Soligenix Reports Third Quarter 2014 Financial Results, Highlighted with the Acquisition of SGX301, Synthetic Hypericin, for the Treatment of Cutaneous T-Cell Lymphoma

Princeton, NJ – November 10, 2014 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today its financial results for the third quarter and nine months ended September 30, 2014.

Soligenix’s revenues for the quarter and nine months ended September 30, 2014 were $2.8 million as compared to $0.3 million for the quarter and $5.1 million as compared to $1.8 million for the nine months ended September 30, 2014 and 2013, respectively.  For the nine months ended September 30, 2014 as compared to September 30, 2013, revenues increased $3.3 million primarily related to contracts with the US Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) in support of OrbeShield™ (oral beclomethasone 17,21-dipropionate or BDP) development in the treatment of gastrointestinal acute radiation syndrome (GI ARS).

Soligenix’s net (loss) for the quarter ended September 30, 2014 was $4.3 million, or $(0.21) per share, as compared to $6.6 million, or $(0.34) per share and $8.6 million, or $(0.43) per share as compared to $11.1 million, or $(0.78) for the nine months ended September 30, 2014.

Research and development expenses were $5.1 million as compared to $1.2 million and $7.3 million as compared to $4.1 million for the quarter and nine months ended September 30, 2014 and 2013, respectively.  For the quarter ended September 30, 2014, the increase of $3.9 million is attributable to the acquisition of SGX301, synthetic hypericin, from Hy BioPharma paid in the form of $0.25 million in cash and $3.75 million in restricted common stock.  For the nine months ended September 30, 2014, the increase of $3.2 million is attributable to the acquisition of SGX301 offset by a $1.5 million non-cash charge which was included in the 2013 nine months expenses relating to our collaboration with Intrexon Corporation (Intrexon).

General and administrative expenses were $0.7 million as compared to $0.7 million and $2.4 million as compared to $1.9 million for the quarter and nine months ended September 30, 2014 and 2013, respectively.

Operating expenses increased by $3.9 million and $3.7 million for the quarter and nine months ended September 30, 2014, respectively. The increase in operating expenses for the quarter ended September 30, 2014 is primarily related to the acquisition of SGX301, synthetic hypericin, and for nine months ended September 30, 2014 primarily related to the acquisition of SGX301, synthetic hypericin, offset by a $1.5 million non-cash charge in 2013 nine months expenses related to our collaboration with Intrexon.

For the three and nine months ended September 30, 2014, other net income/(expense) included a $0.8 million and $(0.2) million change in fair value of the warrant liability related to warrants issued in connection with the Company’s June 2013 registered public offering.

As of September 30, 2014, the Company’s cash position was $4.2 million.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, “During this quarter we made significant progress in both our business segments. In our BioTherapeutics segment we expanded our pipeline with the acquisition of SGX301, synthetic hypericin, with plans to initiate a pivotal Phase 3 clinical trial in the first half of 2015.  We are also continuing to actively enroll patients in our Phase 2 study with SGX942 in the treatment of oral mucositis in head and neck cancer.  In our Vaccine/BioDefense segment, our RiVax™ program utilizing our ThermoVax™ platform was further validated with the award of a multi-year NIAID contract valued up to $24.7 million.  This contract award coupled with our contracts awarded for OrbeShield™ in GI ARS of up to $32.7 provides up to $57 million in non dilutive program funding.  As we further expanded our development pipeline, while continuing to advance our current clinical programs, we continue to effectively manage cash burn ending the quarter with $4.2 million in cash.  I look forward to providing updates for the balance of 2014 and throughout 2015.”

 Soligenix Recent Highlights: 

• On September 23, 2014, the Company announced that it had appointed Rasappa Arumugham, PhD, as its Vice President of Biopharmaceutical Development.  Dr. Arumugham has over 25 years of diverse experience in biopharmaceutical research and development (R&D) in the areas of formulation research, analytical method development, quality control (QC), and manufacturing.  He  has a proven track record in development, scale-up, and technology transfer supporting commercialization of vaccines and biologics, including Prevnar®, TetramuneTM, HibTITER®, Meningitec® Conjugate and meningitis B (bivalent  rLP2086) Lipoprotein Subunit Vaccines.
• On September 19, 2014, the Company announced that it was awarded a contract valued at up to $24.7 million inclusive of options by the US Department of Health and Human Service’s National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID).  The objectives of the contract are to advance the development of Soligenix’s thermostabilization technology, ThermoVax™, combined with the company’s ricin toxin vaccine, Rivax™, as a medical countermeasure to prevent the effects of ricin exposure.
• On September 17, 2014, the Company announced that an agreement had been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).
• On September 9, 2014, the Company announced that the US Patent and Trademark Office (US PTO) granted patent 8,808,710 entitled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition.”  The newly issued patent claims cover compositions and methods for manufacturing vaccines utilizing ThermoVax™, the Company’s proprietary vaccine thermostabilization technology. The new patent complements US patent 8,444,991, granted on May 21, 2013, that primarily included claims for methods of making stabilized vaccines.
• On September 5, 2014, the Company announced the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin).  SGX301 is poised to enter pivotal Phase 3 clinical testing for the treatment of CTCL and is highly synergistic with the company’s existing development pipeline.  As part of the acquisition, Soligenix acquired all rights for synthetic hypericin, including intellectual property, and preclinical and clinical data. SGX301 is a novel, first-in-class, photodynamic therapy utilizing safe visible light for activation.  The active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by fluorescent light.
• On September 2, 2014, the Company announced promising preliminary results from a preclinical study with its ricin toxin vaccine RiVax™, in a non-human primate (NHP) lethal aerosol exposure model. The study demonstrated that NHPs vaccinated with RiVax™ were completely protected against a lethal aerosol of ricin toxin with a highly significant survival benefit (p<0.002). RiVax™, manufactured with the Company’s thermostabilization platform technology ThermoVax™, provides for stabilized, lyophilized (freeze-dried) subunit vaccines that are resistant to exposure to heat, avoiding refrigeration during storage and distribution.

About Soligenix, Inc. 

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201). Soligenix is also advancing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis and SGX301, its novel first-in-class photodynamic technology utilizing synthetic hypericin with safe visible light, for the treatment of cutaneous T-cell lymphoma.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure.  RiVax™ has demonstrated statistically significant preclinical survival results in a lethal aerosol exposure non-human primate model, and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers.  Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax™.  Recently, Soligenix was awarded a NIAID contract valued up to $24.7 million to further advance the development of its heat stable RiVax™ as a medical countermeasure to prevent the effects of ricin exposure. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million.  OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID.  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company’s Website at www.soligenix.com.

This press release contains 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,” “intends,” “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 vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing 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.