Post by stocksdivas on Feb 29, 2012 14:05:03 GMT -5
ORAGENICS INC (ORNI.OB)
Oragencis Inc is a biopharmaceutical company focused primarily on oral health products and novel antibiotics. Within oral health, we are developing our pharmaceutical product candidate, SMaRT Replacement Therapy™, and we are also commercializing our oral probiotic blend, ProBiora3®. Within antibiotics, we are developing our pharmaceutical product candidate, MU1140-S™, and we intend to use our patented, novel organic chemistry platform to create additional antibiotics for therapeutic use.
Our SMaRT Replacement Therapy product candidate is designed to be a painless, one-time, five-minute topical treatment applied to the teeth that has the potential to offer lifelong protection against dental caries, or tooth decay. Our SMaRT Replacement Therapy is based on the creation of a genetically modified strain of bacteria that colonizes in the oral cavity and replaces native bacteria that cause tooth decay. We expect to commence a second Phase 1 clinical trial for SMaRT Replacement Therapy which is scheduled to conclude in 2011. We have also developed and are commercializing a variety of products that contain the active ingredient ProBiora3, a patented blend of oral probiotics that promote fresher breath, whiter teeth and supports overall oral health. We have conducted extensive scientific studies on ProBiora3 in order to market our products under self-affirmed Generally Recognized As Safe status, or GRAS. We sell our ProBiora3 products through multiple distribution channels and our customers include Walgreens, Rite Aid, the Kroger family of stores and Garden of Life, among others.
While developing SMaRT Replacement Therapy, members of our scientific team discovered that the SMaRT bacterial strain produces MU1140, a molecule belonging to the novel class of antibiotics known as lantibiotics. MU1140 has proven active preclinically against Gram positive bacteria responsible for a number of healthcare-associated illnesses. We are in the process of scaling up production of our synthetic form of MU1140, or MU1140-S, and expect to commence preclinical testing and to file an Investigational New Drug, or IND, application with the FDA in 2011. The key technology behind the production of MU1140-S is our Differentially Protected Orthogonal Lanthionine Technology platform, or DPOLT, which is a patented, novel organic chemistry platform that we believe will enable the first ever commercial scale, cost-effective production of any of the 50 known lantibiotics. We intend to use DPOLT to create a pipeline of lantibiotics for therapeutic use. Additionally, we are developing non-core technologies that originated from the discoveries of our scientific team, including LPT3-04, which is a weight loss product, and PCMAT, which is a biomarker discovery platform, both of which we believe could provide significant potential opportunities for us.
We were incorporated in November 1996 and commenced operations in 1999. We consummated our initial public offering in June 2003. We have substantially devoted all of our resources to the commercialization of our ProBiora3 products as well as our discovery efforts comprising research and development, clinical trials for our product candidates, protection of our intellectual property and the general and administrative support of these operations. We have generated limited revenues from grants and ProBiora3 product sales through 2010, and have principally funded our operations through the sale of debt and equity securities, including the exercise of warrants issued in connection with these financing transactions. Prior to 2008 our revenues were derived solely from research grants.
Oragenics Inc.
3000 Bayport Drive
Suite 685
Tampa, FL 33607
Phone: 813-286-7900
Fax: 813-286-7904
Website: www.oragenics.com
www.otcmarkets.com/stock/ORNI/company-info
Management Team
Dr. John Bonfiglio, Chief Executive Officer and President
Most recently, Dr. Bonfiglio worked as the President and Chief Executive Officer and as a director of Transdel Pharmaceuticals, Inc. Prior to that he worked as the President and Chief Executive Officer of Argos Therapeutics in Durham, NC and prior to that he was the Chief Executive Officer of The Immune Response Corporation in Carlsbad, CA. He was also the Chief Executive Officer of Peregrine Pharmaceuticals and held senior management positions with Cypress Biosciences, Baxter Healthcare and Allergan, Inc.
Brian Bohunicky, Chief Financial Officer, Treasurer and Secretary
Mr. Bohunicky has served as our Chief Financial Officer since June 2009 and as Secretary and Treasurer since August 2009. Mr. Bohunicky joined the Company in January 2009 as the Company Controller. Prior to joining the Company, Mr. Bohunicky was the Vice President and Controller of Idex Corporation’s (NYSE: IEX) Fire & Safety Segment from October 2002 to November 2008. Mr. Bohunicky holds a B.A. degree in Economics from Moravian College.
