PRINCETON, N.J., Feb. 24, 2021 /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,
I would like to start by thanking you for your continued
support, and hope that you and your families are all healthy and
well. As 2020 recedes in the rearview mirror, we seem to be
turning a corner on the challenges the COVID-19 pandemic has
imposed on our everyday lives with promising coronavirus vaccines
and a hope to return to a more normal existence in the not too
distant future. Hope and recovery appear to be the early
theme of 2021, and we are energized by the promise of the coming
year. Last year posed a number of challenges and some
disappointment for Soligenix, but more importantly a number of
successes. Most notably, our positive Phase 3 study of SGX301
(synthetic hypericin) in the treatment of cutaneous T-cell lymphoma
(CTCL), allowing us to advance toward a new drug application (NDA)
with the U.S. Food and Drug Administration (FDA) for marketing
authorization in the not too distant future. We also debuted
new opportunities in our robust pipeline, such as our novel heat
stable COVID-19 vaccine candidate, CiVax™, where we announced
positive preclinical results and expect more data to follow
shortly. Additionally, we have followed through on our
efficient and shareholder-friendly financing strategies, providing
us with sufficient capital and cash runway to meet our goals
through 2022 as we move towards U.S. commercialization of SGX301 in
CTCL. We expect peak annual net sales of SGX301 in the U.S.
to exceed $90 million, with the total
addressable worldwide market estimated at approximately
$250 million annually. Overall,
we are excited about our near-term and future upcoming catalytic
milestones.
Corporate Highlights
Since our last update, we have continued to advance our
development programs across both the Specialized BioTherapeutics
and Public Health Solutions business segments of our rare disease
pipeline, where we currently anticipate achieving multiple
important milestones in 2021 and 2022.
Specialized Biotherapeutics Business Segment
In late October, we were very
happy to announce completion of our pivotal Phase 3 FLASH
("Fluorescent Light Activated Synthetic Hypericin") study with
SGX301 and share the continued positive benefits for our CTCL
patients. Compared to the currently approved CTCL therapies
for early disease, the treatment response to SGX301 was very rapid,
being detected in as little as 6 weeks of treatment (Cycle 1,
p=0.0416). Responses continued to improve through 12 weeks of
treatment (Cycle 2, p<0.0001 vs end Cycle 1) and 18 weeks of
treatment (Cycle 3, p<0.0001 vs end Cycle 1), ultimately
enabling nearly half of patients who continued treatment to see
sustained and significant improvement in their response rates.
SGX301 also demonstrated statistically significant responses in
both patch (Cycle 2 response 37%, p=0.0009) and plaque (Cycle 2
response 42%, p<0.0001) lesions, highlighting the unique
benefits of the more deeply penetrating visible light activation of
hypericin. Unlike other second line and off-label therapies for
CTCL, SGX301 was both better tolerated with a reduced dropout rate
and more broadly effective, with equal efficacy against both plaque
and patch lesions. Further, no synthetic hypericin was
detected in the bloodstream of patients, minimizing safety concerns
of drug effects outside of the tumor area.
As Brian
Poligone, MD, PhD, Lead Enrolling Investigator in the FLASH
study and Director of the Rochester Skin Lymphoma Medical
Group, Fairport, NY, USA stated in the announcement,
"Along with SGX301's rapid response time and safety profile, the
patch and plaque data from the study are extremely compelling.
Current treatments for CTCL are generally less effective against
plaques and deeper lesions, very similar to the problem observed in
psoriasis. The ability of SGX301 to target both patches and
thicker plaques in CTCL is an important feature for this therapy
and, if approved, will be of benefit to patients, regardless of
their presentation. These results are consistent with the
positive findings highlighted in a recently reported case
study of folliculotropic mycosis fungoides, a hard to treat
variant of CTCL where lesions are associated with the hair
follicles deep in the skin and more resistant to phototherapy."
With the study complete, we are
now preparing to begin submission of the rolling NDA in 2Q 2021 for
this first-in-class therapy. SGX301 has received Orphan Drug
and Fast Track designations from the FDA. Additionally,
SGX301 was granted Orphan Drug designation from the European
Medicines Agency (EMA) and Promising Innovative Medicine
designation from the Medicines and Healthcare products Regulatory
Agency in the United Kingdom.
January
2021 was a busy month for us. We announced a strategic
partnership with Daavlin, a leading manufacturer of phototherapy
products used worldwide by dermatologists and patients, for supply
and distribution of our SGX301 companion light device. This
exclusive supply, distribution and services agreement with Daavlin
will secure long-term supply and distribution of a commercially
ready light device that is an integral component of the regulatory
and commercial strategy for SGX301 for the treatment of CTCL.
We also held an investor webcast event to discuss the unique U.S.
commercialization opportunity for SGX301 in the treatment of
CTCL. During the webcast, we reviewed in some detail the
disease, competitive landscape, and our intent to commercialize
SGX301 ourselves in a cost efficient and most profitable
manner. As CTCL is a highly specialized orphan market with a
discrete prescriber base, it presents a tailor-made market
opportunity for us, where peak annual net sales in the U.S. are
expected to exceed $90 million, with
total U.S. revenues during the 10-year forecast period projected to
be greater than $700 million.
