UNITED
      STATES
    SECURITIES
      AND EXCHANGE COMMISSION
    Washington,
      D.C. 20549
    
    FORM
      10-Q
    
    
      
          
            | x | QUARTERLY
                REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
                1934
                 For
                the quarterly period ended June 30, 2008. | 
          
            |  |  | 
          
            |  | OR | 
          
            |  |  | 
          
            | o | TRANSITION
                REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
                ACT | 
          
            |  |  | 
          
            |  | For
                the transition period from ________ to
                __________ | 
      
     
    
    Commission
      File Number: 000-50614
    
    ORAGENICS,
      INC.
    (Exact
      name of small business issuer as specified in its charter)
    
    
      
          
            | FLORIDA |  | 59-3410522 | 
          
            | (State
                or other jurisdiction of incorporation or organization) |  | (IRS
                Employer Identification No.) | 
      
     
    
    13700
      Progress Boulevard
    Alachua,
      Florida 32615
    (Address
      of principal executive offices)
    
    (386)
      418-4018
    (Issuer's
      telephone number)
    
    Check
      whether the issuer (1) filed all reports required to be filed by Section 13
      or
      15(d) of the Exchange Act during the past 12 months (or for such shorter period
      that the registrant was required to file such reports), and (2) has been subject
      to such filing requirements for the past 90 days. 
    Yes
x
      No o
    
     
    Indicate
      by check mark whether the registrant is a large accelerated filer, an
      accelerated filer, a non-accelerated filer, or a smaller reporting company.
      See
      the definitions of “large accelerated filer, “accelerated filer,”
“non-accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the
      Exchange Act.
     
    
      
          
            |  | Large
                accelerated filer  
                 |  | Accelerated
                filer  
                 |  |  | 
          
            |  |  |  |  |  |  | 
          
            |  | Non-accelerated
                filer  
                 |  | Smaller
                reporting company 
                 |  |  | 
      
     
    
    Indicate
      by check mark whether the registrant is a shell company (as defined in Rule
      12b-2 of the Exchange Act). 
    Yeso
      No x
    
    State
      the
      number of shares outstanding of each of the issuer’s classes of common equity,
      as of the latest practicable date:
    
    As
      of
      August 11, 2008, there were 38,316,585 shares of Common Stock, $.001 par value,
      outstanding.
    
    
    
      
          
            |  |  | Page | 
          
            | PART
                I - FINANCIAL INFORMATION |   |   | 
          
            | Item
                1. | Financial
                Statements |   |   | 
          
            |   | Balance
                Sheets as of June 30, 2008 (unaudited) and December 31, 2007
                 |   | 3 | 
          
            |   | Statements
                of Operations for the Three and Six Months ended June 30, 2008 and
                2007
                (unaudited) |   | 4 | 
          
            |   | Statements
                of Cash Flows for the Six Months ended June 30, 2008 and 2007
                (unaudited) |   | 5 | 
          
            |   | Notes
                to Financial Statements (unaudited) |  | 6 | 
          
            | Item
                2. | Management’s
                Discussion and Analysis of Financial Condition and Results of Operations
                 |  | 8 | 
          
            | Item
                4T. | Controls
                and Procedures   |  | 16 | 
          
            |   |  |  | 
          
            | PART
                II - OTHER INFORMATION |  |  | 
          
            | Item
                1A. | Risk
                Factors |  | 17 | 
          
            | Item
                2. | Unregistered
                Sales of Equity Securities and Use of Proceeds |  | 20 | 
          
            | Item
                4. | Submission
                of Matters to a Vote of Security Holders |  | 21 | 
          
            | Item
                5. | Other
                Information |  | 22 | 
          
            | Item
                6.  | Exhibits
                 |  | 23 | 
      
     
    
    
     
    PART
      I - FINANCIAL INFORMATION
    
    ITEM
      1. FINANCIAL
      STATEMENTS
    
    Oragenics,
      Inc.
    
    Balance
      Sheets
    
    
      
          
            |  |  | June
                30, 2008 |  |  December
                31,  2007 |  | 
          
            |  |  | (Unaudited) |  |  |  | 
          
            | Assets |  |  |  |  |  | 
          
            | Current
                assets: |  |  |  |  |  | 
          
            | Cash
                and cash equivalents |  | $ | 3,634,145 |  | $ | 475,508 |  | 
          
            | Prepaid
                expenses and other current assets |  |  | 215,999 |  |  | 116,520 |  | 
          
            | Total
                current assets |  |  | 3,850,144 |  |  | 592,028 |  | 
          
            |  |  |  |  |  |  |  |  | 
          
            | Property
                and equipment, net |  |  | 413,878 |  |  | 559,349 |  | 
          
            | Total
                assets |  | $ | 4,264,022 |  | $ | 1,151,377 |  | 
          
            |  |  |  |  |  |  |  |  | 
          
            | Liabilities
                and stockholders’ equity |  |  |  |  |  |  |  | 
          
            | Current
                liabilities: |  |  |  |  |  |  |  | 
          
            | Accounts
                payable and accrued expenses  |  | $ | 253,395 |  | $ | 244,994 |  | 
          
            | Current
                portion of note payable |  |  | 69,215 |  |  | - |  | 
          
            | Deferred
                compensation |  |  | 42,750 |  |  | 86,500 |  | 
          
            | Total
                current liabilities |  |  | 365,360 |  |  | 331,494 |  | 
          
            |  |  |  |  |  |  |  |  | 
          
            |  |  |  |  |  |  |  |  | 
          
            | Stockholders’
                equity: |  |  |  |  |  |  |  | 
          
            | Preferred
                stock, no par value; 20,000,000 shares authorized; none issued and
                outstanding at June 30, 2008 and December 31, 2007 |  |  | 
               
               - |  |  | 
               
               - |  | 
          
            | Common
                stock, $0.001 par value; 100,000,000 shares authorized; 38,316,585
                and
                28,002,443 shares issued and outstanding at June 30, 2008 and December
                31,
                2007, respectively |  |  | 
               
               
               38,316 |  |  | 
               
               
               28,002 |  | 
          
            | Additional
                paid-in-capital |  |  | 19,717,887 |  |  | 14,762,674 |  | 
          
            | Accumulated
                deficit |  |  | (15,857,541 | ) |  | (13,970,793 | ) | 
          
            | Total
                stockholders’ equity |  |  | 3,898,662 |  |  | 819,883 |  | 
          
            | Total
                liabilities and stockholders’ equity |  | $ | 4,264,022 |  | $ | 1,151,377 |  | 
      
     
    
    See
      accompanying notes.
     
    
     
    Oragenics,
      Inc.
    
    Statements
      of Operations 
    (Unaudited)
     
    
      
          
            |  |  | Three
                months ended June
                30 |  | Six
                months ended June
                30 |  | 
          
            |  |  | 2008 |  | 2007 |  |  2008 |  | 2007 |  | 
          
            | Revenue |  | $ | - |  | $ | 26,673 |  | $ | 125,000 |  | $ | 59,761 |  | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | Operating
                expenses: |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | Research
                and development |  |  | 492,667 |  |  | 401,353 |  |  | 971,040 |  |  | 772,276 |  | 
          
            | General
                and administration |  |  | 618,886 |  |  | 221,612 |  |  | 1,066,608 |  |  | 439,425 |  | 
          
            | Total
                operating expenses |  |  | 1,111,553 |  |  | 622,965 |  |  | 2,037,648 |  |  | 1,211,701 |  | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | Loss
                from operations |  |  | (1,111,553 | ) |  | (596,292 | ) |  | (1,912,648 | ) |  | (1,151,940 | ) | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | Other
                income: |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | Interest
                income |  |  | 9,731 |  |  | 4,567 |  |  | 14,330 |  |  | 14,393 |  | 
          
            | Gain
                on sale of property and equipment |  |  | - |  |  | - |  |  | 4,860 |  |  | - |  | 
          
            | Sales
                tax refund |  |  | 6,710 |  |  | - |  |  | 6,710 |  |  | - |  | 
          
            | Total
                other income  |  |  | 16,441 |  |  | 4,567 |  |  | 25,900 |  |  | 14,393 |  | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | Net
                loss |  | $ | (1,095,112 | ) | $ | (591,725 | ) | $ | (1,886,748 | ) | $ | (1,137,547 | ) | 
          
            |   |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | Basic
                and diluted net loss per share |  | $ | (0.03 | ) | $ | (0.03 | ) | $ | (0.06 | ) | $ | (0.05 | ) | 
          
            | Shares
                used to compute basic and diluted net loss per share |  |  | 
               33,694,363 |  |  | 
               23,198,927 |  |  | 
               31,768,114 |  |  | 
               20,764,214 |  | 
      
     
    
    See
      accompanying notes.
    
