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Kite Pharma (KITE) Posts Narrower-than-Expected Loss in Q1

Kite Pharma, Inc. KITE reported a loss of 90 cents per share in the first quarter of 2016, narrower than the Zacks Consensus Estimate of a loss of $1.22 per share but wider than the year-ago loss of 36 cents.

First-quarter revenues came in at $5.1 million, in line with the Zacks Consensus Estimate and up 78% from the year-ago period. Revenues consisted entirely of the amortization of deferred collaboration revenues related to the $60 million upfront payment received under the collaboration agreement with Amgen AMGN in the first quarter of 2015.

KTE-C19 Year End Filing Remains on Track

While Kite’s research and development expenses shot up 271.6% from the year-ago period to $34.4 million in the reported quarter, general and administrative expenses were $16.5 million, up 79.8% from the year-ago period.

Kite continues to expect cash burn of $235–$250 million in 2016 including both operating expenses and about $20 million of capital expenditures but excluding the impact of business development activities.

With no approved product in its portfolio at the moment, focus remains on KTE-C19, Kite’s lead pipeline candidate, which is currently in the pivotal phase of a phase I-II study (ZUMA-1) in patients with refractory diffuse large B cell lymphoma (DLBCL) including primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). All these are types of aggressive non-Hodgkin’s lymphoma (NHL).

Initial NCI-conducted study results for these indications have been promising. If the study generates positive data (top-line data from the phase I portion presented at ASH in December; interim results expected in the second half of 2016), Kite intends to seek accelerated FDA approval for the treatment of refractory DLBCL, PMBCL and TFL by year end. If all goes well, KTE-C19 could be launched as early as 2017.

Kite is also evaluating KTE-C19 in a phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and in two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL) - ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL, with results from all these studies due in 2017.

Kite plans to move KTE-C19 into a second series of studies for additional indications and earlier lines of therapy in DLBCL patients in 2017.

A phase Ib/II combination study evaluating KTE-C19 plus Genentech’s atezolizumab in patients with chemorefractory DLBCL is scheduled to commence in the second half of 2016.

Meanwhile, the company expects to file an IND application this year for a T cell receptor (TCR) candidate targeting MAGE in a solid tumor study.

Kite is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the healthcare sector include Cambrex Corporation CBM and Heska Corporation HSKA. Both are Zacks Rank #1 (Strong Buy) stocks.

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