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Oragenics Inc (OGEN) RSS Feed

Followers
0
Posters
4
Posts (Today)
0
Posts (Total)
22
Created
02/28/11
Type
Free
Moderators


Contact Us

Corporate Headquarters    

3000 Bayport Dr. Suite 685
Tampa, FL 33607

Phone:
813.286.7900

Fax:
813.286.7904

Email:
info@oragenics.com    

 

Research & Development Address:

13700 Progress Blvd
Alachua, FL 32615

Phone:
386.418.4018

Fax:
386.418.1660

 

 

Overview

We are 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.

Mission Statement

Our mission is to create a profitable, high-impact business that uses innovation to develop and monetize unique solutions for global public health problems. To that end, we desire to leverage our innovative capabilities in science and business and utilize agility and efficiency to achieve and maintain an advantage over our competitors, who may have financial, structural and political advantages.

 

Cavity Prevention

History of Oragenics

Oragenics, Inc. was founded in 1996 by Dr. Jeffrey Hillman and Dr. Robert Zahradnik.

We are a biopharmaceutical company focusing on developing breakthrough technologies aimed at maintaining and improving human health conditions. Oragenics is committed to building long-term shareholder value by internally developing or in-licensing technologies and partnering with industry leaders to create novel therapies and diagnostic products.

Dr. Jeffery Hillman began his basic research into the concept of replacement therapy for preventing dental caries or cavities in the late 1970s at the Forsyth Institute in Boston. He transferred his research to the University of Florida College of Dentistry in 1992. There, he continued to pursue the development of a genetically engineered strain of Streptococcus mutans that could help prevent cavities by replacing the body’s natural caries-causing strains of S. mutans.

Currently in clinical trials, Oragenics’ patented SMaRT Replacement Therapy™ is a painless, one-time, five-minute treatment that has the potential to offer lifelong protection against tooth decay. Applied topically to the teeth with a swab, the therapy can be administered by dentists in the office or in the field.

During his work with S. mutans, Dr. Hillman discovered MU 1140™, or a mutacin, a powerful lantibiotic that is produced by the bacterium in tiny amounts. This new broad-spectrum antibiotic has demonstrated activity against Gram-positive bacteria responsible for a variety of clinically important diseases, such as MRSA (methicillin-resistant Staphylococcus aureus), VRE (vancomycin-resistant Enterococcus faecalis) and both growing and non-replicating Mycobacterium tuberculosis cells.

Preclinical studies indicate that MU 1140 has the potential to replace current antibiotic drugs that are increasingly failing due to the development of bacterial resistance. The Centers for Disease Control estimates that bacteria resistant to known antibiotics cause 44% of hospital infections, which cause as many as 70,000 patient deaths per year.

MU 1140 belongs to the novel class of molecules called lantibiotics, one of which was first discovered more than 80 years ago. However, there has never been a practical way to produce lantibiotics in sufficient amounts and with sufficient purity to enable comprehensive testing and commercial viability – until recently.

In the fourth quarter of 2008, Oragenics announced the successful synthesis of the MU 1140 molecule through our patented organic chemistry synthesis platform, DPOLT™ (Differentially Protected Orthogonal Lantionine Technology). DPOLT would enable large-scale, cost-effective production of clinical grade MU 1140 and potentially 50 other known lantibiotics. This represents a substantial pipeline of antibiotics to replace ones that are currently failing, which could save 70,000 lives among U.S. hospital patients alone.

Under the research leadership of Dr. Hillman, the company is also developing two proprietary platforms for the identification of genetic targets that can be used in diagnostic tests as well as in vaccines and therapeutics. PIVIAT™ (Proteomic-based In Vivo-Induced Antigen Technology) enables rapid identification of novel targets for use in the diagnosis and treatment of human infectious diseases. The method is faster, more cost effective and more sensitive than other methods currently in use. A tuberculosis project has yielded 44 novel targets for Mycobacterium tuberculosis that are currently being analyzed for their use in vaccine and diagnostic strategies.

