GW Pharma Reports Third Quarter 2015 Financial Results And Operational Progress

- Four Phase 3 epilepsy clinical trials underway – First Phase 3 trial fully enrolled -

- U.S. operations established with appointment of new President and headquarters -

- Conference Call Today at 8:00 a.m. EDT, 1:00 p.m. BST -

LONDON, Aug. 6, 2015 (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 2015.

RECENT OPERATIONAL HIGHLIGHTS

• U.S. operations update:
  • Seasoned industry executive Julian Gangolli appointed as President, North America and to the GW Board of Directors as Executive Director
  • GW CEO Justin Gover relocates to California from London
  • U.S. operations now comprise 25 employees and will be headquartered in Carlsbad, California
• Epidiolex^® (CBD) childhood epilepsy program:
  • Dravet syndrome – First Phase 3 pivotal trial now fully enrolled with a total of 120 patients, exceeding original target of 100 patients. Top-line data expected early Q1 2016. Second Phase 3 trial on track for top-line data in Q1 2016
  • Lennox-Gastaut syndrome – Two Phase 3 trials underway and on track for top-line data in Q1 2016
  • Tuberous Sclerosis Complex – Phase 3 trial expected to start in Q4 2015
  • Additional clinical development for Epidiolex beyond initial three indications expected to commence during 2016
  • Expanded access program:
    • Approximately 320 children on treatment at 19 U.S. clinical sites
    • Approximately 750 children authorized for treatment by FDA under Expanded Access Treatment INDs and 4 U.S. State programs
    • Additional data expected Q4 2015
• Orphan/Neurology cannabinoid pipeline product candidates:
  • Phase 2a CBD schizophrenia study complete with data expected H2 2015
  • Phase 2 Cannabidivarin (CBDV) epilepsy study underway with data expected in H1 2016
  • Orphan Drug and Fast Track Designations granted for intravenous CBD in the treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) from the FDA and recently received from the EMA
  • Plans advancing to commence clinical trials within field of autism spectrum disorders in 2016.
  • Phase 1b/2a study of GWP42002:GWP42003 for the treatment of Recurrent Glioblastoma Multiforme (GBM) is fully recruited with data expected in mid-2016
• Other cannabinoid pipeline product candidates
  • Second and third Sativex Phase 3 cancer pain trials expected to read out in H2 2015 - First trial did not show a statistically significant difference for Sativex compared with placebo
  • Phase 2 study of GWP42004 in type-2 diabetes underway with data expected in 2016
• Extensive pre-clinical progress in conjunction with network of academic collaborators addressing:
  • New therapeutic targets:
    • Autism Spectrum Disorders
    • Duchenne Muscular Dystrophy
    • A range of oncology programs
    • Cachexia
  • Mechanisms of action of Epidiolex in epilepsy

FINANCIAL HIGHLIGHTS

• Follow-on offering in May 2015 raising total net proceeds after expenses of $193.3 million (£127.5 million).
• Revenue for the nine months ended 30 June 2015 of £22.9 million ($36.0 million) compared to £22.6 million for the nine months ended 30 June 2014.
• Loss for the nine months ended 30 June 2015 of £32.3 million ($50.8 million) compared to £14.9 million for the nine months ended 30 June 2014.
• Cash and cash equivalents at 30 June 2015 of £254.0 million ($398.9 million) compared to £164.5 million as at 30 September 2014.

"GW has unprecedented momentum with four phase 3 trials progressing for Epidiolex in pediatric epilepsy as well as a full pipeline of other early and late stage clinical programmes across a range of indications", stated Justin Gover, GW's Chief Executive Officer. "We expect to carry this momentum through the remainder of 2015 as we approach pivotal Phase 3 data for Epidiolex and GW moves confidently forward with preparations for an expected NDA submission in 2016 as well as continuing to build a high quality U.S. commercial infrastructure ahead of commercial launch."

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the 2015 third quarter financial results today at 8:00 a.m. EDT / 1:00 p.m. BST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada), or 0800-756-3429 (toll free from the UK) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company's website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID #13615856.

GW Pharmaceuticals plc

("GW" or "the Company" or "the Group")

2015 Third Quarter Financial Results

GW Overview

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. In 16 years of operations, GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise. 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 27 countries outside the United States. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex^®, 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 by the end of 2015. GW has a deep pipeline of additional cannabinoid product candidates which includes Sativex in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer, as well as compounds in Phase 1 and 2 development for both orphan (Neonatal Hypoxic Ischemic Encepholapthy and glioma) and non-orphan (type 2 diabetes and schizophrenia) indications.

U.S. Operations Update

In June 2015, Julian Gangolli joined GW in the newly created position of President, North America, and has been appointed to the GW Board of Directors. Previously, Mr Gangolli was President of the North American Pharmaceutical division of Allergan Inc., with responsibility for a 1,400-person integrated commercial operation with sales exceeding $3.8 billion in 2014. GW also announced the relocation of the Company's CEO, Justin Gover, to the U.S. Together, Mr. Gangolli and Mr. Gover will lead GW's growth in the U.S. and prepare for the expected NDA submission and build the in-house U.S. commercial infrastructure required for a successful commercial launch of Epidiolex. In total, GW now has 25 U.S.-based employees. Mr. Gangolli and Mr. Gover will be based at the U.S. operation in Carlsbad, California.

U.S. Follow-on Offering

In May 2015, GW successfully completed a U.S. follow-on offering on the NASDAQ Global Market issuing a total of 1,840,000 American Depositary Shares ("ADSs") at a price of $112.00 per ADS. This total included the full exercise of the underwriters option to purchase an additional 240,000 ADSs and resulted in total net proceeds after expenses of approximately $193.3 million (£127.5 million). The funds raised in this offering are primarily intended to support further expansion of GW's Epidiolex manufacturing capability and build-up of inventory in preparation for U.S. launch, if Epidiolex is approved; clinical development of other orphan indication opportunities for Epidiolex, with an initial focus on Tuberous Sclerosis Complex; the advancement of other pipeline opportunities, including an intravenous CBD formulation in the treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE); pre-launch commercialization activities for Epidiolex in the United States; and for other general corporate purposes.

Epilepsy Drug Development Programs

GW's epilepsy franchise centers around two product candidates, Epidiolex, a liquid formulation of pure plant-derived cannabidiol (CBD), and GWP42006 (CBDV). GW is currently pursuing the development of CBD for a series of individual orphan epilepsy-related indications providing GW with significant new market opportunities. These development programs are funded completely by GW and GW retains all rights to commercialize any and all products that evolve from these programs.

Epidiolex^®

GW is undertaking a formal development program for Epidiolex in the field of severe, drug-resistant childhood epilepsy with initial focus on conducting formal development programs for Epidiolex in the treatment of three indications - Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC). The Company has to date received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Epidiolex for the treatment of both Dravet syndrome and LGS. Additionally, GW has received Fast Track Designation from the FDA and Orphan Designation from the European Medicines Agency (EMA) for Epidiolex for the treatment of Dravet syndrome.

Investigations to clarify the pharmacological targets which underlie CBD's anticonvulsant effects are on-going. Overall, CBD is likely to be acting via more than one mechanism of action with the effect of reducing neuronal hyperexcitability. Importantly, the anti-seizure effects of CBD are not dependent on cannabinoid receptors, nor on sodium channels.