PRINCETON, N.J., Aug. 14, 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 quarter ended June 30,
2020.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "We
continue to execute on our strategy with a number of positive
accomplishments. Our pivotal Phase 3 FLASH (Fluorescent Light
Activated Synthetic Hypericin) trial continues to demonstrate
SGX301's potential to be an important new treatment for early-stage
cutaneous T-cell lymphoma (CTCL). In the double-blind,
placebo controlled Cycle 1 portion of the study, a statistically
significant treatment response (p=0.04) was achieved in the primary
endpoint after 6 weeks of therapy. This positive treatment
response continued to significantly improve with extended SGX301
treatment in the open-label treatment cycle, referred to as Cycle
2, with an additional 6 weeks of therapy (p<0.0001 compared to
placebo and p<0.0001 compared to 6-weeks treatment). The
optional, compassionate-use, treatment cycle (Cycle 3) and the
subsequent 6-month follow-up is expected in the fourth quarter of
2020, with the majority of patients enrolled having elected to
continue with this optional cycle of the study – a clear indication
of their satisfaction. We also continue to advance our
pivotal Phase 3 clinical trial of SGX942 (dusquetide), referred to
as the DOM-INNATE (Dusquetide treatment in Oral Mucositis – by
modulating INNATE Immunity) study, for the treatment of oral
mucositis in patients with head and neck cancer (HNC) receiving
chemoradiation therapy. Following the positive recommendation
received from the independent Data Monitoring Committee (DMC) and
after taking a conservative approach to assessing the potential
impact of COVID-19 on the study, we have successfully enrolled 268
subjects. With enrollment completed, top-line results
continue to be expected in the fourth quarter 2020."
Dr. Schaber continued, "Under our Public Health Solutions
business segment, we continue to advance our work with the
University of Hawaiʻi at Mānoa (UHM) and Hawaii Biotech Inc.
on filovirus vaccines (protecting against viruses such as Ebola and
Marburg) and the development of vaccines to potentially combat
coronaviruses, including SARS-CoV-2, the cause of COVID-19.
We recently announced publication of positive pre-clinical data
from immunogenicity studies with CiVax™ (heat stable COVID-19
vaccine candidate), demonstrating immunity of both broad-spectrum
antibody and cell-mediated, rapid onset immunity is possible using
the CoVaccine HT™ adjuvant. Our heat stable ricin
vaccine, RiVax®, continues to be supported with a
National Institute of Allergy and Infectious Disease contract award
of $21.2 million. With over
$11M in cash, not including our
non-dilutive government funding, along with the at-the-market sales
issuance agreement with B. Riley FBR, Inc. to judiciously
supplement our cash runway as needed, we anticipate having
sufficient capital to achieve multiple inflection points across our
rare disease pipeline, including final top-line results in our
SGX942 Phase 3 clinical trial in oral mucositis."
Soligenix Recent Accomplishments
- On July 28, 2020, the Company
announced publication of pre-clinical immunogenicity studies for
its CiVax™ program (heat stable COVID-19 vaccine candidate),
demonstrating immunity of both broad-spectrum antibody and
cell-mediated, rapid onset immunity is possible using the CoVaccine
adjuvant. The article, authored by collaborators at the UHM, is
titled, "CoVaccine HT™ adjuvant potentiates robust immune responses
to recombinant SARS-CoV-2 spike-S1 immunization," and has been
submitted for peer-review to the journal npj Vaccines. An
accelerated preprint of the manuscript has been made available
here. To view this press release, please click here.
- On July 20, 2020, the Company
announced that it had issued an update letter from its President
and Chief Executive Officer, Dr. Christopher J. Schaber, highlighting important
catalysts for the second half of 2020. To view this press release
and letter, please click here.
- On June 24, 2020, the Company
announced that it had completed patient enrollment in its Phase 3
DOM-INNATE study for SGX942 (dusquetide) in the treatment of oral
mucositis in HNC patients. The study successfully enrolled 268
subjects, following positive interim analysis, which included a
prospectively defined, unblinded assessment of the study's primary
efficacy endpoint by an independent DMC. To view this press
release, please click here.
- On June 22, 2020, the Company
announced that it would join the Russell Microcap® Index
at the conclusion of the 2020 Russell indexes annual
reconstitution, effective after the US market opens on June 29th, according to a final list of additions
posted June 15th. To view this press
release, please click here.
Financial Results – Quarter Ended June
30, 2020
Soligenix's revenues for the quarter ended June 30, 2020 were $0.5
million as compared to $1.4
million for the quarter ended June
30, 2019. Revenues included payments on a contract in
support of RiVax®, our ricin toxin vaccine candidate,
grants received to support the development of SGX943 for treatment
of emerging and/or antibiotic-resistant infectious diseases,
ThermoVax®, our thermostabilization technology, and the
assessment of SGX942 safety in juvenile animals.
Soligenix's basic net loss was $2.8
million, or ($0.10) per share,
for the quarter ended June 30, 2020,
as compared to $2.1 million, or
($0.12) per share, for the quarter
ended June 30, 2019. This
increase in net loss was primarily the result of increased research
and development spending primarily attributable to higher clinical
trial site and patient fees for the pivotal Phase 3 clinical trials
of SGX301 and SGX942.
Research and development expenses were $2.2 million as compared to $1.9 million for the quarters ended June 30, 2020 and 2019, respectively. The
increase in research and development spending for the quarter ended
June 30, 2020 was primarily
attributable to the site and patient fees for the pivotal Phase 3
clinical trials of SGX301 and SGX942, compared to the same period
in 2019.
General and administrative expenses were $0.8 million for both the three months ended
June 30, 2020 and 2019.
As of June 30, 2020, the Company's
cash position was approximately $11.2
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 vaccine programs
targeting both filoviruses (such as Marburg and Ebola) and
coronaviruses. 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, such as
experienced with the COVID-19 outbreak. 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 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. The Company cannot offer assurance as to
any result from the arbitration against, or that it will recover
any damages from, Emergent BioSolutions, Inc., Emergent Product
Development Gaithersburg, Inc. and Emergent Manufacturing
Operations Baltimore LLC. 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.
View original
content:http://www.prnewswire.com/news-releases/soligenix-announces-recent-accomplishments-and-second-quarter-2020-financial-results-301112122.html
SOURCE Soligenix, Inc.