-----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, FaEf5TIE8yQB5SC8C3D/bayTHENCtCzKcwpSRqO9EHRyCH4N3jXj09ZY5Yrstr5H 3pUskKsOVPrqIricY5VG2A== 0001144204-04-009302.txt : 20040630 0001144204-04-009302.hdr.sgml : 20040630 20040630114458 ACCESSION NUMBER: 0001144204-04-009302 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040630 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040630 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DISCOVERY LABORATORIES INC /DE/ CENTRAL INDEX KEY: 0000946486 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943171943 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26422 FILM NUMBER: 04890473 BUSINESS ADDRESS: STREET 1: 350 MAIN STREET SUITE 307 CITY: DOYLESTOWN STATE: PA ZIP: 18901 BUSINESS PHONE: 2152404699 MAIL ADDRESS: STREET 1: 350 MAIN STREET SUITE 307 CITY: DOYLESTOWN STATE: PA ZIP: 18901 FORMER COMPANY: FORMER CONFORMED NAME: ANSAN PHARMACEUTICALS INC DATE OF NAME CHANGE: 19961121 FORMER COMPANY: FORMER CONFORMED NAME: ANSAN INC DATE OF NAME CHANGE: 19950609 8-K 1 v04280_8k.txt 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 JUNE 30, 2004 Date of Report (Date of earliest event reported) DISCOVERY LABORATORIES, INC. (Exact name of Registrant as specified in its charter) DELAWARE 000-26422 94-3171943 (State or other jurisdiction (Commission File Number) (IRS Employer of incorporation) Identification Number) 350 MAIN STREET, SUITE 307 DOYLESTOWN, PENNSYLVANIA 18901 (Address of principal executive offices) (215) 340-4699 (Registrant's telephone number, including area code) (Former name or former address, if changed since last report) 1 ITEM 5. OTHER EVENTS On June 30, 2004, Discovery Laboratories, Inc. (the "Registrant"), issued a press release to announce approval for trading of its common stock on the NASDAQ National Market under its current symbol DSCO. The Registrant's common stock previously traded on the NASDAQ SmallCap Market. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL STATEMENTS AND EXHIBITS (c) Exhibits: 99.1 Press Release dated June 30, 2004. 2 SIGNATURES 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. DISCOVERY LABORATORIES, INC. By: /s/ Robert J. Capetola --------------------------------------- Name: Robert J. Capetola, Ph.D. Title: President and Chief Executive Officer Date: June 30, 2004 3 EX-99.1 2 v04280_ex99-1.txt EXHIBIT 99.1 Discovery Laboratories Elevated to NASDAQ National Market DOYLESTOWN, PA -- JUNE 30, 2004 -- DISCOVERY LABORATORIES, INC. (NASDAQ: DSCO), announced that it has received approval to trade its common stock on the NASDAQ National Market under its current symbol DSCO, starting today. Discovery's stock was previously traded on the NASDAQ SmallCap Market. John G. Cooper, Discovery's Executive Vice President and Chief Financial Officer commented, "Discovery has evolved quite significantly during the past year with the successful achievement of several critical milestones. Consistent with that growth, we have attracted a significant institutional and retail investor base. Trading on the NASDAQ National Market further enhances our visibility throughout the investing community." ABOUT DISCOVERY LABORATORIES Discovery Laboratories, Inc. is a biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases. Surfactants are compositions produced naturally in the lungs and essential for breathing. Discovery's technology produces an engineered version of natural human lung surfactant that is designed to closely mimic the essential properties of human lung surfactant. Discovery believes that through its technology, pulmonary surfactants have the potential, for the first time, to be developed into a series of respiratory therapies for critical care and other hospitalized patients where there are few or no approved therapies available. Discovery has filed a New Drug Application with the FDA for clearance to market Surfaxin(R), the Company's lead product, for the prevention of Respiratory Distress Syndrome in premature infants. Discovery is currently conducting a Phase 2 clinical trial for Acute Respiratory Distress Syndrome in adults, Phase 3 and Phase 2 clinical trials for Meconium Aspiration Syndrome in full-term infants and with aerosolized surfactant formulations is preparing to initiate a Phase 2 trial for asthma (development name DSC-104) and a Phase 2 trial for Respiratory Dysfunction in premature infants. More information about Discovery is available on the Company's Web site at www.DiscoveryLabs.com. To the extent that statements in this press release are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's product development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect the Company's actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the risk that financial conditions may change, risks relating to the progress of the Company's research and development, the risk that the Company will not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for our aerosol and Surfactant Replacement Therapies), risk of delay in the Company's preparation and filing of applications for regulatory approval, risk of delay in the FDA's approval of any applications filed by the Company, risks that the FDA will not approve the marketing and sale of a drug product even after the FDA has accepted the application filed by the Company for any such drug product, risks relating to the ability of the Company's third party contract manufacturers to provide the Company with adequate supplies of drug substance and drug products for completion of any of the Company's clinical studies, other risks relating to the lack of adequate supplies of drug substance and drug product for completion of any of the Company's clinical studies, and risks relating to the development of competing therapies and/or technologies by other companies. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising earlier trial results. Data obtained from tests are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. Those associated risks and others are further described in the Company's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. COMPANY CONTACTS: John G. Cooper, EVP and CFO Kori Beer, IR & Communications 215-340-4699 4 -----END PRIVACY-ENHANCED MESSAGE-----