PRINCETON, N.J., Nov. 8, 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 quarter ended
September 30, 2024.
"We remain focused on multiple clinical activities and
upcoming milestones, including the initiation of our confirmatory
Phase 3 placebo-controlled study evaluating HyBryte™ (synthetic
hypericin) in the treatment of early-stage cutaneous T-cell
lymphoma (CTCL) before yearend," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. Additionally, we are set to
initiate a Phase 2 study for SGX945 (dusquetide) in Behçet's
disease shortly, with top-line results expected in the first half
of 2025, which will be accompanied by data readout from our ongoing
SGX302 (synthetic hypericin) Phase 2 study in mild-to-moderate
psoriasis in the first half as well."
Dr. Schaber continued, "With approximately $9.8 million in
cash at September 30, 2024, we
continue to prioritize resource allocation to achieve our goals.
While we remain focused on our future, we are diligently pursuing
strategies to enhance long-term shareholder value, including
strategic partnerships and mergers and acquisitions."
Soligenix Recent Accomplishments
- On October 22, 2024, the Company
announced that the Hong Kong Patent Office had granted the patent
entitled "Systems and Methods for Producing Synthetic Hypericin",
allowing claims for a novel proprietary process of producing highly
purified synthetic hypericin. To view this press release, please
click here.
- On October 7, 2024, the Company
announced its lead investigators from the University of Pennsylvania and the Rochester Skin
Lymphoma Medical Group would present findings from recent
supportive studies with HyBryte™ in the treatment of CTCL at the
European Organisation for Research and Treatment of Cancer. To view
this press release, please click here.
- On October 3, 2024, the Company
announced it has established a partnership agreement with Sterling
Pharma Solutions to optimize and implement a commercially viable,
scalable production technology for synthetic hypericin. To view
this press release, please click here.
- On September 3, 2024, the Company
announced the European Patent Office had granted the patent
entitled "Systems and Methods for Producing Synthetic Hypericin",
allowing claims for a novel proprietary process of producing highly
purified synthetic hypericin. To view this press release, please
click here.
Financial Results – Quarter Ended September 30, 2024
Soligenix received no revenue for the quarter ended September 30, 2024 as compared to $0.1 million for the quarter ended September 30, 2023. Revenues primarily relate to
government contracts, grants and subawards awarded in support of
SGX943 for treatment of emerging and/or antibiotic-resistant
infectious diseases; development of CiVax™, our vaccine candidate
for the prevention of COVID-19, and evaluation of HyBryte™ for
expanded treatment in patients with early-stage CTCL.
Soligenix's net loss was $1.7
million for the quarters ended September 30, 2024 and 2023, or ($0.78) per share and ($2.56) per share, respectively. This increase in
net loss was primarily due to decreases in gross profit and tax
credits as well as an increase in operating expenses, offset by
increases in interest income and the change in the fair value of
debt during the three months ended September
30, 2024.
Research and development expenses were $1.0 million as compared to $0.8 million for the quarters ended September 30, 2024 and 2023, respectively. The
increase was preliminary due to costs associated with the
initiation of our Phase 2 study in Behçet's Disease and the second
confirmatory Phase 3 CTCL trial offset by an adjustment of
estimated accruals for completed clinical trials.
General and administrative expenses were $0.9 million and $1.0
million for the quarters ended September 30, 2024 and 2023, respectively. The
decrease in general and administrative expenses for the three
months ended September 30, 2024 was
primarily attributable to decreases in legal and professional
fees.
As of September 30, 2024, the
Company's cash position was approximately $9.8 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 successful completion of the second Phase 3 study,
regulatory approvals will be sought to support potential
commercialization worldwide. 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
(SGX945) in Behçet's Disease.
Our Public Health Solutions business segment includes
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's current expectations about its future results,
performance, prospects and opportunities, including but not limited
to, potential market sizes, patient populations, clinical trial
enrollment, the expected timing for closing the offering described
herein and the intended use of proceeds therefrom. 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 first
HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of
cutaneous T-cell lymphoma, there can be no assurance that the
second HyBryte™ (SGX301) Phase 3 clinical trial will be successful
or that a marketing authorization from the FDA or EMA will be
granted. Additionally, although the EMA has agreed to the key
design components of the second HyBryte™ (SGX301) Phase 3 clinical
trial, no assurance can be given that the Company will be able to
modify the development path to adequately address the FDA's
concerns or that the FDA will not require a longer duration
comparative study. Notwithstanding the result in the first 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. Additionally, despite the biologic activity observed in
aphthous ulcers induced by chemotherapy and radiation, 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.
