Kite Pharma Q3 Loss Betters Estimate; KTE-C19 On Track

Zacks

Kite Pharma, Inc. KITE reported a loss of $1.49 per share in the third quarter of 2016, narrower than the Zacks Consensus Estimate of a loss of $1.68 per share but wider than the year-ago loss of 63 cents.

Third-quarter revenues came in at $7.3 million, much above the Zacks Consensus Estimate of $4.95 million and up 44.3% from the year-ago period.

Shares of the company rose around 9% on Wednesday.

KITE PHARMA INC Price and EPS Surprise

KITE PHARMA INC Price and EPS Surprise | KITE PHARMA INC Quote

Third-quarter revenues included $5.5 million from the amortization of deferred collaboration revenues related to the $60 million upfront payment received under the collaboration agreement with Amgen Inc. AMGN in the first quarter of 2015.

KTE-C19 Poised for Launch in 2017

With no approved product in its portfolio, investor focus remains on KTE-C19, Kite’s lead pipeline candidate. KTE-C19 is being evaluated presently in five studies.

In September, the company announced encouraging top-line results from the phase II part of the ZUMA-1 pivotal study 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).

Kite expects to file a Biologic License Application (BLA) for a broader label for aggressive NHL including DLBCL, TFL and PMBCL indications, based on ZUMA-1 data and also six months follow up data (expected in the first quarter of 2017).

Kite plans to initiate a rolling submission of the BLA by the end of December this year with a targeted completion by the end of the first quarter 2017. KTE-C19 is expected to be launched in 2017. In October, the company reported positive 12-month follow-up data from the phase I portion of ZUMA-1 study at a medical meeting.

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 (ZUMA-6) evaluating KTE-C19 plus Genentech’s Tecentriq (atezolizumab) in patients with chemorefractory DLBCL commenced in October.

Note that Kite inked the collaboration with Genentech, a member of the Roche Holding AG RHHBY this March, with an aim to evaluate the safety and efficacy of the combination therapy.

While Kite’s research and development expenses flared up 163.6% from the year-ago period to $57.3 million in the reported quarter, general and administrative expenses were $25.0 million, 124.8% higher than the year-ago period.

Kite had approximately $477 million in cash and investments at the end of the third quarter, which it believes will carry it through the first half of 2018.

Kite carries a Zacks Rank #4 (Sell). A better-ranked stock in the healthcare sector is Anika Therapeutics Inc. ANIK with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates have increased 5% for 2016 and 3% for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters, with an average beat of 33.1%. Its share price has increased 14% year to date.

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