PRINCETON, N.J., Nov. 13,
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 September 30, 2023.
"We continue 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. "We continue 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. Under our
Public Health Solutions business segment, we continue to advance
our heat stable vaccine platform technology, ThermoVax®.
Most recently, we successfully demonstrated two year stability of
thermostabilized bivalent and trivalent filovirus vaccine
candidates at temperatures of 40 degrees Celsius (104 degrees
Fahrenheit) when formulated in a single vial, needing
reconstitution only with sterile water immediately prior to use.
This follows the previous successful demonstration of 100%
protection of non-human primates against lethal Sudan ebolavirus and Marburg marburgvirus
challenge with the bivalent vaccine."
Dr. Schaber continued, "With approximately $10.3 million in
cash at September 30, 2023, not
including our non-dilutive government funding, we are managing cash
burn very carefully in order to achieve our near-term milestones.
We continue to evaluate a number of strategic options,
including but not limited to, partnership and merger and
acquisition opportunities."
Financial Results – Quarter Ended September 30, 2023
Soligenix's revenues for the quarters ended September 30, 2023 were $0.1 million as compared to $0.2 million for the quarter ended September 30, 2022. Revenues primarily relate to
government contracts and grants awarded in support of SGX943, our
therapeutic candidate for treatment of emerging and/or
antibiotic-resistant infectious diseases; and CiVax™, our vaccine
candidate for the prevention of COVID-19.
Soligenix's net loss was $1.7
million, or ($0.16) per share,
for the quarter ended September 30,
2023, as compared to $3.3
million, or ($1.15) per share,
for the quarter ended September 30,
2022. The decrease in net loss was primarily due to
decreases in operating expenses and interest expense and an
increase in other income.
Research and development expenses were $0.8 million as compared to $1.8 million for the quarters ended September 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 $1.0 million and $1.3
million for the quarters ended September 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 September 30, 2023, the
Company's cash position was approximately $10.3 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.