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
13, 2009
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
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
Number)
|
2600
Kelly Road, Suite 100
Warrington,
Pennsylvania 18976
(Address
of principal executive offices)
(215)
488-9300
(Registrant's
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
8.01. Other
Events.
On May
13, 2009, the Company issued a press release announcing that it has completed
its previously announced registered direct offering of 14 million shares of the
Company’s common stock to select institutional investors for gross proceeds of
approximately $11.3 million. For each share of common stock
purchased, investors also received warrants to purchase 0.5 shares of common
stock at an exercise price of $1.15 per share. The Company received
approximately $10.6 million in net proceeds after deducting the placement agent
fee of approximately $0.68 million and other fees and expenses of the
offering. Lazard Capital Markets LLC acted as the exclusive placement
agent for the transaction. The press release, dated May 13, 2009, is
filed as Exhibit 99.1 to this report and is incorporated herein by
reference.
Item
9.01. Financial
Statements and Exhibits.
|
(d)
|
Exhibits:
|
|
|
99.1
|
Press
Release, dated May 13, 2009.
|
Cautionary
Note Regarding Forward-looking Statements:
To the
extent that statements in this Current Report on Form 8-K 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 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
Current Report are subject to certain risks and uncertainties that could cause
actual results to differ materially from the statements made. Such
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.
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: May
15, 2009
Exhibit
99.1
Discovery
Labs Announces Completion of $11.3 Million Registered Direct
Offering
Warrington, PA — May 13, 2009 —
Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced that it has
completed its previously announced registered direct offering of 14 million
shares of its common stock and warrants for 7 million shares of common
stock. The shares were issued and sold to select institutional
investors at a price of $0.81 for each share of common stock, together with a
related warrant to purchase 0.5 shares of common stock. The warrants
are exercisable for a period of five years at an exercise price of $1.15 per
share of common stock. As a result of the offering, Discovery Labs
has received gross proceeds of approximately $11.3 million, before deducting
placement agent’s fees and other offering expenses. Lazard Capital Markets LLC
acted as the exclusive placement agent for the transaction.
This
press release shall not constitute an offer to sell or the solicitation of an
offer to buy any securities, nor shall there be any sale of these securities in
any state or jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the securities laws of any
such state or jurisdiction. The shares of common stock, the warrants and the
shares of common stock issuable upon exercise of the warrants were offered and
sold pursuant to a registration statement previously declared effective by the
Securities and Exchange Commission and a prospectus, forming a part of the
effective registration statement. Copies of the final prospectus
supplement for this offering and accompanying base prospectus may be obtained at
the Securities and Exchange Commission web site at http://www.sec.gov, or from
Lazard Capital Markets LLC, 30 Rockefeller Plaza, New York, NY
10020.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing Surfactant Therapies
for respiratory diseases. Surfactants are produced naturally in the lungs
and are essential for breathing. Discovery Labs’ novel proprietary KL4 Surfactant
Technology produces a synthetic, peptide-containing surfactant that is
structurally similar to pulmonary surfactant and is being developed in liquid,
aerosol or lyophilized formulations. In addition, Discovery Labs’ proprietary
Capillary Aerosolization Technology produces a dense aerosol, with a defined
particle size that is capable of potentially delivering aerosolized KL4 surfactant
to the deep lung without the complications currently associated with liquid
surfactant administration. Discovery Labs is focused initially on
developing its KL4 surfactant
pipeline to build a pediatric franchise that will potentially address several
respiratory conditions affecting neonates and young children, beginning with
Respiratory Distress Syndrome (RDS). For more information, please visit the
Company’s website at www.Discoverylabs.com.
Forward
Looking Statements
To the extent that statements in
this press release are not strictly historical, all such statements are
forward-looking, and are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements are subject to certain risks and uncertainties that
could cause actual results to differ materially from the statements
made. Examples of such risks and uncertainties are: risks relating to
the rigorous regulatory requirements required for approval of any drug or
drug-device combination products that Discovery Labs may develop, including
that: (i) Discovery Labs and the U.S. Food and Drug Administration (FDA) will
not be able to agree on the matters raised by the FDA in its Complete Response
letter dated April 17, 2009, or the FDA may require Discovery Labs to conduct
significant additional activities to potentially gain approval of
Surfaxin, if ever (ii) the FDA or other regulatory
authorities may not accept or may withhold or delay consideration of any of
Discovery Labs’ applications, or may not approve or may limit approval of
Discovery Labs’ products to particular indications or impose unanticipated label
limitations, and (iii) changes in the national or
international political and regulatory environment may make it more difficult to
gain FDA or other regulatory approval; risks relating to Discovery Labs’
research and development activities, including time-consuming and expensive
pre-clinical studies, clinical trials and other efforts, which may be subject to
potentially significant delays or regulatory holds, or fail; risks relating to
Discovery Labs’ ability to develop and manufacture drug products and capillary
aerosolization systems for clinical studies, and, if approved, for
commercialization of drug and combination drug-device products, including risks
of technology transfers to contract manufacturers and problems or delays
encountered by Discovery Labs, its contract manufacturers or suppliers in
manufacturing drug products, drug substances and capillary aerosolization
systems on a timely basis or in an amount sufficient to support Discovery Labs’
development efforts and, if approved, commercialization; risks that (a) market
conditions, the competitive landscape or otherwise, may make it difficult to
launch and profitably sell products, (b) Discovery Labs may be unable to
identify potential strategic partners or collaborators to market its products,
if approved, in a timely manner, if at all, and (c) Discovery Labs’ products
will not gain market acceptance by physicians, patients, healthcare payers and
others in the medical community; the risk that Discovery Labs or its strategic
partners or collaborators will not be able to attract or maintain qualified
personnel; the risk that Discovery Labs will not be able in a changing financial
market to raise additional capital or enter into strategic alliances or
collaboration agreements, or that the ongoing credit crisis will adversely
affect the ability of Discovery Labs to fund its activities, or that additional
financings could result in substantial equity dilution; the risk that Discovery
Labs will not be able to access credit from its committed equity financing
facilities, or that the share price at which Discovery Labs may access the
facilities from time to time will not enable Discovery Labs to access the full
dollar amount potentially available under the facilities; the risk that
Discovery Labs will be unable to maintain The Nasdaq Global Market listing
requirements, causing the price of Discovery Labs’ common stock to decline; the
risk that recurring losses, negative cash flows and the inability to raise
additional capital could threaten Discovery Labs’ ability to continue as a going
concern; the risks that Discovery Labs may be unable to maintain and
protect the patents and licenses related to its products, or other companies may
develop competing therapies and/or technologies, or health care reform may
adversely affect Discovery Labs; risks of legal proceedings, including
securities actions and product liability claims; risks relating to reimbursement
and health care reform; and other risks and uncertainties described in Discovery
Labs’ 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.
Contact
Information:
Lisa
Caperelli, Investor Relations
215-488-9413