Soligenix Receives Positive Scientific Advice from the European Medicines Agency for SGX942 in the Treatment of Oral Mucositis in Head and Neck Cancer Patients

Follows UK Health Ministry’s Granting SGX942 Promising Innovative Medicine Designation in the Treatment of Oral Mucositis

 

Princeton, NJ, January 5, 2017 – Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the company had received positive Scientific Advice from the European Medicines Agency (EMA) for the development of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.  The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study (IDR-OM-02), if successful, in conjunction with the Phase 2 dose-ranging study IDR-OM-01, is generally considered sufficient to support a marketing authorization application (MAA) to the EMA for potential licensure in Europe.  The advice also provides several constructive suggestions to strengthen the study design and data collection that will be integrated into the final protocol.

“We are pleased that the EMA agrees that the proposed Phase 3 clinical study, if positive, is sufficient to establish the efficacy of SGX942 and support an MAA filing,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “We believe that this positive Scientific Advice outcome represents a significant step forward in our oral mucositis development program and has the potential to accelerate the registration timetable in Europe.  We look forward to incorporating the EMA’s protocol suggestions with those from the US Food and Drug Administration.  Given the current timeline, we anticipate initiating this pivotal Phase 3 clinical trial in the first half of 2017.”

About Scientific Advice

Scientific Advice is a procedure offered by the EMA to stakeholders for clarification of questions arising during development of medicinal products. The scope of Scientific Advice is limited to scientific issues, i.e. to quality, non-clinical, and clinical aspects of the concerned medicinal product not yet unequivocally covered by published scientific guidelines. Scientific Advice focuses on development strategies rather than pre-evaluation of data to support an MAA. Scientific Advice is legally non-binding and is based on the current scientific knowledge which may be subject to future changes.

About SGX942

Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides.  It has a novel mechanism of action in that it modulates the body’s reaction to both injury and infection towards an anti-inflammatory and an anti-infective response.  IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections.  Some of these preclinical findings have been published in an article entitled “A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy” and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers.  Recently, SGX942 has demonstrated preliminary efficacy and safety in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation (CRT) therapy for head and neck cancer.  Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099).  In patients at highest risk of oral mucositis (e.g., those exposed to the most aggressive concomitant chemotherapy), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04).  The p-values meet the prospectively defined statistical threshold of p<0.1 in the study protocol.  Additional observations included an improved tumor response to CRT therapy at the one month follow-up visit, as well as decreases in infection rate.  The study results are reviewed in “Dusquetide: A Novel Innate Defense Regulator Demonstrating a Significant and Consistent Reduction in the Duration of Oral Mucositis in Preclinical Data and a Randomized, Placebo-Controlled Phase 2a Clinical Study” published online in the Journal of Biotechnology and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.10.010.

Long-term (12 month) follow-up data further indicated the safety and tolerability of SGX942 treatment, with a trend towards reduced mortality and increased tumor resolution in the 1.5 mg/kg SGX942 treatment group compared to the placebo group.  Opioid pain medication use was also seen to decrease over the course of CRT in the 1.5 mg/kg SGX942 treatment group at the point of highest oral mucositis risk, while it increased in the placebo group.

The Phase 2 oral mucositis clinical study was partially funded with a grant from the National Institute of Dental and Craniofacial Research Small Business Innovation Research grant #1R43 DE024032-01 (Soligenix, Inc).

Dusquetide and related analogs have a strong intellectual property position, including composition of matter.  Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada.

Drug products containing dusquetide have also received Fast Track Designations from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients, and as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis. Orphan Drug Designations for use of dusquetide in the treatment of MAS as well as for the treatment of acute radiation syndrome have also been granted. In additon, dusquetide has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies.  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia.  The gastrointestinal damage causes severe diarrhea.  These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system.  Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in head and neck cancer is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe.  Oral mucositis almost always occurs in patients with head and neck cancer treated with chemoradiation therapy and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in head and neck cancer remains an area of unmet medical need where there are currently no approved drug therapies.

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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is 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 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.  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.

Soligenix Announces Extension of Development Agreement with Emergent BioSolutions

Supported with NIAID Contract Funding of up to $24.7 million 

 

Princeton, NJ – January 3, 2017 – 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 that it has extended its development agreement with Emergent BioSolutions to implement a commercially viable, scalable production technology for the RiVax™ drug substance protein antigen.  RiVax™ is a vaccine candidate being developed to protect against ricin exposure.  This specific agreement will build upon process development work conducted to date in support of manufacturing scale-up that will eventually be performed in accordance with current good manufacturing practices (cGMPs) at Emergent’s manufacturing facility located in Baltimore, MD.

Soligenix has been developing RiVax™, in conjunction with its heat stabilization technology, ThermoVax®, as a heat-stable biodefense vaccine.  RiVax™ has demonstrated both 100% protection in a preclinical model of lethal ricin exposure and stability up to 1 year at 40 degrees Celsius facilitating storage at ambient temperature.  RiVax™ is being developed as a safe and effective biodefense vaccine which does not require cold chain shipment and storage.

