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
December 19, 2003
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)
Item 5. Other Events and Regulation FD Disclosure
On December 19, 2003, the Company issued a press release to announce
the filing of a Form S-3 shelf registration statement with the Securities and
Exchange Commission (SEC) for the proposed offering from time to time of up to
6.5 million shares of its common stock. The Company has no immediate plans to
sell its securities under the shelf registration, however, once the registration
statement is declared effective by the SEC, the Company will be able to issue
the securities from time to time in response to market conditions or other
circumstances on terms and conditions that will be determined at such time.
Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits
(c) Exhibits:
99.1 Press Release dated December 19, 2003
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: December 19, 2003
3
Exhibit 99.1
Discovery Laboratories Files Shelf Registration Statement
Doylestown, PA -- December 19, 2003 -- Discovery Laboratories, Inc. (Nasdaq:
DSCO), a biopharmaceutical company developing its proprietary surfactant
technology as Surfactant Replacement Therapies for respiratory diseases, has
filed a Form S-3 shelf registration statement with the Securities and Exchange
Commission (SEC) for the proposed offering from time to time of up to 6.5
million shares of its common stock.
Discovery has no immediate plans to sell its securities under this shelf
registration. Once this registration statement is declared effective by the SEC,
the Company will be able to issue these securities from time to time in response
to market conditions or other circumstances on terms and conditions that will be
determined at such time.
A registration statement relating to the securities listed in the shelf
registration statement has been filed with the SEC but has not yet become
effective. These securities may not be sold nor may offers to buy be accepted
before the registration statement becomes effective. This press release shall
not constitute an offer to sell or the solicitation of an offer to buy nor shall
there be any sale of these securities in any state in which such offer,
solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such state.
About Discovery Laboratories
Discovery Laboratories, Inc. is a biopharmaceutical company developing its
proprietary surfactant technology as Surfactant Replacement Therapies for
respiratory diseases including Respiratory Distress Syndromes in infants and
adults, Acute Lung Injury, asthma, Chronic Obstructive Pulmonary Disease and
upper airway disorders. 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 recently completed Phase 3 trials of Surfaxin(R), the Company's lead
product, for the treatment of Respiratory Distress Syndrome in premature infants
and is preparing to file new drug applications with the United States Food and
Drug Administration and other regulatory authorities in the rest of the world.
Discovery's Surfactant Replacement Therapy is also in a Phase 2 clinical trial
for Acute Respiratory Distress Syndrome in adults, a Phase 3 and a Phase 2
clinical trial for Meconium Aspiration Syndrome in full-term infants, and a
Phase 1b clinical trial for asthma.
More information about Discovery Laboratories 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), risks relating
to the progress of the Company's research and development, risks relating to the
ability of the Company's third party contract manufacturers to provide the
Company with sufficient amounts of drug products for completion of any of the
Company's clinical studies, other risks relating to the lack of sufficient 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-KSB, 8-K, 10-Q and 10-QSB, and amendments thereto.
Company Contacts:
John G. Cooper, SVP, CFO
Kori Beer, IR & Communications
215-340-4699