Dr. Robert Zahradnik, Vice President of Operations
Dr. Zahradnik, one of the co-founders of Oragenics has served in several senior capacities for the Company. He has held a variety of senior level positions in the health care arena and is currently working on expanding Oragenics' patented blend of probiotics, ProBiora3®, for oral care.
Dr. Martin Handfield, Vice President of Research
Dr. Handfield has served as our Director of Research and Development since January 2009. Prior to joining our Company, Dr. Handfield held a position as Tenured Associate Professor at the Center for Molecular Microbiology and the Department of Oral Biology at the University of Florida College of Dentistry, where he co-invented IVIAT and co-founded ivi Gene Corp. and Epicure Corp. to commercialize this and related technologies. Dr. Handfield holds a B.S. degree in Biochemistry, and a MS degree and PhD in Microbiology and Immunology from the Université Laval College of Medicine in Canada, and did postdoctoral training at the University of Florida under the mentorship of Dr. Hillman.
What ORNI does
ProBiora3® is a patented blend of three of beneficial bacteria naturally present in healthy mouths, including Streptococcus oralis KJ3™, Streptococcus uberis KJ2™, and Streptococcus rattus JH145™. This blend of probiotics promotes fresher breath, whiter teeth and supports gum and tooth health.
Based on research begun more than 30 years ago by Oragenics’ Founder and Chief Scientific Officer Dr. Jeffrey D. Hillman, ProBiora3 represents a new application of probiotics that support overall oral health.
ProBiora3 is a food ingredient utilizing self-affirmed Generally Recognized as Safe (GRAS) status.
Benefits
Naturally Supports Gum and Tooth Health
S. oralis KJ3™, S. uberis KJ2™ and S. rattus JH145™
These natural colonizers of the mouth adhere to the tooth surfaces and deep below the gum line to support gum and tooth health.
Naturally Freshens Breath
S. oralis KJ3™ and S. uberis KJ2™
By binding to the teeth and deep beneath the gum line, the combination of S. oralis KJ3™, and S. uberis KJ2™ leaves little room or nutrients for the bad-breath causing bacteria to inhabit a healthy mouth. This reduction in bad bacteria equals a direct reduction in those chemical compounds responsible for bad breath.
Naturally Whitens Teeth
S. oralis KJ3™ and S. uberis KJ2™
Natural and on-going low doses of hydrogen peroxide produced by these beneficial bacteria gently whiten and brighten teeth without creating tooth sensitivity or gum irritation.
Oragenics’ has four oral care consumer products that feature the ProBiora3 technology utilizing different ratios of the three natural strains of beneficial bacteria contained in ProBiora3, to suit intended use of the product.
Oragenics' Oral Care Products
EvoraPlus: A probiotic mint with equal portions of all three strains that is optimally designed for those over the age of 11. Taken twice daily (ideally after brushing) this probiotic mint supports gum and tooth health, naturally freshens breath and gently whitens teeth.
EvoraPro: A professional-strength version of EvoraPlus used to accelerate the repopulation of the beneficial bacteria that are removed – along with bad bacteria – during a professional prophylaxis. This highly concentrated blend of ProBiora3 probiotics comes in a mint form and is distributed exclusively by the dental professionals.
EvoraKids: A Wild Very Berry Cherry chew that has higher levels of S. rattus JH145™, which supports dental health, and reduced levels of S. oralis KJ3™ and S. uberis KJ2™, since periodontal health is not typically a concern for children.
EvoraPet: An odorless and tasteless probiotic powder that has higher levels of S. oralis KJ3™ and S. uberis KJ2™, which address the tooth staining and breath problems common to dogs and cats, and reduced levels of S. rattus JH145™, since tooth decay is not typically a concern in companion pets.
In addition to these products, we also market ProBiora3 as an active ingredient for private label products and in bulk for licensing applications.
LPT3-04™ is a naturally occurring compound, which is normally consumed in the human diet in small amounts. In the course of our SMaRT Replacement Therapy research program, we discovered that consumption of significantly larger amounts of LPT3-04 resulted in dose-dependent weight loss in experimental animal models. The mechanism of action appears to be induction of apoptosis, or programmed cell death, specifically in white fat cells. LPT3-04 consumption in the required amounts has been shown to be safe in humans. Anecdotally, weight loss has been observed in human volunteers. Due to the natural sweetness of LPT3-04 and the relatively large amounts of it that need to be consumed on a daily basis to achieve the desired weight loss effect, current product development efforts are focused on incorporating the compound into bars, milkshakes, and other food products.
