PRINCETON, N.J., May 15, 2020 /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,
2020.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "This
has been a very rewarding year for us thus far. Our pivotal Phase 3
FLASH (Fluorescent Light Activated Synthetic Hypericin) trial
continues to demonstrate SGX301's potential to be an important
new treatment for early-stage cutaneous T-cell lymphoma
(CTCL). In the double-blind, placebo controlled Cycle 1
portion of the study, a statistically significant treatment
response (p=0.04) was achieved in the primary endpoint after 6
weeks of therapy. This positive treatment response continued
to significantly improve with extended SGX301 treatment in the
open-label treatment cycle, referred to as Cycle 2, with an
additional 6 weeks of therapy (p<0.0001 compared to placebo and
p<0.0001 compared to 6-weeks treatment). We also continue
to advance our pivotal Phase 3 clinical trial of SGX942 (dusquetide) for
the treatment of oral mucositis in patients with head and neck
cancer (HNC) receiving chemoradiation therapy. Following the
positive recommendation received from the independent Data
Monitoring Committee, we have successfully achieved our target of
260 patients randomized into the study; however, due to the
uncertainty surrounding the coronavirus pandemic, we decided to
enroll up to 25 additional patients into the study. We are
taking this cautious approach in order to maintain the statistical
integrity of the trial, by accounting for patients that may
potentially drop out of the study before completing their protocol
required study treatment and evaluations. Therefore, the
study target to complete enrollment and provide top-line results
has been revised to the fourth quarter 2020; however, this will
continue to remain dependent on the medical and logistical
challenges caused by the coronavirus showing a reasonable level of
improvement in the relative near-term."
Dr. Schaber continued, "Under our Public Health Solutions
business segment, we continue to advance our work with University
of Hawaiʻi at Mānoa (UH Mānoa) on filovirus vaccines
(protecting against viruses such as Ebola and Marburg) and the
development of vaccines to potentially combat coronaviruses,
including SARS-CoV-2, the cause of COVID-19. We continue to
support our heat stable ricin vaccine, RiVax®, with a
National Institute of Allergy and Infectious Disease contract award
of $21.2 million. With over
$8M in cash, not including our
non-dilutive government funding, along with the at-the-market sales
issuance agreement with B. Riley FBR, Inc. to judiciously
supplement our cash runway as needed, we anticipate having
sufficient capital to achieve multiple inflection points across our
rare disease pipeline, including top-line results in our SGX942
Phase 3 clinical trial in oral mucositis."
Soligenix Recent Accomplishments
- On May 11, 2020, the Company
announced publication of immunogenicity studies for
RiVax® identifying novel correlates of immune protection
to facilitate potential approval under the United States Food and
Drug Administration (FDA) "Animal Rule." The article, titled "A
Multivariate Model Combining Endpoint and Epitope-specific Antibody
Responses as a Correlate of Protection to Ricin Toxin," has been
submitted to the peer-reviewed medical journal Vaccine and a
preprint is available here. To view this press release, please
click here.
- On May 7, 2020, the Company
announced that it had received approximately $840,000, net of transaction costs, in
non-dilutive financing via the State of
New Jersey's Technology Business Tax Certificate Transfer
Program. To view this press release, please click here.
- On April 30, 2020, the Company
announced that continued treatment with SGX301 (synthetic
hypericin) twice weekly for 12 weeks increased the positive
response rate to 40% (p<0.0001 compared to placebo and
p<0.0001 compared to 6-weeks treatment) in Cycle 2 of its
pivotal Phase 3 FLASH study for the treatment of early-stage CTCL.
These highly statistically significant results confirm the benefit
of continued SGX301 treatment in CTCL patients. To view this press
release, please click here.
- On April 16, 2020, the Company
announced it had executed an agreement for the exclusive worldwide
license of CoVaccine HT™, a novel vaccine adjuvant, from BTG
Specialty Pharmaceuticals, a division of Boston Scientific
Corporation (NYSE: BSX), for the fields of pandemic flu and
coronaviruses, including SARS-CoV-2, the cause of COVID-19. To view
this press release, please click here. This collaboration further
builds on the recently announced collaboration between the UH Mānoa
and Soligenix to develop a SARS-CoV-2 vaccine (available
here).
- On April 6, 2020, the Company
announced that the European patent office has granted the
divisional patent application titled "Formulations and Methods of
Treatment of Skin Conditions" (No. 2932973). The granted claims are
directed to the therapeutic use of synthetic hypericin in the
treatment of CTCL. To view this press release, please click
here.
Financial Results – Quarter Ended March 31, 2020
Soligenix's revenues for the quarter ended March 31, 2020 were $0.9
million as compared to $1.1
million for the quarter ended March
31, 2019. Revenues included payments on a contract in
support of RiVax®, our ricin toxin vaccine candidate,
grants received to support the development of SGX943 for treatment
of emerging and/or antibiotic-resistant infectious diseases,
ThermoVax®, our thermostabilization technology, and the
assessment of SGX942 safety in juvenile animals.
Soligenix's basic net loss was $7.6
million, or ($0.32) per share,
for the quarter ended March 31, 2020,
as compared to $1.6 million, or
($0.09) per share, for the quarter
ended March 31, 2019. This
increase in net loss was primarily the result of the issuance of
$5 million of common stock as a
milestone payment triggered by the successful Phase 3 clinical
trial of SGX301 for the treatment of CTCL and increased research
and development spending. The number of shares of common stock
issued as a milestone payment was calculated using an effective
price of $2.56 per share, based upon
a formula set forth in the applicable agreement.
Research and development expenses were $2.7 million as compared to $1.6 million for the quarters ended March 31, 2020 and 2019, respectively. The
increase in research and development spending for the quarter ended
March 31, 2020 was primarily
attributable to the site and patient fees for the pivotal Phase 3
clinical trials of SGX301 and SGX942, compared to the same period
in 2019.
General and administrative expenses were $0.9 million for both the three months ended
March 31, 2020 and 2019.
As of March 31, 2020, the
Company's cash position was approximately $7.2 million, not including the approximate
$840,000 recently received from the
State of New Jersey's Technology
Business Tax Certificate Transfer Program.
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 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 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 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 the
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 any of
our other 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.