The RiVax™ project has been funded with Federal funds of up to $24.7 million from the National Institute of Allergy and Infectious Diseases (NIAID) under Contract No. HHSN272201400039C.  The agreement between Soligenix and Emergent is specifically funded under this same contract.

“We are pleased to extend our agreement with Emergent BioSolutions as we expand our efforts to develop an effective, first-in-class vaccine against ricin toxin exposure in combination with our thermostabilization technology,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “Collaborating with NIAID and Emergent is an important step in advancing the development of our ThermoVax® technology platform. Soligenix intends to use this innovative technology to develop a heat stable ricin toxin vaccine that meets US Government requirements and advances a vaccine thermostabilization platform that may apply to other vaccines.”

“Emergent’s overarching focus on medical countermeasures that address public health threats complements the objectives of this program. We look forward to leveraging our contract manufacturing expertise and flexibility to help meet Soligenix’s needs,” stated Adam Havey, Executive Vice President and President, Biodefense Division at Emergent BioSolutions.

About Ricin Toxin

Ricin toxin is a plant toxin and potential biological weapon because of its stability, high potency, and availability as a by-product of castor oil production.  Ricin comes in many forms like powder, mist, or pellet. Ricin can also be dissolved in water and other liquids.  The US Centers for Disease Control and Prevention (CDC) estimates the lethal dose in humans is about the size of a grain of salt.  Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure.  Ricin is especially toxic when inhaled.  Ricin works by getting inside the cells of the body and preventing the cells from making the proteins it needs.  Without the proteins, cells die, which is eventually harmful to the whole body.

There are currently no effective treatments for ricin poisoning.  The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.

About RiVax™

RiVax™ is Soligenix’s proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin.  With RiVax™, Soligenix is a world leader in the area of ricin toxin vaccine research.

RiVax™ contains a genetically altered version of a RTA chain containing two mutations that inactivate the toxicity of the ricin molecule.  A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant.  This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers.  The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.  To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial.  Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants.  The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™.  In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.  Vaccination with the Alum-adjuvanted RiVax™ formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin.  The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.

The development of RiVax™ has been sponsored through a series of grants and contracts from both the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the FDA, which were granted to Soligenix and to the University of Texas Southwestern (UTSW) where the vaccine originated.  To date, Soligenix and Dr. Ellen Vitetta and colleagues at UTSW have collectively received approximately $50 million in grant and contract funding from NIAID for development of RiVax™ and related vaccine technologies.  RiVax™ would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.

About ThermoVax®

ThermoVax® is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines.  According to the Biopharma Cold Chain Sourcebook of 2010, more than 90% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain.  Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  Further, the World Health Organization (WHO) reports that as much as 50% of all global vaccine doses are wasted due, in part, to excursions outside required temperature ranges.  NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production.  For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency situations.

The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit).  By employing ThermoVax® during the final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.

The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado.

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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is 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 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 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. 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.

Soligenix Advances Collaboration with IDT Biologika

Supported with NIAID Contract Funding of up to $24.7 million 

 

Princeton, NJ – December 20, 2016 – 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 that it has extended its collaboration with IDT Biologika (hereafter referred to as IDT) for the manufacture of RiVax™, the Company’s proprietary heat-stable ricin toxin vaccine.  Under the terms of the collaboration, Soligenix will scale-up the formulation/filling processes and continue development and validation of analytical methods established at IDT to advance the program towards a commercially viable scalable technology for the RiVax™ vaccine product compliant with current Good Manufacturing Practices (cGMPs).

Soligenix has been developing RiVax™, in conjunction with its heat stabilization technology, ThermoVax®, as a heat-stable biodefense vaccine.  RiVax™ has demonstrated both 100% protection in a preclinical model of lethal ricin exposure and stability up to 1 year at 40 degrees Celsius (104 degrees Fahrenheit) facilitating storage and distribution at ambient temperature.  RiVax™ is being developed as a safe and effective biodefense vaccine which does not require cold chain shipment and storage.

The RiVax™ project has been funded with Federal funds of up to $24.7 million over the next 6 years, if all contract options are exercised. The collaboration between Soligenix and IDT is specifically funded by Contract No. HHSN272201400039C from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

“We are pleased to be working with Soligenix on the manufacture of thermostable RiVax™, supported by this contract from NIAID. We believe that IDT provides an excellent combination of manufacturing and vaccine expertise/capabilities to add to the Soligenix team to advance this critical program forward,” stated Ralf Pfirmann, PhD, Chief Executive Officer, of IDT Biologika.

“This collaboration with IDT advances our effort to develop an effective, first-in-class vaccine against ricin toxin exposure in combination with our thermostabilization technology,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “Collaborating with NIAID and IDT is an important step in advancing the development of our ThermoVax® technology platform. Soligenix intends to use this innovative technology to develop a heat stable ricin toxin vaccine capable of achieving the goals of the US Government’s Strategic National Stockpile program.”