    
     
    Oragenics,
      Inc.
    
    Statements
      of Cash Flows
    (Unaudited)
    
      
        
            
              |   |  | Six
                  months ended  June
                  30 |  | 
            
              |  |  | 2008 |  |  2007 |  | 
            
              | Operating
                  activities |  |  |  |  |  | 
            
              | Net
                  loss |  | $ | (1,886,748 | ) | $ | (1,137,547 | ) | 
            
              | Adjustments
                  to reconcile net loss to net cash used in operating
                  activities: |  |  |  |  |  |  |  | 
            
              | Depreciation |  |  | 125,581 |  |  | 137,997 |  | 
            
              | Gain
                  on sale of property and equipment |  |  | (4,860 | ) |  | - |  | 
            
              | Stock-based
                  compensation expense resulting from fair value based
                  method |  |  | 454,527 |  |  | 99,036 |  | 
            
              | Changes
                  in operating assets and liabilities: |  |  |  |  |  |  |  | 
            
              | Prepaid
                  expenses and other current assets |  |  | (84,479 | ) |  | (151,093 | ) | 
            
              | Accounts
                  payable and accrued expenses |  |  | 8,401 |  |  | 92,620 |  | 
            
              | Deferred
                  compensation |  |  | (43,750 | ) |  | (45,500 | ) | 
            
              | Net
                  cash used in operating activities |  |  | (1,431,328 | ) |  | (1,004,487 | ) | 
            
              |  |  |  |  |  |  |  |  | 
            
              | Investing
                  activities  |  |  |  |  |  |  |  | 
            
              | Purchases
                  of property and equipment |  |  | (17,500 | ) |  | (6,079 | ) | 
            
              | Proceeds
                  from sale of property and equipment |  |  | 27,250 |  |  | - |  | 
            
              | Net
                  cash provided by (used in) investing activities |  |  | 9,750 |  |  | (6,079 | ) | 
            
              |  |  |  |  |  |  |  |  | 
            
              | Financing
                  activities |  |  |  |  |  |  |  | 
            
              | Net
                  proceeds from note payable |  |  | 69,215 |  |  | - |  | 
            
              | Net
                  proceeds from issuance of common stock  |  |  | 4,511,000 |  |  | 454,757 |  | 
            
              | Net
                  cash provided by financing activities |  |  | 4,580,215 |  |  | 454,757 |  | 
            
              |  |  |  |  |  |  |  |  | 
            
              | Net
                  increase (decrease) in cash and cash equivalents |  |  | 3,158,637 |  |  | (555,809 | ) | 
            
              | Cash
                  and cash equivalents at beginning of period |  |  | 475,508 |  |  | 707,278 |  | 
            
              | Cash
                  and cash equivalents at end of period |  | $ | 3,634,145 |  | $ | 151,469 |  | 
        
       
     
     
    See
      accompanying notes.
    
    
    Oragenics,
      Inc.
    
    Notes
      to Financial Statements
    (Unaudited)
    
    1. Organization
      and Significant Accounting Policies
     
    Oragenics,
      Inc. (d/b/a ONI BioPharma, Inc., formerly known as Oragen, Inc.) (the Company)
      was incorporated in November 1996; however, operating activity did not commence
      until 1999. The Company is dedicated to developing technologies associated
      with
      oral health, broad spectrum antibiotics and general health benefits.
    
    Basis
      of
      Presentation
    
    The
      accompanying unaudited condensed financial statements as of June 30, 2008 and
      December 31, 2007 and for the three and six months ended June 30, 2008 and
      2007
      have been prepared in accordance with accounting principles generally accepted
      in the United States of America (GAAP) for interim financial information and
      with the instructions to Form 10-Q and Article 10 of Regulation S-X.
      Accordingly, they do not include all of the information and footnotes required
      by GAAP for complete financial statements. In the opinion of management, the
      accompanying financial statements include all adjustments, consisting of normal
      recurring accruals, necessary for a fair presentation of the financial
      condition, results of operations and cash flows for the periods presented.
      The
      results of operations for the interim period June 30, 2008 are not necessarily
      indicative of the results that may be expected for the year ended December
      31,
      2008 or any future period.
     
    These
      financial statements should be read in conjunction with the audited financial
      statements and notes thereto for the year ended December 31, 2007 which are
      included in our Annual Report on Form 10-KSB filed with the Securities and
      Exchange Commission on March 18, 2008. In that report the Company disclosed
      that
      it expects to incur substantial expenditures to further develop each of its
      technologies. It further stated that it believes its working capital will be
      insufficient to meet the business objectives as presently structured and that
      without sufficient capital to fund its operations, the Company will be unable
      to
      continue as a going concern. The accompanying financial statements do not
      include any adjustments that might result from the outcome of this
      uncertainty.
     
    2. Net
      Loss
      Per Share
    
    Net
      loss
      per share is computed using the weighted average number of shares of common
      stock outstanding. Common equivalent shares from stock options and warrants
      are
      excluded as their effect is anti-dilutive.
    
    3. Income
      Taxes
    
    Income
      taxes are accounted for under the asset and liability method. Deferred tax
      assets and liabilities are recognized for future tax consequences attributable
      to differences between the financial statement carrying amounts of existing
      assets and liabilities and their respective tax bases and operating loss and
      tax
      credit carryforwards. Deferred tax assets and liabilities are measured using
      enacted tax rates expected to apply to taxable income in the years in which
      those temporary differences are expected to be recovered or settled. The effect
      on deferred tax assets and liabilities of a change in tax rate is recognized
      in
      operations in the period that includes the enactment date. Deferred tax assets
      are reduced to estimated amounts expected to be realized by the use of a
      valuation allowance.
    
    In
      September 2006, the FASB issued FASB Interpretation No. 48, “Accounting
      for Uncertainty in Income Taxes, an interpretation of FASB Statements
      No. 109”
(FIN
      48). FIN 48 clarifies the accounting for uncertainty in income taxes by
      prescribing a two-step method of first evaluating whether a tax position has
      met
      a more likely than not recognition threshold and second, measuring that tax
      position to determine the amount of benefit to be recognized in the financial
      statements. FIN 48 provides guidance on the presentation of such positions
      within a classified statement of financial position as well as on derecognition,
      interest and penalties, accounting in interim periods, disclosure, and
      transition. FIN 48 was adopted by the Company effective January 1, 2007. As
      a result of the implementation of FIN 48, the Company did not recognize a change
      in its tax liabilities or assets as of June 30, 2008.
     
    
     
    4. Fair
      Value of Financial Instruments
     
    SFAS
      No.
      157, Fair
      Value Measurements (“SFAS
      157”), defines fair value, establishes a framework for measuring fair value in
      accordance with generally accepted accounting principles, and expands
      disclosures about fair value measurements. SFAS 157 establishes a three-tier
      fair value hierarchy which prioritizes the inputs used in measuring fair value
      as follows: 
     
    Level
      1. Observable
      inputs such as quoted prices in active markets;
     
    Level
      2.
      Inputs,
      other than the quoted prices in active markets, that are observable either
      directly or indirectly; and
     
    Level
      3.
      Unobservable inputs in which there is little or no market data, which require
      the reporting entity to develop its own assumptions.
     
    The
      Company does not have any assets or liabilities measured at fair value on a
      recurring basis at June 30, 2008. The Company did not have any fair value
      adjustments for assets and liabilities measured at fair value on a nonrecurring
      basis during the six months ended June 30, 2008.
    
    
    
    On
      June
      12, 2008, our Securities Purchase Agreement with accredited investors became
      binding and we closed on $2,600,000 in equity based financing with net proceeds
      of $2,515,000. We issued a total of 5,777,778 shares of restricted common stock
      in the private placement. The shares were sold to accredited investors at $0.45
      per share. Each participating investor also received warrants to purchase shares
      of common stock at the price of $1.30 per share. One warrant was issued for
      each
      share of common stock issued for a total of 5,777,778 shares that may be
      acquired upon exercise of the warrants. The warrants are exercisable and expire
      July 1, 2013. We intend to use the net proceeds of the private placement,
      including any proceeds from exercise of the warrants, for working capital and
      general corporate purposes. 
     
