Prothena Reports Third Quarter 2016 Financial Results And Provides R&D Update

  • Net cash used in operating and investing activities was $39.1 million in the third quarter and  $96.8 million for the first nine months of 2016; quarter-end cash and restricted cash position of $412.6 million supports advancement of a diverse pipeline and commercial capabilities
  • Appointed Gene G. Kinney, PhD President and Chief Executive Officer, following the passing of Prothena Co-founder, President and Chief Executive Officer Dale B. Schenk, PhD
  • Announced strategy to advance a Phase 2 clinical trial for PRX003 in psoriatic arthritis

DUBLIN, Ireland, Nov. 01, 2016 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, today reported financial results for the third quarter and first nine months of 2016. In addition, the Company provided an update on its R&D programs and 2016 financial guidance.

"With the continued expansion of our team and capabilities, we are advancing our vision of establishing a fully-integrated biotechnology company that can take a potential new therapy from discovery to patients," stated Gene Kinney, PhD, President and Chief Executive Officer of Prothena. "During the next 18 months, we expect to achieve significant milestones for each of our clinical programs. Later this month, we plan to report topline data from the Phase 1b multiple ascending dose study for PRX002 in patients with Parkinson's disease, and in 2017 we expect both interim and full results from the Phase 1b proof-of-biology study of PRX003 in patients with psoriasis. For our lead program NEOD001, the VITAL study is on track to be fully enrolled by the second quarter of 2017 and based on the current status of the PRONTO study enrollment, we expect topline results from this study in early 2018."

Recent Highlights and Program Updates:
  • Announced that Gene Kinney, PhD was appointed as President and Chief Executive Officer. Dr. Kinney succeeded Prothena Co-founder, President and Chief Executive Officer Dale Schenk, PhD, who passed away on September 30, 2016. Dr. Kinney was also appointed to Prothena's Board of Directors.
  • During a webcast, announced strategy to advance a Phase 2 clinical study of PRX003 in psoriatic arthritis, based on certain pre-specified criteria being met in an ongoing Phase 1b proof-of-biology study in patients with psoriasis. PRX003 targets CD146, also known as melanoma cell adhesion molecule (MCAM), a cellular adhesion molecule expressed on the surface of Th17 cells, and is designed to block pathogenic Th17 cells from infiltrating into tissue and releasing multiple cytokines that contribute to inflammatory disease pathology.
  • In an oral session at the 6th International Charcot-Marie-Tooth and Related Neuropathy Consortium (CMTR) meeting, presented preclinical data from a series of novel, conformation-specific protein immunotherapy antibodies that selectively bind to amyloidogenic (diseased) forms of the transthyretin (ATTR) protein in tissues from ATTR amyloidosis patients.
  • Published a paper in the journal Amyloid that further supports the proposed mechanism of action of NEOD001. The publication features preclinical data demonstrating the binding and phagocytosis clearance properties of NEOD001 and the related murine form of the antibody in tissue samples from multiple organs of patients with AL amyloidosis.
  • In an oral session at the 15th International Symposium on Amyloidosis (ISA), Morie A. Gertz, MD, of Mayo Clinic, presented clinical data from the NEOD001 Phase 1/2 dose-escalation and expansion study, demonstrating best response rates of 53% and 63% for cardiac- (n=36) and renal- (n=35) evaluable patients, respectively. Improvement in peripheral neuropathy, a third organ system, was demonstrated by a mean 35% (median 23%, n=11) decrease in the Neuropathy Impairment Score- Lower Limb (NIS-LL) as a change from baseline to month 10, leading to an 82% response rate. NEOD001 continued to be generally safe and well tolerated. These data were also presented in poster sessions at the 2016 European Society of Cardiology Congress, the Heart Failure Society of America 2016 Annual Meeting, and the American Neurological Association's 141st Annual Meeting.

Upcoming Research and Development Milestones

Prothena's pipeline includes four protein immunotherapy programs.

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