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Soligenix (SNGX) Publishes Year-End 2015 Financial Results Highlighted by Revenues of $8.8 Million

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Soligenix

Princeton, NJ based Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Soligenix’s 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. Soligenix’s Vaccines/BioDefense business segment includes active development programs for RiVaxTM, our ricin toxin vaccine candidate, OrbeShield®, their GI acute radiation syndrome therapeutic candidate and SGX943, their melioidosis therapeutic candidate. The development of their vaccine programs incorporates the use of their 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).

Soligenix announced today its recent accomplishments and financial results for the year ended December 31, 2015. Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, “We were extremely pleased with the positive results from the Phase 2 study of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer. The observed positive results will enable us to accelerate discussions with the US Food and Drug Administration (FDA) and other world health authorities regarding the design of a pivotal Phase 2b/3 clinical program, as well as allow us to better define the business development path forward with our Greater China commercial partner SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN). In addition, we ended the year with the initiation of our pivotal Phase 3 study of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). Results of this registration study are expected during the second half of 2016. Our Vaccine/BioDefense business segment achieved revenues of $8.8 million through our contracts with the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). Collectively under these contracts we have approximately $43 million remaining through current and future option awards to support the ongoing development of our heat stable ricin vaccine, RiVaxTM and our therapeutic for gastrointestinal acute radiation syndrome, OrbeShield®. We also continued to see advancement with our ThermoVax® platform technology, collaborating with the University of Hawaii at Mānoa and Hawaii Biotech, Inc. in developing a heat stable Ebola vaccine.”

Soligenix Recent Accomplishments According to their press release are as follows:

  • On March 17, 2016, the Company announced that NIAID had exercised a contract option of $660,000 to accelerate regulatory interactions with the FDA for its heat stable ricin toxin vaccine, RiVaxTM. This funding will further advance the development of its thermostabilization technology, ThermoVax®, combined with RiVaxTM as a medical countermeasure to prevent the effects of ricin exposure.
  •   On December 16, 2015, the Company announced positive preliminary results from its Phase 2 randomized, double-blind, dose-ranging, placebo-controlled clinical trial of SGX942 (dusquetide). This exploratory study, enrolled 111 patients into four dose groups (placebo, 1.5, 3.0 and 6.0 mg/kg of SGX942) achieving all objectives, including identifying a best dose of 1.5mg/kg. This dose of SGX942 decreased 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 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 surpass the prospectively defined statistical threshold of p<0.1 in the study protocol. Additional observations included increased incidence of “complete response” of tumor at the one month follow up visit (47% in placebo vs. 63% in SGX942 at 1.5 mg/kg), as well as decreases in mortality and infection rate. SGX942 has fast track designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients.
  •   On December 14, 2015, the Company announced the initiation of patient enrollment for its pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating SGX301 (synthetic hypericin) as a treatment for CTCL. SGX301 has orphan drug designations from the FDA and the European Medicines Agency Committee for Orphan Medicinal Products, as well as fast track designation from the FDA for the first- line treatment of CTCL. CTCL is a rare class of non-Hodgkin’s lymphoma, a cancer of the white blood cells that are an integral part of the immune system.Soligenix’s financial results for the year ended December 31, 2015were stated in the press release as follows:Soligenix’s revenues for the year ended December 31, 2015 were $8.8 million as compared to $7.0 million for the prior year. Revenues included contracts with BARDA and NIAID in support of OrbeShield® (oral beclomethasone 17,21-dipropionate or BDP) development in the treatment of gastrointestinal acute radiation syndrome (GI ARS) and advanced development of the Company’s thermostabilization technology, ThermoVax®, combined with its ricin toxin vaccine RiVaxTM , as a medical countermeasure to prevent the effects of ricin exposure.Soligenix’s basic net loss was $7.8 million, or $0.30 per share, as compared to $6.7 million, or $0.32 per share, for the years ended December 31, 2015 and 2014 respectively. Included in the net loss for years ended December 31, 2015 and 2014 is a non-cash expense of ($1.2) million and a non-cash income of $3.4 million, respectively. This non-cash item reflects the change in fair value of the liability related to warrants issued in the Company’s June 25, 2013 registered public offering and is included in other income/(expense).Research and development expenses, including acquired in-process research and development, were $5.4 million as compared to $9.1 million for the years ended December 31, 2015 and 2014, respectively. The significant decrease was related to the 2014 expenditure of $4.0 million attributable to the asset 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. Expenses in 2015 included the completion of patient enrollment in the Phase 2 trial of SGX942 for oral mucositis in head and neck cancer patients and costs associated with the initiation of the pivotal Phase 3 trial of SGX301 for the treatment of patients with CTCL.
  • General and administrative expenses were $3.6 million as compared to $3.4 million for the years ended December 31, 2015 and 2014, respectively. This increase is primarily related to an increase in outside professional fees.
  • As of December 31, 2015, the Company’s cash position was $4.9 million.

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