Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the third quarter ended September 30, 2018.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "Our primary focus remains the quality execution of our two pivotal Phase 3 clinical programs. Following the positive recommendation recently received from the independent Data Monitoring Committee (DMC), we continue to enroll patients in our double-blind, placebo-controlled Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin). With this new level of clarity from the DMC's analysis of the interim Phase 3 study data, we expect to complete the study before the end of 2019 with topline results coming no later than the first quarter of 2020. Additionally, we are actively enrolling patients in our double-blind, placebo-controlled, multinational Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy. We currently anticipate final results for this pivotal study in the second half of 2019."

Dr. Schaber continued, "We have been fortunate to secure non-dilutive funding from various government sources, allowing us to advance multiple development programs across our biodefense and biotherapeutics pipelines. For the third quarter of 2018, our combined revenues from both our business segments were $1.4 million, and we expect this non-dilutive government funding to continue throughout the remainder of 2018 and beyond."

Soligenix Recent Accomplishments:

• On October 15, 2018, the Company announced it had received a positive recommendation from the independent DMC to continue enrolling into the Company's Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin) in the treatment of CTCL. No safety concerns were reported by the DMC based on the interim analysis. To view this press release, please click here.
• On September 13, 2018, the Company announced that the National Institutes of Health (NIH) selected Soligenix's SGX942 (dusquetide) development program for the treatment of oral mucositis in HNC patients as a Small Business Innovation Research/Small Business Technology Transfer Commercialization Accelerator Program Phase II awardee for 2018-2019. To view this press release, please click here.
• On September 4, 2018, the Company announced publication of extended stability studies for RiVax® showing up to 100% protection in mice even after 12 months storage at 40 degrees Celsius (104 degrees Fahrenheit), as well as the identification of a potential in vitro stability indicating assay, critical to adequately confirming long-term shelf-life of the vaccine. The article, entitled "Thermal Stability and Epitope Integrity of a Lyophilized Ricin Toxin Subunit Vaccine", is published in the journal Vaccine online and is available here. To view this press release, please click here.
• On August 22, 2018, the Company announced that the United States Patent Office had granted the patent titled "Systems and Methods for Producing Synthetic Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the Company's photodynamic therapy currently in a Phase 3 clinical trial for the treatment of CTCL. To view this press release, please click here.

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 novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and 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).

Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine program incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with 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.