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
2, 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
3.01. Notice of Delisting or
Failure to Satisfy a Continued Listing Rule or Standard; Transfer of
Listing.
On
December 2, 2009, Discovery Laboratories, Inc. (the “Company”) received a letter
from The Nasdaq Stock Market indicating that for 30 consecutive business days
the Company’s common stock did not maintain a minimum closing bid price of $1.00
(“Minimum Bid Price Requirement”) per share as required by Nasdaq Listing Rule
5450(a)(1).
The
notification of noncompliance has no immediate effect on the listing or trading
of the Company’s common stock on the Nasdaq Global Market. Under the
Nasdaq Listing Rules, if during the 180 calendar days following the date of the
notification, or prior to June 1, 2010, the closing bid price of the Company’s
stock is at or above $1.00 for a minimum of 10 consecutive business days, the
Company will regain compliance with the Minimum Bid Price Requirement and the
common stock will continue to be eligible for listing on the Nasdaq Global
Market.
If the
Company does not achieve compliance with the Minimum Bid Price Requirement by
June 1, 2010, Nasdaq will provide written notification to the Company that the
common stock is subject to delisting. The Company may, at that time,
appeal Nasdaq’s determination to a Nasdaq Hearing Panel. Such an appeal, if
granted, would stay delisting until a Panel ruling. Alternatively, if at that
time the Company is in compliance with all initial listing standards for the
Nasdaq Capital Market other than the Minimum Bid Price Requirement, the Company
could apply to transfer the listing of its common stock to the Nasdaq Capital
Market and thereby receive an additional grace period to gain compliance with
the Minimum Bid Price Requirement.
The
Company intends to monitor the closing bid price of its common stock and may, if
appropriate, consider implementing available options to regain compliance with
the Minimum Bid Price Requirement under the Nasdaq Listing Rules.
On
December 4, 2009, the Company issued a press release announcing its receipt of
the Nasdaq deficiency letter. A copy of the please release is filed as Exhibit
99.1 to this Current Report on Form 8-K and is incorporated herein by
reference.
Item
9.01. Financial Statements and
Exhibits.
| (d) | Exhibits | |
|
|
99.1
|
Press
release dated December 4, 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. | |||
|
Date
|
By:
|
/s/ W. Thomas Amick | |
| Name: | W. Thomas Amick | ||
| Title: | Chairman of the Board and Interim | ||
| Chief Executive Officer | |||
Date: December
4, 2009
Exhibit
99.1
Discovery
Labs Receives Nasdaq Notification Related
to
Minimum Bid Price
Warrington, PA – December 4, 2009 --
Discovery Laboratories, Inc. (Nasdaq:DSCO) announced today that, on
December 2, 2009, the Company received a letter from The Nasdaq Stock Market
indicating that the Company is no longer in compliance with Nasdaq Listing Rule
5450(a)(1) because the Company’s common stock did not maintain a minimum closing
bid price of $1.00 (“Minimum Bid Price Requirement”) per share over the previous
30 consecutive business days.
The
notification of noncompliance has no immediate effect on the listing or trading
of Discovery Labs’ common stock on the Nasdaq Global Market. Under
the Listing Rules, if during the 180 calendar days following the date of the
notification, or prior to June 1, 2010, the closing bid price of the Company’s
stock is at or above $1.00 for a minimum of 10 consecutive business days, the
Company will regain compliance with the Minimum Bid Price Requirement and the
common stock will continue to be eligible for listing on the Nasdaq Global
Market.
If the
Company does not achieve compliance with the Minimum Bid Price Requirement by
June 1, 2010, Nasdaq will provide written notification to the Company that the
common stock is subject to delisting. The Company may, at that time, appeal
Nasdaq’s determination to a Nasdaq Hearing Panel. Such an appeal, if granted,
would stay delisting until a Panel ruling. Alternatively, if at that time the
Company is in compliance with all initial listing standards for the Nasdaq
Capital Market other than the Minimum Bid Price Requirement, the Company could
apply to transfer the listing of its common stock to the Nasdaq Capital Market
and thereby receive an additional grace period to gain compliance with the
Minimum Bid Price Requirement.
The
Company intends to monitor the closing bid price of its common stock and may, if
appropriate, consider implementing available options to regain compliance with
the Minimum Bid Price Requirement under the Nasdaq Listing Rules.
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 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 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:
John G.
Cooper, EVP and Chief Financial Officer
215-488-9300