Regulatory status
We have submitted a patent application for the use of LPT3-04 for weight regulation with the United States Patent and Trademark Office, or U.S. PTO
Oragencis Inc is a biopharmaceutical company focused primarily on oral health products and novel antibiotics. Within oral health, we are developing our pharmaceutical product candidate, SMaRT Replacement Therapy™, and we are also commercializing our oral probiotic blend, ProBiora3®. Within antibiotics, we are developing our pharmaceutical product candidate, MU1140-S™, and we intend to use our patented, novel organic chemistry platform to create additional antibiotics for therapeutic use.
Our SMaRT Replacement Therapy product candidate is designed to be a painless, one-time, five-minute topical treatment applied to the teeth that has the potential to offer lifelong protection against dental caries, or tooth decay. Our SMaRT Replacement Therapy is based on the creation of a genetically modified strain of bacteria that colonizes in the oral cavity and replaces native bacteria that cause tooth decay. We expect to commence a second Phase 1 clinical trial for SMaRT Replacement Therapy which is scheduled to conclude in 2011. We have also developed and are commercializing a variety of products that contain the active ingredient ProBiora3, a patented blend of oral probiotics that promote fresher breath, whiter teeth and supports overall oral health. We have conducted extensive scientific studies on ProBiora3 in order to market our products under self-affirmed Generally Recognized As Safe status, or GRAS. We sell our ProBiora3 products through multiple distribution channels and our customers include Walgreens, Rite Aid, the Kroger family of stores and Garden of Life, among others.
While developing SMaRT Replacement Therapy, members of our scientific team discovered that the SMaRT bacterial strain produces MU1140, a molecule belonging to the novel class of antibiotics known as lantibiotics. MU1140 has proven active preclinically against Gram positive bacteria responsible for a number of healthcare-associated illnesses. We are in the process of scaling up production of our synthetic form of MU1140, or MU1140-S, and expect to commence preclinical testing and to file an Investigational New Drug, or IND, application with the FDA in 2011. The key technology behind the production of MU1140-S is our Differentially Protected Orthogonal Lanthionine Technology platform, or DPOLT, which is a patented, novel organic chemistry platform that we believe will enable the first ever commercial scale, cost-effective production of any of the 50 known lantibiotics. We intend to use DPOLT to create a pipeline of lantibiotics for therapeutic use. Additionally, we are developing non-core technologies that originated from the discoveries of our scientific team, including LPT3-04, which is a weight loss product, and PCMAT, which is a biomarker discovery platform, both of which we believe could provide significant potential opportunities for us.
We were incorporated in November 1996 and commenced operations in 1999. We consummated our initial public offering in June 2003. We have substantially devoted all of our resources to the commercialization of our ProBiora3 products as well as our discovery efforts comprising research and development, clinical trials for our product candidates, protection of our intellectual property and the general and administrative support of these operations. We have generated limited revenues from grants and ProBiora3 product sales through 2010, and have principally funded our operations through the sale of debt and equity securities, including the exercise of warrants issued in connection with these financing transactions. Prior to 2008 our revenues were derived solely from research grants.
Oragenics Inc.
3000 Bayport Drive
Suite 685
Tampa, FL 33607
Phone: 813-286-7900
Fax: 813-286-7904
Website: www.oragenics.com
www.otcmarkets.com/stock/ORNI/company-info
Management Team
Dr. John Bonfiglio, Chief Executive Officer and President
Most recently, Dr. Bonfiglio worked as the President and Chief Executive Officer and as a director of Transdel Pharmaceuticals, Inc. Prior to that he worked as the President and Chief Executive Officer of Argos Therapeutics in Durham, NC and prior to that he was the Chief Executive Officer of The Immune Response Corporation in Carlsbad, CA. He was also the Chief Executive Officer of Peregrine Pharmaceuticals and held senior management positions with Cypress Biosciences, Baxter Healthcare and Allergan, Inc.
Brian Bohunicky, Chief Financial Officer, Treasurer and Secretary
Mr. Bohunicky has served as our Chief Financial Officer since June 2009 and as Secretary and Treasurer since August 2009. Mr. Bohunicky joined the Company in January 2009 as the Company Controller. Prior to joining the Company, Mr. Bohunicky was the Vice President and Controller of Idex Corporation’s (NYSE: IEX) Fire & Safety Segment from October 2002 to November 2008. Mr. Bohunicky holds a B.A. degree in Economics from Moravian College.
Dr. Robert Zahradnik, Vice President of Operations
Dr. Zahradnik, one of the co-founders of Oragenics has served in several senior capacities for the Company. He has held a variety of senior level positions in the health care arena and is currently working on expanding Oragenics' patented blend of probiotics, ProBiora3®, for oral care.
