GW Pharmaceuticals Turns In Solid Quarter, New Studies Delayed

GW Pharmaceuticals plc (Nasdaq: GWPH) delivered total revenue of $120.6 million for the first quarter ending March 31, 2020, versus last year’s $39.2 million for the same time period. The net loss for the quarter was $8 million versus last year’s net loss of $50.1 million for the same time period.

“In the first quarter of 2020, we have seen continued strength of the Epidiolex brand in both the U.S. and Europe and remain confident about prospects for growth in the remainder of the year. Having been granted priority review by the FDA for our proposed label expansion to include TSC, our US commercial team is actively preparing for the launch of this indication in August,” stated Justin Gover, GW’s CEO. “In this current environment caused by COVID-19, we have been able to support the epilepsy community remotely and maintain production of Epidiolex, while taking necessary steps to maintain the wellbeing of our employees.”

Looking Ahead

GW Pharma said that the start of new clinical programs would be delayed until the second half of 2020 due to current COVID restrictions. Still, the company outlined the following items in the pipeline:

  • Nabiximols (Sativex outside of the US)
    • Multiple Sclerosis spasticity
      • US pivotal clinical program expected to commence in H2 2020 to augment existing data package
      • 3 positive Phase 3 trials completed in Europe
    • Spinal cord injury spasticity – clinical program expected to commence in H2 2020
    • PTSD – clinical program expected to commence in H2 2020
  • Schizophrenia (GWP42003)
    • Phase 2b trial expected to commence H2 2020
  • CBDV in autism
    • 30-patient open label study in autism
    • Investigator-led 100 patient placebo-controlled trial in autism
    • Open label study in Rett syndrome and seizures
  • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program commenced
    • Phase 1b safety study in patients continues to recruit due to emergency care environment
    • Orphan Drug and Fast Track Designations granted from FDA and EMA

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