Soligenix Announces Recent Accomplishments and Year-End 2014 Financial Results

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Mar 24, 2015, 07:00 ET

PRINCETON, N.J., March 24, 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 accomplishments and financial results for the year ended December 31, 2014.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We have strengthened our development product candidate pipeline in both our business segments while extending our cash runway through the completion of a common stock offering. In our BioTherapeutics business segment, we expanded our pipeline with the acquisition of SGX301, synthetic hypericin, with plans to initiate a pivotal Phase 3 clinical trial for first-line treatment of cutaneous T-cell lymphoma (CTCL) in the first half of 2015. Early in 2015, we also received positive recommendation from the Data Review Committee (DRC) for our Phase 2 study with SGX942 in the treatment of oral mucositis in head and neck cancer to enroll an additional 20 subjects into either a single SGX942 dose group or placebo to provide for a more targeted assessment for final dose selection."

Dr. Schaber continued, "Our Vaccine/BioDefense business segment is currently funded up to $57 million in non-dilutive program funding. This funding consists of a 2014 contract award, from the National Institute of Allergy and Infectious Diseases (NIAID), valued up to $24.7 million for our ricin toxin vaccine (RiVax™) program utilizing our ThermoVax™ vaccine thermostablization platform, and adds to government contracts previously awarded for OrbeShield™ in gastrointestinal acute radiation syndrome (GI ARS) of up to $32.7 million. We continued to effectively manage our cash burn ending 2014 with $5.5 million in cash. I look forward to providing updates on our progress throughout the year."

Soligenix Recent Accomplishments:

On March 11, 2015, the Company announced the publication 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 the publication 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 US Food and Drug Administration.
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.
On December 24, 2014, the Company announced the closing of a registered public offering of 1,886,530 units at an offering price of $1.21 per unit, with each unit consisting of one share of common stock and 0.6 of a warrant to purchase one share of common stock with an exercise price of $1.48. The Company raised approximately $2.3 million in gross proceeds to fund its research and development activities including the conduct of a pivotal Phase 3 clinical trial of SGX301 for the treatment of CTCL.
On December 11, 2014, the Company announced receiving approximately $617,000, net of transaction costs, via the State of New Jersey's Technology Business Tax Certificate Transfer Program.
On December 10, 2014, the Company announced the appointment of Oreola Donini, PhD, as Senior Vice President and Chief Scientific Officer.
On November 17, 2014, the Company announced the formation of a Medical Advisory Board to provide medical/clinical strategic guidance as the Company advances the Phase 3 clinical development of SGX301 for the treatment of CTCL.

Financial Results – Year Ended December 31, 2014

Soligenix's revenues for the year ended December 31, 2014 were $7.0 million as compared to $3.2 million for the prior year. Revenues included contracts with the US Department of Health and Human Service's Biomedical Advanced Research and Development Authority (BARDA) and the NIAID in support of OrbeShield™ (oral beclomethasone 17,21-dipropionate or BDP) development in the treatment of GI ARS. In addition, during the third quarter of 2014, the Company was awarded 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 $6.7 million, or $0.32 per share, as compared to $10.1 million, or $0.65 per share, for the year ended December 31, 2014 and 2013 respectively. Included in the net loss for years ended December 31, 2014 and 2013 is a non-cash gain of $3.4 million and a non-cash loss of $(3.7) 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 $9.1 million as compared to $5.1 million for the year ended December 31, 2014 and 2013, respectively. For the year ended December 31, 2014, the increase of $4.0 million is 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.

General and administrative expenses were $3.4 million as compared to $2.8 million for the year ended December 31, 2014 and 2013, respectively. This increase is primarily related to an increase in headcount and an increase in outside professional fees.

As of December 31, 2014, the Company's cash position was $5.5 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.