On May 8, 2017 Kite Pharma, Inc. (NASDAQ:KITE), a cell therapy company, reported first quarter 2017 financial results and provided a corporate update for the period ended March 31, 2017 (Press release, Kite Pharma, MAY 8, 2017, View Source [SID1234518912]). Schedule your 30 min Free 1stOncology Demo! "Kite is intensely focused on bringing axicabtagene ciloleucel to market in 2017. Our preparation for the potential commercialization of the first CAR-T therapy in aggressive non-Hodgkin lymphoma began two years ago. With the team and infrastructure we now have in place, we are confident in our readiness to deliver upon potential approval in the U.S. and expect to file for approval in Europe in the third quarter of this year," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "We are also keeping an eye toward future growth with additional indications across the KTE-C19 program and development of earlier stage product candidates, including KITE-585, which we believe has the potential to become the next significant opportunity for Kite."
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First Quarter 2017 Financial Results
Revenues were $9.8 million for the first quarter of 2017.
Research and development expenses were $65.9 million for the first quarter of 2017, which includes $12.7 million of non-cash stock-based compensation expense.
General and administrative expenses were $35.8 million for the first quarter of 2017, which includes $11.4 million of non-cash stock-based compensation expense.
Net loss was $90.4 million, or $1.74 per share, for the first quarter of 2017.
Non-GAAP net loss for the first quarter of 2017 was $66.3 million, or $1.28 per share, excluding non-cash stock-based compensation expense of $24.1 million.
As of March 31, 2017, Kite had $804.0 million in cash, cash equivalents, and marketable securities. A public offering of common stock generated approximately $409.7 million in gross proceeds to Kite. In addition, Kite received a $50 million upfront payment related to its strategic collaboration with Daiichi Sankyo.
2017 Financial Guidance
Kite continues to expect the full year 2017 net cash burn to be between $325 million and $340 million. This guidance assumes GAAP operating expenses to be between $490 million and $515 million, which includes approximately $135 million in non-cash stock based compensation expense. Kite expects 2017 total operating expenses to consist of approximately 60 percent Research and Development and approximately 40 percent General and Administrative.
First Quarter 2017 and Recent Highlights
Axicabtagene Ciloleucel/KTE-C19 Progress
Presented positive topline results from the primary analysis of the ZUMA-1 study of axicabtagene ciloleucel in patients with aggressive non-Hodgkin lymphoma (NHL) at the 2017 American Association of Cancer Research annual meeting. Data included the 99 percent success rate in the manufacturing of clinical product patient dose from a single apheresis for the multi-center ZUMA-1 clinical trial.
Completed the submission of a Biologics License Application (BLA) to the FDA for axicabtagene ciloleucel in patients with aggressive NHL.
Initiated ZUMA-5 study of axicabtagene ciloleucel in patients with follicular NHL.
Initiated ZUMA-9 study to provide patients access to axicabtagene ciloleucel during the regulatory review period.
Strategic Collaborations
Entered a strategic collaboration with Daiichi Sankyo to develop and commercialize axicabtagene ciloleucel in Japan.
Established a joint venture with Fosun Pharma to develop and commercialize T-cell therapies, including axicabtagene ciloleucel, in China.
Pipeline Expansion
Cleared an investigational new drug (IND) application for KITE-718, a T cell receptor (TCR) cell therapy candidate that targets MAGE-A3/A6 antigens expressed on solid tumors.
Commercial Preparation
Started recruitment and training of cell therapy account managers to support customer service and logistical coordination.
Additional 2017 Clinical Milestones
KTE-C19 and axicabtagene ciloleucel
Submit marketing authorization application (MAA) to the European Medicines Authority (EMA) for axicabtagene ciloleucel in aggressive NHL in the third quarter of 2017.
Availability of preliminary 12-month follow-up data from ZUMA-1 study of axicabtagene ciloleucel in patients with aggressive NHL.
Availability of preliminary follow-up Phase 1 data from ZUMA-3 and ZUMA-4 studies of pediatric and adult acute lymphoblastic leukemia, respectively.
Advance ZUMA-3 and ZUMA-4 studies into Phase 2.
Availability of preliminary data from ZUMA-6 combination study of axicabtagene ciloleucel and atezolizumab PD-L1 checkpoint inhibitor in aggressive NHL.
Cell Therapy Pipeline
Initiate Phase 1 study of KITE-718 in patients with solid tumors in the second quarter of 2017.
File IND for KITE-585, a CAR T cell therapy candidate that targets BCMA for the treatment of multiple myeloma, in the third quarter of 2017.