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
Date of Report (Date of Earliest Event Reported) February 24, 2000
Discovery Laboratories, Inc.
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(Exact Name of Registrant as Specified in its Charter)
Delaware 000-26422 13-3711775
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(State or Other (Commission (I.R.S. Employer
Jurisdiction of File Number) Identification
incorporation) No.)
350 Main Street, Suite 307, Doylestown, Pennsylvania 18901
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(Address of Principal Executive Offices) (Zip Code)
(Registrant's Telephone Number, Including Area Code) (215) 240-4699
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(Former Name or Former Address, If Changed Since Last Report.)
928415.1
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ITEM 5. Other Events.
On February 24, 2000, Registrant issued a press release regarding
its exploration of a Surfaxin(R) platform for aerosolized formulations for
asthma and other respiratory diseases.
On February 25, 2000, Registrant issued a press release to announce
that it has received a warrant exercise notice from its largest shareholder,
OrbiMed Advisors LLC of New York ("OrbiMed"). OrbiMed acquired a total of
1,652,892 shares of Common Stock of Registrant for an aggregate price of
$2,198,346.00.
Registrant also announced that it has given notice to its Series B
Convertible Preferred shareholders of its intention to convert all of the
1,251,505 outstanding shares of Series B Preferred Stock into 3,896,255 shares
of Common Stock.
ITEM 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits.
Exhibit Description
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99.1 Press Release, dated February 24, 2000.
99.1 Press Release, dated February 25, 2000.
928415.1
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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/ Robert J. Capetola, Ph.D.
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Name: Robert J. Capetola, Ph.D.
Title: President and Chief
Executive Officer
Date: March 6, 2000
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928415.1
FOR IMMEDIATE RELEASE:
Contact: Robert J. Capetola, Ph.D.
President & CEO
Discovery Laboratories, Inc.
215.340.4699, Ext. 111
Dian Griesel, Ph.D., CEO/
Shayne Payne
The Investor Relations Group
212.736.2650
DISCOVERY TO BEGIN EXPLORATION OF SURFAXIN(R) PLATFORM FOR AEROSOLIZED
FORMULATIONS FOR ASTHMA AND OTHER RESPIRATORY DISEASES
Doylestown, PA, February 24, 2000 - Discovery Laboratories, Inc. (Discovery)
(Nasdaq small cap: DSCO, DSCOU) announced that it has begun preclinical research
into converting its unique pulmonary surfactant, Surfaxin(R), into aerosolized
forms for the potential therapy of asthma, chronic obstructive pulmonary disease
(COPD), acute and chronic bronchitis and a variety of other respiratory
diseases.
"Our strategic mission is to achieve commercialization of Surfaxin(R) in the
respiratory distress syndromes currently under late stage development. However,
we have always considered Surfaxin(R) to be a platform technology with multiple
applications for respiratory therapies. After extensive evaluation with The
Scripps Research Institute in La Jolla, California where Surfaxin(R) was
invented, we decided to begin investigations into the other potential
indications," said Robert J. Capetola, Ph.D., President/CEO. "Because of its
unique surface tension lowering properties, these new Surfaxin(R) preparations
have the capability to be used in a variety of clinical conditions such as
asthma, COPD, emphysema, cystic fibrosis and acute lung injury. It also has the
capability to be used as a pulmonary drug delivery vehicle when combined with
antibiotics, pulmonary vasodilators, bronchodilators, steroids or a variety of
proteins currently being administered by injection."
One of the prominent pulmonary disorders where Surfaxin(R) may play a key role
is asthma. According to Duncan Hite, M.D., Wake Forest University School of
Medicine, some of the pivotal pathology in asthma takes place in the distal
bronchioles whose patency is maintained to some degree by endogenous surfactant.
"This surfactant appears to be degraded as a result of the inflammatory
reactions evident in asthmatics. Therefore, it is perfectly logical to evaluate
a modern day, high quality synthetic surfactant such as Surfaxin(R)," said Dr.
Hite. According to data from the Centers for Disease Control in Atlanta, asthma
afflicts approximately 14 million people in the United States and its incidence
rate has been growing steadily year after year.
