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, Feb. 10, 2016 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) (AIM: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® (CBD) childhood epilepsy program:
- 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
- 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
- Company sponsored Phase 3 development programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS)
- Advanced clinical programs in multiple cannabinoid pipeline product candidates:
- THCV Phase 2 study in type-2 diabetes data expected Q2 2016
- 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
- Sativex® Phase 2 study in spasticity due to cerebral palsy ongoing with data expected H2 2016
- 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
- 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
- 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 £3.7 million ($5.4 million) compared to £8.0 million for the three months ended 31 December 2014
- Loss for the three months ended 31 December 2015 of £17.7 million ($26.2 million) compared to £3.4 million for the three months ended 31 December 2014
- Cash and cash equivalents at 31 December 2015 of £219.3 million ($324.1 million) compared to £234.9 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.
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, type 2 diabetes, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com
Full press release: http://gwpharma.com/uploads/2016q1results-rnsfinal-10feb2016.pdf