About Ricin Toxin

Ricin toxin is a plant toxin and potential biological weapon because of its stability, high potency, and availability as a by-product of castor oil production.  Ricin comes in many forms like powder, mist, or pellet. Ricin can also be dissolved in water and other liquids.  The US Centers for Disease Control and Prevention (CDC) estimates the lethal dose in humans is about the size of a grain of salt.  Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure.  Ricin is especially toxic when inhaled.  Ricin works by getting inside the cells of the body and preventing the cells from making the proteins it needs.  Without the proteins, cells die, which is eventually harmful to the whole body.

There are currently no effective treatments for ricin poisoning.  The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.

About RiVax™

RiVax™ is Soligenix’s proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin.  With RiVax™, Soligenix is a world leader in the area of ricin toxin vaccine research.

RiVax™ contains a genetically altered version of a RTA chain containing two mutations that inactivate the toxicity of the ricin molecule.  A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant.  This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers.  The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.  To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial.  Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants.  The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™.  In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.  Vaccination with the Alum-adjuvanted RiVax™ formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin.  The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.

The development of RiVax™ has been sponsored through a series of grants and contracts from both the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the FDA, which were granted to Soligenix and to the University of Texas Southwestern (UTSW) where the vaccine originated.  To date, Soligenix and Dr. Ellen Vitetta and colleagues at UTSW have collectively received approximately $50 million in grant and contract funding from NIAID for development of RiVax™ and related vaccine technologies.  RiVax™ would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.

About ThermoVax®

ThermoVax® is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines.  According to the Biopharma Cold Chain Sourcebook of 2010, more than 90% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain.  Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  Further, the World Health Organization (WHO) reports that as much as 50% of all global vaccine doses are wasted due, in part, to excursions outside required temperature ranges.  NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production.  For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency situations.

The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit).  By employing ThermoVax® during the final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.

The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado.

About IDT Biologika

IDT Biologika is an innovative life science company headquartered in Dessau, Germany with extensive expertise in research, development and manufacturing of vaccines, and in addition providing fill, finish and packaging services for antibodies and proteins.  It has expanded its longstanding activity in vaccine development for Phase 1 and Phase 2 clinical projects for the human vaccine market through its recently acquired Rockville, Maryland, USA facility.  The company also operates vaccine development and manufacturing facilities in Riems, Germany and Cambridge, Canada and sales offices for its own animal health vaccines and biologics product portfolio in Denmark, the Netherlands, France, Spain, China and Canada.  IDT Biologika is a portfolio company of the Klocke Group.  The Klocke portfolio companies specialize in contract manufacturing and packaging of pharmaceuticals and cosmetic products. More information can be found at www.idt-biologika.com.

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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is 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 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 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. 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.

Soligenix Announces Closing of Public Offering

Princeton, NJ, December 16, 2016 Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the closing of its previously announced underwritten public offering of 1,670,000 shares of its common stock and warrants to purchase up to an aggregate of 2,087,500 shares of its common stock at a combined offering price of $3.16. In addition, the underwriters partially exercised the over-allotment to purchase an additional 282,505 warrants. The warrants have a per share exercise price of $3.95, are exercisable immediately and will expire five years from the date of issuance. Gross proceeds to Soligenix, Inc. from this offering are approximately $5,277,270 before deducting underwriting discounts and commissions and other estimated offering expenses payable by Soligenix, Inc.

Aegis Capital Corp. acted as the sole book-running manager for the offering.

Maxim Group LLC acted as the co-manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on November 22, 2016.

The offering will be made only by means of a prospectus. A copy of the final prospectus, dated December 12, 2016, relating to the offering may be obtained by contacting Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY 10019, telephone: 212-813-1010, e-mail: prospectus@nullaegiscap.com. Investors may also obtain these documents at no cost by visiting the SEC’s website at http://www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is supported with up to $58 million in 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 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, the offering is subject to market and other conditions, and there can be no assurance as to the underwriter’s exercise of the remaining portion of their over-allotment option to purchase additional securities, as well as risks and uncertainties associated with, the anticipated use of proceeds from the offering.  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.

Soligenix, Inc. Prices $5,277,000 Public Offering and Completes Listing on Nasdaq

Princeton, NJ, December 13, 2016 Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the pricing of an underwritten public offering of 1,670,000 shares of its common stock and warrants to purchase up to an aggregate of 2,087,500 shares of its common stock at a combined offering price of $3.16. The warrants will have an initial per share exercise price of $3.95, subject to customary adjustment in connection with stock splits, stock dividends, reclassifications, combinations and other similar events, are exercisable immediately and will expire five years from the date of issuance. The gross proceeds to Soligenix, Inc. from this offering are expected to be approximately $5,277,200, before deducting underwriting discounts and commissions and other estimated offering expenses. Soligenix, Inc. has granted the underwriters a 45-day option to purchase up to an additional 250,500 shares of common stock and/or 313,125 additional warrants to cover over-allotments, if any. The offering is expected to close on December 16, 2016, subject to customary closing conditions.