Dr. Martin Handfield, Vice President of Research
Dr. Handfield has served as our Director of Research and Development since January 2009. Prior to joining our Company, Dr. Handfield held a position as Tenured Associate Professor at the Center for Molecular Microbiology and the Department of Oral Biology at the University of Florida College of Dentistry, where he co-invented IVIAT and co-founded ivi Gene Corp. and Epicure Corp. to commercialize this and related technologies. Dr. Handfield holds a B.S. degree in Biochemistry, and a MS degree and PhD in Microbiology and Immunology from the Université Laval College of Medicine in Canada, and did postdoctoral training at the University of Florida under the mentorship of Dr. Hillman.
What ORNI does
ProBiora3® is a patented blend of three of beneficial bacteria naturally present in healthy mouths, including Streptococcus oralis KJ3™, Streptococcus uberis KJ2™, and Streptococcus rattus JH145™. This blend of probiotics promotes fresher breath, whiter teeth and supports gum and tooth health.
Based on research begun more than 30 years ago by Oragenics’ Founder and Chief Scientific Officer Dr. Jeffrey D. Hillman, ProBiora3 represents a new application of probiotics that support overall oral health.
ProBiora3 is a food ingredient utilizing self-affirmed Generally Recognized as Safe (GRAS) status.
Benefits
Naturally Supports Gum and Tooth Health
S. oralis KJ3™, S. uberis KJ2™ and S. rattus JH145™
These natural colonizers of the mouth adhere to the tooth surfaces and deep below the gum line to support gum and tooth health.
Naturally Freshens Breath
S. oralis KJ3™ and S. uberis KJ2™
By binding to the teeth and deep beneath the gum line, the combination of S. oralis KJ3™, and S. uberis KJ2™ leaves little room or nutrients for the bad-breath causing bacteria to inhabit a healthy mouth. This reduction in bad bacteria equals a direct reduction in those chemical compounds responsible for bad breath.
Naturally Whitens Teeth
S. oralis KJ3™ and S. uberis KJ2™
Natural and on-going low doses of hydrogen peroxide produced by these beneficial bacteria gently whiten and brighten teeth without creating tooth sensitivity or gum irritation.
Oragenics’ has four oral care consumer products that feature the ProBiora3 technology utilizing different ratios of the three natural strains of beneficial bacteria contained in ProBiora3, to suit intended use of the product.
Oragenics' Oral Care Products
EvoraPlus: A probiotic mint with equal portions of all three strains that is optimally designed for those over the age of 11. Taken twice daily (ideally after brushing) this probiotic mint supports gum and tooth health, naturally freshens breath and gently whitens teeth.
EvoraPro: A professional-strength version of EvoraPlus used to accelerate the repopulation of the beneficial bacteria that are removed – along with bad bacteria – during a professional prophylaxis. This highly concentrated blend of ProBiora3 probiotics comes in a mint form and is distributed exclusively by the dental professionals.
EvoraKids: A Wild Very Berry Cherry chew that has higher levels of S. rattus JH145™, which supports dental health, and reduced levels of S. oralis KJ3™ and S. uberis KJ2™, since periodontal health is not typically a concern for children.
EvoraPet: An odorless and tasteless probiotic powder that has higher levels of S. oralis KJ3™ and S. uberis KJ2™, which address the tooth staining and breath problems common to dogs and cats, and reduced levels of S. rattus JH145™, since tooth decay is not typically a concern in companion pets.
In addition to these products, we also market ProBiora3 as an active ingredient for private label products and in bulk for licensing applications.
LPT3-04™ is a naturally occurring compound, which is normally consumed in the human diet in small amounts. In the course of our SMaRT Replacement Therapy research program, we discovered that consumption of significantly larger amounts of LPT3-04 resulted in dose-dependent weight loss in experimental animal models. The mechanism of action appears to be induction of apoptosis, or programmed cell death, specifically in white fat cells. LPT3-04 consumption in the required amounts has been shown to be safe in humans. Anecdotally, weight loss has been observed in human volunteers. Due to the natural sweetness of LPT3-04 and the relatively large amounts of it that need to be consumed on a daily basis to achieve the desired weight loss effect, current product development efforts are focused on incorporating the compound into bars, milkshakes, and other food products.
Regulatory status
We have submitted a patent application for the use of LPT3-04 for weight regulation with the United States Patent and Trademark Office, or U.S. PTO