PRINCETON, N.J., Jan. 25, 2018 /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, today issued an update letter from its President and Chief
Executive Officer, Dr. Christopher J.
Schaber. The content of this letter is provided
below.
Dear Friends and Shareholders,
Now that we have concluded 2017, I wanted to take this
opportunity to provide a summary of our progress and highlight our
accomplishments made during the year, as well as to provide some
further guidance on our development programs as we begin
2018.
Our focus this coming year remains, first and foremost, the
quality execution of our two pivotal Phase 3 clinical trials,
including SGX942 (dusquetide) for the treatment of oral mucositis
in head and neck cancer and SGX301 (synthetic hypericin) for the
treatment of cutaneous T-cell lymphoma (CTCL). In addition,
we are continuing to advance development of our heat stable ricin
toxin vaccine (RiVax®) with the financial support of the
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH), while we also continue
to actively pursue non-dilutive funding to support our rare disease
pipeline.
Corporate Highlights
Non-Dilutive Funding
Throughout the year, we were awarded in excess of $8.6 million in non-dilutive funding from various
government sources across our entire biodefense and biotherapeutics
pipeline in order to advance multiple development programs, which
support we greatly appreciate. As part of this funding, we
received approval for a tax credit from the New Jersey Economic
Development Authority's New Jersey Technology Business Tax
Certificate Transfer program and received approximately
$417,000 in net proceeds from the
transfer of this credit.
During the third quarter, we received two Small Business
Innovative Research (SBIR) grant awards totaling approximately
$3 million over two years by the NIH
National Cancer Institute (NCI) and the National Institute of
Dental and Craniofacial Research (NIDCR) for two of our
biotherapeutics development programs. The award from the NCI
is to support the conduct of our ongoing pivotal Phase 3 trial of
SGX301 as a treatment for CTCL, and the award from the NIDCR is to
support the conduct of our ongoing pivotal Phase 3 trial of SGX942
as a treatment for severe oral mucositis in patients with head and
neck cancer receiving chemoradiation therapy (CRT).
During the year, we also received over $5
million of non-dilutive funding in our biodefense business
segment. NIAID exercised a $2.5
million option to fund good manufacturing practice compliant
RiVax® bulk drug substance and finished drug product
manufacturing and a $2 million option
to fund additional RiVax® animal efficacy studies.
The overall objective of the contract, totaling up to $24.7 million over six years, is to advance the
development of our thermostabilization technology,
ThermoVax®, in combination with RiVax®, our
ricin toxin vaccine, as a countermeasure to prevent the effects of
ricin exposure. Additionally, we were awarded funding of
approximately $700,000 over five
years, as collaborators in a NIAID Research Project grant awarded
to the University of Hawai'i at Manoa for the development of a
trivalent thermostabilized Ebola vaccine.
Equity Financing
In addition to the non-dilutive funding received, we completed a
registered direct offering of 1,575,500 shares of common stock and
a concurrent private placement of 982,000 shares of common stock at
an above the market purchase price of $2.00 per share. Our gross proceeds from
these offerings were $5,115,000
before deducting offering expenses. The lead investors in the
financing included Knoll Capital Management, LP and ACT Capital
Management, LLLP, two fundamental life science investors, and two
of our largest existing shareholders.
We begin 2018 with approximately $8
million in cash, not including our non-dilutive NIH
funding.
Biotherapeutics Business Segment
During the year, we made good progress in advancing our clinical
development programs. We continue to actively enroll patients
in our pivotal Phase 3 study in CTCL with SGX301 (synthetic
hypericin) and are encouraged by this development program as a
potential front line treatment where there is currently an unmet
medical need. This trial, referred to as the "FLASH" study
(Fluorescent Light Activated Synthetic Hypericin), aims to evaluate
the response to SGX301 as a skin directed therapy to treat early
stage CTCL. SGX301 has received Orphan Drug designation as
well as Fast Track designation from the
United States (US) Food and Drug Administration (FDA).
Additionally, SGX301 was granted Orphan Drug designation from the
European Medicines Agency (EMA) and Promising Innovative Medicine
(PIM) designation from the Medicines and Healthcare Products
Regulatory Agency (MHRA) in the United
Kingdom (UK).
Approximately thirty CTCL centers across the US are
participating in this pivotal trial. Although the trial
begins with a double-blind, placebo-controlled portion (referred to
as Cycle 1), all participants in the trial eventually receive
active study drug (referred to as Cycle 2) and an optional portion
of the trial is available to them to continue with SGX301 treatment
(referred to as Cycle 3). We remain encouraged by the
response to this trial and by the majority of patients that have
elected to continue into the optional open-label portion of the
study. We continue to work closely with the Cutaneous
Lymphoma Foundation, as well as the National Organization for Rare
Disorders. As CTCL is a chronic disease that patients can
potentially live with for many years, if closely managed, study
enrollment can ebb and flow with the summer vacation and winter
holiday seasons, as some patients tend to not start new treatments
that may interfere with important family events; therefore, we
continue to take a conservative approach to estimating study
completion and availability of top-line data. As a result, we
have adjusted our trial guidance, with the prospectively defined,
blinded interim analysis taking place in the second half of 2018
and top-line final study results potentially moving into the first
half of 2019. Rest assured, we take development timelines
very seriously. To this end, quality enrollment and
completion of this pivotal Phase 3 CTCL study continues to be our
top priority.
