GW Pharmaceuticals Plc Reports 2014 Third Quarter Financial Results

LONDON, Aug. 6, 2014 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) ("GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the third quarter and nine months ended 30 June 2014.

  • Follow-on offering of American Depositary Shares ("ADSs") on the NASDAQ Global Market closed in June 2014 raising total net proceeds after expenses of approximately $118 million (£69.5 million)  
  • Advancement of Epidiolex® (Cannabidiol or CBD) childhood epilepsy program:
    • U.S. Food and Drug Administration (FDA) Authorized Physician-Led Expanded Access Program
      • Treatment effect data on initial patient cohort released in June 2014 with data showing promising signals of efficacy and safety
      • Number of children suffering from intractable epilepsy syndromes authorized for treatment with Epidiolex by FDA increased to approximately 395
      • Approximately 100 children now receiving treatment with Epidiolex in the U.S. at six hospital sites
      • Treatment data on additional cohort of patients to be released H2 2014
    • Dravet syndrome development program
      • Orphan Drug Designation, Fast Track Designation granted and Investigational New Drug Application (IND) opened with the FDA for Epidiolex in the treatment of Dravet Syndrome
      • Phase 2/3 Dravet syndrome trial protocol finalized and on track to commence H2 2014
      • Additional Phase 3 Dravet syndrome trial on track to commence early 2015
    • Lennox-Gastaut syndrome (LGS) development program
      • Orphan Drug Designation granted by FDA in the treatment of LGS
      • FDA comments received on proposed Phase 3 trial protocols
      • Phase 3 trials on track to commence early 2015
    • State Programs
      • Initiatives announced with States of Georgia and New York to collaborate with GW on state-based Epidiolex clinical trials in epilepsy
  • Sativex ® program developments:
    • Fast Track designation granted by FDA for Sativex in the treatment of chronic cancer pain in patients with advanced cancer who have failed to respond adequately to optimized opioid therapy
    • Initial top-line Phase 3 cancer pain data on track for release towards the end of 2014. Data intended to lead to a New Drug Application (NDA) filing with the FDA in the U.S.
    • Special Protocol Assessment (SPA) ongoing with the FDA for proposed Sativex Phase 3 trial in the treatment of Multiple Sclerosis (MS) spastici  
  • Significant additional on-going clinical trial activity for cannabinoid pipeline product candidates:
    • Advancement of Cannabidivarin (CBDV) epilepsy program with a Phase 2 trial expected to commence at end of 2014/early 2015
    • Phase 2a trial of GWP42003 for the treatment of ulcerative colitis recruitment complete - data expected H2 2014
    • Phase 2b 12-week randomized, double blind, placebo controlled trial of GWP42004 in type-2 diabetes commenced in March 2014 with expected completion in H2 2015
    • Phase 2a trial of GWP42003 for the treatment of schizophrenia commenced in March 2014 with expected completion in H2 2015
    • Phase 1b/2a trial of GWP42002:GWP42003 in the treatment of glioma ongoing with safety data on an initial cohort due in 2014

  • Revenue for the three months ended 30 June 2014 of £7.6 million ($13.0 million) compared to £7.3 million for the three months ended 30 June 2013  
  • Loss for the three months ended 30 June 2014 of £6.9 million ($11.9 million) compared to a loss of £2.0 million for the three months ended 30 June 2013. The increased loss primarily reflects the planned increase in GW funded R&D in order to fund the development of Epidiolex and other pipeline candidates  
  • Cash and cash equivalents at 30 June 2014 of £168.3 million ($287.8 million) compared to £38.1 million as at 30 September 2013

"During the third quarter GW announced important initial data on Epidiolex which provides promising signals of efficacy in children with treatment-resistant epilepsy, including patients with Dravet syndrome. Our preparations for Phase 3 clinical trials in both Dravet and Lennox-Gastaut syndromes are advancing rapidly and we look forward to the start of the first pivotal placebo-controlled trial in the second half of this year. The funds raised this quarter in the follow-on offering will not only allow GW to complete these development programs but also to commence pre-launch activities in the United States and build-up of inventory in readiness for future launch," stated Justin Gover, GW's Chief Executive Officer. "In parallel with GW's Epidiolex program, we are also progressing towards the conclusion of our U.S. Phase 3 cancer pain trials for Sativex and look forward to reporting initial top-line data from the first trial around the end of 2014. Finally, we continue to make strong progress across our cannabinoid pipeline, which continues to yield interesting new product candidates in a wide variety of therapeutic areas."

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