June 30, 2019, the Company's
cash position was approximately $7.0
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 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 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
Biomedical Advanced Research and Development Authority (BARDA) and
the Defense Threat Reduction Agency (DTRA).
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 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 RiVax®,
that RiVax® will be approved for the Priority Review
Voucher (PRV) program or the amount for which a PRV for
RiVax® 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.