PRINCETON, N.J., March 30, 2020 /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,
2019.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "We are
extremely pleased to have achieved positive top-line results in our
pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic
Hypericin) trial that demonstrates SGX301's potential to be an
important new treatment for early stage cutaneous T-cell Lymphoma
(CTCL). Having demonstrated statistical significance in the
study's primary endpoint, we will now look to report results from
the extended treatment portion of the trial, which we anticipate
announcing in June 2020. Following the positive
recommendation received from the independent Data Monitoring
Committee, we have successfully achieved our target of 260 patients
randomized into the pivotal Phase 3 clinical trial of SGX942
(dusquetide) for the treatment of oral mucositis in patients with
head and neck cancer (HNC) receiving chemoradiation therapy;
however, due to the uncertainty surrounding the coronavirus
pandemic, we have decided to enroll approximately 25 additional
patients into the study. We are taking this cautious approach
in order to maintain the statistical integrity of the trial, by
accounting for patients that may potentially drop out of the study
before completing their protocol required study treatment and
evaluation. Therefore, the study target to complete
enrollment and provide top-line results is being revised from the
second quarter of 2020 to the fourth quarter 2020; however, this
will remain dependent on the medical and logistical challenges
caused by the coronavirus showing a reasonable level of improvement
in the relative near-term."
Dr. Schaber continued, "Under our Public Health Solutions
business segment, we continue to progress 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. We are also
excited to advance our work with University of Hawaiʻi at Mānoa (UH
Mānoa) beyond filovirus vaccines (protecting against viruses
such as Ebola and Marburg) to the development of vaccines to
potentially combat coronaviruses, including SARS-CoV-2, the cause
of COVID-19. With over $7.5M in
cash, not including our State and Federal funding, we anticipate
having the cash resources sufficient to achieve multiple inflection
points across our rare disease pipeline, including top-line results
in our SGX942 Phase 3 clinical trial in oral mucositis."
Soligenix Recent Accomplishments
- On March 23, 2020, the Company
announced that it expanded its research collaboration with UH Mānoa
to investigate potential coronavirus vaccines. The Company and UH
Mānoa are expanding the technology platform, developed as part of
their filovirus program, to assess compatibility with coronaviruses
including SARS-CoV-2, the cause of COVID-19. The resulting vaccines
have the potential to be broadly applicable, including to
individuals often excluded from common viral vector vaccine
approaches such as children, the elderly and the immunocompromised.
To view this press release, please click here.
- On March 19, 2020, the Company
announced positive preliminary top-line results for its pivotal
Phase 3 FLASH trial evaluating SGX301 (synthetic hypericin) in the
treatment of CTCL. The study enrolled 169 patients randomized 2:1
to receive either SGX301 or placebo, demonstrating statistically
significant treatment response (p=0.04) in the Composite Assessment
of Index Lesion Score (CAILS) primary endpoint assessment at 8
weeks for Cycle 1. To view this press release, please click
here.
- On February 13, 2020, the Company
announced that its RiVax® (heat stable ricin toxin
vaccine) development program for prevention of ricin intoxication
had received "Fast Track" designation from the FDA. To view this
press release, please click here.
- On February 3, 2020, the Company
announced that its ongoing collaboration with the UH Mānoa and
Hawaii Biotech Inc. had resulted in what the Company believes is a
significant milestone in the development of heat stable filovirus
vaccines, in which the platform has demonstrated feasible
thermostable formulations and protection in non-human primate
models with both monovalent and bivalent vaccine candidates in the
three most deadly human pathogenic filoviruses (Ebola virus,
Sudan virus and Marburg virus). To
view this press release, please click here.
- On February 3, 2020, the Company
announced that the Japanese Patent Office had granted the patent
titled "Novel Peptides and Analogs for Use in the Treatment of Oral
Mucositis." This allowance builds on similar intellectual property
in the US, New Zealand,
Australia and Singapore and patent applications pending in
other jurisdictions worldwide. The new claims cover therapeutic use
of dusquetide (active ingredient in SGX942) and related innate
defense regulator (IDR) analogs, and add to composition of matter
claims for dusquetide and related analogs that have been granted in
the US and worldwide. To view this press release, please click
here.
- On January 14, 2020, the Company
issued an update letter from its President and Chief Executive
Officer, Dr. Christopher J. Schaber.
To view this press release, please click here.
- On December 18, 2019, the Company
announced that it had received preliminary approval for a tax
credit from the New Jersey Economic Development Authority's (NJEDA)
New Jersey Technology Business Tax Certificate Transfer program. As
a result, the Company anticipates being able to transfer this
credit and receive approximately $850,000 in net proceeds. To view this press
release, please click here.
- On December 3, 2019, the Company
announced it had completed patient enrollment in its Phase 3 FLASH
study for SGX301 in the treatment of CTCL. The study successfully
enrolled 169 subjects, following positive interim analysis, which
included a prospectively defined, unblinded assessment of the
study's primary efficacy endpoint by an independent Data Monitoring
Committee. To view this press release, please click here.
Financial Results – Year Ended December 31, 2019
Soligenix's revenues for the year ended December 31, 2019 were $4.6 million as compared to $5.2 million for the year ended December 31, 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 $9.4
million, or ($0.48) per share,
for the year ended December 31, 2019,
as compared to $8.9 million, or
($0.68) per share, for the year ended
December 31, 2018.
Research and development expenses were $8.1 million as compared to $6.8 million for the years ended December 31, 2019 and 2018, respectively. The
increase in research and development spending for the year ended
December 31, 2019 was primarily
attributable to the expansion of the Phase 3 clinical trial of
SGX942 as well as the ongoing Phase 3 clinical trial of SGX301,
compared to the same period in 2018.
General and administrative expenses were $3.4 million as compared to $3.0 million for the years ended December 31, 2019 and 2018, respectively.
As of December 31, 2019, the
Company's cash position was approximately $5.4 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, SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease, and our research
programs to identify and develop novel vaccine candidates targeting
viral infection including Ebola, Marburg and SARS-CoV-2 (the cause
of COVID-19). 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 any of our other clinical/preclinical
trials. Despite the statistically significant result achieved in
the SGX301 Phase 3 clinical trial for the treatment of cutaneous
T-cell lymphoma, there can be no assurance that a marketing
authorization from the FDA or EMA will be successful. 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.