PCMAT™ (Proteomic-based Change Mediated Antigen Technology) rapidly identifies proteins and their genes that are expressed when a cell undergoes any sort of change. It has been used to identify proteins of both plants and pathogens that are expressed during infection. Such genes are excellent targets for manipulation to increase the resistance of the plant to infection. In a study on colorectal cancer, PCMAT has been used to identify novel proteins of human bowel cells that are expressed when the cell undergoes transformation to a cancerous cell. Such proteins are excellent targets for new diagnostics and therapeutic strategies. PCMAT has the potential to study an extraordinary range of medical and agricultural applications.
 

Building shareholder value through
R&D leadership
 
ProBiora3 Info
Investor Overview
Market Capitalization (as of September 30, 2010)
Common shares authorized     15,000,000
Common shares issued and outstanding     5,663,076
Preferred shares authorized     20,000,000
Preferred shares issued     0
Warrants issued and unexercised     306,388
Stock options granted and unexercised     398,114
Fully diluted     6,367,578


Exchanges
OTCBB - Over-the-Counter-Bulletin-Board - ORNI

Transfer Agent
Confidential Stock Transfer and Trust Company
17 Battery Place
New York, NY 10004
Phone: 212-509-4000

   
Independent Accountants
Kirkland Russ Murphy and Tapp
13577 Feather Sound Drive, Suite 400
Clearwater, FL 33762
Phone: 727-752-1400
Corporate Counsel
Shumaker, Loop, and Kendrick, LLP
101 East Kennedy Boulevard, Suite 2800
Tampa, FL 33672
Phone: 813-229-7600    

CUSIP Number: 684023 10 4

ISIN: US6840231046

 

ORAGENICS INC (ORNI:OTC BB)

LAST $3.50 USD
CHANGE TODAY 0.00 0.00%
VOLUME 0.0
As of 8:10 PM 02/25/11 All times are local (Market data is delayed by at least 15 minutes).

Snapshot of ORAGENICS INC (ORNI)

OPEN
$3.50
 
PREVIOUS CLOSE
$3.50
DAY HIGH
$3.50
 
DAY LOW
$3.50
52 WEEK HIGH
04/12/10 - $14.60
 
52 WEEK LOW
12/22/10 - $2.95
MARKET CAP
19.8M
 
AVERAGE VOLUME 10 D
1.2K
EPS TTM
--
 
SHARES OUTSTANDING
5.7M
ORNI Does Not Pay Dividends
 
P/E TTM
--
K = Thousands  M = Millions  B = Billions

ORNI Details

Oragenics, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of various products and technologies associated with oral health, antibiotics, and other general health benefits in the United States. The company also has various products in discovery, preclinical, and clinical development concentrating in the therapeutic area of infectious diseases, in diagnostics, and in oral health. It operates in four divisions: Consumer Healthcare, Biomarker Discovery, Antibiotics, and Biologics. The Consumer Healthcare division develops oral probiotics based on the ProBiora3 technology that employs three natural strains of beneficial bacteria, which promote oral health; and weight loss products based on the LPT3-04, a weight loss agent (food/nutritional supplement). The Biomarker Discovery division offers Proteomic-based in-vivo induced antigen technology and Proteomic-based change mediated antigen technology platforms for the identification of genetic targets used in diagnostic tests, as well as in vaccines and therapeutics. The Antibiotics division is developing DPOLT or differentially protected orthogonal lantionine technology, a solid/liquid phase peptide synthesis platform technology that has various application for the manufacture of commercially important bioactive peptides, including lantibiotics; and MU 1140 an antibiotic with antimicrobial activity against drug resistant organisms, such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecalis, and Streptococcus pneumoniae. The Biologics division develops SMaRT Replacement Therapy, a topical treatment under Phase I clinical trial against dental caries. The company, formerly known as Oragen, Inc., was founded in 1996 and is based in Alachua, Florida.

14 Employees
Last Reported Date: 10/5/10
Founded in 1996

ORNI Top Compensated Officers

Interim Chief Executive Officer, Chief Financ...
Age: 56
Total Annual Compensation: $156.8K
 
Co-Founder, Chief Scientific Officer and Dire...
Age: 61
Total Annual Compensation: $182.3K
 
 
Executive Vice President of Sales & Marketing
Age: 58
Total Annual Compensation: $161.3K
 
 
 
Director of Research & Development
Age: 39
Total Annual Compensation: $158.8K
Compensation as of Fiscal Year 2009.

   
 

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