The Company’s common stock and warrants are expected to begin trading on The Nasdaq Capital Market under the symbols “SNGX” and “SNGXW,” respectively, on December 13, 2016.

Aegis Capital Corp. is acting as the sole book-running manager for the offering.

Maxim Group LLC is acting as co-manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on November 22, 2016.

The offering will be made only by means of a prospectus. A copy of the prospectus relating to the offering may be obtained, when available, by contacting Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY 10019, telephone: 212-813-1010, e-mail: prospectus@nullaegiscap.com. Investors may also obtain these documents at no cost by visiting the SEC’s website at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is supported with up to $58 million in 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 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 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, the offering is subject to market and other conditions, and there can be no assurance as to the estimated proceeds from the offering and the anticipated use of proceeds from the offering.  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.

Soligenix Announces SGX942 Receives Promising Innovative Medicine Designation from the UK Medicines and Healthcare Products Regulatory Agency

Princeton, NJ – December 12, 2016 – Soligenix, Inc. (OTCQB: 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 SGX942 (dusquetide) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy.

The PIM designation is the first step towards inclusion in the Early Access to Medicines Scheme (EAMS).  Launched in April 2014, EAMS offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally be accessible.

PIM status, the first phase of EAMS, which is awarded following an assessment of early nonclinical and clinical data by the MHRA, has been created as an early signal to companies that the development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme, once further development work has been conducted.  In this second phase, the product is made available to UK patients before a marketing authorization is approved.  This early boost to a drug’s potential is expected to be beneficial to companies, especially small and medium-sized enterprises.

The criteria products must meet to obtain the PIM designation are:

  1. Criterion 1 – The condition should be life-threatening or seriously debilitating with a high unmet medical need (i.e., there is no method of treatment, diagnosis or prevention available or existing methods have serious limitations).
  2. Criterion 2 – The medicinal product is likely to offer major advantage over methods currently used in the UK.
  3. Criterion 3 – The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance. A positive benefit risk balance should be based on preliminary scientific evidence, as justified by the applicant, that the safety profile of the medicinal product is likely to be manageable and acceptable in relation to the estimated benefits.

“We are excited that the MHRA agrees that dusquetide meets the specified criteria for PIM designation based on the Phase 2 oral mucositis clinical data, in conjunction with the consistency that has been observed in previous preclinical and Phase 1 clinical studies,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “We look forward to working with the MHRA to advance the program and leverage the potential benefits of the EAMS scheme to make this important product available to patients and physicians facing the challenges of severe oral mucositis.”

About SGX942

 Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides.  It has a novel mechanism of action in that it modulates the body’s reaction to both injury and infection towards an anti-inflammatory and an anti-infective response.  IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections.  Some of these preclinical findings have been published in an article entitled “A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy” and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers.  Recently, SGX942 has demonstrated preliminary efficacy and safety in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation (CRT) therapy for head and neck cancer.  Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099).  In patients at highest risk of oral mucositis (e.g., those exposed to the most aggressive concomitant chemotherapy), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04).  The p-values meet the prospectively defined statistical threshold of p<0.1 in the study protocol.  Additional observations included an improved tumor response to CRT therapy at the one month follow-up visit, as well as decreases in infection rate.  The study results are reviewed in “Dusquetide: A Novel Innate Defense Regulator Demonstrating a Significant and Consistent Reduction in the Duration of Oral Mucositis in Preclinical Data and a Randomized, Placebo-Controlled Phase 2a Clinical Study” published online in the Journal of Biotechnology and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.10.010. Long-term (12 month) follow-up data further indicated the safety and tolerability of SGX942 treatment, with a trend towards reduced mortality and increased tumor resolution in the 1.5 mg/kg SGX942 treatment group.  Opioid pain medication use was also seen to decrease over the course of CRT in the 1.5 mg/kg SGX942 treatment group at the point of highest oral mucositis risk, while it increased in the placebo group.

The Phase 2 oral mucositis clinical study was partially funded with a grant from the National Institute of Dental and Craniofacial Research Small Business Innovation Research grant #1R43 DE024032-01 (Soligenix, Inc).

Dusquetide and related analogs have a strong intellectual property position, including composition of matter.  Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada.

Drug products containing dusquetide have also received Fast Track Designations from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients, and as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis. Orphan Drug Designations for use of dusquetide in the treatment of MAS as well as for the treatment of acute radiation syndrome have also been granted.

About Oral Mucositis

 Mucositis is the clinical term for damage done to the mucosa by anticancer therapies.  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia.  The gastrointestinal damage causes severe diarrhea.  These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system.  Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in head and neck cancer is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe.  Oral mucositis almost always occurs in patients with head and neck cancer treated with chemoradiation therapy and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in head and neck cancer remains an area of unmet medical need where there are currently no approved drug therapies

 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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate.  The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is supported with up to $58 million in 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 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 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. 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.

