DISCOVERY LABORATORIES INC /DE/ Files SEC form 8-K, Results of Operations and Financial Condition, Other Events, Fina

Item 8.01. Other Events. Also on November 4, 2009, the Company issued a press release providing a business and pipeline development status update. The second press release is attached as Exhibit 99.2 hereto. As of September 30, 2009, the Company had $10.4 million outstanding under its loan with Novaquest, a strategic investment group of Quintiles Transnational Corp. The outstanding principal and all accrued interest is due and payable on April 30, 2010. The Company's plans to seek a potential strategic restructuring of this loan with Novaquest and is assessing alternative means of financing its payment; however, there can be no assurance that any such restructuring will occur or financing alternatives will be obtained. The Company has taken steps to conserve its financial resources, predominantly by curtailing investments in its pipeline programs. As a result of these efforts, the Company anticipates that its estimated net cash outflow for the fourth quarter of 2009 will be $2.7 million ($7.0 million of cash outflow for operating activities and debt service offset by $4.3 million aggregate proceeds received from the CEFF financings in October), before taking into account any further use of the CEFFs, any strategic alliances or other financing alternatives. Estimates of H1N1 infection and hospitalization rates included in the press release are based in part on information obtained from the World Health Organization website (at http://www.who.int/csr/don/2009_10_30/en/index.html) and the U.S. Government Center for Disease Control (at http:/www/cdc.gov/h1n1/images/qa_hospitalizaitons.gif). Estimates of RDS market size and business opportunities included in the press release are based on the Company's analysis of data derived from the following sources, among others: IMS Midas Data MAT, September 2008 (IMS Data); Vermont Oxford Network Data, 2005/2006 (VON Data); Soll, Cochrane Database of Systematic Reviews, 1997, Issue 4 (SC Data); CDC National Vital Statistics, 2005 (CDC NVS...
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Discovery Labs to Present at the Lazard Capital Markets Healthcare Conference

Discovery Labs to Present at the Lazard Capital Markets Healthcare Conference - Yahoo! Finance.gnwlistitemmarginbottom {margin-bottom: 10.0px} .gnwtablebottommargin {margin-bottom: 10.0px} .gnwcellpaddingleft0 {padding-left: 0.0px} .gnwverticalaligntop {vertical-align: top} .gnwtextaligncenter {text-align: center} .gnwcellparagraphmargin {margin-bottom: 0px; margin-top: 0px} .gnwverticalalignbottom {vertical-align: bottom} .gnwwhitespacenowrap {white-space: nowrap} .gnwtextalignright {text-align: right} .gnwcellpaddingright0 {padding-right: 0.0px} .gnwunderlinestyle {text-decoration: underline} .gnwtextalignleft {text-align: left} .gnw_heading {font: 16px Arial; text-align: center} .gnw_subhead {font: 12px Arial; text-align: center} .gnw_colhead {font: 12px Arial; text-align: center} .gnw_colhead_uline {font: 12px Arial; text-align: center; border-bottom: solid black 1.0pt;} .gnw_colhead_dline {font: 12px Arial; text-align: center; border-bottom: double black 2.5pt;} .gnw_label {font: 12px Arial; vertical-align: bottom; text-align: left } .gnw_label_uline {font: 12px Arial; vertical-align: bottom; text-align: left; border-bottom: solid black 1.0pt;} .gnw_label_uline_i10 {font: 12px Arial; vertical-align: bottom; text-align: right; border-bottom: solid black 1.0pt;} .gnw_label_uline_i15 {font: 12px Arial; vertical-align: bottom; text-align: right; border-bottom: solid black 1.0pt;} .gnw_label_uline_i20 {font: 12px Arial; vertical-align: bottom; text-align: right; border-bottom: solid black 1.0pt;} .gnw_label_uline_i25 {font: 12px Arial; vertical-align: bottom; text-align: right; border-bottom: solid black 1.0pt;} .gnw_label_uline_i30 {font: 12px Arial; vertical-align: bottom; text-align: right; border-bottom: solid black 1.0pt;} .gnw_label_dline {font: 12px Arial; vertical-align: bottom; text-align: left; border-bottom: double black 2.5pt;} .gnw_label_i10 {font: 12px Arial; vertical-align: bottom; text-align: left; padding-left: 10.0px;} .gnw_label_i15 {font: 12px Arial; vertical-align: bottom; text-align: l...
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DISCOVERY LABORATORIES INC /DE/ Files SEC form 10-Q, Quarterly Report

Note 2 - Liquidity Risks and Management's Plans We have incurred substantial losses since inception due to investments in research and development, manufacturing and potential commercialization activities and we expect to continue to incur substantial losses over the next several years. Historically, we have funded our business operations through various sources, including public and private securities offerings, draw downs under our Committed Equity Financing Facilities (CEFFs), capital equipment and financing and debt facilities, and strategic alliances. We expect to continue to fund our business operations through a combination of these sources, as well as sales revenue from our product candidates, if approved. Following receipt of the April 2009 FDA Complete Response Letter for Surfaxin, we made fundamental changes in our business strategy. We are actively assessing various strategic and financial alternatives to secure necessary capital to advance our KL4 respiratory pipeline programs to maximize shareholder value. Although we are presently actively engaged in discussions with potential strategic and financial partners, there can be no assurance that any strategic alliance or other financing transaction will be successfully concluded. Our capital requirements will depend upon many factors, including the success of our product development and commercialization plans. Currently, we are focused on developing our lead KL4 surfactant products, Surfaxin LS, Aerosurf and Surfaxin, to address the most significant respiratory conditions affecting pediatric populations. However, there can be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory approval, that any approved product will be commercially viable, that any CEFF will be available for future financings, or that we will be able to obtain additional capital when needed on acceptable terms, if at all. Even if we succeed in raising additional ca...
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New Star Analyst Rankings for Discovery Laboratories, Inc.