Surfaxin(R) was originally discovered in the laboratories of Dr. Charles
Cochrane, who is a founder of and Professor at The Scripps Research Institute.
Dr. Cochrane is one of the world's foremost authorities in inflammation and
Discovery is supporting Dr. Cochrane's laboratories at Scripps. According to
-more-
Capetola, "Scripps is an extraordinary research institute and our support will
serve to continue the research at Scripps that is so important to the later
phases of rational drug development.
Discovery is a bio-pharmaceutical company whose mission is to develop and
commercialize medically novel therapeutics for critical care. Presently,
Discovery is developing proprietary pharmaceuticals to treat respiratory
distress syndrome (RDS) in premature infants, meconium aspiration syndrome (MAS)
in full-term infants, direct acute respiratory distress syndrome (ARDS) and
cystic fibrosis. More information about Discovery is available on the company's
web site at: www.discoverylabs.com.
To the extent that statements in this press release are not strictly historical,
including statements as to future financial conditions, events conditioned on
stockholder or other approval, or otherwise as to future events, such statements
are forward-looking, and are made pursuant to the safe harbor provisions of the
Securities Litigation Reform Act of 1995. The forward-looking statements
contained in this release 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 the company's actual results and could cause
results to differ from those contained in the forward-looking statements
contained herein are the risk that financial conditions may change, risks
relating to the progress of the company's research and development and the
development of competing therapies and/or technologies by other companies. Those
associated risks and others are further described in the company's filings with
the Securities and Exchange Commission.
* * *
EXHIBIT 99.1
FOR IMMEDIATE RELEASE:
Contact: Evan Myrianthopoulos
Vice President of Finance
Discovery Laboratories, Inc.
215.340-4699 ext. 113
Dian Griesel, Ph.D., CEO/
Shayne Payne
The Investor Relations Group
212.736.2650
ORBIMED ADVISORS, LLC ELECTS TO INCREASE OWNERSHIP STAKE
IN DISCOVERY THROUGH EXERCISE OF WARRANTS
Doylestown, PA, February 25, 2000 - Discovery Laboratories, Inc. (NASDAQ Small
Cap: DSCO, DSCOU) announced today that it has received a warrant exercise notice
from its largest shareholder, OrbiMed Advisors, LLC of New York. Proceeds from
the transaction will total $2.2 million.
"We are extremely pleased to increase our ownership stake in Discovery," said
Samuel D. Isaly, Managing Partner of OrbiMed Advisors. "We are very excited
about the prospects for Surfaxin(R) in treating respiratory distress
indications."
Discovery also announced today that it has given notice to its Series B
Convertible Preferred shareholders of its intention to convert all of the
outstanding shares of Series B Preferred Stock into Common Stock. "This
conversion simplifies our capital structure as well as our financial reporting
statements," said Dr. Capetola. "We believe that this conversion will eliminate
any uncertainty and confusion with respect to our financial statements and
hopefully lead to increased shareholder value."
Discovery is a bio-pharmaceutical company whose mission is to develop and
commercialize medically novel therapeutics for critical care. Presently,
Discovery is developing proprietary pharmaceuticals to treat respiratory
distress syndrome (RDS) in premature infants, meconium aspiration syndrome (MAS)
in full term babies, direct acute respiratory distress syndrome (ARDS), and
cystic fibrosis. More information about Discovery is available on the company's
web site at: www.discoverylabs.com.
To the extent that statements in this press release are not strictly historical,
including statements as to future financial conditions, events conditioned on
stockholder or other approval, or otherwise as to future events, such statements
are forward-looking, and are made pursuant to the safe harbor provisions of the
Securities Litigation Reform Act of 1995. The forward-looking statements
contained in this release 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 the company's actual results and could cause
results to differ from those contained in the forward-looking statements
contained herein are the risk that financial conditions may change, risks
relating to the progress of the company's research and development and the
development of competing therapies and/or technologies by other companies. Those
associated risks and others are further described in the company's filings with
the Securities and Exchange Commission.
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