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Driving Towards Key Inflection Points

Key Takeaway: - Driving Towards Key Inflection Points Two Pivotal Phase 3 Clinical Trials provides mid-year update and guidance NJ - July 19, 2018 - Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing p

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- Driving Towards Key Inflection Points
Two Pivotal Phase 3 Clinical Trials
provides mid-year update and guidance
NJ - July 19, 2018 - 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
Friends and Shareholders,
wanted to take this opportunity to provide a mid-year update, as well as to provide some further guidance on our development programs.
focus remains, first and foremost, on 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 continue to advance the 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.
continue to make good progress in advancing our two (2) pivotal Phase 3 clinical programs.
thirty CTCL centers across the US are participating in this pivotal trial, which is targeted to enroll approximately 120 patients.
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.
CTCL development program has partial funding of approximately $1.5 million over two years from a Small Business Innovative Research
(SBIR) grant awarded by the NIH National Cancer Institute (NCI).
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. 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.
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 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
anticipate that approximately fifty US and European oncology centers will be participating in this pivotal Phase 3 study, which
is targeted to enroll approximately 190 patients. Currently, the study is enrolling in the US, which includes a number of centers
that had previously participated in the Phase 2 study, with expansion into Europe anticipated to occur in the next several weeks.
oral mucositis development program has partial funding of approximately $1.5 million over two years from a SBIR grant awarded
by the NIH National Institute of Dental and Craniofacial Research (NIDCR).
are advancing the development of our thermostabilized ricin toxin vaccine, RiVax , with the support of up to $24.7
million over six years awarded by NIAID, where we have 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.
will continue to provide preclinical findings, as they become available, later this year. We also anticipate initiating a Phase
2 vaccine immunogenicity and safety study in healthy volunteers utilizing RiVax . In parallel, additional efficacy
studies in non-human primates are planned for initiation, enabling a larger database of biomarker correlates for correlation with
human clinical results. Identification of biomarkers that correlate protection 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, and both vaccine regimens are planned to be tested in the Phase 2 study planned to begin this year.
has received Orphan Drug designations from both the FDA and EMA, 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. Recent events, including a foiled bioattack with ricin in Germany, suggest that the RiVax
vaccine may be of increasing interest to multiple countries.
development work with the University of Hawai'i on a trivalent thermostabilized Ebola vaccine continues as planned with
the support of a $700,000 sub-award over five years from NIAID. The subunit vaccine offers broader coverage to different strains
of Ebola, as well as Marburg virus, and offers the potential for a simpler chain of custody with no refrigerated conditions required.
noted above, we aggressively pursue non-dilutive funding sources to support our rare disease pipeline. We have received two NIH
SBIR grant awards totaling approximately $3 million for two of our biotherapeutics development programs. We are also operating
under NIAID grant and contract awards of up to $25.4 million to support RiVax development and our collaboration
with the University of Hawai'i at Manoa for the development of a trivalent thermostabilized Ebola vaccine in our BioDefense
business segment. This non-dilutive funding continues to provide a meaningful offset to our development expenses while better
positioning us to more effectively manage our overall cash burn.
addition to the non-dilutive funding received, we recently completed an at the market registered direct offering of 8,932,038
shares of common stock at $1.03 together with warrants to purchase up to 3,572,815 shares of our common stock with an exercise
price of $2.25 per share. Our gross proceeds from these offerings, which include the exercise of the underwriter's over-allotment
option to purchase additional shares of common stock and warrants, were approximately $9.2 million before deducting offering expenses.
The lead investor was Altamont Pharmaceutical Holdings, LLC, a long, fundamental life science investor, and currently our largest
existing shareholder at approximately 13%.
believe that, given current development assumptions, the approximate $8.4 million in net proceeds coupled with our existing cash
on hand, which at the end of March 2018 was $6.4 million, and including our non-dilutive government funding, provides a cash runway
of at least 12 months. With this available funding, we are now positioned to achieve multiple potential key milestones across
our rare disease pipeline.
closing, thank you for your interest and your continued support of Soligenix. We look forward to a productive second half of 2018
as we further advance our development programs, and will strive to provide similar updates on a periodic basis moving forward.
Best wishes to you and your families for a happy and safe remainder of the summer!
Christopher J. Schaber
and Chief Executive Officer
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).
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).
further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
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
Last updated: Jul 19, 2018