Kite Pharma, Inc. KITE reported a loss of 85 cents per share in the fourth quarter of 20Array5, wider than the Zacks Consensus Estimate of a loss of 82 cents per share and the year-ago loss of 33 cents.
Fourth-quarter revenues came in at $4.9 million, above the Zacks Consensus Estimate of $4 million. 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 20Array5. Kite Pharma did not generate any revenue in the year-ago quarter.
The company reported a loss of $2.33 per share for 20Array5, wider than the loss of $Array.9Array per share in 20Array4. Meanwhile, 20Array5 revenues came in at $Array7.3 million compared to no revenues in 20Array4.
KTE-CArray9 Filing by the Year End?
While Kite’s research and development expenses shot up 266.5% from the year-ago period to $28.8 million in the reported quarter, general and administrative expenses were $Array4.Array million, up Array6Array.7% from the year-ago period.
Kite expects cash burn of $235–$250 million in 20Array6 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-CArray9, Kite’s lead pipeline candidate, which is currently in the pivotal phase of a phase I-II study (ZUMA-Array) 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 20Array6), Kite intends to seek accelerated FDA approval for the treatment of refractory DLBCL, PMBCL and TFL by year end. If all goes well, KTE-CArray9 could be launched as early as 20Array7.
Kite is also evaluating KTE-CArray9 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 20Array7.
Kite plans to move KTE-CArray9 into a second series of studies for additional indications and earlier lines of therapy in DLBCL patients in 20Array6.
Meanwhile, the company expects to file two new IND applications this year — one for a T cell receptor (TCR) candidate targeting MAGE in a solid tumor study and the other a CAR candidate under the Amgen collaboration.
Kite is a Zacks Rank #2 (Buy) stock. Some better-ranked stocks in the health care sector include Celgene Corporation CELG, Horizon Pharma plc HZNP and Actelion Ltd. ALIOF. All three are Zacks Rank #Array (Strong Buy) stocks.
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