Soligenix Announces Recent Highlights and Second Quarter 2015 Financial Results

Aug 12, 2015, 07:00 ET from Soligenix, Inc.

PRINCETON, N.J., Aug. 12, 2015 /PRNewswire/ -- 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 recent highlights and financial results for the second quarter and six months ended June 30, 2015.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "During the quarter we continued enrollment of additional patients in the SGX942 Phase 2 clinical trial in oral mucositis and expect data during the second half of 2015.  We entered into a collaboration with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to support recruitment into the SGX301 pivotal Phase 3 cutaneous T-cell lymphoma (CTCL) clinical study set to begin in the second half of 2015.  We were also pleased that the European Commission granted orphan designation for SGX301 for the treatment of CTCL.  Within our Biodefense business segment, we initiated a development agreement with Emergent BioSolutions Inc. to implement a commercially viable, scalable production process for our RiVax™ drug substance.  We further expanded our ThermoVax™ technology platform via a collaboration with the University of Hawaiʻi at Manoa and Hawaii Biotech, Inc. to develop a heat stable Ebola vaccine.        

Dr. Schaber continued, "Following the end of the second quarter, we increased our access to capital by entering into a $10 million equity purchase agreement with accredited investors.  This funding, to be used at our sole discretion, has the potential to fund ongoing development initiatives for our late-stage product candidates, including the Phase 3 CTCL clinical study. Our cash position for the second quarter ended June 30, 2015 was $4.0 million versus $5.0 million at March 31, 2015. I look forward to providing further updates throughout the year."

Soligenix Recent Highlights

  • 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 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 (FDA) for the first-line treatment of CTCL.
  • On August 3, 2015, the Company announced it entered into a $10.0 million equity purchase agreement with accredited institutional investors, Kodiak Capital Group, LLC, Kingsbrook Opportunities Master Fund LP and River North Equity, LLC.  Brean Capital, LLC served as financial advisor for this transaction.
  • On June 23, 2015, the Company announced collaborations with NORD and CLF to educate and recruit patients for its pivotal Phase 3 clinical study of SGX301 for first-line treatment of CTCL.
  • On June 2, 2015, the Company announced the publication of data by the University of Colorado demonstrating a heat stable vaccine formulation of a Human Papillomavirus (HPV) vaccine. The study was funded by the University of Colorado, Boulder and conducted by Drs. Randolph and Garcea. The study demonstrated the successful conversion of a commercial virus-like particle based vaccine requiring cold-chain storage to a subunit, alum adjuvanted, vaccine which is stable at ambient temperatures.  In this study, the new HPV vaccine formulation was found to be stable for at least 12 weeks at 50 degrees Celsius (122 degrees Fahrenheit), which is consistent with previous findings.  The results are published online in the European Journal of Pharmaceutics and Biopharmaceutics.  Soligenix has not licensed or acquired any rights to this HPV vaccine and related patent applications.
  • On May 28, 2015, the Company announced a collaboration agreement with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical and Pharmacology, John A. Burns School of Medicine, University of Hawaiʻi at Manoa and Hawaii Biotech, Inc. to develop a heat stable subunit Ebola vaccine.  Under the terms of the feasibility agreement, the Company will evaluate its proprietary vaccine thermostabilization technology, ThermoVax™, to stabilize components of the Ebola vaccine.  Ultimately, the objective is to produce a thermostable Ebola vaccine for worldwide distribution that does not require cold storage. 
  • On May 13, 2015, the Company announced it had initiated a development agreement with Emergent BioSolutions, Inc. to implement a commercially viable, scalable production technology for the Company's RiVax™ drug substance protein antigen.  RiVax™ is a vaccine candidate in development to protect against ricin exposure.  The Company will transfer the manufacturing processes and analytics to Emergent to conduct process development work that could potentially lead to a future commercial manufacturing collaboration.
  • On April 14, 2015, the Company announced it reached agreement with the FDA on the design of a pivotal Phase 3 clinical trial evaluating SGX203 (oral beclomethasone 17,21-dipropionate or BDP) in the treatment of pediatric Crohn's disease.  SGX203 has previously been granted both orphan drug and fast track designations from the FDA for the treatment of Crohn's Disease in the pediatric population.

Financial Results – Second Quarter and Six Months Ended June 30, 2015

Soligenix's revenues were $1.1 million as compared to $1.4 million for the quarter ended June 30, 2015 and 2014, respectively and $1.9 million as compared to $2.3 million for the six months ended June 30, 2015 and 2014, respectively.  For the six months ended June 30, 2015 as compared to June 30, 2014, revenues decreased $0.4 million primarily related to the Company's ThermoVax™ grant expiring during the fourth quarter of 2014.

Soligenix's net (loss) for the quarter ended June 30, 2015 was $4.0 million, or $(0.15) per share, as compared to $0.9 million, or $(0.05) per share and $8.5 million, or $(0.34) per share as compared to $4.3 million, or $(0.22) for the six months ended June 30, 2014.

Research and development expenses were $1.4 million as compared to $1.2 million and $2.5 million as compared to $2.2 million for the quarter and six months ended June 30, 2015 and 2014, respectively. 

General and administrative expenses were $0.9 million as compared to $0.9 million and $1.7 million as compared to $1.7 million for the quarter and six months ended June 30, 2015 and 2014, respectively.

Operating expenses were $2.3 million as compared to $2.1 million and $4.2 million as compared to $4.0 million for the quarter and six months ended June 30, 2015 and 2014, respectively. The increase in operating expenses relate to the manufacture of SGX301 clinical supplies to support the Phase 3 trial of SGX301 for the treatment of cutaneous T-cell lymphoma.

For the quarter and six months ended June 30, 2015, other net income (expense) included a $(1.9) million and $(5.0) 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, 2015, the Company's cash position was $4.0 million.

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. 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 SGX101 and SGX943, our melioidosis therapeutic candidates. 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).  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of SGX101 for the treatment for melioidosis.

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.

SOURCE Soligenix, Inc.



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