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
February
23, 2010
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
February 23, 2010, Discovery Laboratories, Inc. (the “Company”) issued a press
release announcing that it had completed the previously announced public
offering contemplated by the Underwriting Agreement dated February 18, 2010,
with Lazard Capital Markets LLC (“Lazard”) acting as sole
underwriter. The press release is attached as Exhibit 99.1
hereto.
In the
offering, the Company sold 27,500,000 shares of common stock, par value $.001
per share (“Common Stock”), and warrants to purchase 13,750,000 shares of Common
Stock (“Warrants”), as units (“Units”), at a public offering price of $0.60 per
Unit. Each Unit was comprised of one share of Common Stock and a Warrant
to purchase one half of a share of Common Stock. The shares of Common Stock and
the Warrants were issued and are transferable separately. As such, no
Units were issued. The terms of the Warrants are further described in
the Company’s current report on Form 8-K filed on February 18, 2010 and the form
of Warrant is attached as Exhibit 4.1 thereto.
The
offering generated net proceeds, after deducting the underwriting discount and
other estimated offering expenses, of approximately $15.1 million, assuming no
exercise of Warrants. The Company currently anticipates using the net
proceeds from the offering primarily to support its general corporate activities
and for expenses associated with maintaining its research and development
operations, including manufacturing, quality and analytical capabilities,
product development and clinical operations, which include:
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·
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Expenses
related to resolving the remaining issue (related to optimization and
revalidation of the Company’s rabbit
Biological Activity Test (BAT, an important quality control release and
stability test) and establishing that the BAT is capable of
discriminating changes in Surfaxin® drug product over time) that must be
addressed to secure the potential approval of Surfaxin® for the prevention
of Respiratory
Distress Syndrome (“RDS”), including implementing a comprehensive
pre-clinical program.
|
|
·
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Expenses
related to ongoing development of the Company’s Surfaxin LS™ and Aerosurf®
programs, which, together with Surfaxin, are focused on addressing the
most significant respiratory conditions affecting pediatric populations,
beginning with RDS. Surfaxin LS is a lyophilized formulation of
Surfaxin that is manufactured as a dry powder and reconstituted as a
liquid prior to administration and offers ease of administration and other
potential benefits. Aerosurf, the Company’s KL4 surfactant in
aerosolized form, is a drug-device combination product based on the
Company’s proprietary capillary aerosolization technology and potentially
can be administered without the invasive procedures that are required for
the currently-approved surfactants. Expenses related to
Surfaxin LS include the Company’s preclinical development program and
costs to meet with the U.S.
Food and Drug Administration and comparable European regulatory
authorities to discuss the Company’s proposed Phase 3 global registration
clinical program. Expenses related to Aerosurf include
activities to advance the Company’s ongoing device development and
preclinical work and the costs of preparing an investigational new drug
application (IND) in anticipation of its planned Phase 2 clinical
program. The Company also plans to initiate the Surfaxin LS and
Aerosurf clinical development programs after it has secured additional
capital resources in the form of strategic alliances or other financial
alternatives.
|
|
·
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Expenses
related to completing the final stages of the Company’s Phase 2 trials: to
determine if restoration of surfactant with Surfaxin will improve lung
function and result in a shorter duration of mechanical ventilation and
hospital stay for children up to two years of age suffering with Acute
Respiratory Failure; and an investigator-initiated Phase 2a clinical trial
in Cystic Fibrosis (“CF”) patients that has been designed to assess the
safety, tolerability and short-term effectiveness of aerosolized KL4
surfactant in CF patients. Results from these trials are anticipated in
2010.
|
The
amounts and timing of the expenditures may vary significantly depending on
numerous factors, such as the progress of the Company’s research and development
efforts, technological advances and the competitive environment for Surfaxin and
the Company’s other SRT drug candidates and their intended
uses. Pending the application of the net proceeds, the Company
intends to invest the proceeds in short-term, interest-bearing instruments or
other investment-grade securities.
2
Item
9.01. Financial Statements and
Exhibits.
(d) Exhibits:
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99.1
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Press
Release, dated February 23, 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.
3
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:
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/s/ W. Thomas Amick | |
| Name: | W. Thomas Amick | ||
| Title: | Chairman of the Board and interim | ||
|
Chief
Executive Officer
|
|||
Date: February
25, 2010
Exhibit
99.1
Discovery
Labs Announces Completion of
$16.5
Million Public Offering
Warrington,
PA — February 23, 2010 — Discovery Laboratories, Inc. (Nasdaq: DSCO)
today
announced that it has completed its previously announced public offering to sell
an aggregate
of 27,500,000 shares of its common stock and warrants to purchase 13,750,000
shares of its
common stock under the Company’s previously filed registration statement that
was declared
effective by the Securities and Exchange Commission on June 18, 2008. Each share
was
issued and sold as a unit, together with a related warrant to purchase one half
of a share of common
stock, at a public offering price of $0.60 per share. The warrants are
exercisable for a period
of five years at an exercise price of $0.85 per share of common stock. As a
result of the offering,
Discovery Labs has received net proceeds of approximately $15.1 million, after
deducting
underwriting discounts and commissions and other fees and expenses related to
the offering.
Lazard Capital Markets LLC (“Lazard”) acted as the sole underwriter of the
offering.
The net
proceeds from the offering will be used to support Discovery Labs’ general
corporate activities
and for expenses associated with maintaining its research and development
operations, including
manufacturing, quality and analytical capabilities, product development and
clinical operations
and for other general corporate purposes.
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 the 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. 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.
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 Global Market listing requirements
prior to the expiration
of the grace period currently in effect, which could eventually result in
delisting of Discovery Labs’
common stock and 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