Kite Pharma, Inc. (KITE - Free Report) reported narrower-than-expected loss in the second quarter of 2017 and beat estimates for sales. Shares of the biotech company rose 5.8% on Tuesday.
In fact, this year so far, Kite Pharma’s stock is up 167.9%, which compares favorably with a 9.7% increase registered by the industry.
Kite Pharma reported a loss of $1.94 per share in the second quarter of 2017, narrower than the Zacks Consensus Estimate of a loss of $1.97 per share. The company had reported a loss of $1.31 per share in the year-ago period.
Second-quarter revenues came in at $10.05 million, which beat the Zacks Consensus Estimate of $9.23 million and were up 109.6% from the year-ago period.
Kite Pharma’s research and development expenses shot up almost 50% from the year-ago period to $70.9 million owing to increased funding for multiple clinical studies. General and administrative expenses were $41.1 million, up 73.3% from the year-ago period as the company prepares for a potential commercial launch of axicabtagene ciloleucel, its lead drug, in the U.S. this year.
Kite Pharma ended the year with $781.1 million in cash and marketable securities compared with $804.0 million at the end of the first quarter.
Kite Pharma’s lead drug axicabtagene ciloleucel is currently under priority review in the U.S. for treating aggressive non-Hodgkin lymphoma (NHL) with a FDA decision expected on Nov 29. The Biologics License Application (BLA) filing was based on data from a phase I-II study ZUMA-1.
Axicabtagene ciloleucel is expected to be approved and launched in the U.S this year. At the conference call, the company announced that the FDA has informed that an Advisory Committee meeting will not be needed for the review of its Biologics License Application for axicabtagene ciloleucel.
In Europe, a regulatory application was filed last week with an approval and launch expected next year.
Immuno-oncology is one of the most actively pursued areas of research today. There are several other companies working to bring innovative immuno-oncology treatments to market. Juno Therapeutics Inc. (JUNO - Free Report) and Novartis AG (NVS - Free Report) are also developing JCAR017 and CTL019, respectively utilizing the CAR T cell technology. Though the efficacy profile of all the three candidates is comparable, axicabtagene ciloleucel looks set to hit the markets first.
Other studies with axicabtagene ciloleucel are also advancing. These include a phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL) – ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL.
ZUMA-5 study is evaluating axicabtagene ciloleucel in patients with indolent NHL. Last week, the company announced that the first patient was dosed in this phase II study.
ZUMA-9 study is being conducted to provide patients access to axicabtagene ciloleucel during the regulatory review period. ZUMA-8 is evaluating the candidate for chronic lymphocytic leukemia. A phase Ib/II combination study (ZUMA-6) evaluating axicabtagene ciloleucel plus Roche Holding AG’s (RHHBY - Free Report) Tecentriq (atezolizumab) in patients with chemorefractory DLBCL is also ongoing.
Preliminary data from ZUMA-3, ZUMA-4 and ZUMA-6 are expected later this year. The company also plans to move ZUMA-3 and ZUMA-4 into phase II studies later this year.
Kite Pharma is also developing other TCR/CAR cell therapy based candidates, including KITE-585 and KITE-718.
Phase I study on the first of the four TCR/CAR T candidates - KITE-718 in solid tumors, including non-small cell lung cancer bladder cancer and head and neck cancer – was initiated in the quarter. KITE-718, a TCR cell therapy candidate, targets cancer antigens MAGE A3 and MAGE A6 in a solid tumor. Kite Pharma announced that it has filed an investigational new drug (IND) application for CAR T candidate KITE-585 targeting BCMA antigen for multiple myeloma. Phase I studies are expected to be initiated in the second half of the year.
Kite Pharma carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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