    
      
          
            | 6. | Stock
                Options Issued During 2nd
                Quarter, 2008 | 
      
     
    
    During
      the quarter, the Company issued 2,780,000 stock options of which 1,191,667
      vested immediately. The remaining options that have yet to vest will vest
      subject to the price of the stock reaching certain levels. The stock options
      were granted (1) to existing employees to supplement or replace options that
      were previously granted that had exercise prices far out-of-the-money, and
      (2)
      to executive employees who recently joined the Company. This increase in the
      number of options granted was partially offset by the number of stock options
      that have been forfeited. Since the beginning of the 2nd
      Quarter,
      2008, through the date of this filing, 715,000 options that were previously
      granted have been forfeited. From January, 1, 2008 to the date of this filing,
      850,000 stock options have been forfeited. It is important to note that stock
      options compensation expense is a non-cash expense.
     
    
    ITEM
      2. MANAGEMENT’S
      DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
      OPERATIONS
    
    The
      following information should be read in conjunction with the Financial
      Statements, including the notes thereto, included elsewhere in this Form 10-Q.
      This discussion contains certain forward-looking statements that involve risks
      and uncertainties. Our actual results and the timing of certain events could
      differ materially from those discussed in these forward-looking statements
      as a
      result of certain factors, including, but not limited to, those set forth herein
      and elsewhere in this Form 10-Q.
    
    Oragenics,
      Inc. d/b/a ONI Biopharma, Inc, (the “Company” or “ONI”) has changed its strategy
      as it has the name under which it does business. ONI is no longer strictly
      a
      research and development company, but, as management expects, is now securely
      on
      the road towards the commercialization of some of its products. ONI is also
      moving forward with the clinical testing of other products to achieve
      registration in as timely a manner as possible. These opportunities have derived
      from our focus on creating novel technologies that apply to individual products
      as well as platforms from which numerous products can be developed.
    
    Second
      Quarter Highlights
    
    During
      the quarter the following significant events occurred:
    
      
        
            
              |  | · | Officer
                  and Board of Director Changes. During
                  the quarter, our Board of Directors appointed Mr. Stanley B. Stein
                  as
                  President and Chief Executive Officer and David B. Hirsch as Chief
                  Operating Officer and Chief Financial Officer. During the quarter,
                  our
                  Board of Directors also appointed Mr. Kevin H. Sills as an independent
                  director and Dr. Marc Siegel as a director. The change in management
                  and
                  the additions to our Board of Directors has brought a greater depth
                  of
                  experience for us to draw upon in our commercialization
                  efforts. | 
        
       
      
      
        
            
              |  | · | Launch
                  of Probiora3. We
                  announced the test marketing of our oral probiotic product, Probiora3
                  through chewable tablets which we believe help to whiten teeth
                  and improve
                  breath. Probiora3 is a unique combination of safe, naturally occurring
                  bacteria that are released in the mouth by chewing on a mint-flavored
                  tablet that we have designed to be used twice daily.
                   | 
        
       
      
      
        
            
              |  | · | Name
                  Change.
                  On
                  May 13, 2008 we announced that we approved our name change to “ONI
                  BioPharma Inc.” which is how we will refer to ourselves until we are able
                  to seek shareholder approval to amend our articles of incorporation
                  in
                  order to formally change our name. We believe the new name more
                  accurately
                  reflects the broad range of scientific platforms and products we
                  have
                  under development.  | 
        
       
      
      
        
            
              |  | · | Financing
                  Transaction. On
                  June 12, 2008 we announced that we had entered into a stock purchase
                  agreement with accredited investors, pursuant to which we received
                  net
                  proceeds of $2,515,000, which will be used for general corporate
                  purposes.
                  In the transaction we issued 5,777,778 shares of common stock and
                  warrants
                  to acquire 5,777,778 shares of common stock at an exercise price
                  of $1.30
                  per share.  | 
        
       
      
      
        
            
              |  | · | Amex
                  Compliance Extension. We
                  obtained an extension from the American Stock Exchange to meets
                  its
                  requirements for continued listing. Our deadline for meeting Amex’s
                  continued listing requirements which require us to have minimum
                  shareholder equity of $4,000,000 is October 27, 2008. Additionally,
                  these
                  AMEX minimum listing requirements will increase the minimum shareholder
                  equity requirement to $6,000,000 at year end. Our plan is to have
                  in
                  excess of $6,000,000 in shareholder equity by year end, thereby
                  complying
                  with current and future AMEX listing
                  requirements. | 
        
       
     
     
    Since
      ONI’s inception, the Company has funded a significant portion of its operations
      from the public and private sales of its securities. There have been no
      significant revenues from operations during the last two years. All of our
      revenues have been from sponsored research agreements and various governmental
      grants. At this time we have not generated revenues from sales of products.
      
    
    Management
      believes that we are now positioned over the next several months to generate
      revenues from a number of technologies. Furthermore, with respect to products
      that are not ready for immediate commercialization, we are taking what we regard
      to be concrete steps in completing the research and development of pending
      products and platforms. Consequently, our proofs of concept are essentially
      complete, and we are taking the steps necessary to bring our product portfolio
      to market, with the expectation, but not assurance that our products, where
      necessary will be approved for marketing.
     
    
    
    Business
      Objectives and Milestones
     
    We
      have a
      number of products and platforms. For ease in understanding., we have broken
      these products and platforms down into four distinct categories; (1) Consumer
      Products, which consists of ProBiora3 and LPT3-04, (2) Diagnostics, which
      consists of the IVIAT and CMAT platforms, (3) Antibiotics, which consists the
      DPOLT lantibiotic synthesis platform, and (4) SMaRT replacement
      therapy.
     
    Consumer
      Products
    
    The
      specific goal for our consumer products is to rapidly and effectively
      commercialize ProBiora3 and LPT3-04.
    
    Probiora3™
      (Probiotics) 
    
    We
      have
      made strides in its commercialization efforts regarding our oral probiotic,
      ProBiora3. We are currently in the final stages in the development of a
      comprehensive global marketing strategy for the Probiora3 technology. We expect
      to unveil this comprehensive strategy in the near future. We believe ProBiora3
      to be a safe and efficacious treatment for oral care including the gums, teeth
      and breath. 
    
    Although
      it will take some time to generate sufficient sales that may be produced by
      such
      efforts, we expect the product to be profitable. Furthermore, we will expect
      to
      comply with applicable regulations with respect to each foreign jurisdiction
      in
      which we expect to sell the product, and intend to test the product on a
      continuing basis to increase the amount of benefits that we may claim with
      respect to it. Currently, we are planning to market ProBiora3 in the United
      States this September. In order to effectively launch the product, we have
      retained experts in marketing, sales, media, design, and regulatory
      matters.
    
    Despite
      our commitment to commercializing ProBiora3, there can be no assurances that
      it
      will meet its timeline for commercialization or that the product will meet
      our
      sales projections that are anticipated.
     
    Probiora3
      contains three naturally occurring, live microorganisms that helps maintain
      dental and oral health when administered to the host in adequate amounts. The
      use of yogurt containing live Lactobacillus
      cultures
      is an example of a probiotic application. Because probiotic treatments may
      be
      marketed as a cosmetic or as "health supplements" in certain geographic areas
      without the need for extensive regulatory oversight, we believe we can expedite
      our marketing efforts. Two sets of subjects completed our Probiora3 human study
      in 2006, and we believe the results confirmed that the product is safe for
      human
      use and demonstrated a substantial effect of Probiora3 in reducing the levels
      of
      specific bacteria in the mouths of young, healthy adult subjects. 
     
    LPT3-04™ 
    
    We
      have
      made material progress with respect to commercialization of our weight loss
      product LPT3-04. We are currently exploring several marketing and packaging
      options and anticipate a product launch of LPT3-04 in the first-half of 2009.
      However, there can be no assurances that the product will launch at that time.
      Initial clinical testing has shown the need for coating of the product to
      eliminate an uncomfortable side-effect of transient nausea. Management expects
      that a number of coatings will eliminate this side-effect. 
    