Soligenix Announces Investor Webcast Event: Origins of Innate Defense Regulators and Review of the SGX942 Phase 2 Study Results in Oral Mucositis

Friday, December 16, 2016, from 8:30-9:30 am ET

Princeton, NJ – December 8, 2016 – Soligenix, Inc. (OTCQB: 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 that it will be hosting an Investor Webcast Event Friday, December 16, 2016, from 8:30-9:30 am ET on the origins of innate defense regulators (IDRs) as a new drug class, as well as a review of oral mucositis and the recently announced and published Phase 2 clinical data for SGX942 (dusquetide) in the treatment of oral mucositis in head and neck cancer patients, available online in the Journal of Biotechnology at the following link: http://www.sciencedirect.com/science/article/pii/S0168165616315668.

The live webcast event can be accessed at: https://engage.vevent.com/rt/soligenixinc~121616, with replay of the event to be made accessible on the Soligenix corporate website.  A question and answer (Q&A) session with the featured experts and management will follow the presentations. If you would like to ask a question during the live Q&A, please submit your request via email to ir@nullsoligenix.com.  For a more detailed technical response, you are encouraged to e-mail questions no later than December 14, 2016. Alternatively, audio can be accessed by dialing Toll-Free 866-563-6458, Conference ID: 33796918.

The Investor Event will include presentations from the following:

Dr. Oreola Donini, Chief Scientific Officer of Soligenix and an inventor of Soligenix’s IDR technology: “Origins of IDRs, dusquetide and their unique mechanism of action as demonstrated in preclinical animal models of oral mucositis and infection.”

Dr. Steve Sonis, Senior Surgeon, Brigham and Women’s Hospital and Dana Farber Cancer Institute, Chief Scientific Officer, Biomodels, LLC, and Chair of Soligenix’s Oral Mucositis Medical Advisory Board, and an expert in the field of oral mucositis: “Overview of oral mucositis as a significant complication in head and neck cancer and the unmet medical need that exists in its effective treatment.”

Dr. Richard Straube, Chief Medical Officer of Soligenix and Medical Monitor for the Oral Mucositis Clinical Program: “Review of the recently published SGX942 (dusquetide) clinical results, including the acute and long-term Phase 2 study data (IDR-OM-01) for the treatment of oral mucositis in head and neck cancer patients.” 

Dr. Mahesh Kudrimoti, Professor of Radiation Medicine, University of Kentucky and Principal Investigator for the IDR-OM-01 clinical trial will also contribute to the meeting.

Featured Clinical Experts Biographical Background

Stephen Sonis, DMD, DMSc

Dr. Sonis is a Clinical Professor of Oral Medicine at Harvard School of Dental Medicine and Senior Surgeon, Divisions of Oral Medicine at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, and Chief Scientific Officer, BioModels, LLC.  He is also a consultant to a number of biotechnology and pharmaceutical companies, advising directly on the conduct of clinical trials in oral mucositis.  Throughout his career, Dr. Sonis has focused on the biology and clinical significance of cancer regimen-related mucosal toxicities.  In particular, Dr. Sonis was pivotal in identifying the crucial role of innate immunity in the generation of severe oral mucositis.  The results of his studies have provided treatment targets for biological and pharmaceutical development.  Dr. Sonis and his collaborators have identified specific pathways that are critical in toxicity development and have used these to form the basis for models of gene-based risk prediction.  Dr. Sonis has published and lectured extensively on the clinical, biological, and health economic aspects of cancer and complications associated with its treatment.  He serves on a number of editorial boards, and is a founding member of the International Society of Oral Oncology and the International Academy of Oral Oncology.  Dr. Sonis received his Doctor of Dental Medicine (DMD) from Tufts University, his Doctor of Medical Sciences (DMSc) from Harvard University and was a Knox Fellow at Oxford University.

Mahesh Kudrimoti, MD

Dr. Kudrimoti is a Professor of Radiation Medicine at the University of Kentucky.  Dr. Kudrimoti received his medical degree from Osmania Medical College, Andhra Pradesh, India, and completed residencies at the University of Kentucky in Lexington, Robert Parker Hospital in Sayre, PA and Post Graduate Institute of Medical Education and Research in Chandigarh, India.  He is board-certified by the American Board of Radiology in Radiation Oncology.  Dr. Kudrimoti treats cancer patients, including many with head and neck cancer and has participated in multiple clinical trials in oral mucositis and trials in head and neck cancer.

About Dusquetide

Dusquetide is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action in that it modulates the body’s reaction to both injury and infection towards an anti-inflammatory and an anti-infective response.  IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections.  Some of these preclinical findings have been published in an article entitled “A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy” and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.

