GW Pharma (GWPH) Posts Q2 Loss of 5c/Share

GW Pharma (NASDAQ: GWPH) reported Q2 EPS of ($0.05), $1.07 better than the analyst estimate of ($1.12). Revenue for the quarter came in at $9.43 million versus the consensus estimate of $11.38 million.

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.

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

For earnings history and earnings-related data on GW Pharma (GWPH) click here.

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