    LPT3-04
      is a small molecule weight management agent for which we filed a U.S. patent
      application on April 5, 2006 to protect our intellectual property rights to
      the
      agent and its analogs. As a natural substance, LPT3-04 is orally available,
      and
      we believe it has an excellent safety and tolerability profile. 
    
    Diagnostics
    
    The
      goal
      of our Diagnostics unit is to utilize the IVIAT and C MAT platforms to identify
      and secure intellectual property rights to gene targets associated with the
      natural onset and progression of infections, cancers and other diseases in
      humans, animals, and agricultural products. There are a number of profitable
      business models to realize value from these platforms. 
     
    
    
    One
      model
      that already has proven itself, is that of a third-party diagnostic company
      that
      requests genetic markers or targets from ONI. Such third-party diagnostic
      company pays for the markers or targets that it uses as well as a license fee
      if
      the diagnostic kit that encompasses the markers or targets receives regulatory
      approval. 
    
    IVIAT™
      and CMAT™ 
    
    The
      first
      major commercial effort that we have undertaken utilizing the CMAT platform
      has
      been to extract genetic targets from tissue samples containing colorectal
      cancer. Colorectal cancer affects millions of people worldwide. The current
      “Gold Standard” in the detection of colorectal cancer is the use of a
      colonoscopy. Due to the invasive nature and cost of colonoscopies, patient
      compliance is low. As such, many cases of bowel cancer go undetected until
      the
      cancer has reached an advanced stage. Using the CMAT diagnostic platform, we
      have discovered what we believe to be unique genetic markers that appear during
      the earliest stages of colorectal cancer. At this time we are in active
      discussions with a major company in the diagnostics market to determine the
      potential of these markers. We intend to form a collaborative arrangement with
      the diagnostics company referred to herein to test and subsequently incorporate
      the CMAT markers into a diagnostic blood test for the early detection of
      colorectal cancer.
    
    Although
      we are aggressively undertaking the completion of this arrangement, there can
      be
      no assurances that such genetic markers will result in a diagnostic test that
      will be marketed to appropriate health care professionals, nor can there be
      any
      assurance that upon further examination, the diagnostic company will elect
      to
      use these markers.
    
    Our
      IVIAT
      platform, which revolves around the extraction of gene targets for infectious
      diseases, has also made progress. We are currently in discussions with major
      foundations and institutions with respect to diseases of epidemic
      proportions.
     
    CMAT
      and
      IVIAT are technologies that enable the simple, fast identification of novel
      and
      potentially important gene targets associated with the natural onset and
      progression of infections, cancers and other diseases in humans and other living
      organisms, including plants. These technologies offer the potential to generate
      and develop a number of product candidates as diagnostics or therapeutics for
      future out-licensing to corporate partners, particularly in the areas of cancer
      and infectious diseases. 
     
    Antibiotics
      
    
    DPOLT™
      (Differentially Protected Orthogonal Lantionine
      Technology)
    
    Through
      the DPOLT platform, we believe we have the ability to synthesize lantibiotic
      molecules that have historically been un-synthesizable. In proving this concept,
      the company is currently in the process of using the platform to synthesize
      the
      MU 1140 molecule. We have extensively studied MU 1140, in its naturally
      occurring state. As a result of such tests, MU 1140 has proven itself to be
      a
      uniquely effective antibiotic. If our efforts to synthesize MU 1140 are
      successful, we believe we will then have the ability to produce the synthetic
      version of the molecule in commercial quantities. We will then have the ability
      to use the DPOLT platform to potentially synthesize numerous other
      lantibiotics.
    
    DPOLT
      is
      a solid and/or liquid phase peptide synthesis platform technology that has
      broad
      application for the cost-effective manufacture of a number of commercially
      important bioactive peptides. Scientific literature has demonstrated that
      various Lantibiotics are highly effective at accomplishing their goals of
      killing off foreign bacteria. These Lantibiotics, which include our lead
      antibiotic, MU 1140, are a potentially important class of antibiotics, and
      constitute a family of polycyclic peptides that are produced by bacteria, and
      are highly modified structurally. However, attempts to study Lantibiotics for
      their potential usefulness as therapeutic agents have been hindered by the
      difficulty of producing sufficient pure material in amounts adequate for
      clinical testing let alone commercialization. DPOLT provides a basis to overcome
      this impediment to further research and development in this area as we believe
      it constitutes a platform from which such Lanitbiotics would be able to be
      produced in sufficiently pure quantities for research and ultimately
      commercialization. 
    
    SMaRT
      Replacement Therapy™
    
    We
      currently have FDA approval for Phase 1B clinical trial for SMaRT. It may make
      sense for us to commence this clinical trial in Mexico where there appears
      to be
      broad public health demand for this product.
     
    
    
    SMaRT
      Replacement Therapy is a single, painless one time topical treatment to teeth
      that has the potential to offer significant lifelong protection against dental
      caries (tooth decay). The therapy is based on genetically altering the
      bacterium, Streptococcus mutans (S. mutans), which is the primary etiologic
      agent in tooth decay. Present in the normal flora of the mouth, S. mutans
      convert dietary sugar to lactic acid; the lactic acid, in turn, causes the
      erosion of tooth enamel that results in the destruction of the tooth surface
      and
      eventually the entire tooth. SMaRT Replacement Therapy permanently replaces
      resident acid-producing S. mutans with a patented genetically modified strain
      of
      S. mutans that does not produce lactic acid. Applied topically to tooth surfaces
      with a cotton-tipped swab, the therapy may require only one application.
     
    Global
      Expansion
    
    We
      are in
      active negotiations with various parties in Mexico to create a research and
      development business, and ultimately, a base for clinical studies, manufacturing
      and distribution of our products in Mexico, Central America, South America
      and
      the Caribbean. We hope to benefit from collaboration with a leading academic
      center as well as working with individual or corporate partners.
    
    Although
      discussions have been on going for some time, there is a risk that an agreement
      that is satisfactory to the Company cannot be completed.
     
    Critical
      Accounting Policies
     
    Our
      discussion and analysis of our financial condition and results of operations
      are
      based upon our financial statements, which have been prepared in accordance
      with
      accounting principles generally accepted in the United States of America. The
      preparation of financial statements in accordance with accounting principles
      generally accepted in the United States of America requires us to make estimates
      and assumptions that affect reported amounts and related disclosures. We
      consider an accounting estimate to be critical if it requires assumptions to
      be
      made that were uncertain at the time the estimate was made; and changes in
      the
      estimate or different estimates that could have been made could have a material
      impact on our results of operations or financial condition. Our financial
      statements do not include any significant estimates other than stock based
      compensation that would have a material impact on our results of operations
      or
      financial condition.
     
    New
      Accounting Pronouncements
     
    In
      September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS
      No. 157, Fair
      Value Measurements (“SFAS
      157”). SFAS 157 defines fair value, establishes a framework for measuring fair
      value in accordance with generally accepted accounting principles, and expands
      disclosures about fair value measurements. SFAS 157 is effective for fiscal
      years beginning after November 15, 2007. In February 2008, the FASB
      deferred the effective date of SFAS 157 until the fiscal year beginning after
      November 15, 2008 for all non-financial assets and non-financial liabilities,
      except those that are recognized or disclosed at fair value in the financial
      statements on a recurring basis (at least annually). The partial adoption of
      SFAS 157 for financial assets and liabilities did not have a material effect
      on
      the Company’s financial statements. The remaining requirements of SFAS 157 are
      not expected to have a material effect on the Company’s financial
      statements.
    
    In
      February 2007, the FASB issued SFAS No. 159, The
      Fair Value Option for Financial Assets and Financial
      Liabilities
      (“SFAS
      159”), which gives entities the option to measure eligible financial assets, and
      financial liabilities at fair value on an instrument by instrument basis, that
      are otherwise not permitted to be accounted for at fair value under other
      accounting standards. The election to use the fair value option is available
      when an entity first recognizes a financial asset or financial liability.
      Subsequent changes in fair value must be recorded in earnings. This statement
      is
      effective as of the beginning of a Company’s first fiscal year after
      November 15, 2007. The adoption of SFAS 159 did not have an effect on the
      Company’s financial statements as it did not elect this fair value
      option.
    
