PRINCETON, N.J., Nov. 12, 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 September 30,
2020.
"We continue to look to the future with our Specialized
BioTherapeutics business segment," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "With the recent successful
completion of our pivotal Phase 3 FLASH (Fluorescent Light
Activated Synthetic Hypericin) trial, SGX301 has demonstrated
the potential to be a significant 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 just 6 weeks of therapy. This positive
treatment response continued to significantly improve with extended
SGX301 treatment in the open-label treatment cycles at 12 weeks
(Cycle 2) and 18 weeks (Cycle 3), reinforcing the positive SGX301
primary endpoint treatment response demonstrated in Cycle 1.
With the study now concluded, we will begin preparing our new drug
application for submission to the FDA. We also continue to
progress our pivotal Phase 3 DOM-INNATE (Dusquetide treatment
in Oral Mucositis – by modulating INNATE Immunity) study for SGX942
(dusquetide), for the treatment of oral mucositis in patients with
head and neck cancer receiving chemoradiation therapy. With
enrollment of 268 subjects completed, top-line final results
continue to be expected before the end of the year."
Dr. Schaber continued, "Under our Public Health Solutions
business segment, supported by non-dilutive government funding, we
continue to advance our work with the University of Hawaiʻi at
Mānoa (UHM) and Hawaii Biotech Inc. 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 recently
announced publication of positive pre-clinical data from
immunogenicity studies with CiVax™ (heat stable COVID-19 vaccine
candidate), demonstrating immunity of both broad-spectrum antibody
and cell-mediated, rapid onset immunity is possible using the novel
CoVaccine HT™ adjuvant in-licensed from BTG Specialty
Pharmaceuticals (a division of Boston Scientific
Corporation). Our heat stable ricin vaccine,
RiVax®, continues to be supported with a National
Institute of Allergy and Infectious Disease contract award.
With over $11M 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 final top-line results in our
SGX942 Phase 3 clinical trial in oral mucositis."
Soligenix Recent Accomplishments
- On October 22, 2020, the Company
announced the continued optional treatment with SGX301 (synthetic
hypericin) across all lesions during the compassionate use, safety
portion of the trial (Cycle 3), for a total of 6 months in the
study, continued to significantly improve responses and remained
safe and well-tolerated in its FLASH study. This data reinforces
the positive SGX301 primary endpoint treatment response
demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further
improved response rates, with 49% of patients electing to receive
SGX301 for a total of 18 weeks demonstrating a 50% or greater
reduction in their combined CAILS (Composite Assessment of Index
Lesion Score) lesion score compared to 40% of patients
demonstrating such a reduction after completing 12 weeks of SGX301
treatment in Cycle 2 (p=0.046). In addition, continued analysis of
results has revealed that 12 weeks of SGX301 treatment (Cycle 2) is
equally effective on both patch (response 37%, p=0.0009) and plaque
(response 42%, p<0.0001) lesions of CTCL when compared to Cycle
1 placebo lesion responses. SGX301 continued to be very well
tolerated, benefiting from the lack of hypericin circulation in the
blood stream after targeted topical application to the lesions, as
well as the use of visible light. To view this press release,
please click here.
- On September 15, 2020, the
Company announced the publication of nonclinical results
characterizing filovirus protein antigens (including for Ebola and
Marburg viruses) and their thermostabilization. The article,
authored by collaborators at the University of
Colorado, University of Hawaiʻi at Mānoa (UHM) and
Soligenix, is titled, "Preservation of Quaternary Structure in
Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search
for Stability-Indicating Assays" and has been accepted for
publication in the Journal of Pharmaceutical Sciences. A copy of
manuscript has been made available here. To view this press
release, please click here.
- On September 10, 2020, the
Company conducted an Investor Webcast presentation on the use of
its thermostabilized glycoprotein vaccine platform for the
development of a COVID-19 vaccine, called CiVax™. To listen to this
Webcast Event, please click here and to view the press release,
please click here.
Financial Results – Quarter Ended September 30, 2020
Soligenix's revenues for the quarter ended September 30, 2020 were $0.6 million as compared to $1.3 million for the quarter ended September 30, 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 $1.8
million, or ($0.06) per share,
for the quarter ended September 30,
2020, as compared to $2.7
million, or ($0.14) per share,
for the quarter ended September 30,
2019. This decrease in net loss was primarily the result of
decreased research and development spending due to the completion
of the CTCL trial.
Research and development expenses were $1.3 million as compared to $2.3 million for the quarters ended September 30, 2020 and 2019, respectively.
The decrease in research and development spending for the quarter
ended September 30, 2020 was
primarily attributable to the reduction in expense due to the
completion of the CTCL trial.
General and administrative expenses were $0.8 million for both the three months ended
September 30, 2020 and 2019.
As of September 30, 2020, the
Company's cash position was approximately $11.3 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 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.