GW Pharmaceuticals PLC (GWPH) Reports Fiscal Third Quarter 2015 Financial Results and Operational Progress
GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH), 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
- Mechanisms of action of Epidiolex in epilepsy
- 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.” (Original Source)
Shares of GW Pharmaceuticals plc closed yesterday at $114.26. GWPH has a 1-year high of $133.98 and a 1-year low of $58.16. The stock’s 50-day moving average is $121.55 and its 200-day moving average is $103.48.
On the ratings front, GW Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on July 29, Piper Jaffray analyst Joshua Schimmer maintained a Buy rating on GWPH, with a price target of $147, which implies an upside of 28.7% from current levels. Separately, on April 14, Leerink Swann’s Joseph Schwartz reiterated a Buy rating on the stock and has a price target of $120.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joshua Schimmer and Joseph Schwartz have a total average return of 11.5% and 36.1% respectively. Schimmer has a success rate of 61.3% and is ranked #248 out of 3727 analysts, while Schwartz has a success rate of 69.1% and is ranked #33.
GW Pharmaceuticals PLC is engaged in the research, development and commercialisation of cannabinoid prescription medicines to meet patient needs.