PRINCETON, N.J., August 21, 2023 /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, 2023.
"During the second quarter we advanced multiple clinical trials,
while continuing our collaborative discussions with the U.S. Food
and Drug Administration (FDA) regarding the design of a second,
confirmatory Phase 3 pivotal study evaluating HyBryte™ (synthetic
hypericin sodium) in the treatment of cutaneous T-cell lymphoma
(CTCL), where we successfully demonstrated statistically
significant results in the first Phase 3 clinical
trial," stated Christopher J. Schaber, PhD, President and
Chief Executive Officer of Soligenix. "A HyBryte™ expanded
treatment CTCL trial at the University of
Pennsylvania was recently opened for patient enrollment,
supported by a $2.6
million Orphan Products Development grant award from the
FDA. We are continuing to actively enroll patients in
the Phase 2a trial of SGX302 (synthetic hypericin sodium) for the
treatment of mild-to-moderate psoriasis after demonstration of a
clear biological signal in all five of the initial patients, with
the majority recording an improvement in their PASI (psoriasis area
and severity index) score. Additionally, we announced positive
clinical results from a compatibility study evaluating HyBryte™ in
the treatment of CTCL that confirmed and extended response results
from the first Phase 3 study conducted."
Dr. Schaber continued, "During the second quarter of 2023, we
completed a public offering with gross proceeds of
approximately $8.5 million, which has
allowed us to continue to move our rare disease pipeline
forward. With approximately $13.2 million in cash at
June 30, 2023, we are managing cash
burn very carefully in order to achieve our near-term milestones,
as we continue to assess all strategic options, including but not
limited to, partnership and merger and acquisition
opportunities."
Soligenix Recent Accomplishments
- On August 10, 2023, the Company
announced that patient enrollment had been opened for the HyBryte™
expanded treatment investigator-initiated CTCL study at the
University of Pennsylvania, supported
by a $2.6 million Orphan Products
Development grant award from the FDA. To view this press release,
please click here.
- On July 11, 2023, the Company
announced the expansion of its Phase 2a trial of SGX302 for the
treatment of mild-to-moderate psoriasis after demonstration of
biological effect in all five of the initial subjects. To view this
press release, please click here.
- On May 16, 2023, the Company
announced the European Patent Office had granted a patent entitled
"Novel Peptides and Analogs for Use in the Treatment of Oral
Mucositis". To view this press release, please click here.
Financial Results – Quarter Ended June
30, 2023
Soligenix's revenues for the quarters ended June 30, 2023 and 2022 were $0.2 million. Revenues primarily relate to third
party licensing and the government contracts and grants awarded in
support of HyBryte™, our therapeutic candidate for early-stage
CTCL; SGX943, our therapeutic candidate for treatment of emerging
and/or antibiotic-resistant infectious diseases;
ThermoVax®, our thermostabilization technology; and
CiVax™, our vaccine candidate for the prevention of COVID-19.
Soligenix's net loss was $1.6
million, or ($0.22) per share,
for the quarter ended June 30, 2023,
as compared to $2.4 million, or
($0.83) per share, for the quarter
ended June 30, 2022. The decrease in
net loss was primarily due to a decrease in operating expenses.
Research and development expenses were $0.8 million as compared to $2.0 million for the quarters ended June 30, 2023 and 2022, respectively. The
decrease was primarily due to the decrease in manufacturing and
regulatory costs associated with the HyBryte™ new drug application
filing.
General and administrative expenses were $0.9 million and $1.4
million for the quarters ended June
30, 2023 and 2022, respectively. This decrease in general
and administrative expenses is primarily attributable to a
reduction in legal and consulting expenses associated with the
arbitration against Emergent BioSolutions, Inc. and certain of its
subsidiaries.
As of June 30, 2023, the Company's
cash position was approximately $13.2
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 and moving toward
potential commercialization of HyBryte™ (SGX301 or synthetic
hypericin sodium) as a novel photodynamic therapy utilizing safe
visible light for the treatment of cutaneous T-cell lymphoma
(CTCL). With a successful Phase 3 study completed, regulatory
approval is being sought and commercialization activities for this
product candidate are being advanced initially in the U.S.
Development programs in this business segment also include
expansion of synthetic hypericin (SGX302) into psoriasis, our
first-in-class innate defense regulator (IDR) technology,
dusquetide (SGX942) for the treatment of inflammatory diseases,
including 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).
Our Public Health Solutions business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate, as well as our vaccine programs targeting filoviruses
(such as Marburg and Ebola) and CiVax™, our vaccine candidate for
the prevention of COVID-19 (caused by SARS-CoV-2). 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 Agency (DTRA) and the Biomedical Advanced
Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at https://www.soligenix.com and
follow us on LinkedIn and Twitter at @Soligenix_Inc.
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, and include the
expected amount and use of proceeds from the offering and the
expected closing date of the offering. 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 any of its clinical/preclinical trials.
Despite the statistically significant result achieved in the
HyBryte™ (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.
Notwithstanding the result in the HyBryte™ (SGX301) Phase 3
clinical trial for the treatment of cutaneous T-cell lymphoma and
the Phase 2a clinical trial of SGX302 for the treatment of
psoriasis, there can be no assurance as to the timing or success of
the clinical trials of SGX302 for the treatment of psoriasis.
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 (the "SEC"), including,
but not limited to, the Company's preliminary prospectus
(Registration No. 333-271049) filed with the SEC on May 4, 2023, and 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.