SGX942 (the drug product containing dusquetide) has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers.  Recently, SGX942 has demonstrated preliminary efficacy and safety in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation (CRT) therapy for head and neck cancer.  Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099).  In patients at highest risk of oral mucositis (e.g., those exposed to the most aggressive concomitant chemotherapy), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04).  The p-values meet the prospectively defined statistical threshold of p<0.1 in the study protocol.  Additional observations included an improved tumor response to CRT therapy at the one month follow-up visit, as well as decreases in infection rate.  The study results are reviewed in “Dusquetide: A Novel Innate Defense Regulator Demonstrating a Significant and Consistent Reduction in the Duration of Oral Mucositis in Preclinical Data and a Randomized, Placebo-Controlled Phase 2a Clinical Study” published online in the Journal of Biotechnology and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.10.010.  Long-term (12 month) follow-up data further indicated the safety and tolerability of SGX942 treatment, with a trend towards reduced mortality and increased tumor resolution in the 1.5 mg/kg SGX942 treatment group.  Opioid pain medication use was also seen to decrease over the course of CRT in the 1.5 mg/kg SGX942 treatment group at the point of highest oral mucositis risk, while it increased in the placebo group.

The Phase 2 oral mucositis clinical study was partially funded with a grant from the National Institute of Dental and Craniofacial Research Small Business Innovation Research grant #1R43 DE024032-01 (Soligenix, Inc).

Dusquetide and related analogs have a strong intellectual property position, including composition of matter.  Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada.

Drug products containing dusquetide have also received Fast Track Designations from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients, and as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis. Orphan Drug Designations for use of dusquetide in the treatment of MAS as well as for the treatment of acute radiation syndrome have also been granted.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa of the entire gastrointestinal tract by anticancer therapies.  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition, intravenous rehydration, and narcotic analgesia.  The intestinal damage can cause severe diarrhea.  These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system.  Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by anti-cancer therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in head and neck cancer is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe.  Oral mucositis almost always occurs in patients with head and neck cancer treated with chemoradiation therapy and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in head and neck cancer remains an area of unmet medical need where there are currently no approved drug therapies

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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate.  The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is supported with up to $58 million in 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 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 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. 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.

Soligenix Announces Positive Long-Term Follow-up Results from its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients

Study data supports advancing development to pivotal Phase 2b/3 program

 

Princeton, NJ – December 8, 2016 – Soligenix, Inc. (OTCQB: 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 the long-term follow-up data from its Phase 2 clinical trial with SGX942 (dusquetide), a first-in-class Innate Defense Regulator (IDR), in the treatment of oral mucositis (OM) in head and neck cancer patients undergoing chemoradiation therapy (CRT).  The additional 12-month safety data remains consistent with the preliminary positive safety and efficacy findings from the Phase 2 study and provide further support for advancing SGX942 into a pivotal Phase 2b/3 clinical trial.  Following the positive results announced in December 2015, in which SGX942 at a dose of 1.5 mg/kg, successfully reduced the median duration of severe OM by 50% in all patients and by 67% in patients at highest risk of developing severe OM, long-term follow-up visits conducted throughout 2016 further demonstrated that SGX942 was safe, well-tolerated, and did not interfere with CRT as demonstrated by improved survival and tumor resolution at one and 12 months.  Overall, there were no drug-related toxicities identified in this study.

While the placebo population experienced the expected 12-month survival rate of approximately 80%, as defined in the Surveillance, Epidemiology, and End Results (SEER) statistics 1975-2012 from the National Cancer Institute, the SGX942 1.5 mg/kg treatment group reported a 12-month survival rate of 93% (7% mortality in the SGX942 1.5 mg/kg group compared to 19% in the placebo group).  Similarly, tumor resolution (complete response) at 12 months was better in the SGX942 1.5 mg/kg treatment group relative to the placebo population (80% in the 1.5 mg/kg group compared to 74% in the placebo group).

In addition to safety, evaluations of other secondary efficacy endpoints, such as the utilization of opioid pain medication, indicated that the SGX942 1.5 mg/kg treatment group had a 40% decrease in the use of opioids at the later stage of the treatment phase of the trial, when OM is usually most severe and expected to increase pain medication use.  This was in contrast to the placebo group, which demonstrated a 10% increase in use of opioids over this same period.  These results are consistent with the observed significant decrease in the duration of severe OM.  There were no differences observed in the rates of xerostomia (dry mouth) and trismus (limited jaw range of motion) across the SGX942 and placebo dose groups in the study.

“We are extremely pleased with the findings from the Phase 2 study of SGX942.  The study met all of its objectives including defining a clinically effective dose of SGX942 – specifically the 1.5 mg/kg as seen in both the acute and long-term follow-up phases of the trial.  We also identified the most appropriate clinical endpoint and patient population to use in a future pivotal study,” stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix.  “The positive and clinically meaningful effect observed on the duration of ulcerative and severe OM clearly demonstrates the significant biologic activity that SGX942 exerts on this catastrophic side effect of cancer treatment.  Additionally, the positive impact of the drug on the reported infection rates as well as the trends in improved survival rates and complete tumor responses at both one and 12 months following CRT is consistent with preclinical findings, not only confirming the long-term safety and tolerability of SGX942 in a sick patient population, but the drug’s exciting potential as an effective treatment in OM.”

