UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-KSB/A [X] Annual report under Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2004 [ ] Transition report under Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ________________ to _________________ Commission file number 000-50614 ORAGENICS, INC. (Name of small business issuer in its charter) FLORIDA 59-3410522 - -------------------------------------------- ------------------------- (State or Other Jurisdiction of (IRS Employer Incorporation or Organization) Identification No.) 13700 PROGESS BLVD., ALACHUA, FLORIDA 32615 - -------------------------------------------- ------------------------- (Address of Principal Executive Offices) (Zip Code) (386) 418-4018 (Issuer's Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Act: Common stock, par value $.001 per share Securities registered pursuant to Section 12(g) of the Act: Common stock, par value $.001 per share 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. [X] Yes [ ] No Check if there is no disclosure of delinquent filers in response to Item 405 of Regulation S-B is not contained in this form, and no disclosure will be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB [ ] The revenues of registrant for the fiscal year ended December 31, 2004 were $196,210. The aggregate market value of the voting stock held by non-affiliates of the registrant, as of March 4, 2005 was approximately $15,692,932 based upon a last sales price of $2.38 as reported by the American Stock Exchange. As of March 4, 2005 there were 14,597,224 shares of the registrant's Common Stock outstanding. DOCUMENTS INCORPORATED BY REFERENCE: No documents are incorporated by reference into this Form 10-KSB/A. Portions of the Registrant's Definitive Proxy Statement for its 2005 Annual Meeting of Shareholders are incorporated by reference into Part III of the Form 10-KSB Report filed on March 14, 2005. Transitional Small Business Disclosure Format (check one): Yes ___ No _X_ EXPLANATORY NOTE This Amendment No. 1 to the Registrant's Form 10-KSB filed with the Securities and Exchange Commission ("SEC") on March 14, 2005 (the "Original Filing" ) is being filed solely for the purpose of reflecting revised disclosures in response to comments received from the staff of the SEC. This Amendment No. 1 provides revised disclosures under the following captions: o Part II, Item 8A. Disclosure Controls, specifically, a new paragraph replaced the existing paragraph under the subsection entitled "Evaluation of Disclosure Controls and Procedures" to remove the words "subject to the limitations noted below" and to clarify that the review was done as of the end of the period covered by the report; and o Part IV, Item 15. Exhibits, Financial Statement Schedules, and Reports on Form 8-K - updated 302 certifications in exhibits 31.1 and 31.2. None of these revisions change our previously reported results, loss from operations, net loss, loss per share or cash flows for the periods included, nor result in a restatement to our financial position or results of operations. Except as described above, no other changes have been made to the Original Filing. This Amendment continues to speak as of the date of the Original Filing, and we have not updated the disclosures contained therein to reflect any events that occurred at a date subsequent to the filing of the Original Filing. ITEM 8A. 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. LIMITATIONS ON THE EFFECTIVENESS OF CONTROLS Our management, including our CEO and CFO, does not expect that our Disclosure Controls and internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management or board override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. CEO AND CFO CERTIFICATIONS Appearing immediately following the Signatures section of this report there are Certifications of the CEO and the CFO. The Certifications are required in accordance with Section 302 of the Sarbanes-Oxley Act of 2002 (the Section 302 Certifications). This Item of this report, which you are currently reading is the information concerning the Evaluation referred to in the Section 302 Certifications and this information should be read in conjunction with the Section 302 Certifications for a more complete understanding of the topics presented. SIGNATURES Pursuant to the requirements of Section 13 and 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this amendment to the report to be signed on its behalf by the undersigned, thereunto duly authorized. Dated: June 22, 2005 ORAGENICS, INC. (Registrant) By: /s/ Mento A. Soponis ------------------------------------- Mento A. Soponis Chief Executive Officer and President