Soligenix Announces Recent Accomplishments And Second Quarter 2017 Financial Results

PRINCETON, N.J., Aug. 11, 2017

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We are  pleased to initiate the pivotal Phase 3 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer that incorporates feedback from both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and that has the potential to support marketing approval in both the US and the European Union. In an effort to better maintain study quality and more effectively manage clinical expense, we intend to begin with a controlled roll-out of US study sites, followed by the addition of European centers in early 2018.  This will allow us to first ensure protocol adherence in the US before expansion of the study to centers outside the US.  We look forward to advancing this pivotal trial in an effort to address the significant unmet medical need that currently exists in this patient population."

Dr. Schaber continued, "We also continue to actively enroll patients in our pivotal Phase 3 study in cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin), in which we expect data in the first half of 2018.  In our Vaccines/BioDefense business segment, we are encouraged by the continued support of the National Institute of Allergy and Infectious Diseases (NIAID) as we advance the development of RiVax^®, our ricin toxin vaccine program."

Soligenix Recent Accomplishments:

• On July 27, 2017, the Company announced that patient enrollment has been opened for its Phase 3, multinational, randomized, double-blind, placebo-controlled study evaluating SGX942 (dusquetide) as a treatment for severe oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (CRT). The trial, referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity), incorporates feedback from the FDA as well as from the EMA via the Scientific Advice process.  The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, Phase 3 study, if successful, in conjunction with results from the Phase 2 dose-ranging study, generally will be considered sufficient to support a marketing authorization application for potential licensure in Europe.
• On June 21, 2017, the Company announced that NIAID, part of the National Institutes of Health, has exercised a $2M option to fund additional RiVax^® animal efficacy studies. The overall objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax^®, in combination with the Company's ricin toxin vaccine, RiVax^®, as a medical countermeasure to prevent the effects of ricin exposure.
• On May 18, 2017, the Company announced that long-term follow-up data from its recent positive Phase 2 clinical trial, in which SGX942 (dusquetide) demonstrated a significant reduction in the median duration of severe oral mucositis in patients with head and neck cancer, have been published in the peer-reviewed journal Biotechnology Reports. These 12-month data further support the safety and tolerability of SGX942, with the 1.5 mg/kg treatment group demonstrating accelerated tumor resolution and a decreased (p=0.08)  mortality rate relative to the placebo group. The results were published online and are available here.
• On May 9, 2017, the Company announced that it has been granted a Japanese patent (number 6110845) further extending protection around ThermoVax^® including coverage of the Company's ricin toxin vaccine candidate, RiVax^®. ThermoVax^® is a proprietary vaccine heat stabilization platform technology and the patent, entitled "Thermostable vaccine compositions and methods of preparing same," is also being pursued in other major markets worldwide, such as China, Europe, and the US.
• On May 3, 2017 the Company announced that it has received FDA clearance to advance a pivotal Phase 3 clinical trial evaluating SGX942 for the treatment of oral mucositis in head and neck cancer patients being treated with CRT. Based on positive Phase 2 results (Study IDR-OM-01), the upcoming pivotal Phase 3 clinical trial (Study IDR-OM-02) will be a highly powered, double-blind, randomized, placebo-controlled, multinational trial that will seek to enroll approximately 190 subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects will be randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for 2 weeks following completion of CRT.

Financial Results – Second Quarter Ended June 30, 2017

Soligenix's revenues for the quarter ended June 30, 2017 were $1.0 million as compared to $3.2 million for the prior year. Revenues included a contract with NIAID in support of the development of the Company's thermostabilization technology, ThermoVax^®, combined with its ricin toxin vaccine, RiVax^®, as a medical countermeasure to prevent the effects of ricin exposure.

Research and development expenses were $1.78 million as compared to $0.83 million for the quarters ended June 30, 2017 and 2016, respectively. The increase was related to expenditures incurred in the preparation and initiation of the Phase 3 oral mucositis clinical trial of SGX942, as well as the ongoing CTCL clinical trial of SGX301.