Princeton, NJ – November 12, 2013 – 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 quarter and nine months ended September 30, 2013.
Soligenix’s revenues for the quarter and nine months ended were $0.3 million as compared to $0.9 million for the quarter and $1.8 million as compared to $2.3 million for the nine months ended September 30, 2013 and 2012, respectively. For the nine months ended September 30, 2013 compared to September 30, 2012, revenues decreased by $0.5 million primarily related to the timing of reimbursable costs from the Company’s ThermoVax™ thermostability technology grant focused on a novel method of rendering aluminum salt adjuvanted vaccines stable at elevated temperatures.
Soligenix’s net loss was $6.6 million, or $0.34 per share, as compared to $0.8 million, or $0.07 per share, for the quarter and $11.1 million, or $0.78 per share, as compared to $3.2 million, or $0.29 per share for the nine months ended September 30, 2013 and 2012, respectively. Included in the net loss for the quarter ended September 30, 2013 is a non-cash charge of $4.7 million due to the change in fair value of the liability related to warrants issued in the Company’s June 25, 2013 registered public offering. The net loss for the nine months ended September 30, 2013 included a $1.5 million non-cash charge related to the exclusive worldwide collaboration with Intrexon Corporation (Intrexon) and a $5.3 million non-cash charge resulting from the change in fair value of the liability related to warrants issued in the Company’s June 25, 2013 registered public offering.
Research and development expenses were $1.2 million as compared to $0.4 million and $4.1 million as compared to $1.7 million for the quarter and nine months ended September 30, 2013 and 2012, respectively. Included in the nine months expenses is a $1.5 million non-cash charge related to the collaboration with Intrexon.
General and administrative expenses were $0.7 million as compared to $0.6 million and $1.9 million as compared to $1.8 million for the quarter and nine months ended September 30, 2013 and 2012, respectively.
Excluding the $1.5 million non-cash charge relating to the collaboration with Intrexon, total operating expenses for the nine months ended September 30, 2013, increased by $0.9 million relating to the completed pediatric Crohn’s disease Phase 1 study, activities in preparation for initiating clinical trials in oral mucositis, pediatric Crohn’s, chronic gastrointestinal Graft-versus-Host disease (GI GVHD) and stock based compensation on newly issued stock option grants.
For the quarter and nine months ended September 30, 2013, other net income/expense includes a $4.7 million, or $0.25 per share, and $5.3 million, or $0.38 per share, respectively, non-cash charge related to the change in fair value of the liability for warrants issued in the Company’s June 25, 2013 registered public offering.
As of September 30, 2013, the Company’s cash position was $6.6 million.
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, “This quarter we were extremely pleased to be awarded two multi-year government contracts from the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) to support the development of OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS).”
Dr. Schaber continued, “In the fourth quarter, we intend to initiate a Phase 2 clinical trial in chronic GI GVHD with orBec® our two tablet delivery system of oral beclomethasone 17,21-dipropionate (BDP) and a Phase 2 clinical trial for oral mucositis in head and neck cancer patients with SGX942. SGX942 is our innate defense regulator (IDR) technology that modulates the innate immune system to simultaneously reduce inflammation, eliminate infection and enhance tissue healing. I look forward to providing updates through the balance of this year and in 2014.”
Soligenix’s Key Highlights:
On November 1, 2013, the Company hosted a webcast, conference call entitled: Oral Mucositis – Advancing the Next Generation of Therapies. The webcast was moderated by Jason Kolbert, Managing Director of Biotechnology Research at the Maxim Group. Participants in the webcast included Christopher J. Schaber, PhD, President and Chief Executive Officer, Oreola Donini, PhD, Vice President of Preclinical Research and Development, and Stephen T. Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard School of Dental Medicine, Senior Surgeon and Chief, Divisions of Oral Medicine at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, and Chief Scientific Officer of Biomodels, LLC.
On October 31, 2013, the Company announced the submission of a full contract proposal to NIAID, Division of Microbiology and Infectious Diseases. Successful award of the proposal would support a multi-year, multi-million dollar contract for the advanced development of thermostable RiVax™ as a vaccine medical countermeasure (MCM) candidate for biodefense threats to protect the public. NIAID is interested in supporting the advanced development of candidate vaccines against potentially lethal pathogens and toxins which consist of a dry formulation technology to enhance stability and minimize cold chain storage or preservative requirements.
On October 21, 2013, the Company announced the appointment of Marco Maria Brughera, DVM, Global Head of the Rare Disease Franchise for Sigma-Tau SpA, to its Board of Directors. Dr. Brughera has held several positions for the Sigma-Tau Group, including Corporate Research and Development Managing Director of Sigma-Tau SpA, President of Sigma-Tau Research and Board Member of Sigma-Tau Pharmaceuticals.
On October 17, 2013, the Company announced the formation of an international melioidosis Scientific Advisory Board (SAB). Comprised of clinicians and researchers from Australia, Thailand, Lao and The Netherlands with extensive experience in melioidosis. The SAB will play an important advisory role in the design and conduct of the research and development to advance SGX943 and SGX101 for the treatment of melioidosis. The SAB will provide feedback, input and guidance to both Soligenix and its collaborative partner, Intrexon Corporation (NYSE: XON), on research strategies and their implementation as well as on other critical issues, such as clinical strategy and health economics.
On October 3, 2013, the Company announced the appointment of Oreola Donini, PhD, as Vice President of Preclinical Research and Development. Dr. Donini has more than 13 years experience in drug discovery and preclinical development with start-up biotechnology companies and has been instrumental in leading early stage development of several novel therapies into the clinic. Dr. Donini is a co-inventor and leader of the SGX94 IDR technology.
On September 25, 2013, the Company announced the award of a contract valued at up to $6.4 million by the US Department of Health and Human Service’s National Institutes of Health (NIH), specifically funded by NIAID. The contract is for the advanced preclinical development of OrbeShield™ (oral BDP) as a MCM for the treatment GI ARS. The potential three year contract contains a one year base period, with two contract options that would extend the contract an additional year each. The total award will support the development activities necessary to evaluate OrbeShield™ as a potential MCM to treat GI ARS.
On September 19, 2013, the Company announced the award of a contract valued at up to $26.3 million by BARDA. The contract is for the advanced preclinical and manufacturing development of OrbeShield™ as a MCM for the treatment of GI ARS. The potential five year contract contains a two year base period, with two contract options that would extend the contract an additional three years. The total award will support the preclinical and manufacturing development activities necessary to successfully navigate and complete the FDA approval process for use of OrbeShield™ to treat GI ARS.
On September 16, 2013, the Company announced that the Office of Orphan Products Development of the FDA has granted orphan drug designation to the active ingredient SGX94 for the treatment of acute radiation syndrome (ARS). SGX94 is an IDR, a new class of short, synthetic peptides that accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy.
About Soligenix, Inc.
Soligenix is a clinical stage biopharmaceutical company 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 lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ 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™. Soligenix is also developing OrbeShield™ 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™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by the NIAID. Recently, Soligenix announced a worldwide exclusive collaboration with Intrexon Corporation that will focus 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 https://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.