    In
      June
      2007, the FASB ratified Emerging Issues Task Force Issue No. 06-11,
Accounting
      for Income Tax Benefits of Dividends on Share-Based Payment Awards
(“EITF
      06-11”). EITF 06-11 specifies how companies should recognize the income tax
      benefit received on dividends that are (a) paid to employees holding
      equity-classified nonvested shares, equity-classified nonvested share units,
      or
      equity-classified outstanding share options and (b) charged to retained
      earnings under SFAS 123(R). The adoption of EITF 06-11 did not have a material
      impact on the Company’s financial statements. 
    
    
     
    In
      December 2007, the FASB issued SFAS No. 141 (revised 2007), Business
      Combinations
      (“SFAS
      141R”). SFAS 141R establishes principles and requirements for an acquiring
      entity to recognize and measure in its financial statements the identifiable
      assets acquired, the liabilities assumed, any noncontrolling interest in the
      acquired entity and the goodwill acquired. SFAS 141R expands on required
      disclosures to improve the statement users’ abilities to evaluate the nature and
      financial effects of business combinations. SFAS 141R is effective for fiscal
      years beginning after December 15, 2008. The Company is currently
      evaluating the potential impact, if any, of the adoption of SFAS 141R on its
      financial statements. 
     
    In
      December 2007, the FASB issued SFAS No. 160, Noncontrolling
      Interests in Consolidated Financial Statements—an amendment of ARB
      No. 51
      (“SFAS
      160”). SFAS 160 requires that a noncontrolling interest in a subsidiary be
      reported within equity and the amount of consolidated net income attributable
      to
      the noncontrolling interest be identified in the consolidated financial
      statements. SFAS 160 calls for consistency in the manner of reporting changes
      in
      the parent’s ownership interest and requires fair value measurement of any
      noncontrolling equity investment retained in a deconsolidation. SFAS No.
      160 also establishes disclosure requirements that clearly identify and
      distinguish between the interests of the parent and the interests of the
      noncontrolling owners. SFAS No. 160 is effective for fiscal years beginning
      after December 15, 2008. The Company is currently evaluating the potential
      impact, if any, of the adoption of SFAS 160 on its financial
      statements.
     
    In
      March
      2008, the FASB issued SFAS No. 161, Disclosures
      about Derivative Instruments and Hedging Activities — an amendment of FASB
      Statement No. 133 (“SFAS
      161”). This statement amends SFAS No. 133 by requiring enhanced
      disclosures about an entity’s derivative instruments and hedging activities, but
      does not change SFAS No. 133’s scope or accounting. SFAS 161
      requires increased qualitative, quantitative and credit-risk disclosures about
      the entity’s derivative instruments and hedging activities. SFAS 161 is
      effective for fiscal years, and interim periods within those fiscal years,
      beginning after November 15, 2008, with earlier adoption permitted. The
      adoption of SFAS 161 is not expected to have a material impact on the Company’s
      financial statements.
     
    
    Results
      of Operations
    
    Three
      Months Ended June 30, 2008 and 2007
    
    We
      had no
      revenues in the three months ended June 30, 2008 compared with $26,673 in
      revenues in the same period in 2007. Our first quarter operating expenses
      increased by 78.4% to $1,111,553 in the three months ended June 30, 2008 from
      $622,965 in the same period in 2007. Research and development (R&D) expenses
      increased 22.8% to $492,667 in the three months ended June 30, 2008 from
      $401,353 in the same period in 2007. This increase was primarily due to clinical
      trials for our LPT3-04 weight loss product. General and administration (G&A)
      expenses increased 179.3% to $618,886 in the three months ended June 30, 2008
      from $221,612 in the same period in 2007, reflecting the shift in corporate
      focus to commercialization. The increase can be attributed to the Company’s
      recruitment of a new management team, the continued use of outside consultants
      for business development to help facilitate our marketing plans for our
      technology and from stock option compensation expense (see Note 6, Notes to
      Financial Statements, p. 6). 
    
    Interest
      income increased 113.1% to $9,731 in the three months ended June 30, 2008 from
      $4,567 during the same period in 2007. This increase is primarily due to the
      Company’s strengthened cash position.
    
    We
      incurred net losses of $1,095,112 and $591,725 during the three months ended
      June 30, 2008 and 2007, respectively. The increase in our net loss was
      principally caused by the increase in general and administrative expenses due
      to
      the shift in Company focus from development to commercialization and increases
      in stock option expense. 
    
    Six
      Months Ended June 30, 2008 and 2007
    
    We
      had
      revenues of $125,000 in the six months ended June 30, 2008 compared with $59,761
      in revenues in the same period in 2007. Our operating expenses increased by
      68.2% to $2,037,648 in the six months ended June 30, 2008 from $1,211,701 in
      the
      same period in 2007. Research and development (R&D) expenses increased 25.7%
      to $971,040 in the six months ended June 30, 2008 from $772,276 in the same
      period in 2007. This increase was primarily due to clinical trials for our
      LPT3-04 weight loss product. General and administration (G&A) expenses
      increased 142.7% to $1,066,608 in the six months ended June 30, 2008 from
      $439,425 in the same period in 2007, reflecting the shift in corporate focus
      to
      commercialization. The increase can be attributed to the increased cash position
      due to our financing and the exercise of warrants, and the Company’s recruitment
      of a new management team and the continued use of outside consultants for
      business development to help facilitate our marketing plans for our technology
      and from stock option compensation expense (see Note 6, Notes to Financial
      Statements, p. 6). 
    
    Interest
      income decreased 0.4% to $14,330 in the six months ended June 30, 2008 from
      $14,393 during the same period in 2007. 
    
    We
      incurred net losses of $1,886,748 and $1,137,547 during the six months ended
      June 30, 2008 and 2007, respectively. The increase in our net loss was
      principally caused by the increase in general and administrative expenses due
      to
      the shift in Company focus from development to commercialization and increase
      in
      stock options expense. 
    
    Liquidity
      and Capital Resources
    
    Since
      our
      inception, we have funded our operations through the sale of equity securities
      in private placement and our initial public offering, the sale of equity
      securities and warrants in private placements, debt financing and grants. For
      the six months ended June 30, 2008, we have received proceeds from the
      following: (i) award of a two-year $500,000 NSF Phase II grant for our DPOLT
      technology; (ii) outstanding warrants to acquire 4,536,364 shares of our common
      stock were exercised which provided $1,996,000 in proceeds to us and resulted
      in
      the issuance of 4,536,364 shares of our common stock; and (iii) the sale of
      5,777,778 shares of our common stock in a private placement to accredited
      investors at a price of $0.45 per share resulting in proceeds of $2,600,000
      before fees and expenses. 
     
    Our
      operating activities used cash of $1,431,328 for the six months ended June
      30,
      2008 and $1,004,487 for the six months ended June 30, 2007. Our working capital
      was $3,484,784 as of June 30, 2008. Cash used by operations in the six months
      ended June 30, 2008 resulted primarily from our net loss from operations of
      $1,912,648.
     
    Our
      investing activities provided net cash of $9,750 during the six month period
      ended June 30, 2008 versus net cash of $6,079 for the same period ending June
      30, 2007.
     
    
     
    Our
      financing activities for the six months ended June 30, 2008 provided net cash
      of
      $4,580,215 from the issuance of shares in private placements, the exercise
      of
      warrants, and the financing of insurance premiums. Additional details of our
      financing activities are provided below: 
    
    Private
      Placement-June 2008
    
    On
      June
      12, 2008, our Securities Purchase Agreement with accredited investors became
      binding and we closed on $2,600,000 in equity based financing with net proceeds
      of $2,515,000. We issued a total of 5,777,778 shares of restricted common stock
      in the private placement. The shares were sold to accredited investors at $0.45
      per share. Each participating investor also received warrants to purchase shares
      of common stock at the price of $1.30 per share. One warrant was issued for
      each
      share of common stock issued for a total of 5,777,778 shares that may be
      acquired upon exercise of the warrants. The warrants are exercisable and expire
      June 12, 2013. We intend to use the net proceeds of the private placement,
      including any proceeds from exercise of the warrants, for working capital and
      general corporate purposes. 
     
