Discovery Laboratories, Inc. Announces 1998 Third Quarter Results.DOYLESTOWN, Pa.--(BUSINESS WIRE)--Nov. 16, 1998--Discovery Laboratories, Inc. (Discovery) (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : DSCO DSCO Deep Space Climate Observatory , DSCOU) announced today results for the third quarter ended September 30, 1998. The Company reported a net loss of approximately $(1,222,000), or $(0.28) per share for the quarter ended September 30, 1998 as compared to a net loss of approximately $(1,148,000) or $(0.43) per share for the quarter ended September 30, 1997. There were 4,356,000 and 2,625,000 weighted average common shares outstanding for the third quarters of 1998 and 1997, respectively. Discovery's lead product is Surfaxin(TM) for the treatment of acute respiratory distress syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. (ARDS Ards District (pop., 2001: 73,244), Northern Ireland. Formerly part of County Down, Ards was established as a district in 1973. Much of its land is devoted to crops and pasture. Newtownards, settled c. 1608 by Scots, is its administrative seat and manufacturing centre. ), meconium aspiration syndrome Meconium aspiration syndrome Breathing in of meconium (a newborn's first stool) by a fetus or newborn, which can block air passages and interfere with lung expansion. (MAS), and infant (idiopathic) respiratory distress syndrome respiratory distress syndrome or hyaline membrane disease Common complication in newborns, especially after premature birth. Symptoms include very laboured breathing, bluish skin tinge, and low blood oxygen levels. (IRDS IRDS - Information Resource Dictionary System. A set of ISO standards for CASE repositories. It governs the definition of data dictionaries to be implemented on top of relational databases (see repository, data dictionary). ). Surfaxin(TM) is a novel, peptide-containing lung surfactant Surfactant Definition Surfactant is a complex naturally occurring substance made of six lipids (fats) and four proteins that is produced in the lungs. It can also be manufactured synthetically. invented at the Scripps Research Institute. The peptide is sinapultide (KL4-Surfactant), a 21 amino acid peptide modeled after human surfactant protein B Surfactant protein B is a membrane protein. See also
Surfaxin(TM) is being studied in a pivotal Phase 2/3 clinical trial in the US for the treatment of ARDS. Discovery Laboratories recently completed a Phase 2a trial in MAS and is planning to commence a Phase 3 trial in IRDS during 1999, subject to the receipt of regulatory approvals. "We believe that Surfaxin shows great promise for fulfilling a significant unmet medical need," said Discovery's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Dr. Robert Capetola. "We will aggressively pursue our clinical trials and hope to submit a new drug application to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. as soon as possible." Discovery is a bio-pharmaceutical company whose mission is to develop and commercialize medically novel therapeutics for critical care. In addition to Surfaxin(TM), Discovery is developing SuperVent(TM), its aerolosized formulation of tyloxapol for 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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. -0-
Discovery Laboratories, Inc. and Subsidiary
Consolidated Statements of Operations
(Unaudited)
Three Months Ended
September 30,
1998 1997
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Interest income $ 127,000 $ 288,000
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Expenses:
Research and development 846,000 1,246,000
General and administrative 503,000 190,000
Total expenses 1,349,000 1,436,000
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$(1,222,000) $(1,148,000)
Net loss $(1,222,000) $(1,148,000)
-------------------------
Net loss per share -
basic and diluted $ (0.28) $ (0.43)
Weighted average number of common
shares outstanding 4,356,000 2,625,000
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