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
October
11, 2005
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:
[
] Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[
] Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[
] Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
[
] 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
October 11, 2005, Discovery Laboratories, Inc. (the “Company”) issued a press
release to announce that it had filed a universal shelf registration statement
on Form S-3 (File No. 333-128929) (the “Registration Statement”) with the
Securities and Exchange Commission (“SEC”) for the proposed offering from time
to time of up to $100 million of the Company’s debt or equity securities. The
Company has no immediate plans to sell its securities under the Registration
Statement. Once the Registration Statement is declared effective by the SEC,
however, 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. The full text of the press release
is set
forth in Exhibit 99.1 to this Current Report on Form 8-K.
Item
9.01. Financial
Statements, Pro Forma Financial Statements and
Exhibits
(c) Exhibits:
|
99.1
|
Press
Release dated October 11, 2005.
|
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: October 12, 2005 | By: | /s/ Robert J. Capetola, Ph.D. |
|
Robert J. Capetola, Ph.D. |
||
| Title: President and Chief Executive Officer | ||
Exhibit
99.1
Discovery
Labs Files Universal Shelf Registration Statement
Warrington,
PA — October 11, 2005 — Discovery Laboratories, Inc. (Nasdaq: DSCO)
announced
today that it has filed a universal shelf registration statement with the
Securities Exchange Commission (SEC) relating to the possible issuance of up
to
$100 million in securities. The filing should allow Discovery flexibility as
to
the type of security it could choose to sell, including common stock, preferred
stock, and varying forms of debt securities, and is intended to enable Discovery
to react to market opportunities as they arise.
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 Labs
Discovery
Laboratories, Inc. is a biotechnology company developing its proprietary
surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory
diseases. Surfactants are produced naturally in the lungs and are essential
for
breathing. Discovery’s technology produces a precision-engineered surfactant
that is designed to closely mimic the essential properties of natural human
lung
surfactant. Discovery believes that through its technology, pulmonary
surfactants have the potential, for the first time, to address respiratory
diseases where there are few or no approved therapies available.
Discovery’s
SRT pipeline is initially focused on the most significant respiratory conditions
prevalent in the neonatal intensive care unit. The Company’s lead product,
Surfaxin®,
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants, has
received an Approvable Letter from the FDA and is under review for approval
in
Europe by the EMEA. Surfaxin is also being developed for the treatment of
Chronic Lung Disease (CLD) in premature infants. Aerosurf™, aerosolized SRT
administered through nasal continuous positive airway pressure (nCPAP), is
in
development to address neonatal respiratory failures.
To
address the various respiratory conditions affecting pediatric, young adult
and
adult patients in the critical care and other hospital settings, Discovery
is
conducting a Phase 2 clinical trial to address Acute Respiratory Distress
Syndrome (ARDS) in adults, and is also developing aerosol formulations of SRT
to
address Acute Lung Injury (ALI), asthma, COPD, and other respiratory
conditions.
For
more
information, please visit our corporate website 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 Discovery’s product development, events
conditioned on stockholder or other approval, or otherwise as to future events,
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. Among
the factors which could affect Discovery’s actual results and could cause
results to differ from those contained in these forward-looking statements
are
the risk that financial conditions may change, risks relating to the progress
of
Discovery’s research and development, the risk that Discovery will not be able
to raise additional capital or enter into additional collaboration agreements
(including strategic alliances for our aerosol and Surfactant Replacement
Therapies), risk that Discovery will not be able to develop a successful sales
and marketing organization in a timely manner, if at all, risk that Discovery’s
internal sales and marketing organization will not succeed in developing market
awareness of Discovery’s products, risk that Discovery’s internal sales and
marketing organization will not be able to attract or maintain qualified
personnel, risk of delay in the FDA’s or other health regulatory authorities’
approval of any applications filed by Discovery, risks that any such regulatory
authority will not approve the marketing and sale of a drug product even after
acceptance of an application filed by Discovery for any such drug product,
risks
relating to the ability of Discovery’s third party contract manufacturers to
provide Discovery with adequate supplies of drug substance and drug products
for
completion of any of Discovery’s clinical studies, other risks relating to the
lack of adequate supplies of drug substance and drug product for completion
of
any of Discovery’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 Discovery’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.
Company
Contacts:
John
G.
Cooper, EVP and CFO
215-488-9490
Lisa
Caperelli, Investor Relations
215-488-9413