    Warrant
      Exercises-Q1 2008
    
    On August 7,
      2007, we closed on $1,171,591 in equity based financing. We issued a total
      of
      4,600,000 shares of restricted common stock and warrants to acquire 4,600,000
      shares of common stock in a private placement to accredited investors. The
      shares were sold to accredited investors at $0.25 per share, except that per
      AMEX requirements, our former CEO, Dr. Ronald Evens acquired his shares at
      $0.44 per share, which was the closing share price on August 7, 2007. Each
      warrant to purchase shares of common stock is exercisable at the price of $0.58
      per share. The warrants expire on August 8, 2008 (the “August 2007
      Warrants”). On January 31, 2008 we amended the August 2007 Warrants, to
      reduce the exercise price to $0.44, which was the fair market value on the
      date
      of the amendment for a designated period of time (from January 28, 2008 to
      February 29, 2008) following which the exercise price reverted back to
      $0.58. Prior to the expiration of the August 2007 Warrants, 3,386,364 were
      issued upon exercise at the amended exercise price resulting in additional
      working capital proceeds to us of $1,490.000. The remaining unexercised August
      2007 warrants expired unexercised on August 8, 2008.
    
    On March 6,
      2006, we issued a total of 1,500,000 shares of our common stock and warrants
      to
      purchase 1,500,000 shares of our common stock in a private placement to
      accredited investors. We received gross proceeds of $600,000 in the private
      placement and incurred estimated costs of approximately $75,000 resulting in
      net
      proceeds of approximately $525,000. Each warrant is exercisable on or before
      February 8, 2008 to acquire one share of common stock at a price of $0.60
      per share (the “March 2006 Warrants”). On January 17, 2008 we amended the
      March 2006 Warrants. Pursuant to the amendment, the warrant exercise price
      was
      reduced to $0.44, which was the fair market value on the date of the amendment.
      Prior to the expiration of the March 2006 Warrants, 1,150,000 were issued upon
      exercise at the amended exercise price resulting in additional working capital
      proceeds to us of $506,000. The remaining unexercised March 2006 Warrants
      expired and are no longer outstanding.
    
    Warrant
      Exercises Q1 2007
    
    On December 14,
      2005, we issued a total of 2,937,500 shares of our common stock and warrants
      to
      purchase 2,937,500 shares of our common stock in a private placement to
      accredited investors. The issuance of the shares of common stock and warrants
      was made pursuant to the exemptions from registration provided by
      Section 4(2) of the Securities Act and Regulation D promulgated there
      under. We received gross proceeds of $1,175,000 in the private placement and
      incurred estimated costs of approximately $70,000 resulting in net proceeds
      of
      approximately $1,105,000. The warrants representing shares of common stock
      were
      exercisable by the accredited investors at any time over a two-year period
      at an
      exercise price of $0.60 per share. On January 16, 2007, we called all
      outstanding warrants associated with our December, 2005 private placement
      pursuant to the terms of the warrant. A total of 1,387,500 warrants were
      exercised that provided $832,500 in additional working capital and following
      the
      call of the warrants no further warrants associated with the private placement
      remain outstanding. 
    
    Fusion
      Stock Purchase Agreement Termination 
    
    On
      May 23, 2005, we entered into a stock purchase agreement with Fusion
      Capital Fund II, LLC (“Fusion Capital”). Pursuant to the terms of the stock
      purchase agreement, Fusion Capital has agreed to purchase from us up to
      $9,000,000 of our common stock over a 30 month period commencing from the date
      of the stock purchase agreement. The stock purchase agreement has expired per
      the 30-month contract terms. On August 12, 2008, we sent Fusion our Notice
      of
      Termination of the stock purchase agreement and expect to withdraw the
      previously filed registration statement relating to the stock purchase
      agreement. In connection with the stock purchase agreement and pursuant thereto,
      we have issued an aggregate 205,732 shares to Fusion Capital and received
      aggregate proceeds of approximately $200,000 in 2006 and since that time we
      have
      not issued any other shares to Fusion Capital. 
     
    
    
    On
      February 15, 2008, we were awarded a two year NSF SBIR Phase II grant to
      advance development of its small peptide antibiotic synthesis program using
      the
      Company’s proprietary DPOLT. This federal grant will support studies focused on
      the synthesis and testing of our lead antibiotic, MU 1140. While the grant
      will
      total $500,000, to date we have received $125,000 of these restricted funds
      with
      the remaining balance to be issued during the remaining two-year grant period.
      
    
    While
      management is encouraged by the aforementioned financing, the proceeds are
      insufficient, alone, to regain final compliance with the American Stock
      Exchange’s continued listing requirements. We have until October 27, 2008
      to achieve compliance with AMEX’s minimum shareholder equity requirement of
      $4,000,000. There can be no assurance that we will be able to do so and if
      we
      are not able to do so we will be subject to delisting by AMEX. Additionally,
      these AMEX minimum listing requirements will increase the minimum shareholder
      equity requirement to $6,000,000 at year end. Our plan is to have in excess
      of
      $6,000,000 in shareholder equity by year end, thereby complying with current
      and
      future AMEX listing requirements.
    
    Our
      business is based on commercializing entirely new and unique technologies,
      and
      our current business plan contains a variety of assumptions and expectations
      that are subject to uncertainty, including assumptions and expectations about
      manufacturing capabilities, clinical testing cost and pricing, regulatory
      matters, continuing technological improvements, strategic licensing
      relationships and other relevant matters. These assumptions take into account
      recent financings, as well as expected but currently unidentified additional
      financings.
      We have
      experienced losses from operations during the last three fiscal years and have
      an accumulated deficit of $15,857,541 as of June 30, 2008. The net loss from
      operations for the second quarter of 2008 was $1,111,553.
      Cash
      used in operations for the year ended December 31, 2007 was $1,913,760 and
      for
      the six months ending June 30, 2008 was $1,431,328. As of June 30, 2008, our
      principal source of liquidity was $3,634,145 of cash and cash equivalents.
      Our
      current and historical operating results occurred while developing and
      attempting to commercialize and manufacture products from entirely new and
      unique technologies. Our business plan requires significant spending related
      primarily to the commercialization of our consumer products, clinical testing,
      as well as conducting basic research. These factors place a significant strain
      on our limited financial resources. Our ultimate success depends on our ability
      to continue to generate revenue and to raise capital for our operations.
     
    Our
      capital requirements for 2008 will depend on numerous factors, including the
      success of our commercialization efforts and of our research and development,
      the resources we devote to develop and support our technologies and the success
      of pursuing strategic licensing and funded product development relationships
      with external partners. Subject to our ability to generate income from our
      consumer products and our ability to raise additional capital through joint
      ventures and/or partnerships, we expect to need to incur substantial
      expenditures to further commercialize or develop each of our technologies
      including continued increases in costs related to research, preclinical testing
      and clinical studies, as well as significant costs associated with being a
      public company.
      We
      will
      require substantial funds to conduct research and development and preclinical
      and Phase I clinical testing of our licensed, patented technologies and to
      develop sublicensing relationships for the Phase II and III clinical testing
      and
      manufacture and marketing of any products that are approved for commercial
      sale.
      We must generate additional capital resources to enable us to continue as a
      going concern. Our plans include seeking financing, alliances or other
      partnership agreements with entities interested in our technologies, or other
      business transactions that would generate sufficient resources to assure
      continuation of our operations and research and development programs as well
      as
      seeking equity financing.
     
    Our
      future success depends on our ability to continue to raise capital and
      ultimately generate revenue and attain profitability. We cannot be certain
      that
      additional capital, whether through selling additional debt or equity securities
      or obtaining a line of credit or other loan, will be available to us or, if
      available, will be on terms acceptable to us. If we issue additional securities
      to raise funds, these securities may have rights, preferences, or privileges
      senior to those of our common stock, and our current stockholders may experience
      substantial dilution. 
     
    We
      will
      continue to seek additional funds for conducting
      preclinical studies for our LPT3-04
      weight loss agent,
      and the
      commercialization of Probiora3 and LPT3-04. As
      we
      move into more advanced stages concerning our product development and testing
      is
      likely to increase our monthly budget accordingly. Our available
      working capital at
      June
      30, 2008 is $3,484,784
      which
      includes the proceeds from the sale of common stock as discussed above. While
      we
      believe our available working capital is sufficient for us to continue to
      operate through the next twelve months, we expect to continue to need to raise
      capital to operate beyond this period. If additional capital is not raised,
      we
      would likely need to adjust our anticipated plan of operations until we are
      able
      to acquire the necessary funds.
     
