-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IC1VILixsrP17d2K+erZihyQuGiUT57P+zoEl/beLlq9SoU5lWiL1gYS7MnNLrw6 FdqOucD1KopxfXvBR9FZ0g== 0001144204-05-013635.txt : 20050502 0001144204-05-013635.hdr.sgml : 20050502 20050502164857 ACCESSION NUMBER: 0001144204-05-013635 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050502 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050502 DATE AS OF CHANGE: 20050502 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ORAGENICS INC CENTRAL INDEX KEY: 0001174940 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 593410522 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32188 FILM NUMBER: 05791380 BUSINESS ADDRESS: STREET 1: 12085 RESEARCH DRIVE CITY: ALACHUA STATE: FL ZIP: 32615 BUSINESS PHONE: 3864184018 MAIL ADDRESS: STREET 1: 12085 RESEARCH DRIVE CITY: ALACHUA STATE: FL ZIP: 32615 8-K 1 form8.txt ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 May 2, 2005 - -------------------------------------------------------------------------------- Date of Report (Date of earliest event reported) ORAGENICS, INC. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) Florida 000-50614 59-3410522 - -------------------------------------------------------------------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 13200 Progress Boulevard Alachua, Florida 32615 - -------------------------------------------------------------------------------- (Address of principal executive offices including zip code) (386) 418-4018 - -------------------------------------------------------------------------------- Registrant's telephone number, including area code None - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report.) ================================================================================ ITEM 8.01 OTHER EVENTS Oragenics, Inc. issued a press release to announce the start of a Phase I clinical study of its Replacement Therapy technology, a novel approach to the prevention of tooth decay. ITEM 9.01 FINANCIAL INFORMATION AND EXHIBITS Exhibit No. Description -------------------- ----------------------------------------------------- 99.1 Press Release -------------------- ----------------------------------------------------- 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 2nd day of May, 2005. ORAGENICS, INC. (Registrant) BY: /s/ Mento A. Soponis ----------------------------------------- Mento A. Soponis President and Chief Executive Officer EX-99 2 ex99.txt [LOGO] Contact: For Media: Chuck Soponis Joan Kureczka Chief Executive Officer Kureczka/Martin Associates Oragenics, Inc. (415) 821-2413 (386) 418-4018 Jkureczka@comcast.net FOR IMMEDIATE RELEASE ORAGENICS INITIATES PHASE I SAFETY STUDY OF NOVEL TREATMENT FOR PREVENTING TOOTH DECAY ALACHUA, FL (May 2, 2005): Oragenics, Inc. (AMEX:ONI) today announced the start of a Phase I clinical study of its Replacement Therapy, a novel approach to the prevention of tooth decay. The study, being conducted in six couples and an additional nine individuals at Hill Top Research in West Palm Beach, Florida, will look at the safety of Replacement Therapy and the potential for horizontal transmission of the Replacement Therapy organism to the non-treated member of each couple. "We are very pleased to begin human testing of Replacement Therapy, which our research to date suggests has great potential as a new preventive therapy against tooth decay," said Chuck Soponis, Oragenics' president and chief executive officer. Tooth decay is caused by lactic acid produced by a naturally occurring bacterium residing on the tooth surface called Streptococcus mutans. Oragenics' Replacement Therapy employs a patented strain of S. mutans that is unable to produce this decay-causing acid. When applied topically to a person's teeth by a dentist, this engineered bacterium is expected to displace the resident decay-causing organism, potentially providing life-long protection against most dental decay. For this safety study, all of the participants in the trial must be in good health, without teeth, with full sets of dentures, and under the age of 55. About Oragenics Oragenics, Inc. is an emerging biotechnology company focused on the development and licensure of innovative products and technologies for improving human health. The company's lead product is a novel oral rinse for the prevention of tooth decay. The company is also developing a novel antibiotic with broad-spectrum activity against gram-positive bacteria and a probiotic product aimed at maintaining oral health. The company is headquartered in Alachua, Florida. For more information about Oragenics, please consult the company's website at www.oragenics.com. Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements which reflect Oragenics' current views with respect to future events and financial performance. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe", "expect", "anticipate", "intend", "estimate", "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to (1) the ability to successfully complete development and commercialization of Oragenics' Replacement Therapy for prevention of tooth decay, novel antibiotic, and probiotic product for oral health; (2) the ability to obtain substantial additional funding; (3) the ability to develop and commercialize products before competitors;(4) the ability to develop commercial products with the in-licensed technology; and (5) other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements. # # # -----END PRIVACY-ENHANCED MESSAGE-----