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discovery laboratories inc (DSCO) Key Developments

Discovery Laboratories Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Provides Operating Cash Outflows Guidance for the Fourth Quarter of 2014

Discovery Laboratories Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported total revenue of $527,000 compared to $60,000 a year ago. Operating loss was $10,327,000 compared to $10,813,000 a year ago. Net loss was $11,324,000 or $0.13 per basic and diluted share compared to $12,224,000 or $0.22 per basic and diluted share a year ago. Net cash outflows before financing activities for the quarter ended September 30, 2014 were $10.6 million. For the nine months period, the company reported total revenue of $1,651,000 compared to $315,000 a year ago. Operating loss was $32,032,000 compared to $34,242,000 a year ago. Net loss was $33,423,000 or $0.41 per diluted share compared to $33,486,000 or $0.69 per diluted share a year ago. For the fourth quarter of 2014, the company anticipates operating cash outflows before financing activities of approximately $11 million.

Discovery Laboratories Inc. Announces Executive Changes

Discovery Laboratories Inc. announced organizational changes to the development leadership team and a special advisory appointment to augment the company's expertise in neonatology and aerosolized drug delivery. Steven G. Simonson, M.D., has been appointed Senior Vice President and Chief Development Officer, with responsibility for research, clinical development, aerosol device development, regulatory affairs, and patient safety /pharmacovigilance. Dr. Simonson joined Discovery Labs in May 2014 as Vice President, Clinical Development, and brings to Discovery Labs over 25 years of medical practice and pharmaceutical industry clinical trial experience with a significant focus in pulmonary critical care and developing respiratory drugs. The company also announced the appointment of Jan Mazela, M.D., Ph.D. as Special Medical and Scientific Advisor - Neonatology. Dr. Mazela is a pediatrician and neonatologist, a global key opinion leader in neonatology, and an expert in the application of aerosolization technology to neonatal medicine. He currently serves as Medical Director in the Department of Neonatology and Infectious Diseases at Poznan University of Medical Sciences in Poznan, Poland. As part of the organizational changes, Russell G. Clayton, D.O., Discovery Labs' Senior Vice President, Research and Development will be leaving the company by mutual agreement in December 2014 to pursue other interests. He will serve in an advisory role to the company through the planned AEROSURF phase 2 program.

Discovery Laboratories Inc. to Report Q3, 2014 Results on Nov 06, 2014

Discovery Laboratories Inc. announced that they will report Q3, 2014 results at 9:00 AM, Eastern Standard Time on Nov 06, 2014

Discovery Laboratories Inc., Q3 2014 Earnings Call, Nov 06, 2014

Discovery Laboratories Inc., Q3 2014 Earnings Call, Nov 06, 2014

Discovery Laboratories, Inc. Announces Strategic Collaboration with Battelle for AEROSURF Program

Discovery Laboratories, Inc. announced that it has entered into a strategic collaboration with Battelle. The parties intend to further develop Discovery Labs' proprietary capillary aerosol generator for use in the planned AEROSURF phase 3 clinical program and, if approved, initial commercialization. The arrangement also reflects the plan to negotiate agreements to provide for the manufacture of phase 3 clinical devices and, if AEROSURF is approved, initial commercial supply. The CAG is currently being used in neonatal intensive care units for the company's AEROSURF phase 2 clinical program for the treatment of respiratory distress syndrome (RDS) in premature infants. Battelle and Discovery Labs generally will share equally in the agreed costs of the device development for the AEROSURF RDS program. In consideration for its investment and expertise, Battelle will receive warrants and future royalties on AEROSURF sales and license sales revenues. Under the terms of the agreement, Battelle and Discovery Labs will co-invest in the development of an AEROSURF phase 3 clinic-ready aerosol device. Upon execution of the agreement, Battelle received two warrants to purchase a total of 1.5 million shares of Discovery Labs' common stock at an exercise price of $5.00 per share, each warrant with a 10-year term. The first warrant to purchase 1 million shares is exercisable only upon successful development of an aerosol device that is ready for a potential AEROSURF phase 3 clinical program. The second warrant to purchase 0.5 million shares will become exercisable only upon meeting the aforementioned milestone by a certain date. In addition, if AEROSURF receives regulatory approval for the treatment of RDS, Battelle will receive a low single-digit royalty on Discovery Labs' AEROSURF commercial revenues, subject to an aggregate cap of $25 million. AEROSURF is a novel investigational combination drug-device product being developed to deliver the company's synthetic KL4 surfactant in aerosolized form via nasal continuous positive airway pressure to premature infants with RDS. AEROSURF could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated. Discovery Labs is developing its proprietary aerosolization drug delivery technologies, including the CAG, to enable efficient delivery of aerosolized KL4 surfactant. The company is currently conducting a phase 2 clinical program for AEROSURF employing the current version of the CAG.


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