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
2, 2010
Date of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-26422
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94-3171943
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
Number)
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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:
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
3.01.
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Notice of Delisting or
Failure to Satisfy a Continued Listing Rule or Standard; Transfer of
Listing.
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On June 2, 2010, Discovery
Laboratories, Inc. (the “Company”) issued a press release announcing that The
Nasdaq Stock Market, LLC (“Nasdaq”) has approved the Company’s application to
transfer its stock listing from The Nasdaq Global Market® to The Nasdaq Capital
Market®. The transfer was effective at the opening of the market on June 4,
2010. The Company’s common stock will continue to be traded under the symbol
“DSCO” and the transfer will have no impact on the ability of investors to trade
the stock. The Nasdaq Capital Market is a continuous trading market that
operates in the same manner as The Nasdaq Global Market. All
companies listed on The Nasdaq Capital Market must meet certain financial
requirements and adhere to Nasdaq’s corporate governance standards. A
copy of the press release is filed as Exhibit 99.1 to this Current Report on
Form 8-K.
The Company had previously announced in
its current report on Form 8-K filed with the SEC on December 4, 2009 that on
December 2, 2009, the Company received a delisting notification from The Nasdaq
Global Market indicating that the Company’s common stock had failed to close at
or above $1.00 per share for more than 30 consecutive trading days and, as
a result, the Company was not in compliance with the Nasdaq Listing Rule
5450(a)(1) (the “Minimum Bid Price Rule”). The delisting notification
also granted the Company 180 calendar days, or until June 1, 2010, to regain
compliance with the Minimum Bid Price Rule.
As the Company’s common stock has not
closed at or above $1.00 per share for 10 consecutive trading days within
the grace period provided, to avoid a second delisting notification, the Company
filed an application to transfer the listing of its common stock from The Nasdaq
Global Market to The Nasdaq Capital Market. In addition, in
connection with the transfer to The Nasdaq Capital Market, on June 2, 2010,
Nasdaq notified the Company that it has in accordance with Nasdaq Listing
Rule 5810(c)(3)(A), granted the Company an additional 180 calendar days, or
until November 29, 2010, to regain compliance with the Minimum Bid Price
Rule, which
would occur if the Company’s common stock closed at or above $1.00 for 10
consecutive trading days.
If compliance is not regained, Nasdaq
will notify the Company of its determination to delist the Company’s common
stock, which decision may be appealed to a Nasdaq Listing Qualifications
Panel.
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Item
9.01.
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Financial Statements
and Exhibits.
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(d)
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Exhibits
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99.1
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Press
release dated June 2,
2010.
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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.
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.
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Discovery
Laboratories, Inc.
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By:
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/s/ W. Thomas Amick
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Name: W.
Thomas Amick
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Title: Chief
Executive Officer
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Date:
June 4, 2010
3
Discovery
Labs Announces Listing Transfer to NASDAQ Capital Market
Warrington, PA – June 2, 2010 —
Discovery Laboratories, Inc. (Nasdaq: DSCO), announced today that The
Nasdaq Stock Market, LLC has approved Discovery Labs’ application to transfer
its stock listing from The NASDAQ Global Market® to The
NASDAQ Capital Market®. The
transfer will be effective at the opening of the market on June 4, 2010. The
Company’s common stock will continue to be traded under the symbol “DSCO” and
the transfer will have no impact on the ability of investors to trade the stock.
The NASDAQ Capital Market is a continuous trading market that operates in the
same manner as The NASDAQ Global Market. All companies listed on The NASDAQ
Capital Market must meet certain financial requirements and adhere to Nasdaq’s
corporate governance standards.
On
December 2, 2009, the Company received a delisting notification from The NASDAQ
Global Market indicating that the Company’s common stock had failed to close
above $1.00 per share for more than 30 consecutive trading days and, as a
result, the Company was not in compliance with the Minimum Bid Price Rule. The
delisting notification also granted the Company 180 calendar days, or until June
1, 2010, to regain compliance with the Minimum Bid Price Rule, which would occur
if the Company’s common stock closed above $1.00 per share for ten consecutive
trading days. As the Company’s common stock has not closed above $1.00 per share
for ten consecutive trading days within the grace period provided, to avoid a
second delisting notification, the Company requested and received approval from
Nasdaq to transfer the listing of its common stock from The NASDAQ Global Market
to The NASDAQ Capital Market. In addition, in connection with the transfer to
the NASDAQ Capital Market, Nasdaq granted the Company an additional 180 calendar
days, or until November 29, 2010, to regain compliance with the Minimum Bid
Price Rule. If compliance is not regained by that date, Nasdaq will notify the
Company of its determination to delist the Company's common stock, which
decision may be appealed to a Nasdaq Listing Qualifications Panel.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing KL4
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 believes that its proprietary technology platform
makes it possible, for the first time, to develop a significant pipeline of
surfactant products to address a variety of respiratory diseases for which there
frequently are few or no approved therapies. For more information, please visit
our 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: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or
other regulatory authorities will not be able to agree on the matters raised
during regulatory reviews, or Discovery Labs may be required to conduct
significant additional activities to potentially gain approval of its product
candidates, if ever, (b) 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 (c) 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 (i) 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, and (ii)
the need for sophisticated and extensive analytical methodologies, including an
acceptable biological activity test, if required, as well as other quality
control release and stability tests to satisfy the requirements of the
regulatory authorities; 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;
the risk that Discovery Labs may be unable to identify potential strategic
partners or collaborators to develop and commercialize its products, if
approved, in a timely manner, if at all; 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 (CEFFs), or that the minimum share
price at which Discovery Labs may access the CEFFs from time to time will
prevent Discovery Labs from accessing the full dollar amount potentially
available under the CEFFs; the risk that Discovery Labs or its strategic
partners or collaborators will not be able to retain, or attract, qualified
personnel; the risk that Discovery Labs will be unable to regain compliance with
The Nasdaq Capital Market listing requirements prior to the expiration of the
additional grace period currently in effect, which could cause 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 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:
John G.
Cooper, EVP and Chief Financial Officer
215-488-9300