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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)
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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.
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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
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Name: Robert J. Capetola, Ph.D.
Title: President and Chief Executive Officer
Date: June 30, 2004
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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
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