GW Pharmaceuticals PLC 1st Quarter Results (6590O)

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RNS Number : 6590O

GW Pharmaceuticals PLC

10 February 2016

GW Pharmaceuticals plc Reports First Quarter 2016 Financial Results and Operational Progress

-Three Phase 3 Epidiolex clinical trials fully recruited above target sample size - on track for initial data in March 2016-

-Conference Call Today at 8:00 a.m. EST, 1:00 p.m. GMT-

London, UK, 10 February 2016: 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 first quarter ended 31 December 2015.

"We are on track to report topline data from four Epidiolex Phase 3 trials in the months ahead and remain very excited at the transformational potential of these data for GW. The treatment effect data from our expanded access program provide a solid basis for confidence in the outcome of these trials and the potential for Epidiolex to make a meaningful difference to the lives of patients with Dravet syndrome and Lennox-Gastaut syndrome," stated Justin Gover, GW's Chief Executive Officer. "We are looking forward to an active 2016, that, in addition to the Epidiolex Phase 3 data, is expected to include our first NDA filing, expansion of our U.S. commercial organization, and ongoing data read-outs from a number of clinical pipeline programs."

RECENT OPERATIONAL HIGHLIGHTS

   --     Epidiolex(R) (CBD) childhood epilepsy program: 

o Company sponsored Phase 3 development programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS)

-- First Phase 3 Dravet syndrome trial fully enrolled above original target sample size (120 randomized), data expected March 2016

-- Second Phase 3 Dravet syndrome trial ongoing, data expected H2 2016

-- Both LGS Phase 3 trials fully enrolled above original target sample sizes (171 for 2-arm, 225 for 3-arm randomized), data expected Q2 2016

-- 97% transition rate of eligible patients from Phase 3 trials to long term open label extension

-- NDA submission with FDA expected Q4 2016

-- Phase 3 Tuberous Sclerosis Complex trial due to commence Q1 2016

-- Additional clinical development for Epidiolex expected to commence in H2 2016

o Expanded access program

-- Recent data update at the American Epilepsy Society December 2015 Annual Meeting showing promising safety and effectiveness consistent with prior updates

-- Over 375 children and young adults on treatment at 22 U.S. clinical sites

-- Over 900 children and young adults authorized for treatment by FDA under Expanded Access Treatment INDs and 6 U.S. State programs

   --     Advanced clinical programs in multiple cannabinoid pipeline product candidates: 

o THCV Phase 2 study in type 2 diabetes data expected Q2 2016

o THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in mid-2016

-- Orphan Drug Designation granted from FDA and EMA

o Sativex(R) Phase 2 study in spasticity due to cerebral palsy ongoing with data expected H2 2016

o CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected around the end of 2016

o Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in H2 2016

-- Orphan Drug and Fast Track Designations granted from FDA and EMA

o Clinical trials within the field of autism spectrum disorders expected to commence in H2 2016

-- Pre-clinical progress addressing a number of areas of unmet need including autism spectrum disorders, Duchenne muscular dystrophy, glioma, ovarian and pancreatic cancers

FINANCIAL HIGHLIGHTS

-- Revenue for the three months ended 31 December 2015 of GBP3.7 million ($5.4 million) compared to GBP8.0 million for the three months ended 31 December 2014

-- Loss for the three months ended 31 December 2015 of GBP17.7 million ($26.2 million) compared to GBP3.4 million for the three months ended 31 December 2014

-- Cash and cash equivalents at 31 December 2015 of GBP219.3 million ($324.1 million) compared to GBP234.9 million as at 30 September 2015

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the first quarter 2016 financial results today at 8:00 a.m. EST / 1:00 p.m. GMT. 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 90 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 13629628.

Enquiries:

 
 GW Pharmaceuticals plc 
 Stephen Schultz, VP Investor 
  Relations                            401 500 6570 
 
   FTI Consulting (Media Enquiries) 
 Ben Atwell / Simon Conway             [phone] 
 
   Peel Hunt LLP (UK NOMAD) 
 James Steel                           [phone] 
 

GW Pharmaceuticals plc

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

Financial Results for the First Quarter Ended 31 December 2015

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 its nearly 20 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(R) , 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(R) , which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC). GW has a deep pipeline of additional cannabinoid product candidates which includes clinical development across a variety of compounds for both orphan and non-orphan indications.

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. 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 in the treatment of three indications - Dravet syndrome, LGS and 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.

Epidiolex development in Dravet syndrome

GW commenced a Phase 2/3 clinical trial of Epidiolex for Dravet syndrome in October 2014. This trial is designed as a two-part randomized double-blind, placebo-controlled parallel group dose escalation, safety, tolerability, pharmacokinetic and efficacy trial of single and multiple doses of Epidiolex to treat Dravet syndrome in children who are not responding adequately to other anti-epileptic drugs. The first part of this trial was completed in February 2015, and included a dose-ranging pharmacokinetic and safety evaluation in a total of 34 patients over a 3 week treatment period.

Following a satisfactory review of the Part A data by an independent panel, Part B of the trial commenced in March 2015. Part B is a Phase 3 pivotal placebo-controlled safety and efficacy evaluation of Epidiolex (at a dose of 20mg/kg per day) over a 14 week treatment period. Originally expected to recruit 100 patients, this trial reached a total of 120 patients randomized. In April 2015, GW commenced an additional dose-ranging Phase 3 trial in Dravet syndrome which is recruiting 150 patients. This placebo-controlled trial differs from the first Phase 3 trial in that it includes two Epidiolex dose arms, at 20mg/kg and at 10mg/kg. Both of these studies will be the largest known controlled trials in Dravet syndrome.

GW expects to report top-line results from the Phase 2/3 pivotal safety and efficacy study in March 2016 and results from the second Phase 3 trial in the second half of 2016. The primary measure of efficacy in both trials will be the comparison between Epidiolex and placebo in the percentage change in number of monthly convulsive seizures (reported tonic-clonic, tonic, clonic and atonic seizures) during the 14 week treatment period (which includes 2 weeks dose titration) compared with the 4 week baseline observation period.

Epidiolex development in LGS

February 10, 2016 07:00 ET (12:00 GMT)

On 29 and 30 December 2015, following the exercise and sale of vested share options on behalf of Dr. Geoffrey Guy and Chris Tovey, previously announced on 21 December, the Group received gross proceeds from the sale of option shares of GBP0.1 million and GBP4.5 million respectively. Having deducted the GBP0.6 million option exercise price due to be retained by the Company and having deducted taxation totalling GBP2.2 million, the net proceeds were paid to Dr. Guy and Mr Tovey in January 2016.

As at 31 December, the liability to pay GBP1.8 million to these Directors is included within other payables, together with the taxation liability of GBP2.2 million.

12. Contingent liabilities

As at 31 December 2015 certain fees associated with ongoing capital expenditure have been estimated. The final fees payable are expected to be agreed and paid when construction is completed, scheduled for the second quarter of the year ending 30 September 2016. The Group estimates that there is a possible contingent liability for incremental fees of up to GBP0.4 million (30 September 2015: GBP0.4 million) of capital expenditure.

This information is provided by RNS

The company news service from the London Stock Exchange

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February 10, 2016 07:00 ET (12:00 GMT)