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
August
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
5.02. Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain
Officers.
(b)
Effective August 13, 2009, Dr. Robert J. Capetola resigned as President, Chief
Executive Officer and as a member of the Board of Directors (the “Board”) of
Discovery Laboratories, Inc. (the “Company”).
Mr.
Capetola’s resignation does not result from any disagreement he has with the
Company about the operations, policies, or practices of the
Company.
(c) On
August 13, 2009, the Board authorized Mr. W. Thomas Amick, presently Chairman of
the Board, to assume the responsibilities of the Chief Executive Officer on an
interim basis. Mr. Amick has been a member of the Board of the
Company since September 2004 and its Chairman since March 2007. Mr.
Amick is an industry veteran with more than 30 years of pharmaceutical and
biotechnology experience as a senior executive with Johnson &
Johnson. Mr. Amick also serves as an advisor to several private
equity firms focused on the biopharmaceutical industry. He currently
serves as CEO and chairman of the board of Aldagen, Inc. a private biotechnology
company, and as either a member or chairman of the boards of directors of
several other private biotechnology companies.
With
respect to Mr. Amick’s appointment as interim CEO, the Board approved a grant of
30,000 options for the purchase of Company common stock upon terms and
conditions, including pricing, vesting and expiry, typically associated with
similar option grants approved by the Company pursuant to its 2007 Long Term
Incentive Plan. In addition, the Board authorized that Mr. Amick will
be paid a per diem fee of $3,000 for his services.
As
of August 13, 2009 the Company entered into a separation agreement and
general release (the “Separation Agreement”) with Dr. Capetola providing for (i)
an upfront severance payment of $250,000, and (ii) periodic payments in an
amount equal to his base salary (calculated at a rate of $490,000 per annum), in
accordance with stated payroll practices and less required withholdings, with
such payment to end the earlier of (x) May 3, 2010 or (y) the date, if ever, a
Corporate Transaction event takes place (as such term is defined in the
Separation Agreement). In addition, Dr. Capetola will be entitled to
the continuation of medical and insurance coverage for a period of 24 or 27
months, depending upon circumstances, and the accelerated vesting of all
outstanding restricted shares and options which shall
remain exercisable to the end of their stated terms. Further, the
Separation Agreement provides that upon the occurrence of a Corporate
Transaction prior to May 4, 2010, Dr. Capetola will receive a payment of up to
$1,580,000 or, if any such Corporate Transaction also constitutes a Change of
Control (as such term is defined in the Separation Agreement), a payment of up
to $1,777,500; provided, however, that in each
case any such payment shall be reduced by the sum of the amounts that may then
have been already paid under clauses (i) and (ii) of this
paragraph. A
“Corporate Transaction” is defined in the Separation Agreement as one or more
corporate partnering or strategic alliance transactions, business combinations
or public or private financings that result in cash proceeds (net of transaction
costs) to the Company of at least $20 million cash.
On August
13, 2009, the Company issued a press release announcing the resignation of Dr.
Capetola and the appointment of Mr. Amick. A copy of the press
release is attached to this Current Report as Exhibit 99.1.
Item
9.01. Financial Statements
and Exhibits.
| (d) | Exhibits | |
|
|
99.1
|
Press
release dated August 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/ W. Thomas Amick | |
| Name: W. Thomas Amick | |||
|
Title:
Chairman of the Board and Interim Chief Executive Officer
|
|||
Date: August
19, 2009
Discovery
Labs Announces Resignation of CEO Robert J. Capetola, Ph.D.; W. Thomas Amick,
Chairman of the Board, Appointed Interim CEO
Warrington, PA — August 13, 2009 —
Discovery Laboratories, Inc. (Nasdaq: DSCO), a biotechnology company
developing its proprietary KL4 surfactant
technology to improve respiratory critical care medicine, today announced the
resignation of President and Chief Executive Officer Robert J. Capetola,
Ph.D. Dr. Capetola has also resigned as a Director of Discovery Labs’
Board of Directors. W. Thomas Amick, Chairman of the Board of
Discovery Labs, has been appointed interim Chief Executive Officer.
Mr. Amick
has served as Discovery Labs’ Chairman since March 2007. Mr. Amick is
a respected industry veteran with more than 30 years of pharmaceutical and
biotechnology experience as a senior executive with Johnson &
Johnson. His leadership was instrumental in building Johnson
& Johnson’s biotechnology business into a multi-billion dollar
operation. Mr. Amick also serves as an advisor to several
well-regarded private equity firms focused on the biopharmaceutical industry and
as a member of the board of directors of several biotechnology
companies.
Dr.
Capetola, together with the Board, felt that a transition in leadership at this
time is appropriate for Discovery Labs to capitalize on its strategic
endeavors. Mr. Amick and the Board of Directors expressed
appreciation for Dr. Capetola’s leadership and tenure as Discovery Labs’
founding CEO. “Bob made a significant contribution to Discovery Labs
by guiding us over the past 13 years. We thank Bob and wish him all
the best in his future endeavors,” commented Mr. Amick.
With
respect to Discovery Labs’ near term objectives and its promising KL4 pipeline
programs, which employ its synthetic KL4 surfactant
technology and Capillary Aerosolization Technology platform, Mr. Amick
commented, “Our top priority is to secure strategic alliance partners and access
capital to advance our KL4 surfactant
pipeline and build shareholder value. The most advanced programs from
our KL4 surfactant
pipeline have the potential to greatly improve the management of RDS and
represent the opportunity, over time, to significantly expand the total RDS
market from a current estimate of approximately $200 million to a worldwide
annual market opportunity approaching $1 billion.”
Mr. Amick
is anticipated to remain in the role of Interim CEO until such time as Discovery
Labs has secured appropriate strategic alliances and necessary
capital. At that time, it is anticipated that the Company will
initiate a search for a new CEO.
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, including without limitation, any relating to the
second half of the Company’s fiscal year, 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) 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, (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 (a) 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 (b) 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;
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