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 second quarter and half-year ended 31 March 2015.
RECENT OPERATIONAL HIGHLIGHTS
- Epidiolex® (CBD) childhood epilepsy program:
- Dravet syndrome – Two Phase 3 pivotal trials recently commenced with top-line data expected from the first trial by end of 2015
- Lennox-Gastaut syndrome – First Phase 3 trial in Lennox-Gastaut syndrome commenced (see separate announcement today). Second Phase 3 trial on track to start in calendar Q2 2015
- Tuberous Sclerosis Complex selected as additional new target indication with Phase 3 trial expected to start in H2 2015
- Recent data on 137 patients from expanded access program presented at American Academy of Neurology further reinforces signals of clinical effect seen in previous data disclosures
- Approx. 290 children currently on treatment in expanded access program at 17 U.S. clinical sites
- Approx. 420 children authorized for treatment by FDA under Expanded Access Treatment INDs and additional 225 patients authorized by FDA under 4 U.S. State programs
- Notice of Allowance issued by the U.S. Patent and Trademark Office (USPTO) covering the use of CBD in the treatment of partial seizures.
- Cannabidivarin (CBDV) epilepsy program:
- Phase 2 CBDV epilepsy study in 130 patients underway
- Notice of Allowance issued by the USPTO for patent application covering use of CBDV for the treatment of epilepsy
- Cannabinoid pipeline product candidates:
- Orphan drug designation granted for CBD in the treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE). Phase 1 trial expected to commence in H2 2015
- Recruitment complete in a Phase 2a study for the treatment of schizophrenia – data expected H2 2015
- First of three Sativex Phase 3 cancer pain trials did not show a statistically significant difference for Sativex compared with placebo. Two additional Phase 3 cancer pain trials expected to read out in H2 2015
- Phase 1b study of GWP42002:GWP42003 underway for the treatment of Recurrent Glioblastoma Multiforme (GBM)
- Phase 2 study of GWP42004 in type-2 diabetes underway with expected completion in 2016
- Follow-on offering closed 5 May 2015 raising total net proceeds after expenses of approximately $167.8 million (£110.4 million).
- Revenue for the six months ended 31 March 2015 of £14.3 million ($21.3 million) compared to £15.0 million for the six months ended 31 March 2014.
- Loss for the six months ended 31 March 2015 of £10.9 million ($16.2 million) compared to £8.0 million for the six months ended 31 March 2014.
- Cash and cash equivalents at 31 March 2015 of £148.6 million ($220.7 million) compared to £164.5 million as at 30 September 2014.
“During the second quarter, we commenced our pivotal Phase 3 trials program for Epidiolex in childhood epilepsy and expect these trials to recruit rapidly with a view to reporting initial top-line data around the end of 2015. The new data presented at the American Academy of Neurology has only served to reinforce our confidence in the potential for Epidiolex to become an important advance in the field of treatment-resistant epilepsy,” stated Justin Gover, GW’s Chief Executive Officer. “With our successful follow-on offering, GW is in a strong position to continue to prepare for a NDA submission to the FDA in 2016 and to make necessary preparations toward a successful commercial launch.”(Original Source)
Shares of GW closed last Friday at $109.91 . GWPH has a 1-year high of $126.78 and a 1-year low of $58.16. The stock’s 50-day moving average is $102.38 and its 200-day moving average is $83.21.
On the ratings front, GW has been the subject of a number of recent research reports. In a report issued on April 22, Piper Jaffray analyst Joshua Schimmer reiterated a Buy rating on GWPH, with a price target of $147, which represents a potential upside of 33.7% from where the stock is currently trading. 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 13.2% and 29.8% respectively. Schimmer has a success rate of 60.2% and is ranked #258 out of 3596 analysts, while Schwartz has a success rate of 66.2% and is ranked #58.
GW Pharmaceuticals PLC is engaged in the research, development and commercialisation of cannabinoid prescription medicines to meet patient needs.