“Given the positive and compelling data generated in OM, where there is a substantial unmet medical need and market potential, we are engaging the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of a pivotal Phase 2b/3 clinical program,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “In parallel, we continue to pursue partnership opportunities to support ongoing SGX942 clinical development.  With the biologic activity of the IDR technology now confirmed in humans, we are also looking to expand its potential utility in the infectious disease space.”

The Phase 2 exploratory study enrolled 111 patients across three SGX942 dose groups (i.e., 1.5, 3.0, and 6.0 mg/kg) and a placebo group and evaluated patients undergoing CRT for head and neck cancer.  This study achieved all objectives, including identifying the best dose of 1.5 mg/kg.  In the 1.5 mg/kg treatment group, the median duration of severe OM was decreased by 50%, from 18 days to 9 days (p=0.099), meeting the prospectively defined statistical threshold of p<0.1 in the study protocol.  Further, patients receiving the most aggressive CRT in this dose group had even more striking reductions in their median duration of severe OM of 67%, from 30 days to 10 days (p=0.040).  Clinicians are most concerned about severe OM, which includes patients who cannot eat and/or drink due to their mouth ulcers.  All dose levels of SGX942 were found to be safe and well tolerated.

In addition to the OM findings and safety assessments, a decrease in infection rate was also observed with SGX942 treatment, particularly with infections of bacterial origin.  Top-line data from this study was recently published in the Journal of Biotechnology, available at: http://dx.doi.org/10.1016/j.jbiotec.2016.10.010.  The long-term (12 month) follow-up data from the trial is also expected to be submitted for future presentation and publication.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa of the entire gastrointestinal tract by anticancer therapies.  It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine.  It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy.  Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition, intravenous rehydration, and narcotic analgesia.  The intestinal damage can cause severe diarrhea.  These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system.  Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by anti-cancer therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in head and neck cancer is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe.  Oral mucositis almost always occurs in patients with head and neck cancer treated with chemoradiation therapy and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

Oral mucositis in head and neck cancer remains an area of unmet medical need where there are currently no approved drug therapies.

About SGX942

Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides.  It has a novel mechanism of action in that it modulates the body’s reaction to both injury and infection towards an anti-inflammatory and an anti-infective response.  IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens.  It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.  Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections.  Some of these preclinical findings have been published in an article entitled “A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy” and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers.  Recently, SGX942 has demonstrated preliminary efficacy and safety in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to chemoradiation (CRT) therapy for head and neck cancer.  Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099).  In patients at highest risk of oral mucositis (e.g., those exposed to the most aggressive concomitant chemotherapy), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04).  The p-values meet the prospectively defined statistical threshold of p<0.1 in the study protocol.  Additional observations included an improved tumor response to CRT therapy at the one month follow-up visit, as well as decreases in infection rate.  The study results are reviewed in “Dusquetide: A Novel Innate Defense Regulator Demonstrating a Significant and Consistent Reduction in the Duration of Oral Mucositis in Preclinical Data and a Randomized, Placebo-Controlled Phase 2a Clinical Study” published online in the Journal of Biotechnology and are available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.10.010. Long-term (12 month) follow-up data further indicated the safety and tolerability of SGX942 treatment, with a trend towards reduced mortality and increased tumor resolution in the 1.5 mg/kg SGX942 treatment group.  Opioid pain medication use was also seen to decrease over the course of CRT in the 1.5 mg/kg SGX942 treatment group at the point of highest oral mucositis risk, while it increased in the placebo group.

The Phase 2 oral mucositis clinical study was partially funded with a grant from the National Institute of Dental and Craniofacial Research Small Business Innovation Research grant #1R43 DE024032-01 (Soligenix, Inc).

Dusquetide and related analogs have a strong intellectual property position, including composition of matter.  Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada.

Drug products containing dusquetide have also received Fast Track Designations from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients, and as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis. Orphan Drug Designations for use of dusquetide in the treatment of MAS as well as for the treatment of acute radiation syndrome have also been granted.

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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate.  The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is supported with up to $58 million in 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 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 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. 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.

Soligenix Announces Recent Accomplishments and Third Quarter 2016 Financial Results

Highlighted by Revenues of $3.0 Million

 

Princeton, NJ – November 10, 2016 – Soligenix, Inc. (OTCQB: 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 third quarter ended September 30, 2016.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, “We continue to be very encouraged with the positive results demonstrated in our Phase 2 oral mucositis trial with SGX942 (dusquetide) and recently announced the publication of these results in the Journal of Biotechnology. These data demonstrate the promising potential of our IDR technology platform in the treatment of oral mucositis but also the potential of this technology to expand into other indications, such as infectious disease.  Based on our ongoing discussions with the regulatory agencies in both the US and Europe, we anticipate having a pivotal Phase 2b/3 study design of SGX942 during the first half of next year. We also continue to actively enroll patients in our pivotal Phase 3 study in cutaneous T-cell lymphoma with SGX301 (synthetic hypericin).”

