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GW Pharmacetuicals PLC Beats Industry Estimates in 3rd Quarter Financials

GW Pharmaceuticals plc (GWPH) announced financial results for the third quarter of 2014 on August 6th. As a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, GWPH has been a hot stock pick for many investors over the past year.


3rd Quarter 3-month Financials (Ending On June 30, 2014)

3-month-GWPH

Revenue for the three months ending on June 30th, of 7.6 million compared to 7.3 million for the same period in 2013.

Loss for the this 3rd quarter period increased year to year 6.9 million vs 2 million in 2013 due to the planned increase in GW funded R&D in order to fund the development of Epidiolex and other pipeline candidates. The continued investment into R&D bolds well for the company heading into 2015.

Cash & cash equivalents of 168.3 million compared to 38.1 million as of 2013.

Quotes from Chief Financial Officer Justin Gover:

“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,”

“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.”

Cannabinoid Pipeline Product Candidates News

  • 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

Sativex Updates

  • 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

Epidiolex Childhood Epilepsy Treatment Updates

  • 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 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



For more information on GW Pharmacuticals visit their official site: gwpharm.com.