-----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, AOE/V+a+0B4MHWF1Q9IMUQgX1x1cge6tT04YHgmmeFEea5fkwV/8gdpFZHFlJq8h 2+XAy/Tzf82iSIScZUAloQ== 0000950168-99-001580.txt : 19990518 0000950168-99-001580.hdr.sgml : 19990518 ACCESSION NUMBER: 0000950168-99-001580 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990513 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19990517 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRIMERIS INC CENTRAL INDEX KEY: 0000911326 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 561808663 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-23155 FILM NUMBER: 99628277 BUSINESS ADDRESS: STREET 1: 4727 UNIVERSITY DR STE 100 CITY: DURHAM STATE: NC ZIP: 27707 BUSINESS PHONE: 9194196050 MAIL ADDRESS: STREET 1: 4727 UNIVERSITY DRIVE STE 100 CITY: DURHAM STATE: NC ZIP: 27707 8-K 1 TRIMERIS, INC. 8-K ================================================================================ 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 ---------- Date of Report (Date of earliest event reported) May 13, 1999 Commission File Number 0-23155 TRIMERIS, INC. (Exact name of registrant) Delaware 56-1808663 (State of organization) (I.R.S. Employer Identification Number) 4727 University Drive, Suite 100, Durham, North Carolina 27707 (Address of principal executive offices and zip code) (919) 419-6050 (Registrant's telephone Number) ================================================================================ ITEM 5. OTHER EVENTS Trimeris, Inc. incorporates herein by reference the information contained in the press release filed as Exhibit 99 to this Current Report. ITEM 7. EXHIBITS EXHIBIT NO. ----------- 99 Press Release by Trimeris, Inc., dated May 13, 1999 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. TRIMERIS, INC. By: /s/ Matthew A. Megaro ---------------------------------------- Matthew A. Megaro President and Chief Financial Officer Dated: May 17, 1999 EX-99 2 EXHIBIT 99 EXHIBIT NO. 99 - -------------- Contacts: Trimeris, Inc. Burns McClellan, Inc. Matthew A. Megaro John Nugent (investors) President/Chief Financial Officer Justin Jackson (media) 919-419-6050 212-213-0006 For Immediate Release TRIMERIS' T-1249, SECOND HIV FUSION INHIBITOR, RECEIVES FAST TRACK DESIGNATION FROM FDA DURHAM, NC, MAY 13, 1999 -- Trimeris, Inc. (NASDAQ: TRMS) announced today that T-1249 has received fast track designation from the United States Food and Drug Administration for the treatment of HIV infected individuals. T-1249 is the company's second drug candidate in a new class of anti-HIV compounds that block the entry of the virus into cells. Fast track designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease, and this designation is intended to expedite the FDA's review of these drugs. T-1249 is a rationally designed proprietary peptide which blocks fusion of HIV with host cells. T-1249 has demonstrated potent HIV suppression in animal models and is highly active against a wide range of HIV strains in culture. "We are very pleased that T-1249 has received fast track designation, particularly at this early stage of its development," stated Dr. Dani Bolognesi, Chief Executive Officer of Trimeris. "We are excited about the upcoming T-1249 Phase I trial planned for this quarter and look forward to expanding the fusion inhibitor class." Trimeris is a development stage biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that treat viral infection by inhibiting viral fusion with host cells. The company's lead product candidate, T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells, is currently in Phase II clinical trials. T-20 has also received fast track designation from the FDA. NOTE: Except for any historical information presented herein, matters presented in this release are forward-looking statements that involve risks and uncertainties. The results of the company's previous clinical trials are not necessarily indicative of future clinical trials, and future results could differ materially from the results presented herein. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the "Risk Factors" section included in the company's Registration Statement on Form S-3 filed with the Securities and Exchange Commission on April 30, 1999. -----END PRIVACY-ENHANCED MESSAGE-----