Schaber continued, “We were also very pleased with the expansion of our partnership with SciClone Pharmaceuticals for the development of SGX942 in China and other markets in Asia.  SciClone will be responsible for all aspects of development and commercialization in the territories having access to data generated by Soligenix. Their upfront investment in Soligenix further demonstrates the promising potential of this innovative technology.”

Soligenix Recent Accomplishments:

  •  On September 12, 2016, the Company announced an exclusive license agreement granting rights to SciClone Pharmaceuticals, Inc. to develop, promote, market, distribute and sell SGX942 (dusquetide), our novel, first-in-class therapy being developed for the treatment of oral mucositis in patients with head and neck cancer, in China as well as Taiwan, South Korea and Vietnam. In exchange for exclusive rights, Soligenix will receive royalties on net sales and supply commercial drug product on a cost-plus basis. Under the terms of the agreement, SciClone made an upfront equity investment in Soligenix of $3 million.
  •  On September 6, 2016, the Company announced the United States Patent Office granted the patent entitled “Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity.” The new issued patent claims composition of matter analogs of dusquetide (research name: SGX94). The recently issued patent broadens the protection around dusquetide and provides further protection for the underlying innate defense regulator (IDR) technology platform.
  • On August 18, 2016, the Company, announced the Office of Orphan Products Development of the US Food and Drug Administration had granted orphan drug designation to the active ingredient dusquetide for treatment of macrophage activation syndrome (MAS). Dusquetide has previously received orphan drug designation for the treatment of acute radiation syndrome (ARS). Dusquetide is a short, synthetic peptide that accelerates bacterial clearance and resolution of tissue damage while modulating inflammation following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy.

 Financial Results – Third Quarter Ended September 30, 2016

Soligenix’s revenues for the quarter ended September 30, 2016 were $3.0 million as compared to $3.9 million for the same period for the prior year.  Revenues included contracts with BARDA and NIAID in support of OrbeShield® development in the treatment of GI ARS and advanced development of the Company’s thermostabilization technology, ThermoVax®, combined with its ricin toxin vaccine RiVax, as a medical countermeasure to prevent the effects of ricin exposure.

Soligenix’s basic net loss was $1.7 million, or $(0.49) per share, as compared to net income of $2.8 million, or $1.05 per share, as adjusted to reflect the reverse stock split effective October 7, 2016, for the quarters ended September 30, 2016 and 2015, respectively.  Included in the net income (loss) for the quarters ended September 30, 2016 and 2015 is a non-cash expense of $0.2 million and non-cash income of $4.0 million, respectively.  This non-cash item reflects the change in fair value of the liability related to warrants issued in the Company’s June 2013 registered public offering and is included in other income/(expense).

Research and development expenses, were $1.2 million as compared to $1.3 million for the quarters ended September 30, 2016 and 2015, respectively. The decrease was related to completion of patient enrollment and treatment in the Phase 2 trial of SGX942 for the treatment of oral mucositis in head and neck cancer. The long-term follow-up safety data from this trial continues to be collected, with completion expected during the fourth quarter of 2016.

General and administrative expenses were $0.7 million as compared to $0.8 million for the quarters ended September 30, 2016 and 2015, respectively.

As of September 30, 2016, the Company’s cash position was $5.7 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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is supported with up to $58 million in 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 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 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. 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.

Soligenix Receives European Medicines Agency Designation as Small and Medium Enterprise

Princeton, NJ – October 25, 2016 – Soligenix, Inc. (OTCQB: SNGXD) (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 that it has been granted Small and Medium Enterprise (SME) designation by the European Medicines Agency (EMA).

The SME designation was established by EMA to promote innovation and the development of new medicinal products by smaller companies.  Companies with SME status are eligible to receive financial incentives as well as administrative and regulatory support through national and regional level programs.  These benefits include access to dedicated EMA personnel during the clinical development process as well as reductions in fees associated with regulatory procedures such as Scientific Advice, Marketing Authorizations, and inspections.  Companies with SME status are also eligible for early application (prior to proof of concept) to the priority medicines (PRIME) scheme. PRIME provides enhanced support for the development of medicines that target an unmet medical need.

“We are pleased to have SME designation, which allows us to benefit from financial incentives and support from the EMA as we aim to bring our product candidates to the global pharmaceutical marketplace,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  “This is expected to provide immediate benefits as we pursue Scientific Advice with EMA to review our proposed Phase 2b/3 protocol to evaluate SGX942 as a treatment for oral mucositis in patients with head and neck cancer.”

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, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  Currently, this business segment is supported with up to $58 million in 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 www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations, beliefs and intentions with respect to the reverse stock split and its effects described in this press release.  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.  Actual results, including the ability to achieve and maintain compliance with the minimum bid listing requirement of the NASDAQ Capital Market, could differ materially from those projected in forward-looking statements as a result of a number of risks and uncertainties. Such risks and uncertainties, include, but are not limited to, risks associated with Soligenix’s ability 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. 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.