As Michael
Young our acting Chief Marketing Officer and Principal,
biomedwoRx: Life Sciences Consulting and a Board member of the
Cutaneous Lymphoma Foundation stated, "The value proposition
for SGX301 is designed around maximizing the opportunity while
minimizing the needed commercial investment, and represents a
significant therapeutic opportunity in changing the landscape for
treatment of early stage CTCL disease."
During this webcast, we also
discussed at a high level the analysis that went into our
determination to ultimately commercialize in the U.S. versus
partnership. This decision was, in large part, based on
maintaining 100% of SGX301's value with a very reasonable
commercial build and launch expense of approximately $7 million compared to us retaining less than
half of its value with partnering. I would urge all those
that want to better understand what a unique value proposition
SGX301 in CTCL represents to listen to the full webcast here.
We remain steadfast in our plans
for partnership in the ex-U.S. markets and are in a number of
active discussions with potential partners with similar reputation
and expertise in this therapeutic area. We anticipate
receiving marketing approval in the U.S. first, and with this
approval in hand we will aggressively pursue marketing
authorizations in other key markets worldwide. Given SGX301's
success in CTCL, we are now evaluating other potential cutaneous
oncology indications that might similarly benefit from the use of
our first-in-class synthetic hypericin.
As many of you know, in December,
we announced preliminary top-line results for our pivotal Phase 3
DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating
INNATE Immunity) trial evaluating SGX942 (dusquetide) in the
treatment of severe oral mucositis (SOM) in patients with head and
neck cancer (HNC) receiving chemoradiation. The study
enrolled 268 patients randomized 1:1 to receive either SGX942 or
placebo. The primary endpoint of median duration of SOM did
not achieve the pre-specified criterion for statistical
significance (p≤0.05); although biological activity was clearly
observed with a 56% reduction in the median duration of SOM from 18
days in the placebo group to 8 days in the SGX942 treatment
group. Other secondary endpoints supported the biological
activity of dusquetide as well, including a statistically
significant 50% reduction in the duration of SOM in the
per-protocol population, which decreased from 18 days in the
placebo group to 9 days in the SGX942 treatment group (p=0.049),
consistent with the findings in the Phase 2 trial.
As I noted during our investor
call, we are very disappointed with this unanticipated outcome of
the study. Despite the fact that SGX942 demonstrated
clinically meaningful reductions in oral mucositis consistent with
the previous Phase 2 study, the Phase 3 trial did not achieve the
statistically significant benefit we expected. We are continuing to
analyze the full dataset to better understand why the study did not
meet expectations. Any clarity gained from further analysis
of the dataset, especially with respect to specific subsets of
patients that may benefit from SGX942 therapy, will be communicated
to and discussed with the FDA and the EMA.
Public Health Solutions Business Segment
We most recently announced a
number of exciting developments in the area of emerging infectious
diseases. We were awarded a Direct to Phase II Small Business
Innovation Research grant of approximately $1.5 million from the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), to support manufacture, formulation
(including thermostabilization) and characterization of COVID-19
(Coronavirus Disease 2019) and Ebola Virus Disease vaccine
candidates in conjunction with our CoVaccine HT™ (CoVaccine)
adjuvant. This award also will support immune
characterization of this novel, emulsified adjuvant that has unique
potency and compatibility with lyophilization strategies to enable
thermostabilization of subunit vaccines.
Ongoing collaborations with
Axel Lehrer, PhD, Associate
Professor (Vaccinology) in the Department of Tropical Medicine,
Medical Microbiology and Pharmacology, John
A. Burns School of Medicine (JABSOM), University of Hawaiʻi
at Mānoa (UHM), have demonstrated the feasibility of developing a
highly immunogenic vaccine for COVID-19, the infection caused by
SARS-CoV-2. This heat stable subunit vaccine program, we call
CiVax™, demonstrated immunity of both broad-spectrum antibody and
cell-mediated, rapid onset immunity using the CoVaccine adjuvant
in-licensed from BTG Specialty Pharmaceuticals, a division of
Boston Scientific Corporation. With significant research
dedicated worldwide to the generation of COVID-19 vaccines, it is
noteworthy that the essential attributes of a vaccine successful in
controlling the ongoing pandemic are believed to include the
ability to rapidly stimulate a Th1/Th2 balanced antibody response,
raising significant virus neutralizing antibodies, as well as
induce potent cell-mediated immunity. Previous work with the
CoVaccine adjuvant has indicated that it has these critical
characteristics. In addition, unlike other vaccines that have
logistical challenges due to cold chain requirements (in some cases
requiring maintenance of temperatures less than –70 degrees
Celsius), the underlying technology platform has demonstrated the
ability to produce single vial vaccines which are stable up to
temperatures at least as high as 40 degrees Celsius (104 degrees
Fahrenheit). We expect to have proof of concept data in non-human
primates (NHPs) no later than the end of Q2 this year.
