prothena corp plc (PRTA) Key Developments
Prothena Corporation plc Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015; Provides Earnings Guidance for the Year 2015
Aug 4 15
Prothena Corporation plc reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company's total revenue was $278,000 compared to $15,121,000 a year ago. Loss from operations was $18,035,000 compared to income from operations of $1,569,000 a year ago. Loss before income taxes was $18,082,000 compared to income before income taxes of $1,586,000 a year ago. Net loss was $18,277,000 compared to net income of $1,290,000 a year ago. Net loss per diluted share attributable to holders of ordinary shares was $0.59 compared to income of $0.06 a year ago. Net cash used in operating activities was $11.1 million and $25.9 million for first six months of 2015.
For the six months, the company's total revenue was $871,000 compared to $47,355,000 a year ago. Loss from operations was $33,064,000 compared to income from operations of $19,588,000 a year ago. Loss before income taxes was $33,018,000 compared to income before income taxes of $19,589,000 a year ago. Net loss was $33,479,000 compared to net income of $19,142,000 a year ago. Net loss per diluted share attributable to holders of ordinary shares was $1.15 compared to income of $0.83 a year ago. The decrease in total revenue was primarily due to $15.0 million and $47.1 million in collaboration revenue recognized in relation to the PRX002 collaboration with Roche in the second quarter and first six months of 2014, compared to $0.3 million and $0.9 million in collaboration revenue recognized in the second quarter and first six months of 2015, respectively.
The company continues to expect the full year 2015 net cash burn from operating and investing activities to be $66 to $72 million, ending the year with approximately $356 million in cash. The estimated full year 2015 net cash burn from operating and investing activities is primarily driven by an estimated net loss of $77 to $83 million, which includes an estimated $9 million of non-cash share-based compensation expense.
Prothena Corporation plc Presents at Wedbush PacGrow Healthcare Conference 2015, Aug-12-2015 01:20 PM
Jul 13 15
Prothena Corporation plc Presents at Wedbush PacGrow Healthcare Conference 2015, Aug-12-2015 01:20 PM. Venue: Le Parker Meridian, 119 West 56th Street, New York, NY 10019, United States.
Prothena Corporation plc Appoints Anders Härfstrand to its Board of Directors
Jun 29 15
Prothena Corporation plc announced the appointment of Anders Härfstrand, MD, PhD, to its Board of Directors. Anders' wealth of strategic expertise leading both entrepreneurial and large commercial organizations will serve as a valuable asset as continue development of pipeline of potential therapies, and in particular as move NEOD001 towards commercialization. Dr. Härfstrand was most recently the CEO of BBB Therapeutics BV.
Prothena Presents Clinical Results Demonstrating Robust, Rapid Reduction in Levels of Free Serum Alpha-Synuclein of Up to 96% After Single Dose of PRX002, Novel Protein Immunotherapy for Parkinson's Disease
Jun 17 15
Prothena Corporation plc presented clinical results from a Phase 1 single ascending dose study of PRX002, a monoclonal antibody for the potential treatment of Parkinson's disease and other related synucleinopathies. PRX002 is the focus of a worldwide collaboration between Prothena and Roche. Presented Presented now as part of the late breaking session at the 19thInternational Congress of Parkinson's Disease and Movement Disorders, the data demonstrated that PRX002 was safe and well-tolerated in healthy volunteers, meeting the primary objective of the study. Further, results from this study showed that administration of PRX002 led to a mean reduction of free serum alpha-synuclein levels of up to 96%. These overall results were highly statistically significant (p < 0.00001). Reduction of free serum alpha-synuclein, a protein potentially involved in the onset and progression of Parkinson's disease and the target of PRX002, was shown to be robust, rapid, and dose- and time-dependent after a single dose. The Phase 1 double-blind, placebo-controlled, single ascending dose study enrolled 40 healthy volunteers. All volunteers enrolled were randomized 3:1 into five escalating dose cohorts (0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg or 30 mg/kg) to receive either PRX002 or placebo. No serious adverse events or hypersensitivity reactions were reported. PRX002 demonstrated favorable pharmacokinetic properties, supporting the current dosing frequency in the on-going Phase 1 multiple ascending dose study in patients with Parkinson's disease. Treatment-emergent adverse events in greater than 5% of subjects were vessel puncture site pain, headache, viral infection, nausea, neutropenia, upper respiratory infection and pruritus. All PRX002-related adverse events were mild and no dose limiting toxicities were observed. No anti-drug antibodies were detected.
Prothena Corporation plc Announces First Human Dosed in Phase 1 Study of PRX003 for the Treatment of Psoriasis and Other Inflammatory Diseases
Jun 9 15
Prothena Corporation plc announced the successful first human dosing in a Phase 1 clinical trial of its proprietary protein immunotherapy, PRX003. PRX003 is a monoclonal antibody targeting melanoma cell adhesion molecule for the potential treatment of psoriasis and other inflammatory diseases. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to assess the safety, tolerability, pharmacokinetics and immunogenicity of PRX003. Prothena plans to enroll up to 40 subjects in the U.S. PRX003 is a monoclonal antibody for the potential treatment of psoriasis and other inflammatory diseases. Within the immune system, Th-17 white blood cells initiate the body's response to infections, and are known to be a key participant in both normal inflammatory reactions and autoimmune diseases. MCAM is expressed on the surface of Th-17 cells, and allows certain cells traveling in the blood stream to leave the circulation and enter tissues, primarily to initiate or continue a disease process. PRX003 is designed to block MCAM and not allow the migration of these pathogenic cells into tissues. PRX003 may be useful for treating a variety of inflammatory diseases such as psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis, sarcoidosis, uveitis, vasculitis, and Behcet's disease.