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Soligenix Reports First Quarter 2014 Financial Results, and Highlights Recent Accomplishments

May 12, 2014

PRINCETON, N.J., May 12, 2014 /PRNewswire/ — Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today its financial results for the first quarter ended March 31, 2014.

Soligenix’s revenues for the quarter ended March 31, 2014 were $0.9 million as compared to $0.9 million for the first quarter of 2013. 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(TM) (oral beclomethasone 17,21-dipropionate or BDP) development in the treatment of gastrointestinal acute radiation syndrome (GI ARS).

Soligenix’s net (loss) for March 31, 2014 was $3.3 million, or $(0.17) per share, as compared to $1.1 million, or $(0.10) per share, for the first quarter ended March 31, 2013. Included in the net loss for the quarter ended March 31, 2014 is a non-cash charge of $1.7 million, or $0.09 per share, due to the change in fair value of the warrant liability related to warrants issued in connection with the Company’s June, 2013 registered public offering.

Research and development expenses for the quarter ended March 31, 2014 were $1.0 million as compared to $0.8 million for the same period in 2013. General and administrative expenses for the quarter ended March 31, 2014 were $0.9 million as compared to $0.5 million for the same period in 2013. Overall operating expenses increased by $0.6 million due to expenses related to the Company’s Phase 2 clinical trials with SGX942 in the treatment of oral mucositis and orBec(®) in the treatment of chronic gastrointestinal Graft-versus-host disease (GI GVHD), as well as from increased headcount and non-cash expenses for stock based compensation from stock options issued to existing and newly hired employees.

For the quarter ended March 31, 2014, other net income/expense includes a $1.7 million, or $0.09 per share, non-cash charge related to the change in fair value of the warrant liability related to warrants issued in connection with the Company’s June 2013 registered public offering.

As of March 31, 2014, the Company’s cash position was $5.6 million.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, “We continue to advance our multiple development programs across our BioTherapeutics and Vaccine/BioDefense business segments, including patient enrollment in the Phase 2 clinical studies with SGX942 in the treatment of oral mucositis in head and neck cancer and orBec(® )in the treatment of chronic GI GVHD. We continued to effectively manage our cash burn ending the quarter with $5.6 million. In addition, we were recently awarded two Small Business Innovation Research (SBIR) grants totaling $500,000. The receipt of these grants further validates the potential of our development programs and continued ability to secure government funding to support them. Within the past twelve months, we have received contract and grant funding totaling up to approximately $33.0 million. I look forward to providing updates throughout the balance of this year and into 2015.”

Soligenix First Quarter Highlights:

    --  On April 7, 2014, the Company announced the award by the National
        Institute of Dental and Craniofacial Research (NIDCR) of a one year
        $200,000 SBIR grant to support the conduct of its Phase 2 study
        evaluating SGX942 as a treatment of oral mucositis in patients
        undergoing chemo radiation therapy for head and neck cancer.
    --  On February 14, 2014, the Company announced the award by NIAID of a one
        year $300,000 SBIR grant to support further preclinical development of
        SGX943 as a treatment for melioidosis. This award will allow the Company
        to conduct studies in collaboration with Tulane University.
    --  On January 16, 2014, the Company announced that it had received
        approximately $750,000, net of transaction costs, in non-dilutive
        funding via the State of New Jersey's Technology Business Tax
        Certificate Transfer Program.
    --  On January 15, 2014, the Company announced significant steps forward in
        the development of ThermoVax(TM), its proprietary vaccine
        thermostabilization platform technology.  Recent studies have
        demonstrated the potential for heat-sensitive vaccines formulated using
        this technology to withstand temperatures exceeding 40 degrees Celsius
        (104 degrees Fahrenheit) for up to one year. The underlying work has
        been conducted with the Company's proprietary ricin toxin vaccine
        (RiVax(TM)) as part of a continuing program to evaluate the
        effectiveness of protein subunit vaccines to withstand extremes of
        temperature and other environmental stress conditions. The research and
        development of ThermoVax(TM) is currently being supported by a $9.4
        million NIAID grant for biodefense vaccines to prevent ricin toxin and
        anthrax exposure.
    --  On January 6, 2014, the Company announced that it had appointed Richard
        Straube, MD, as its Senior Vice President and Chief Medical Officer. Dr.
        Straube is a board-certified pediatrician with clinical research
        experience in host-response modulation.  He has had a long and
        distinguished career of more than 35 years in both academia and
        industry, most notably with Centocor, Ohmeda Pharmaceuticals, INO
        Therapeutics, and Stealth Peptides, Inc. Dr. Straube will lead
        Soligenix's clinical research with primary responsibility for the
        execution and completion of its multiple clinical programs, including
        its Phase 2 study in oral mucositis and its Phase 2/3 study in pediatric
        Crohn's disease.

About Soligenix, Inc.

Soligenix is a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec(®)), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis.

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government’s Strategic National Stockpile. Soligenix’s biodefense products in development are a recombinant subunit vaccine called RiVax(TM), which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax(TM), a vaccine against anthrax exposure. RiVax(TM) has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax(TM) and VeloThrax(TM) are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix’s new vaccine heat stabilization technology known as ThermoVax(TM). Soligenix is also developing OrbeShield(TM) for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield(TM) has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID. Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of a treatment for Melioidosis, a high priority biothreat and an area of unmet medical need.

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

This press release contains 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.


Source: PR Newswire



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