PRINCETON,
N.J., March 15, 2024 /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,
2023.
"Our primary focus in 2024 continues to be
advancing our multiple clinical programs in our rare disease
pipeline," stated Christopher J. Schaber, PhD, President
and Chief Executive Officer of Soligenix. "Our collaborative
discussions continue with the U.S. Food and Drug Administration
(FDA) regarding the design of a second, confirmatory Phase 3
pivotal study evaluating HyBryte™ (synthetic hypericin) in the
treatment of cutaneous T-cell lymphoma (CTCL), where we
successfully demonstrated statistically significant results in the
first Phase 3 clinical trial. We also continue to engage in
discussions with the European Medicines Agency to explore potential
marketing approval and partnership in Europe. Recently, we shared successful
preliminary top-line results of our ongoing Phase 2a clinical trial
of SGX302 (synthetic hypericin) for the treatment of
mild-to-moderate psoriasis. Following the clearance of the
Investigational New Drug (IND) application for a Phase 2a clinical
trial with SGX945 (dusquetide) in Behçet's Disease and the recent
receipt of "Fast Track" designation from the FDA, we anticipate
initiating this study in the second half of 2024. Under our Public
Health Solutions business segment, we recently announced
publication of the preclinical efficacy of a novel, single-vial,
bivalent vaccine providing 100% protection against both
Sudan ebolavirus (SUDV) and
Marburg marburgvirus (MARV) infections. The published paper
describes the potency of the bivalent formulation against both
lethal viruses, demonstrating 100% protection in the most rigorous
non-human primate (NHP) challenge models."
Dr. Schaber continued, "With approximately
$8.4 million in cash at December 31, 2023, not including our non-dilutive
government funding, we are managing cash burn very carefully in
order to achieve our near-term milestones. We recently received
$0.6 million, net of transaction
costs, from the state of New
Jersey's (NJ) Technology Business Tax Certificate Transfer
Program. This is our fourteenth year participating in the program,
over that time we have received approximately $9.4 million in non-dilutive capital. We continue
to evaluate a number of strategic options, including but not
limited to, partnership and merger and acquisition
opportunities."
Soligenix Recent Accomplishments
- On February 8, 2024, the Company
announced the formation of a Medical Advisory Board to provide
medical/clinical strategic guidance to the Company as it advances
the clinical development of SGX945 (dusquetide) for the treatment
of Behçet's Disease. To view this press release, please click
here.
- On January 8, 2024, the Company
announced its SGX945 development program for the treatment of oral
lesions of Behçet's Disease has received "Fast Track"
designation from the FDA. To view this press release, please click
here.
- On January 4, 2024, the Company
announced positive preliminary top-line results of its ongoing
Phase 2a trial of SGX302 for the treatment of mild-to-moderate
psoriasis. To view this press release, please click here.
- On January 2, 2024, the Company
announced publication describing the preclinical efficacy of a
novel, single-vial, bivalent vaccine providing 100% protection
against both SUDV and MARV infections in NHP models. This
vaccine candidate had been previously demonstrated to be stable to
high temperature storage for at least 2 years at 40 degrees Celsius
(104 degrees Fahrenheit). To view this press release, please click
here.
- On December 1, 2023, the Company
announced publication of an article describing the potential use
of HyBryte™ in the treatment of CTCL in Frontiers in Drug
Discovery. To view this press release, please click here.
- On November 30, 2023, the Company
announced the FDA had cleared the IND application for a Phase
2a clinical trial entitled, "Pilot Study of SGX945 (Dusquetide)
in the Treatment of Aphthous Ulcers in Behçet's Disease." To
view this press release, please click here.
Financial Results – Year Ended December 31, 2023
Soligenix's revenues for the year ended
December 31, 2023 was $0.8 million as compared to $0.9 million for the year ended December 31, 2022. Revenues primarily relate to
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; and CiVax™, our vaccine candidate for the
prevention of COVID-19.
Soligenix's net loss was $6.1 million, or ($0.79) per share, for the year ended
December 31, 2023, as compared to
$13.8 million, or ($4.81) per share, for the year ended
December 31, 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
$3.3 million as compared to
$7.9 million for the years ended
December 31, 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
$4.5 million and $6.7 million for the years ended December 31, 2023 and 2022, respectively. This
decrease in general and administrative expenses is primarily
attributable to a reduction in legal and consulting expenses.
As of December 31,
2023, the Company's cash position was approximately
$8.4 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 and moving toward
potential commercialization of HyBryte™ (SGX301 or synthetic
hypericin) as a novel photodynamic therapy utilizing safe visible
light for the treatment of cutaneous T-cell lymphoma (CTCL).
Development programs in this business segment also include
expansion of synthetic hypericin (SGX302) into psoriasis, and our
first-in-class innate defense regulator (IDR) technology,
dusquetide for the treatment of inflammatory diseases, including
oral mucositis in head and neck cancer (SGX942) and in Behçet's
Disease (SGX945).
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, Sudan 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.
Despite the positive efficacy results demonstrated in the Phase 2
and 3 clinical studies of SGX942 for the treatment of oral
mucositis due to chemoradiation therapy for head and neck cancer,
there can be no assurance as to the timing or success of the
clinical trials of SGX945 for the treatment of Behçet's Disease.
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, 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.