PRINCETON, N.J., May 10, 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
March 31, 2024.
"Recently we completed a public offering with gross proceeds of
approximately $4.75 million, which
will allow us to continue to move our rare disease pipeline
forward," stated Christopher J. Schaber, PhD, President and
Chief Executive Officer of Soligenix. "While we continue our
ongoing discussions with the United
States (U.S.) Food and Drug Administration (FDA), we shared
that the European Medicines Agency (EMA) has agreed to the study
design of a 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. This study will enroll
approximately 80 patients across the U.S. and Europe, starting before the end of 2024, with
top-line results expected in the second half of 2026. We also 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. Additionally, we were recently
granted orphan drug designations from the FDA's Office of Orphan
Products Development for the active ingredients in both SuVax™, for
"the prevention and post-exposure prophylaxis against Sudan ebolavirus (SUDV) infection and MarVax™,
for "the prevention and post-exposure prophylaxis against Marburg
marburgvirus (MARV) infection."
Dr. Schaber continued, "With approximately $7.1 million in
cash at March 31, 2024, exclusive of
the approximate $4.3 million in net
proceeds from our recent financing and our non-dilutive government
funding, we continue to manage cash burn very carefully to achieve
our near-term milestones. We have a clear vision for the future,
and we are actively pursuing new opportunities to create long-term
value for our shareholders including but not limited to,
partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
- On April 25, 2024, the Company
announced it had received notice of intent to grant additional
patents based on its patent application titled "Compositions and
Methods of Manufacturing Trivalent Filovirus Vaccines" in the
United Kingdom and South Africa, with other international
jurisdictions pending. To view this press release, please click
here.
- On April 18, 2024, the Company
announced the pricing of its public offering of 11,875,000 shares
of common stock (or common stock equivalents in lieu thereof) and
warrants to purchase up to 11,875,000 shares of common stock at a
combined public offering price of $0.40 per share and accompanying warrants for
aggregate gross proceeds of approximately $4.75 million, before deducting placement agent
fees and other offering expenses. To view this press release,
please click here.
- On April 15, 2024, the Company
announced the Office of Orphan Products Development of the U.S. FDA
had granted orphan drug designation to the active ingredient in
SuVax™, the subunit protein vaccine of recombinantly expressed SUDV
glycoprotein, for "the prevention and post-exposure prophylaxis
against SUDV infection." To view this press release, please click
here.
- On April 11, 2024, the Company
announced the Office of Orphan Products Development of the U.S. FDA
had granted orphan drug designation to the active ingredient in
MarVax™, the subunit protein vaccine of recombinantly expressed
MARV glycoprotein, for "the prevention and post-exposure
prophylaxis against MARV infection." To view this press release,
please click here.
- On April 3, 2024, the Company
announced it had received agreement from the EMA on the key design
components of a confirmatory Phase 3 placebo-controlled study
evaluating the safety and efficacy of HyBryte™ (synthetic
hypericin) in the treatment of CTCL patients with early-stage
disease. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2024
Soligenix's revenues for the quarter ended March 31, 2024 were $0.1
million as compared to $0.3
million for the quarter ended March
31, 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 $1.9
million, or ($0.18) per share,
for the quarter ended March 31, 2024,
as compared to $1.0 million, or
($0.36) per share, for the quarter
ended March 31, 2023. The increase in
net loss was primarily due to the recognition of an income tax
benefit during the three months ended March
31, 2023 with no corresponding income tax benefit recognized
during the three months ended March 31,
2024.
Research and development expenses were $1.1 million as compared to $0.9 million for the quarters ended March 31, 2024 and 2023, respectively. The
increase was primarily due to an increase in preliminary costs
associated with the anticipated initiation of our Phase 2 study in
Behçet's Disease and the second confirmatory Phase 3 CTCL
trial.
General and administrative expenses were $1.0 million and $1.2
million for the quarters ended March
31, 2024 and 2023, respectively. This decrease in general
and administrative expenses is primarily attributable to a
reduction in legal and professional fees associated with the
reverse stock split of our issued and outstanding shares of common
stock during the three months ended March
31, 2023.
As of March 31, 2024, the
Company's cash position, exclusive of the approximate $4.3 million in net proceeds from our recent
financing, was approximately $7.1
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, 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 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. 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, 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.