    
    
    ITEM
      4T. CONTROLS AND PROCEDURES
    
    Evaluation
      of Disclosure Controls and Procedures 
     
    We
      maintain “disclosure controls and procedures,” as such term is defined in Rule
      13a-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”), that
      are designed to ensure that information required to be disclosed in our Exchange
      Act reports is recorded, processed, summarized and reported within the time
      periods specified in the Securities and Exchange Commission rules and forms,
      and
      that such information is accumulated and communicated to our management,
      including our Chief Executive Officer and Chief Financial Officer, as
      appropriate, to allow timely decisions regarding required disclosure. We
      conducted an evaluation (the “Evaluation”), under the supervision and with the
      participation of our Chief Executive Officer (“CEO”) and Chief Financial Officer
      (“CFO”), of the effectiveness of the design and operation of our disclosure
      controls and procedures (“Disclosure Controls”) as of the end of the period
      covered by this report pursuant to Rule 13a-15 of the Exchange Act. Based on
      this Evaluation, our CEO and CFO concluded that our Disclosure Controls were
      effective as of the end of the period covered by this report.
     
    Changes
      in Internal Controls 
     
    We
      have
      also evaluated our internal controls for financial reporting, and there have
      been no significant changes in our internal controls or in other factors that
      could significantly affect those controls subsequent to the date of their last
      evaluation. 
    
    
     
    PART
      II - OTHER INFORMATION
     
    ITEM
      1A. RISK FACTORS
     
    You
      should carefully consider the risks described below which update the risk
      factors contained in our Annual Report on Form 10KSB for the year ended December
      31, 2007, as well as the risks described in the risk factors in such form 10KSB
      before making an investment decision in our securities. These risk factors
      are
      effective as of the date of this Form 10-Q and
      shall be deemed to be modified or superseded to the extent that a statement
      contained in our future filings incorporated herein by reference modifies or
      replaces such statement. All of these risks may impair our business operations.
      The forward-looking statements in this Form 10-Q and
      in the documents incorporated herein by reference involve risks and
      uncertainties and actual results may differ materially from the results we
      discuss in the forward-looking statements. If any of the following risks
      actually occur, our business, financial condition or results of operations
      could
      be materially adversely affected. In that case, the trading price of our stock
      could decline, and you may lose all or part of your
      investment.
    
    We
      have a limited operating history with significant losses and expect losses
      to
      continue for the foreseeable future.
    
    We
      have
      yet to establish any history of profitable operations. Our profitability will
      require the successful commercialization of one or more of the technologies
      we
      either license or own. No assurances can be given when this will occur or that
      we will ever be profitable.
    
    We
      may continue to require additional financing in the
      future
    
    If
      we are
      not able to generate sufficient revenues or raise additional capital, among
      other things:
    
    
      
          
            |  | · | We
                may need to curtail or cease operations and be unable to pursue further
                development of our technologies; | 
      
     
     
    
      
          
            |  | · | We
                may be unable to pursue patenting our small molecule weight loss
                agent and
                development of our technologies and
                products; | 
      
     
     
    
      
          
            |  | · | We
                may have to lay-off personnel; | 
      
     
     
    
      
          
            |  | · | We
                could be unable to continue to make public
                filings; | 
      
     
     
    
      
          
            |  | · | We
                may be de-listed from the American Stock Exchange;
                and | 
      
     
     
    
      
          
            |  | · | Our
                licenses for our SMaRT Replacement Therapy technology and MU 1140
                technology could be terminated which would significantly harm our
                business. | 
      
     
    
    At
      June
      30, 2008 and December 31, 2007, we had working capital of approximately
      $3,484,784 and $260,534, respectively. The report of independent registered
      public accounting firm’s report as of and for the year ended December 31, 2007,
      includes an explanatory paragraph stating that our recurring losses from
      operations and limited working capital raise substantial doubt about our ability
      to continue as a going concern. We have an operating cash flow deficit of
      $1,431,328 for the six months ended June 30, 2008 and have sustained operating
      cash flow deficit of $1,913,760 in 2007. Our ability to obtain additional
      funding may determine our ability to continue as a going concern. Our financial
      statements do not include any adjustments that might result from the outcome
      of
      this uncertainty.
    
    We
      can offer you no assurance the government and the public will accept our
      licensed patented technologies. If they do not, we will be unable to generate
      sufficient revenues from our technologies, which may cause us to cease
      operations.
    
    The
      commercial success of our DPOLT platform, SMaRT Replacement Therapy, Probiora3,
      LPT3-04 and other technologies will depend in part on government and public
      acceptance of their production, distribution and use. Biotechnology has enjoyed
      and continues to enjoy substantial support from the scientific community,
      regulatory agencies and many governmental officials in the United States and
      around the world. Future scientific developments, media coverage and political
      events may diminish such support. Public attitudes may be influenced by claims
      that health products based on biotechnology are unsafe for consumption or pose
      unknown risks to the environment or to traditional social or economic practices.
      Securing governmental approvals for, and consumer confidence in, such products
      poses numerous challenges, particularly outside the United States. The market
      success of technologies developed through biotechnology such as ours could
      be
      delayed or impaired in certain geographical areas because of such factors.
      Products based on our technologies may compete with a number of traditional
      dental therapies and drugs manufactured and marketed by major pharmaceutical
      companies and other biotechnology companies. Market acceptance of products
      based
      on our technologies will depend on a number of factors including potential
      advantage over alternative treatment methods. We can offer you no assurance
      that
      dentists, physicians, patients or the medical and dental communities in general
      will accept and utilize products developed from our technologies. If they do
      not, we may be unable to generate sufficient revenues from our technologies,
      which may cause us to have to cease operations.
     
    
    
    Risk
      Factors Relating to our Common Stock
    
    We
      may be unable to maintain the listing of our common stock on the American Stock
      Exchange and that would make it more difficult for stockholders to dispose
      of
      their common stock.
    
    Our
      common stock is listed on the American Stock Exchange. We cannot guarantee
      that
      it will always be listed. The American Stock Exchange rules for continual
      listing include minimum market capitalization and other requirements, which
      we
      may not meet in the future, particularly if the price of our common stock
      declines or we are unable to raise additional capital to continue operations.
      Under our plan that has been filed with the AMEX, we expect to meet the minimum
      listing requirements in a timely basis.
    
    On
      April
      25, 2007 we received notification from the American Stock Exchange (“AMEX”) that
      we were not in compliance with AMEX’s continued listing requirements because our
      shareholders’ equity is less than $2,000,000 and we have experienced losses from
      continuing operations and/or net losses in two of our most recent fiscal years.
      We submitted a plan on May 24, 2007 to AMEX for regaining compliance with all
      of
      the continued listing standards. On July 2, 2007, AMEX notified the Company
      that
      it had completed its review and has determined that the Company’s compliance
      plan made a reasonable demonstration of the Company’s ability to regain
      compliance with the continued listing standards by the end of the plan period,
      October 27, 2008, and was therefore continuing the Company’s listing pursuant to
      an extension. On May 14, 2008, the Company received a notice from AMEX that
      a review of the Company’s Form 10-KSB for the year ended December 31, 2007
      and Form 10-Q for the period ended March 31, 2008 indicated that it did not
      meet certain of AMEX’s additional continued listing standards. Specifically, the
      Company was not in compliance with Section 1003(a)(ii) of the Company Guide
      because its stockholders’ equity is less than the required $4,000,000 and
      because it has losses from continuing operations and net losses in three of
      its
      four most recent fiscal years. The Company provided a revised plan of compliance
      and supporting documentation, dated June 13, 2008, (the “Plan”) to AMEX with
      respect to its previously announced noncompliance with Section 1003(a)(i)
      of the Company Guide and such Plan was subsequently approved by AMEX.
The
      proceeds from our recent financings and warrant exercises are insufficient,
      alone, to regain compliance with AMEX listing requirements by the end of the
      extension period. We have until October 27, 2008 to regain AMEX compliance
      but
      there can be no assurance that we will be able to do so.
    
    If
      our
      common stock is de-listed from the American Stock Exchange, trading in our
      common stock would be conducted, if at all, on the NASDAQ’s OTC Bulletin Board
      in the United States. This would make it more difficult for stockholders to
      dispose of their common stock and more difficult to obtain accurate quotations
      on our common stock. This could have an adverse effect on the price of our
      common stock.
    
    Our
      stock price historically has been volatile and our stock’s trading volume has
      been low.
    
