PRINCETON, N.J., May 13, 2022
/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, 2022.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "We
remain focused on our significant upcoming milestones for 2022. We
anticipate submitting a new drug application (NDA) to the U.S. Food
and Drug Administration (FDA) for marketing authorization of
HyBryte™ (SGX301 or synthetic hypericin) in the treatment of
cutaneous T-cell lymphoma (CTCL) in the second half of this year.
We expect to initiate a Phase 2a clinical trial in mild-to-moderate
psoriasis with SGX302 (synthetic hypericin) in the second half of
this year as well. With approximately $22.9 million in cash, not including our
non-dilutive government funding, we anticipate having the capital
required to achieve our near-term milestones, including NDA filing
and expansion into psoriasis with the initiation of the Phase 2a
clinical study."
Dr. Schaber continued, "Supported by funding from the National
Institute of Allergy and Infectious Diseases, our Public Health
Solutions business segment continues to achieve key objectives with
our heat stable vaccine platform technology, ThermoVax®.
Recently, we announced results of a booster vaccination study using
CiVax™ (heat stable COVID-19 subunit vaccine program) in
non-human primates (NHPs) demonstrating rapid enhancement of
neutralizing antibody responses to SARS-CoV-2, including against
Delta and Omicron variants. As always, we continue to evaluate
various strategic options, including but not limited to,
partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
- On April 19, 2022, the Company
announced it had received approximately $1.4
million, net of transaction costs, in non-dilutive funding
via multiple government tax programs. To view this press release,
please click here.
- On March 17, 2022, the Company
announced the results of a booster vaccination study using CiVax™
(heat stable COVID-19 subunit vaccine program) in NHPs
demonstrating rapid enhancement of neutralizing antibody responses
to SARS-CoV-2, including against Delta and Omicron variants. To
view this press release, please click here.
Financial Results – Year Ended March
31, 2022
Soligenix's revenues for the quarter ended March 31, 2022 were $0.2
million as compared to $0.1
million for the quarter ended March
31, 2021. Revenues primarily included payments on government
contracts and grants received to support the development of:
RiVax®, our ricin toxin vaccine candidate; SGX943, for
treatment of emerging and/or antibiotic-resistant infectious
diseases; ThermoVax®, our thermostabilization platform
technology; and CiVax™, our vaccine candidate for the prevention of
COVID-19.
Soligenix's basic net loss was $4.3
million, or ($0.10) per share,
for the quarter ended March 31, 2022,
as compared to $2.4 million, or
($0.06) per share, for the quarter
ended March 31, 2021. The increase in
net loss was primarily attributed to an increase in legal and
consulting services associated with the arbitration against
Emergent BioSolutions, Inc. and certain of its subsidiaries as well
as an increase in research and development expenses associated with
preparation of the upcoming HyBryte™ NDA filing.
Research and development expenses were $1.7 million as compared to $1.3 million for the quarter ended March 31, 2022 and 2021, respectively. The
increase in research and development spending for the quarter ended
March 31, 2022 was primarily
attributable to the increased expenses associated with preparation
of the upcoming HyBryte™ NDA filing.
General and administrative expenses were $2.6 million and $1.0
million for the quarter ended March
31, 2022 and 2021, respectively. This increase in general
and administrative expenses is primarily attributable to an
increase in legal and consulting services associated with the
arbitration against Emergent BioSolutions, Inc. and certain of its
subsidiaries.
As of March 31, 2022, the
Company's cash position was approximately $22.9 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). 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) and acute
radiation enteritis (SGX201).
Our Public Health Solutions business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate, and SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease, and 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, such as experienced
with the COVID-19 outbreak. 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 1/2 proof-of-concept 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, 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.
View original
content:https://www.prnewswire.com/news-releases/soligenix-announces-recent-accomplishments-and-first-quarter-2022-financial-results-301546777.html
SOURCE Soligenix, Inc.