During the third quarter, we initiated a pivotal double-blind,
placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide)
for the treatment of oral mucositis in patients with head and neck
cancer receiving CRT. This trial, referred to as the
"DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by
modulating INNATE immunity), aims to evaluate the response of
SGX942 in reducing the duration of severe oral mucositis, in
addition to other clinically meaningful measures, and incorporates
feedback from the FDA as well as the EMA via the Scientific Advice
process. The Scientific Advice from the EMA indicated that a
single, double-blind, placebo-controlled Phase 3 study, if
successful, in conjunction with the positive results from the Phase
2 dose-ranging study, generally will be sufficient to support a
marketing authorization application for potential licensure in
Europe. SGX942 is the first Innate Defense Regulator in
development for oral mucositis and has previously demonstrated
positive results in a Phase 2 clinical trial.
Dusquetide is a new chemical entity with a novel mechanism of
action whereby it modulates the body's reaction to both injury and
infection towards an anti-inflammatory and an anti-infective
response. It also accelerates resolution of tissue damage
following exposure to a variety of agents including bacterial
pathogens, trauma and chemo-and/or radiation therapy.
Long-term follow-up data from the Phase 2 trial, published in the
second quarter of 2017, further indicated the safety and
tolerability of SGX942 treatment, with a sustained trend towards
reduced mortality and increased tumor resolution compared to
placebo. SGX942 has received Fast Track designation from the
FDA for the treatment of oral mucositis as a result of CRT in head
and neck cancer patients as well as PIM designation from the MHRA
in the UK. In addition, the US Patent Office has granted the
patent entitled "Novel Peptides and Analogs for Use in the
Treatment of Oral Mucositis". The newly issued patent claims
therapeutic use of dusquetide and related IDR analogs, and adds to
composition of matter claims for dusquetide and related analogs
that have been granted in the US and worldwide.
We anticipate that approximately fifty US and European oncology
centers will be participating in this pivotal Phase 3 study.
Currently, the study is actively enrolling in the US, which
includes a number of centers that had previously participated in
the Phase 2 study, with expansion into Europe occurring later this year.
Current guidance on timing of study completion continues to be
2019, with a prospectively defined, blinded interim analysis for
the trial occurring in the first half of 2019.
BioDefense/Vaccine Business Segment
In addition to the ongoing funding of up to $24.7 million awarded by NIAID for the
development of our ricin toxin vaccine, RiVax®, we
announced that biomarkers for RiVax® testing have been
successfully identified, facilitating potential approval under the
FDA Animal Rule. The FDA Animal Rule is applied to products
where testing in human clinical trials would be unethical, and in
the case of ricin toxin, fatal. The Animal Rule combines
safety studies in humans and efficacy testing in animals to
facilitate approval. Key to the application of the Animal
Rule is the requirement to establish a correlation between the
immune response observed in clinical trials in healthy volunteers
with the immune response demonstrated in animal efficacy
studies.
In 2018, we intend to initiate a Phase 1/2 vaccine safety and
immunogenicity study utilizing RiVax®. In
parallel, efficacy studies in non-human primates are also planned
in 2018, with initial results currently anticipated for late
2018. Identification of a biomarker to facilitate
demonstrating the correlation between animal and human studies is a
significant accomplishment in the RiVax® development
program. In addition to being protective and thermostable,
RiVax® has demonstrated that a reduced number of
vaccinations may be required to establish protection, potentially
utilizing only two doses instead of three. RiVax®
has received Orphan Drug designation from the FDA and as a new
chemical entity, upon approval, has the potential to qualify for a
biodefense Priority Review Voucher (PRV). PRVs are
transferable and can be sold, with sales in recent years of up to
$350 million.
In closing, thank you for your interest and your continued
support of Soligenix. We look forward to another productive
year as we further advance our development programs, and will
strive to provide similar updates on a quarterly basis moving
forward. Best wishes to you and your families for a happy,
healthy and prosperous 2018!
Dr. Christopher J. Schaber
President and Chief Executive Officer
Soligenix, Inc.
January 25, 2018
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 BioTherapeutics
business segment is developing SGX301 as a novel photodynamic
therapy utilizing safe visible light for the treatment of cutaneous
T-cell lymphoma, our first-in-class innate defense regulator (IDR)
technology, dusquetide (SGX942) for the treatment of 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 Vaccines/BioDefense business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate, OrbeShield®, our GI acute radiation syndrome
therapeutic candidate and SGX943, our therapeutic candidate for
antibiotic resistant and emerging infectious disease. 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) and
the Biomedical Advanced Research and Development Authority
(BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at www.soligenix.com.
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. 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 US
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 US 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 timing or success of the Phase 3
clinical trial of SGX942 (dusquetide) as a treatment for oral
mucositis in patients with head and neck cancer receiving
chemoradiation therapy or the Phase 3 clinical trial of SGX301
(synthetic hypericin) for the treatment of cutaneous T-cell
lymphoma. 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®. 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.
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SOURCE Soligenix, Inc.