We followed this up with an
announcement that we had demonstrated feasibility of developing
heat stable subunit protein vaccine formulations for filovirus
vaccines, including Ebola virus, Sudan virus, and Marburg virus.
Protective efficacy has been demonstrated in NHPs, the gold
standard animal model, against infection with Ebola virus,
Sudan virus, and Marburg virus.
Formulation conditions have been identified to enable heat
stabilization of each antigen, alone or in combination, for at
least 12 weeks at 40 degrees Celsius. These most recent
results demonstrate the thermostabilization of three virus
glycoproteins (from Zaire
ebolavirus, Sudan
ebolavirus and Marburg marburgvirus), and the
identification of key stability-indicating assays to further
support mono-, bi- and tri-valent vaccine formulations.
In December, we demonstrated
extended protection with our heat stable ricin toxin vaccine
candidate, RiVax®. Mice, vaccinated twice on Days
1 and 21 were protected for at least 365 days against subsequent
ricin challenge. These results demonstrate that the
thermostabilized vaccine formulation is capable of eliciting
enduring protection in mice. Coupled with previous
demonstration of efficacy in mice and NHPs as well as long-term
thermostability (at least 1 year at 40 degrees Celsius or 104
degrees Fahrenheit), these results reinforce the practicality of
stockpiling and potentially utilizing the
RiVax® vaccine in warfighters and civilian first
responders without the complexities that arise for vaccines that
require cold chain handling. This same thermostabilization
approach is also being advanced in the development of Soligenix's
CiVax™ vaccine for COVID-19.
RiVax® has received
Orphan Drug designation as well as Fast Track designation from the
FDA, and, as a new chemical entity, upon approval in the US, 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 approximately $100
million. Additionally, RiVax® was granted
Orphan Drug designation from the EMA. Recent events,
including the news of an envelope addressed to President Trump that
was thought to contain this potent and potentially lethal toxin, as
well as a foiled bio attack with ricin in Germany, suggest that the RiVax®
vaccine may be of increasing interest to multiple countries.
Balance Sheet and Capital
With more than $30 million in cash as of February 2021, not including our non-dilutive
government funding, we are now sufficiently capitalized to achieve
multiple key inflection points across our rare disease pipeline,
including moving towards NDA and commercialization of SGX301.
This increase in capital was due to two important events.
- A $20 million strategic
partnership with Pontifax Medison, the healthcare-dedicated venture
and debt fund of the Pontifax life science funds, in December.
Under the terms of the partnership with Pontifax, Soligenix will
have access to up to $20 million in convertible debt
financing in three tranches, which will mature over a
four-and-a-half-year period and have an interest-only period for
the first two years. Upon the closing of this transaction, we
accessed the first tranche of $10 million, and have the option
to draw the second tranche of $5 million at any time over
the next 12 months and the third tranche of $5
million upon filing of the SGX301 NDA, subject to certain
conditions. Pontifax may elect to convert the outstanding
loan drawn under the first two tranches into shares of Soligenix's
common stock at any time prior to repayment at a conversion price
of $4.10 per share. We also have the ability to
force the conversion of the loan into shares of our common stock at
a conversion price of $4.92 per share, subject to certain
conditions.
- The use of our at-the-market (ATM) sales issuance agreement
with B. Riley Securities, Inc. over the last two months to
supplement our cash runway. Given the significant increase in
both stock price and volume, with more than 186 million shares
traded so far during 2021, we were able to add capital to our
balance sheet judiciously while limiting sales to an extremely
small percentage (approximately 4.6%) of the overall
volume.
The combination of these two
facilities provides significant cash runway through 2022.
With a solid balance sheet and other available resources at our
disposal, such as non-dilutive government funding, we are well
positioned to aggressively advance and expand our pipeline.
We also continue to have ongoing confidential business development
discussions, which may lead to more favorable capital inflows,
including the potential to receive additional non-dilutive
capital. Overall, we continue to remain mindful of dilution
and will look at all future capital inflow initiatives in the most
efficient and shareholder-friendly manner as possible.
In closing, thank you for your interest and your ongoing support
of Soligenix. It continues to be a very exciting time in our
life cycle and late stage pipeline. We look forward to 2021
being even more productive than 2020, with the potential for
multiple near-term catalysts on the horizon as we further advance
our development programs towards commercialization. Best
wishes!
Dr. Christopher J. Schaber
President and Chief Executive Officer
Soligenix, Inc.
February 24, 2021
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 commercializing
SGX301 (synthetic hypericin) as a novel photodynamic therapy
utilizing safe visible light for the treatment of cutaneous T-cell
lymphoma. With a successful Phase 3 study completed, regulatory
approval and commercialization for this product is being advanced
initially in the U.S. Development programs in this business
segment also include 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, SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease, and our research
programs to identify and develop novel vaccine candidates targeting
viral infection including Ebola, Marburg and SARS-CoV-2 (the cause
of COVID-19). 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 Agents (DTRA) 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, 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 our clinical/preclinical trials.
Despite the statistically significant result achieved in the 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. 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.
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SOURCE Soligenix, Inc.