Copyright © 2009 Yahoo! Inc. All rights reserved. Privacy Policy - Terms of Service - Copyright/IP Policy - Send Feedback Quotes delayed, except where indicated otherwise.Delay times are 15 mins for NASDAQ, 20 mins for NYSE and Amex. See also delay times for other exchanges.Copyright © 1999-2003, StarMine Corp. All rights reserved.StarMine Corp. derives analyst ratings from estimate and recommendation data supplied by Thomson Financial.Historical chart data and daily updates provided by Commodity Systems, Inc. (CSI). International historical chart data, daily updates, fund summary, fund performance, dividend data and...
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InPlay: Discovery Labs submitted to the FDA its proposed protocol for a Surfaxin

6:26PM Boise Inc. announced that the previously announced secondary offering of 17 mln shares of its common stock has been priced at $4.85 per share (BZ) 5.09 +0.04 :   5:01PM Oncolytics Biotech announces unit offering (ONCY) 3.43 -0.26 : Co announced that it is undertaking an overnight marketed offering of units, each comprised of one common share and a portion of a common share purchase warrant to be effected in each of the Canadian provinces of British Columbia, Alberta, Manitoba and Ontario by way of a prospectus supplement to Oncolytics' base shelf short form prospectus, and in the United States...  ONCY intends to use the net proceeds from the offering to fund its previously announced Phase III combination REOLYSIN and paclitaxel/carboplatin trial for patients with platinum-failed head and neck cancers, its other clinical development and research and development activities, and for general corporate and working capital purposes. 5:00PM Coldwater Creek announced the resignation of Tim Martin, Senior Vice President and Chief Financial Officer (CWTR) 5.81 -0.27 : Co has appointed John E. Hayes, III, Senior Vice President and General Counsel of Coldwater Creek, to serve as interim Chief Financial Officer, effective November 25, 2009, until a permanent successor is named. 4:55PM Quest Diagnostics announces pricing of tender offer for any and all of certain of its outstanding notes (DGX) 59.07 -0.35 : Co announced the determination of the pricing for its previously announced cash tender offer to purchase any and all of its 5.125% Senior Notes due 2010 and any and all of its 7.50% Senior Notes due 2011. 4:44PM Hampton Roads Bankshares defers dividends on TARP preferred stock (...
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Discovery Labs Submits SURFAXIN Pharmacodynamic Trial Protocol to FDA

WARRINGTON, Pa., Nov. 17, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO - News) announced today that it has submitted to the U.S. Food and Drug Administration (FDA) its proposed protocol for a Surfaxin(R) (lucinactant) limited clinical trial. The protocol incorporates a clinical trial design that is primarily intended to assess a pharmacodynamic (PD) response following Surfaxin administration in preterm infants with Respiratory Distress Syndrome (RDS). Discovery Labs proposed this trial design in response to a comment by the FDA that a limited clinical trial could potentially resolve the key remaining issue for approval of Surfaxin for the prevention of RDS in premature infants. Discovery Labs received a Complete Response Letter for Surfaxin in April 2009. At an end-of-review meeting with the FDA on June 2, 2009, the FDA suggested that, to increase the likelihood of gaining Surfaxin approval, Discovery Labs could consider conducting a limited clinical trial. On September 29, 2009, Discovery Labs held a teleconference with the FDA to discuss, among other things, whether a PD approach would satisfy the FDA's requirement for a limited clinical trial. Typically, PD-based clinical trials primarily assess short-term, physiologic responses to therapy and, therefore, are generally less expensive and of shorter duration than trials that have clinical outcomes as a primary endpoint. The FDA indicated that Discovery Labs' proposed concept of a PD trial design is acceptable and also provided direction regarding cert...
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DISCOVERY LABORATORIES INC /DE/ Financials

PERIOD ENDING30-Sep-0930-Jun-0931-Mar-0931-Dec-08Total Revenue -   -   -   -  Cost of Revenue -   -   -   -  Gross Profit -   -   -   -  Operating ExpensesResearch Development4,530  5,052  5,607  5,171  Selling General and Administrative2,417  2,592  3,096  3,121  Non Recurring -   -   -   -  Others -   -   -   -  Total Operating Expenses -   -   -   -  Operating Income or Loss(6,947)(7,644)(8,703)(8,292)Income from Continuing OperationsTotal Other Income/Expenses Net8  16  5  102  Earnings Before Interest And Taxes(6,939)(7,628)(8,698)(8,190)Interest Expense252  280  302  348  Income Before Tax(7,191)(7,908)(9,000)(8,538)Income Tax Expense -   -   -   -  Minority Interest -   -   -   -  Net Income From Continuing Ops(7,191)(7,908)(9,000)(8,538)Non-recurring EventsDiscontinued Operations -   -   -   -  Extraordinary Items -   -   -   -  Effect Of Accounting Changes - &nbs...
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