Soligenix Reports Second Quarter 2014 Financial Results, and Highlights Recent Accomplishments

PRINCETON, N.J., Aug. 11, 2014 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today its financial results for the second quarter and six months ended June 30, 2014.

Soligenix's revenues for the quarter and six months ended June 30, 2014 were $1.4 million as compared to $0.6 million for the quarter and $2.3 million as compared to $1.5 million for the six months ended June 30, 2014 and 2013, respectively.  For the six months ended June 30, 2014 as compared to June 30, 2013, revenues increased $0.8 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 June 30, 2014 was $0.9 million, or $(0.05) per share, as compared to $3.4 million, or $(0.28) per share and $4.3 million, or $(0.22) per share as compared to $4.5 million, or $(0.38) for the six months ended June 30, 2014.

Research and development expenses were $1.2 million as compared to $2.1 million and $2.2 million as compared to $2.9 million for the quarter and six months ended June 30, 2014 and 2013, respectively.  In 2013, a $1.5 million non-cash charge was included in the quarter and six months expenses relating to our collaboration with Intrexon Corporation (Intrexon).

General and administrative expenses were $0.9 million as compared to $0.7 million and $1.7 million as compared to $1.2 million for the quarter and six months ended June 30, 2014 and 2013, respectively.

Excluding the 2013 $1.5 million expense related to the Intrexon collaboration, operating expenses increased by $0.7 million and $1.3 million for the quarter and six months ended June 30, 2014, respectively. The increase in operating expenses related to the Company's Phase 2 clinical trials with SGX942 in the treatment of oral mucositis and orBec® in the treatment of chronic gastrointestinal Graft-versus-host disease (GI GVHD), increased professional fees, increased headcount and non-cash expenses for stock based compensation from stock options issued to existing and newly hired employees.

For the quarter and six months ended June 30, 2014, other net income/(expense) included a $0.7 million and $(1.0) 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 June 30, 2014, the Company's cash position was $5.0 million.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "During this quarter we continued to make steady progress across both our business segments. In Vaccines/BioDefense, we successfully demonstrated that we can formulate a combination ricin and anthrax vaccine with the potential to provide long-term immunity when administered as a single vaccine, as well as provided results for an enhanced heat stable anthrax vaccine with the potential for more rapid onset of protection after only one or two administrations.  In addition, NIAID exercised its 12 month option of $2.1 million supporting continued development of OrbeShield™ in GI ARS.  In our BioTherapeutics business segment, we are proceeding with our Phase 2 clinical studies with SGX942 in the treatment of oral mucositis in head and neck cancer and orBec® in the treatment of chronic GI GVHD.  We continue to effectively manage our cash burn ending the quarter with $5.0 million.  I look forward to providing updates throughout the second half of this year and into 2015."

Soligenix Recent Highlights:

  • On August 7, 2014, the Company announced results demonstrating that a rapidly acting form of its anthrax vaccine, VeloThrax™, has been developed.  The study combined the Company's proprietary vaccine thermostabilization platform technology, ThermoVax™, and a potent adjuvant compound to yield a vaccine that was stable at high temperatures and induced immune responses indicative of protection after no more than two administrations of the vaccine in a shortened (less than one month) vaccination regimen.
  • On August 1, 2014, the Company announced that the NIAID exercised its 12 month option of $2.1 million to advance preclinical development of OrbeShield™ as a medical countermeasure for the treatment GI ARS.
  • On July 9, 2014, the Company announced that the combination of RiVax™ and VeloThrax™ induces protective immunity to both ricin toxin and anthrax exposure.  The combined vaccination provided protection to exposure to both ricin and anthrax toxin that persisted for at least six months after two vaccinations, suggesting that long-term immunity upon simultaneous vaccination can be achieved.

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. 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), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.  

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 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™.  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.

SOURCE Soligenix, Inc.



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