    Because
      of the low trading volume and lack of market liquidity, some institutional
      investors may find it difficult to buy an sell our stock in a sufficiently
      timely manner, which makes an investment in our Company’s stock less appealing.
      The market price of our common stock has been and is expected to continue to
      be
      highly volatile. Factors, including announcements of technological innovations
      by us or other companies, regulatory matters, new or existing
    products
      or procedures, concerns about our financial position, operating results,
      litigation, government regulation, developments or disputes relating to
      agreements, patents or proprietary rights, may have a significant impact on
      the
      market price of our stock. In addition, potential dilutive effects of future
      sales of shares of common stock by us and by stockholders, including Fusion
      Capital, and subsequent sales of common stock acquired by the holders of
      warrants and options could have an adverse effect on the market price of our
      shares.
     
    
    
    Forward-Looking
      Statements
    
    This
      10-Q
      contains forward-looking statements within the meaning of Section 27A of the
      Securities Act of 1933, as amended and Section 21E of the Securities Exchange
      Act of 1934, as amended. Such forward-looking statements include statements
      regarding, among other things, (a) our anticipated needs for and availability
      of
      working capital, (b) our future financing plans, (c) our strategies, (d) our
      projected sales and profitability,(e) anticipated trends in our industry.
      Forward-looking statements, which involve assumptions and describe our future
      plans, strategies, and expectations, are generally identifiable by use of the
      words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,”
“intend,” or “project” or the negative of these words or other variations on
      these words or comparable terminology. This information may involve known and
      unknown risks, uncertainties, and other factors that may cause our actual
      results, performance, or achievements to be materially different from the future
      results, performance, or achievements expressed or implied by any
      forward-looking statements. These statements may be found under “Management’s
      Discussion and Analysis or Plan of Operation” and “Business,” as well as in this
      10-Q generally. Actual events or results may differ materially from those
      discussed in forward-looking statements as a result of various factors,
      including, without limitation, the risks outlined under “Risk Factors” and
      matters described in this 10-Q generally. In light of these risks and
      uncertainties, there can be no assurance that the forward-looking statements
      contained in this filing will in fact occur. In addition to the information
      expressly required to be included in this filing, we will provide such further
      material information, if any, as may be necessary to make the required
      statements, in light of the circumstances under which they are made, not
      misleading.
     
    
    ITEM
      2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
    
    We
      issued
      the following restricted securities during the period covered by this report
      to
      the named individual pursuant to exemptions under the Securities Act of 1933
      including Section 4(2):
    
    On
      June
      12, 2008, we issued an aggregate of 5,777,778 shares of common stock to
      accredited investors at a price of $0.45 per share pursuant to a private
      offering of the Company’s stock. One of the investors, Mr. George T. Hawes, a
      significant shareholder and affiliate, acquired 5,557,778 shares in the private
      offering and the other accredited investor acquired the remaining shares. The
      aforementioned private offering investors also received a commensurate number
      of
      warrants to purchase 5,777,778 shares of common stock at a price of $1.30 per
      share. These warrants expire five years from their vesting date on June 12,
      2013. 
    
    The
      private placement offering and sale of the common stock and warrants was made
      in
      reliance upon the exemption from registration provided by Section 4(2) of
      the Securities Act of 1933 as a transaction by the issuer not involving a public
      offering.
    
    
    
     
    At
      our
      Annual Meeting of Shareholders held on April 8, 2008 our shareholders voted
      on
      two proposals: 
     
    Proposal
      1 Election of Directors
     
    Elected
      each of the following four nominees as directors, each to hold office until
      their successors are duly elected and qualified. The vote for each director
      was
      as follows: 
     
    
      
        
            
              | Nominee
                   |  | For |   | Withheld |  | 
            
              | Jeffrey
                  D. Hillman |  |  | 16,847,014 |  |  | 251,921 |  | 
            
              | Richard
                  T. Welch |  |  | 16,899,264 |  |  | 199,671 |  | 
            
              | Derek
                  G. Hennecke |  |  | 16,899,264 |  |  | 199,671 |  | 
            
              | Stanley
                  B. Stein |  |  | 16,837,014 |  |  | 261,921 |  | 
        
       
     
     
    Proposal
      2 Approval of the Company’s amendment to its Amended and Restated 2002 Stock
      Option and Incentive Plan to increase the number of shares available from
      3,000,000 to 5,000,000
     
    
      
        
            
              | For |   | Against |   | Abstain |  | 
            
              |  | 11,434,220 |  |  | 277,023 |  |  | 1,240,183 |  | 
        
       
       
      
     
    ITEM
      5. OTHER INFORMATION.
    
    On
      May 23, 2005, we entered into a stock purchase agreement with Fusion
      Capital Fund II, LLC (“Fusion Capital”). Pursuant to the terms of the stock
      purchase agreement, Fusion Capital has agreed to purchase from us up to
      $9,000,000 of our common stock over a 30 month period commencing from the date
      of the stock purchase agreement. The stock purchase agreement has expired per
      the 30-month contract terms. On August 12, 2008, we sent Fusion our Notice
      of
      Termination of the stock purchase agreement and expect to withdraw the
      previously filed registration statement relating to the stock purchase
      agreement. In connection with the stock purchase agreement and pursuant thereto,
      we have issued an aggregate 205,732 shares to Fusion Capital and received
      aggregate proceeds of approximately $200,000 in 2006 and since that time we
      have
      not issued any other shares to Fusion Capital. 
    
    
    
    ITEM
      6.  EXHIBITS
      
    
    
      
          
            | Exhibit
                Number |   |   Exhibit
                Description |   | Form |   | File
                No |   | Exhibit |   | Filing
                Date |   | Filed
                Herewith | 
          
            | 10.1 |  | Securities
                Purchase Agreement dated June 12, 2008 |  | 8-K |  | 001-32188 |  |  |  | 6/16/2008 |  |  | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 10.2 |  | Employment
                Agreement of David B. Hirsch |  |  |  |  |  |  |  |  |  | X | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 31.1 |  | Certification
                of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
                promulgated under the Securities and Exchange Act of 1934, as
                amended. |  |  |  |  |  |  |  |  |  | X | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 31.2 |  | Certification
                of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
                promulgated under the Securities and Exchange Act of 1934, as
                amended. |  |  |  |  |  |  |  |  |  | X | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 32.1 |  | Certification
                pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
                906 of
                the Sarbanes-Oxley Act of 2002 (Chief Executive Officer). |  |  |  |  |  |  |  |  |  | X | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 32.2 |  | Certification
                pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
                906 of
                the Sarbanes-Oxley Act of 2002 (Chief Financial Officer). |  |  |  |  |  |  |  |  |  | X | 
      
     
    
    
     
    SIGNATURES
    
    In
      accordance with the requirements of the Exchange Act, the registrant caused
      this
      report to be signed on its behalf by the undersigned, thereunto duly authorized
      on this 10th
      day of
      August, 2007.
    
      
          
            |  |  |  | 
          
            |  | ORAGENICS,
                INC.  | 
          
            | 
 | 
 | 
 | 
          
            |  | BY: | /s/
                Stanley B. Stein | 
          
            |  | 
 Stanley
                B. Stein, President and Chief Executive
                Officer | 
      
     
    
    
    EXHIBIT
      INDEX
    
    
      
          
            | Exhibit
                Number |  |   Exhibit
                Description |  | Form |  | File
                No |  | Exhibit |  | Filing
                Date |  | Filed
                Herewith | 
          
            | 10.1 |  | Securities
                Purchase Agreement dated June 12, 2008 |  | 8-K |  | 001-32188 |  |  |  | 6/16/2008 |  |  | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 10.2 |  | Employment
                Agreement of David B. Hirsch |  |  |  |  |  |  |  |  |  | X | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 31.1 |  | Certification
                of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
                promulgated under the Securities and Exchange Act of 1934, as
                amended. |  |  |  |  |  |  |  |  |  | X | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 31.2 |  | Certification
                of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
                promulgated under the Securities and Exchange Act of 1934, as
                amended. |  |  |  |  |  |  |  |  |  | X | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 32.1 |  | Certification
                pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
                906 of
                the Sarbanes-Oxley Act of 2002 (Chief Executive Officer). |  |  |  |  |  |  |  |  |  | X | 
          
            |  |  |  |  |  |  |  |  |  |  |  |  |  | 
          
            | 32.2 |  | Certification
                pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
                906 of
                the Sarbanes-Oxley Act of 2002 (Chief Financial Officer). |  |  |  |  |  |  |  |  |  | X |