May 8, 2017 2:08pm
The death has distressed investors because death from brain swelling, or cerebral edema, is the same severe toxic event that scuttled a competing CAR-T therapy from Juno Therapeutics (JUNO).
The patient death in a KTE-C19 safety study occurred in April. The FDA was notified but the study was not placed on any clinical hold, KITE said on a Monday morning conference call.
KITE reported a loss of $90.4 M or $1.74 per share and is DOWN -$9.18 or -11.19%
The results missed “Street” expectations. The average estimate of 10 analysts was for a loss of $1.68 per share. KITE posted revenue of $9.8 million falling short of forecasts having expected $15.3 million.
R&D expenses were $65.9 million for the first quarter of 2017, which includes $12.7 million of non-cash stock-based compensation expense.
G&A expenses were $35.8 million for the first quarter of 2017, which includes $11.4 million of non-cash stock-based compensation expense.
Non-cash stock-based compensation expense is affecting the bottom line …
As of 3/31/17, Kite had $804.0 million in cash, cash equivalents, and marketable securities. A public offering of common stock generated approximately $409.7 million in gross proceeds to Kite. In addition, Kite received a $50 M upfront payment related to its strategic collaboration with Daiichi Sankyo.
Kite continues to expect the full year 2017 net cash burn to be between $325 million and $340 million. This guidance assumes GAAP operating expenses to be between $490 million and $515 million, which includes approximately $135 million in non-cash stock based compensation expense. Kite expects 2017 total operating expenses to consist of approximately 60% R&D and approximately 40% G&A.
KITE is DOWN -$9.18 or -11.19%
KITE’s shares had risen 82% since the beginning of the year. The stock had increased 83% in the last 12 months.