GW Pharma (GWPH) Posts Q3 Loss of 6c/Share; THCV Phase 2 Missed Primary Endpoint in T2D

GW Pharma (NASDAQ: GWPH) reported Q3 EPS of ($0.06), $1.15 better than the analyst estimate of ($1.21). Revenue for the quarter came in at $3.1 million versus the consensus estimate of $3.63 million.

RECENT OPERATIONAL HIGHLIGHTS

• Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
  • Phase 3 development programs:
    • Positive results in first Phase 3 Dravet syndrome trial
    • Positive results in first Phase 3 LGS trial
    • Data presentations expected at upcoming American Epilepsy Society Annual Meeting in December
    • Positive Dravet syndrome Pre-NDA meeting held with FDA
    • NDA on track for H1 2017 submission for both Dravet and LGS indications
    • Data from second LGS trial expected at end of Q3
    • Second Phase 3 Dravet syndrome trial ongoing
    • Phase 3 trial in TSC ongoing
    • Phase 3 trial in IS to commence in Q4 2016
  • Expanded access program and open label extension:
    • Over 1,000 patients now on Epidiolex treatment under Expanded Access Treatment INDs, U.S. State programs, and open label extension trial
• Advanced clinical programs in multiple cannabinoid pipeline product candidates:
  • CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected H1 2017
  • CBDV pre-clinical research ongoing within field of autism spectrum disorders. Initial open-label clinical evaluation expected to commence in H2 2016, with Phase 2 trials expected to commence in H1 2017
  • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in Q4 2016
    • Orphan Drug and Fast Track Designations granted from FDA and EMA
  • THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in Q4 2016
  • Sativex® Phase 2 study in children with spasticity due to cerebral palsy fully enrolled with data expected Q4 2016
  • THCV Phase 2 study in type 2 diabetes completed, primary endpoint not achieved

For earnings history and earnings-related data on GW Pharma (GWPH) click here.

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