Kite Pharma, Inc. is a development-stage company focused on the development of immuno-oncology treatments and is looking to revolutionize cancer treatments by engaging the body’s own immune system to treat cancer. Kite uses eACT to genetically modify T cells to express either CARs or TCRs. The modified T-cells are designed to recognize and destroy cancer cells. Immuno-oncology is a hot therapeutic area with huge commercial potential.
With no approved products in its portfolio, investor focus will primarily be on the company’s cash burn and pipeline updates.
Axicabtagene ciloleucel (previously KTE-C19), its lead pipeline candidate, 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). Meanwhile, axicabtagene ciloleucel is also being evaluated in other cancer studies as well.
KITE, which started trading from Jun 2014, has a mixed record of earnings surprises. It delivered positive earnings surprises in two of the past four quarter while missed in the other two, bring the average surprise to a positive 7.89%.
Currently, KITE has a Zacks Rank #3 (Hold), but that could definitely change following the company’s earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:
Loss Narrower-Than-Expected: KITE reported fourth quarter 2016 loss of 1.70 cents per share, narrower than our consensus estimate of a loss of $1.75 cents per share.
Revenues Miss: Revenues in the reported quarter marginally missed expectations. KITE posted revenues of $4.9 million, compared to our consensus estimate of $5.0 million.
Key Stats: While Kite’s research and development expenses shot up almost 105% from the year-ago period to $58.9 million in the reported quarter, general and administrative expenses were $31.8 million, up 122.1% from the year-ago period.
Positive Axicabtagene ciloleucel Data: In a separate announcement today, Kite Pharma announced positive top-line results from the primary analysis of ZUMA-1 study which evaluated 101 patients with chemorefractory aggressive NHL (DLBCL, TFL and PMBCL). The study met the primary endpoint of objective response rate (ORR). At month 6, 41% of patients treated with axicabtagene ciloleuce achieved a response, including 36% achieving a complete response. Full data from the primary analysis will be presented at the American Association for Cancer Research in April 2017.
Kite Pharma expects to file a Biologic License Application (BLA) for a broader label for aggressive NHL including DLBCL, TFL and PMBCL indications, based on the primary analysis of ZUMA-1. Kite Pharma initiated a rolling submission of the BLA in December and still expects to complete the filing by the end of the first quarter of 2017. KTE-C19 is expected to be launched in 2017. In Europe, regulatory applications are expected to be filed this year.
We remind investors that in Sep 2016, the company announced encouraging top-line results from the phase II part of ZUMA-1 study.
Pre-Market Trading: Shares declined 1.5% in pre-market trading.
Check back later for our full write up on this KITE earnings report later!
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Kite Pharma (KITE) Q4 Loss Narrower than Expected
Kite Pharma, Inc. is a development-stage company focused on the development of immuno-oncology treatments and is looking to revolutionize cancer treatments by engaging the body’s own immune system to treat cancer. Kite uses eACT to genetically modify T cells to express either CARs or TCRs. The modified T-cells are designed to recognize and destroy cancer cells. Immuno-oncology is a hot therapeutic area with huge commercial potential.
With no approved products in its portfolio, investor focus will primarily be on the company’s cash burn and pipeline updates.
Axicabtagene ciloleucel (previously KTE-C19), its lead pipeline candidate, 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). Meanwhile, axicabtagene ciloleucel is also being evaluated in other cancer studies as well.
KITE, which started trading from Jun 2014, has a mixed record of earnings surprises. It delivered positive earnings surprises in two of the past four quarter while missed in the other two, bring the average surprise to a positive 7.89%.
Currently, KITE has a Zacks Rank #3 (Hold), but that could definitely change following the company’s earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:
Loss Narrower-Than-Expected: KITE reported fourth quarter 2016 loss of 1.70 cents per share, narrower than our consensus estimate of a loss of $1.75 cents per share.
Revenues Miss: Revenues in the reported quarter marginally missed expectations. KITE posted revenues of $4.9 million, compared to our consensus estimate of $5.0 million.
Key Stats: While Kite’s research and development expenses shot up almost 105% from the year-ago period to $58.9 million in the reported quarter, general and administrative expenses were $31.8 million, up 122.1% from the year-ago period.
Positive Axicabtagene ciloleucel Data: In a separate announcement today, Kite Pharma announced positive top-line results from the primary analysis of ZUMA-1 study which evaluated 101 patients with chemorefractory aggressive NHL (DLBCL, TFL and PMBCL). The study met the primary endpoint of objective response rate (ORR). At month 6, 41% of patients treated with axicabtagene ciloleuce achieved a response, including 36% achieving a complete response. Full data from the primary analysis will be presented at the American Association for Cancer Research in April 2017.
Kite Pharma expects to file a Biologic License Application (BLA) for a broader label for aggressive NHL including DLBCL, TFL and PMBCL indications, based on the primary analysis of ZUMA-1. Kite Pharma initiated a rolling submission of the BLA in December and still expects to complete the filing by the end of the first quarter of 2017. KTE-C19 is expected to be launched in 2017. In Europe, regulatory applications are expected to be filed this year.
We remind investors that in Sep 2016, the company announced encouraging top-line results from the phase II part of ZUMA-1 study.
Pre-Market Trading: Shares declined 1.5% in pre-market trading.
Check back later for our full write up on this KITE earnings report later!
A Full-Blown Technological Breakthrough in the Making
Zacks’ Aggressive Growth Strategist Brian Bolan explores autonomous cars in our latest Special Report, Driverless Cars: Your Roadmap to Mega-Profits Today. In addition to who will be selling them and how the auto industry will be impacted, Brian reveals 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>