OREANDA-NEWS. 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, announced financial results for the third quarter ended 30 June 2016.

“We have now reported two positive Phase 3 trials for Epidiolex and are on track for an NDA filing that includes both the Dravet syndrome and Lennox-Gastaut Syndrome indications. We believe that these Phase 3 data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in these highly treatment-resistant populations together with an acceptable safety and tolerability profile,” stated Justin Gover, GW’s Chief Executive Officer. “Our recent successful financing has provided GW with the necessary capital to move forward with confidence in preparing to execute a highly successful launch.”

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

 

About GW Pharmaceuticals plc

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside the United States. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Tuberous Sclerosis Complex. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the relevance of GW products commercially available and in development, the clinical benefits of Sativex® and Epidiolex® and the safety profile and commercial potential of Sativex and Epidiolex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Enquiries:

GW Pharmaceuticals plc  
Stephen Schultz, VP Investor Relations   401 500 6570
 

FTI Consulting (Media Enquiries)

  
Ben Atwell / Simon Conway +44 20 3727 1000
   
FleishmanHillard (U.S. Media)  
Paddi Hurley / Adam Silverstein 212 453 2382 / 917 697 9313

GW Pharmaceuticals plc
Condensed consolidated income statement
Three months ended 30 June 2016

    30 June 30 June 30 June
  Notes   2016   2016   2015
    $000’s ?000’s ?000’s
Revenue 2   3,097     2,329     8,629  
Cost of sales     (946 )   (711 )   (721 )
Research and development expenditure 3   (34,058 )   (25,609 )   (20,841 )
Sales, general and administrative expenses     (7,452 )   (5,603 )   (2,984 )
Net foreign exchange gain/(loss)     14,883     11,190     (8,851 )
    _______ _______ _______
Operating loss     (24,476 )   (18,404 )   (24,768 )
Interest income     130     98     46  
Interest expense     (24 )   (18 )   (21 )
    _______ _______ _______
Loss before tax     (24,370 )   (18,324 )   (24,743 )
Tax benefit 4   8,125     6,109     3,318  
    _______ _______ _______
Loss for the period     (16,245 )   (12,215 )   (21,425 )
    _______ _______ _______
         
Loss per share – basic and diluted 5 (6.1c) (4.6p) (8.5p)

All activities relate to continuing operations.


Condensed consolidated statement of comprehensive loss                         
For the three months ended 30 June 2016

  30 June
2016
?000’s		 30 June
2015
?000’s
Loss for the period   (12,215 )   (21,425 )
Items that may be reclassified subsequently to profit or loss    
Exchange gain on retranslation of foreign operations   266     16  
Other comprehensive gain for the period   266     16  
Total comprehensive loss for the period   (11,949 )   (21,409 )
             

GW Pharmaceuticals plc
Condensed consolidated income statement
Nine months ended 30 June 2016

    30 June 30 June 30 June
  Notes   2016   2016   2015
    $000’s ?000’s ?000’s
Revenue 2   11,497     8,645     22,945  
Cost of sales     (2,580 )   (1,940 )   (1,935 )
Research and development expenditure 3   (100,406 )   (75,497 )   (51,328 )
Sales, general and administrative expenses     (16,584 )   (12,470 )   (7,581 )
Net foreign exchange gain/(loss)     25,640     19,279     (672 )
    _______ _______ _______
Operating loss     (82,433 )   (61,983 )   (38,571 )
Interest income     388     292     161  
Interest expense     (70 )   (53 )   (60 )
    _______ _______ _______
Loss before tax     (82,115 )   (61,744 )   (38,470 )
Tax benefit 4   19,942     14,995     6,140  
    _______ _______ _______
Loss for the period     (62,173 )   (46,749 )   (32,330 )
    _______ _______ _______
         
Loss per share – basic and diluted 5 (23.7c) (17.8p) (13.4p)

All activities relate to continuing operations.

Condensed consolidated statement of comprehensive loss                         
For the nine months ended 30 June 2016

  30 June
2016
?000’s		 30 June
2015
?000’s
Loss for the period   (46,749 )   (32,330 )
Items that may be reclassified subsequently to profit or loss    
Exchange gain/(loss) on retranslation of foreign operations   166     (20 )
Other comprehensive gain/(loss) for the period   166     (20 )
Total comprehensive loss for the period   (46,583 )   (32,350 )
             

GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Nine months ended 30 June 2016

    Share      
  Share premium Other Accumulated  
  capital account reserves deficit Total
  ?000’s ?000’s ?000’s ?000’s ?000’s
Balance at 1 October 2014 237   220,551     19,260     (81,464 )   158,584  
Issue of share capital 22   127,812     -     -     127,834  
Expense of new equity issue -   (307 )   -     -     (307 )
Exercise of share options 2   1,139     -     -     1,141  
Share-based payment transactions -   -     -     1,161     1,161  
Loss for the period -   -     -     (32,330 )   (32,330 )
Other comprehensive loss -   -     (20 )   -     (20 )
  _________ _________ ________ __________ ________
Balance at 30 June 2015 261   349,195     19,240     (112,633 )   256,063  
  _________ _________ ________ __________ ________
           
           
           
Balance at 1 October 2015 261   349,275     19,189     (123,455 )   245,270  
Exercise of share options 2   633     -     -     635  
Share-based payment transactions -   -     -     5,900     5,900  
Loss for the period -   -     -     (46,749 )   (46,749 )
Deferred tax attributable to unrealized share option gains -   -     -     366     366  
Other comprehensive gain -   -     166     -     166  
  _________ _________ ________ __________ ________
Balance at 30 June 2016 263   349,908     19,355     (163,938 )   205,588  
  _________ _________ ________ __________ ________