AG013 is an ActoBiotics™ therapeutic candidate formulated as a convenient oral rinsing solution and designed by our partner Intrexon Corporation (NYSE:XON) to deliver the therapeutic molecule Trefoil Factor 1 (TFF1) to the mucosal tissues in the oral cavity. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair.Following our Type C meeting with the U.S. Food and Drug Administration (FDA) in August 2016, they provided us with helpful guidance on the manufacturing process for AG013 as well as matters that will help us achieve a successful Phase 2 clinical trial. Another key accomplishment this year was the FDA Fast Track designation we received for AG013 in November of 2016, which further validates our science as well as highlights the serious need for a treatment for oral mucositis. This designation will allow us more frequent interactions with the FDA and potentially shorter review times as we advance the clinical development program for AG013. We are well prepared for our Phase 2 trial after we successfully manufactured AG013 clinical trial material and we look forward to the ability to submit our IND-amendment to the FDA in early 2017, and then treat our first patient shortly thereafter. The Clinical Research Organization that will be overseeing management of the AG013 Phase 2 clinical trial has been selected and I am pleased to note that they are already actively recruiting well-established centers in both the United States and Europe to participate in the study. Lantibiotic Program for Serious Bacterial Infections Preparing for IND Clostridium difficile ( C. difficile) is a bacterial infection that most commonly affects older adults in hospital and long-term care facilities after they receive an antibiotic administration, although there is an increasing rate of infection in younger and healthier populations. C. difficile is now associated with nearly 500,000 infections annually in the U.S., resulting in 29,000 deaths in the United States alone. Certain strains, including NAP-1, have seen a 400% increase in deaths since 2000. We are addressing this severe unmet medical need by developing a lantibiotic against C. difficile with our partner Intrexon. Through our Exclusive Channel Collaboration (ECC) with Intrexon, we have created an extensive library of potential second generation lantibiotic homologs to MU1140, a lantibiotic peptide targeting the bacterial cell wall component called lipid II. We know the lantibiotic class is effective in treating gram(+) infections including serious methicillin resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococci (VRE) and we intend to identify lantibiotics from our library that possess the best physical chemical and microbiological profiles to treat serious bacterial infections. To that end, during the summer of 2016 we completed a series of in vivo animal studies which led us to select OG716 as a second generation MU1140 homolog for advancement into FDA IND-enabling studies for the treatment of C. difficile infections. OG716 has distinct physical chemical advantages over predecessor compounds while also possessing enhanced intellectual property protections. These advantages include improved stability of OG716 in gastric and small intestinal fluids thereby negating the need for special drug formulations to selectively deliver the compound to the large intestine at the site of infection. One of the most significant challenges to advancing lantibiotics into successful therapeutics to treat widespread serious bacterial infections has been the inability to manufacture sufficient quantities in a cost effective manner. Through our collaboration with Intrexon, however, we have been able to enhance yields multiple fold during our fermentation and purification process, thereby enabling us to generate quantities sufficient to proceed with further development.
We have successfully transitioned manufacturing of OG716 to an external contract manufacturer, which has allowed us to begin the process of manufacturing sufficient amounts of OG716 to initiate our toxicology program. The first toxicology study is underway and after completing the additional work, we look forward to being able to file the IND for OG716 in 2017.Key Executive Appointment In June of 2016, I joined Oragenics as President and Chief Executive Officer and a member of the Board of Directors. I have extensive drug development experience along with experience as a CEO at a number of private biotechnology companies and I look forward to helping lead Oragenics to success. Sale of Oral Probiotics Business/Financing In June of 2016, we sold our oral probiotics business to our former Board member Christine Koski, for $1.7MM. While we were able to monetize this business, the sale of the business has enabled Oragenics to focus solely on research and development of treatments for unmet medical needs. In addition to the money raised from the sale of the oral probiotic business, we raised $4.9MM in an offering in June 2016. We plan to raise additional capital as necessary to continue advancing our product portfolio through upcoming milestones. Looking Ahead We are very excited about the path forward for Oragenics. We believe our new strategic focus as a clinical stage development company for the treatment of unmet medical needs will enable the company to create a high value niche in the healthcare space while also bringing relief to patients who currently lack sufficient treatment for their conditions. Both our Biotherapeutics and Lantibiotics programs, if successful, would yield first in class therapeutics for oral mucositis and C. difficile, respectively. While concentrating on the successful development of AG013 and OG716, we also look forward to enhancing our pipeline with additional promising product candidates and partnerships where strategic interests are aligned. Overall, we are pleased with our recent performance and anticipate the continued achievement of our goals and objectives in 2017. Most importantly, we would like to thank our loyal shareholders for their continued support.
With Best Wishes,Alan F. Joslyn, Ph.D.President and CEO About Oragenics, Inc. We are focused on becoming the world leader in novel antibiotics against infectious disease and on developing effective treatments for oral mucositis. Oragenics, Inc. has established two exclusive worldwide channel collaborations with Intrexon Corporation, a synthetic biology company. The collaborations allow Oragenics access to Intrexon's proprietary technologies toward the goal of accelerating the development of much needed new antibiotics that can work against resistant strains of bacteria and the development of biotherapeutics for oral mucositis and other diseases and conditions of the oral cavity, throat, and esophagus. For more information about Oragenics, www.oragenics.com Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect management's current views with respect to future events and performance. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, our current need for financing to meet our operational needs and to be able to move our product candidates forward through pre-clinical and clinical development, our inability to obtain sufficient financing to conduct our business; any inability to obtain or delays in the Food and Drug Administration approval for future clinical studies and testing, the future success of our studies and testing and any inability to also achieve favorable results in human studies, our ability to successfully develop and commercialize products, the financial resources available to us to continue research and development, any inability to regain compliance with the NYSE MKT continued listing requirements and those other factors described in our filings with the U.S. Securities and Exchange Commission. Any responsibility to update forward-looking statements is expressly disclaimed.