PRINCETON,
N.J., Aug. 9, 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 June 30,
2024.
"This is a pivotal time for Soligenix with a
great deal of clinical activity and upcoming milestones,"
stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "While we prepare for the upcoming
initiation of our confirmatory Phase 3 placebo-controlled study
evaluating the safety and efficacy of HyBryte™
(synthetic hypericin) in the treatment of cutaneous T-cell lymphoma
(CTCL) patients with early-stage disease, we are incredibly
encouraged by the recent positive clinical results from our
comparability study evaluating HyBryte™ against
Valchlor® (mechlorethamine gel), which demonstrated a
three-fold higher response rate over a 12-week treatment period and
more favorable safety profile for HyBryte™ in the
treatment of CTCL. These findings, coupled with the promising
interim data from the ongoing open-label, investigator-initiated
study evaluating extended HyBryte™ treatment, reinforce
our excitement about the future of HyBryte™ as a
potential front-line treatment option for patients with early-stage
CTCL. Additionally, we will be initiating a Phase 2 study with
SGX945 (dusquetide) in Behçet's disease later this year with
top-line results expected in the first half of 2025, along with
top-line results expected during the same timeframe from our
ongoing SGX302 (synthetic hypericin) Phase 2 study in
mild-to-moderate psoriasis."
Dr. Schaber continued, "With
approximately $9.1 million in cash at June 30, 2024, exclusive of the approximately
$4.1 million in net proceeds from
recent warrant exercises, we continue to prioritize resource
allocation to achieve our goals. We have a clear vision for the
future, and we are actively pursuing strategies to create long-term
value for our shareholders, including but not limited to,
partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
- On July 24, 2024, the Company
received a letter from Nasdaq confirming that the Company had
regained compliance with the Minimum Bid Price Rule. Accordingly,
the Nasdaq Hearings Panel determined to continue the listing of the
Company's common stock and closed the matter.
- On July 9, 2024, the Company
announced an interim update on the open-label,
investigator-initiated study evaluating
extended HyBryte™ treatment for up to 12 months in
patients with early-stage CTCL. To view this press release, please
click here.
- On June 25, 2024, the Company
announced positive clinical results from a comparability study
evaluating HyBryte™ versus Valchlor® in
the treatment of CTCL. To view this press release, please
click here.
- On May 16, 2024, the Company
announced the publication of results of its compatibility study
evaluating HyBryte™ for the treatment of CTCL in
the Journal of the European Academy of Dermatology &
Venereology (JEADV) Clinical Practice. To view the publication,
please click here. To view this press release, please click
here.
Financial Results – Quarter Ended June 30, 2024
Soligenix's revenues for the quarter ended
June 30, 2024 were less than
$0.1 million as compared to
$0.2 million for the quarter ended
June 30, 2023. Revenues primarily
relate to government contracts and grants 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 $1.6 million, or ($1.31) per share, for the quarter ended
June 30, 2024, as compared to
$1.6 million, or ($3.56) per share, for the quarter ended
June 30, 2023. The 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 changes in the fair value of debt during the
three months ended June 30, 2024.
Research and development expenses were
$0.5 million as compared to
$0.8 million for the quarters ended
June 30, 2024 and 2023, respectively.
The decrease was primarily due to adjustment of estimated accruals
for completed clinical trials offset by preliminary costs
associated with the anticipated initiation of our Phase 2 study in
Behçet's Disease and the second Phase 3 CTCL trial.
General and administrative expenses were
$1.2 million and $0.9 million for the quarters ended June 30, 2024 and 2023, respectively. The
increase in general and administrative expenses for the three
months ended June 30, 2024 was
primarily attributable to an increase in legal and professional
fees associated with the 2024 annual meeting of stockholders, the
April 2024 public offering and the
June 2024 reverse stock split of our
issued and outstanding shares of common stock.
As of June 30,
2024, the Company's cash position, exclusive of the
approximately $4.1 million in net
proceeds from recent warrant exercises, was approximately
$9.1 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. 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.
