PRINCETON, N.J., May 14, 2019 /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,
2019.
Christopher J. Schaber, PhD,
President and Chief Executive Officer of Soligenix stated, "We have
completed the approximate 90 subject enrollment necessary to
support the interim efficacy analysis of our 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 chemoradiation therapy. This interim analysis, to
be conducted by the independent Data Monitoring Committee (DMC) for
the trial, is anticipated to occur in September 2019. We expect completion of full
enrollment in the study in the second half of 2019, with final
top-line results expected in the first half of 2020, pending the
DMC recommendation."
Dr. Schaber continued, "Following the positive recommendation
received from the independent DMC for our double-blind,
placebo-controlled Phase 3 study for the treatment of cutaneous
T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin), we
continue to enroll patients and anticipate completing study
enrollment in the second half of 2019, with final top-line results
in the first quarter of 2020."
Soligenix Recent Accomplishments:
- On April 23, 2019, the Company
issued an update letter from Dr. Schaber. This letter provided an
update as well as further guidance on the development programs for
2019. To view this press release, please click here.
- On April 18, 2019, the Company
announced it had reached a significant milestone in the Phase 3
clinical study (the "DOM-INNATE" study) for SGX942 (dusquetide) in
the treatment of oral mucositis in patients with head and neck
cancer. Patient enrollment is sufficient to support the planned
interim efficacy analysis by the independent DMC. In accordance
with the clinical protocol, approximately 90 subjects have been
enrolled into the study as required for the planned interim
efficacy analysis. To view this press release, please click
here.
- On April 15, 2019, the Company
announced it had received approximately $611,000, 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 9, 2019, the Company
announced that the Pediatric Committee of the European Medicines
Agency agreed to the Company's Pediatric Investigation Plan (PIP)
for SGX942 (dusquetide). It was also agreed that the Company may
defer conducting the PIP until successful completion of its ongoing
pivotal Phase 3 clinical study evaluating SGX942 as a treatment for
oral mucositis in patients with head and neck cancer. To view this
press release, please click here.
- On April 4, 2019, the Company
announced that the US Patent Office would be issuing the patent
titled "Novel Peptides for Treating and Preventing Immune-Related
Disorders, Including Treating and Preventing Infection by
Modulating Innate Immunity". The new patent (#10,253,068) claims
composition of matter for novel innate defense regulator analogs,
expanding patent protection to more diverse analog structures.
Therapeutic use claims in oral mucositis, colitis, and infectious
disease, both alone and in conjunction with antibiotics, will also
issue. To view this press release, please click here.
Financial Results – First Quarter Ended March 31, 2019
Soligenix's revenues for the quarters ended March 31, 2019 and 2018 were each $1.1 million. Revenues included payments on a
contract in support of RiVax®, in addition to the grants
received to support the development of SGX301 for the treatment of
CTCL and SGX942 for the treatment of oral mucositis in head and
neck cancer, as well as the subaward from the Ebola collaboration
with the University of Hawai'i at Mānoa.
Soligenix's basic net loss was $1.6
million, or ($0.09) per share
for the quarter ended March 31, 2019,
as compared to $2.4 million for the
quarter ended March 31, 2018, or
($0.27) per share.
Research and development expenses were $1.6 million as compared to $1.8 million for the quarters ended March 31, 2019 and 2018, respectively. The
decrease in research and development spending for the three months
ended March 31, 2019 was primarily
attributable to higher clinical trial site fees incurred during the
period ended March 31, 2018 compared
to the same period in 2019.
General and administrative expenses were $0.9 million as compared to $0.7 million for the quarters ended March 31, 2019 and 2018, respectively. This
increase was primarily attributable to higher professional fees
incurred during the period ended March 31,
2019.
As of March 31, 2019, the
Company's cash position was approximately $7.2 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 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 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 https://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 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 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. There also can be no assurance as to timing or
success of the preclinical/clinical trials
of RiVax®, that
RiVax® will be approved for the PRV
program or the amount for which a PRV
for RiVax® can be sold. 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.