Soligenix Announces Recent Highlights and Third Quarter 2015 Financial Results

PRINCETON, N.J., Nov. 12, 2015 /PRNewswire/ -- 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 recent highlights and financial results for the third quarter and nine months ended September 30, 2015.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "During the quarter we continued to build positive momentum in our development programs. Most notably, we completed patient enrollment in our SGX942 Phase 2 clinical trial for oral mucositis and anticipate reporting preliminary results before year-end.  Within our Biodefense business segment, we were pleased to have received a total of $4.8 million in option awards from the National Institute of Allergy and Infectious Diseases for our heat stable ricin toxin vaccine, RiVax and for OrbeShield, our medical countermeasure for the treatment of gastrointestinal acute radiation syndrome." 

Soligenix Recent Highlights

• On August 31, 2015, the Company announced the completion of patient enrollment into its Phase 2 proof-of-concept clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer patients.  Consistent with prior guidance the Company anticipates reporting preliminary results in the fourth quarter of 2015.
• On August 27, 2015, the Company announced the National Institute of Allergy and Infectious Diseases (NIAID) exercised a $2.1 million option to further advance the preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate), as a medical countermeasure (MCM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS).
• On August 19, 2015, the Company announced NIAID exercised a $2.7 million option to further advance the development of the Company's heat stabile ricin toxin vaccine, RiVax, as a MCM to prevent the effects of ricin exposure. 
• On August 4, 2015, the Company announced that the European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products granted orphan drug designation to SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare class of non-Hodgkin's lymphoma, a type of cancer of the white blood cells that are an integral part of the immune system.  SGX301 has previously been granted both orphan drug and fast track designations from the US Food and Drug Administration for the first-line treatment of CTCL.

Financial Results Third Quarter and Nine Months Ended September 30, 2015

Soligenix's revenues were $3.9 million as compared to $2.8 million for the quarter ended September 30, 2015 and 2014, respectively and $5.8 million as compared to $5.1 million for the nine months ended September 30, 2015 and 2014, respectively.  For the nine months ended September 30, 2015 as compared to September 30, 2014, revenues increased $0.7 million primarily related to the continued progress on our OrbeShield and RiVax government contracts.

Soligenix's net income (loss) for the quarter ended September 30, 2015 was $2.8 million, or $0.10 per share, as compared to $(4.3) million, or $(0.21) per share, and $(5.8) million, or $(0.23) per share, as compared to $(8.6) million, or $(0.43) per share, for the nine months ended September 30, 2014. Income for the quarter ended September 30, 2015 was primarily attributable to the change in fair value of the warrant liability related to warrants issued in connection with our June 2013 registered public offering.

Research and development expenses were $1.3 million as compared to $5.1 million, and $3.7 million as compared to $7.3 million, for the quarter and nine months ended September 30, 2015 and 2014, respectively.  This decrease is primarily related to acquisition of the synthetic hypericin product candidate, SGX301 from Hy BioPharma for $4.0 million, paid primarily in equity, which was charged to R&D expense during the third quarter 2014.

General and administrative expenses were $0.8 million as compared to $0.7 million, and $2.5 million as compared to $2.4 million, for the quarter and nine months ended September 30, 2015 and 2014, respectively.

Operating expenses were $2.1 million as compared to $5.8 million, and $6.3 million as compared to $9.8 million, for the quarter and nine months ended September 30, 2015 and 2014, respectively. This decrease is primarily related to acquisition of the synthetic hypericin product candidate, SGX301, from Hy BioPharma for $4.0 million, which was charged to R&D expense during the third quarter 2014.

For the quarter and nine months ended September 30, 2015, other net income (expense) included a $4.0 million and $(0.9) 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, 2015, the Company's cash position was $4.0 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 first-in-class photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, 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), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.

Our Vaccines/BioDefense business segment includes active development programs for RiVax, our ricin toxin vaccine candidate, VeloThrax, our anthrax 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 $57 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," "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.

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SOURCE Soligenix, Inc.