Soligenix Announces First Quarter 2015 Highlights and Financial Results

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May 14, 2015, 07:00 ET

PRINCETON, N.J., May 14, 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 first quarter ended March 31, 2015.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "During the quarter we received positive feedback on three of our BioTherapuetics programs: SGX301, for first-line treatment of cutaneous T-cell lymphoma (CTCL), SGX203, for the treatment of pediatric Crohn's disease, and SGX942, for the treatment of oral mucositis. For SGX301, we received fast track designation from the US Food and Drug Administration (FDA), for SGX203, we received FDA agreement on our pivotal, Phase 3 clinical trial design and for SGX942, the Data Review Committee (DRC) recommended that we increase the enrollment of our Phase 2 study by 20 subjects. The increased enrollment in this study will be directed in either a single SGX942 dose group or placebo to provide a more targeted assessment for final dose selection. As we continue to carefully manage our cash burn, our cash position for the first quarter ended March 31, 2015 was $5.0 million versus $5.5 million at December 31, 2014. I look forward to providing further updates throughout the year."

Soligenix First Quarter Highlights:

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.
On March 11, 2015, the Company announced publication in the Proceedings of the National Academy of Sciences of data demonstrating complete protection and immunogenicity of its heat-stable ricin vaccine, RiVax™, in preclinical studies, with analysis of previous human clinical samples. In this study, vaccination with RiVax™ provided 100% protection for non-human primates subsequently exposed to lethal doses of aerosolized ricin.
On March 3, 2015, the Company announced receiving a positive recommendation from the DRC to continue enrolling patients into its Phase 2 dose-ranging study evaluating SGX942, a first-in-class innate defense regulator (IDR), as a treatment for oral mucositis in patients undergoing chemoradiation therapy for head and neck cancer. Following DRC review of available data on the subjects enrolled in the trial, the committee recommended that enrollment include an additional 20 subjects randomized into either a single SGX942 dose group or the placebo group to allow for a more targeted assessment of the drug's potential effect and to inform final dose selection in this patient population.
On February 11, 2015, the Company announced that it presented preclinical melioidosis results at the 2015 ASM BioDefense and Emerging Disease Research meeting held in Washington, DC. The data from the preclinical study demonstrated statistically significant efficacy of SGX943 in a mouse model of acute, lethal pneumonic melioidosis.
On January 29, 2015, the Company announced publication in the Journal of Pharmaceutical Sciences of data demonstrating enhanced immunogenicity and rapid action of its heat-stable anthrax vaccine, VeloThrax™. The use of the Company's proprietary vaccine stabilization technology, ThermoVax™, has been previously demonstrated to enhance the thermostability of VeloThrax™, enabling distribution without cold chain requirements.
On January 7, 2015, the Company announced that the SGX301 (synthetic hypericin) development program for first-line treatment of CTCL received fast track designation from the FDA.
On January 5, 2015, the Company announced preliminary efficacy had been demonstrated in an animal model of Macrophage Activation Syndrome (MAS) with its SGX94 IDR technology, significantly mitigating the pancytopenia characteristic of MAS.

Financial Results – First Quarter Ended March 31, 2015

Soligenix's revenues for the quarter ended March 31, 2015 were $0.8 million as compared to $0.9 million for the first quarter of 2014. Revenues included 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 for the treatment of gastrointestinal acute radiation syndrome (GI ARS) and a contract with NIAID to advance the development of RiVax™, its proprietary ricin toxin vaccine, in conjunction with its heat stabilization technology, ThermoVax™, as a medical countermeasure to prevent the effects of ricin exposure.

Soligenix's basic net loss was $4.6 million, or $0.19 per share, as compared to $3.3 million, or $0.17 per share, for the first quarter ended March 31, 2015 and 2014, respectively. Included in the net loss for the quarter ended March 31, 2015 and 2014 is a non-cash loss of $3.0 million and $1.7 million, respectively. This non-cash item reflects the increase in fair value of the liability related to warrants issued in connection with the Company's June 25, 2013 registered public offering and is included in other income (expense).

Research and development expenses were $1.1 million for each of the quarters ended March 31, 2015 and 2014.

General and administrative expenses were $0.8 million for each of the quarters ended March 31, 2015 and 2014.

As of March 31, 2015, the Company's cash position was $5.0 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 photo-dynamic 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.