On February 29, 2016 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous cell therapy (eACT) products for the treatment of cancer, reported a corporate update and reported full-year and fourth quarter 2015 financial results for the period ended December 31, 2015 (Press release, Kite Pharma, FEB 29, 2016, View Source [SID:1234509308]).
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"2015 was a year of solid execution and transformation for Kite," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "The development of KTE-C19, our breakthrough immunotherapy candidate for patients with refractory hematological malignancies who have limited or no treatment options, is currently advancing in four Kite-sponsored multi-center clinical studies. We expect interim pivotal data from ZUMA-1, our lead study of KTE-C19, in the second half of this year, positioning us to submit our registrational filing with the FDA by year end. Construction of our commercial manufacturing facility is complete, and commercial planning is currently progressing under the leadership of our Chief Commercial Officer, Shawn Tomasello, and her capable team."
Dr. Belldegrun continued, "We are advancing what we believe is the most robust clinical pipeline of chimeric antigen receptors and T cell receptors for both solid and hematological oncology. This effort is supported by our ongoing collaborations with distinguished academic and industry leaders in immuno-oncology. We expect that our pipeline progress in 2016 will include additional human proof of concept data supporting the potential of our TCRs for the treatment of solid tumors."
Full Year 2015 and Recent Highlights
KTE-C19 Program
Initiated Kite’s lead multi-center study (ZUMA-1) for KTE-C19 for the treatment of aggressive, refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL). DLBCL is the most common form of non-Hodgkin Lymphoma (NHL).
Announced positive data from the Phase 1 portion of ZUMA-1 and advanced the study to the pivotal phase. The overall safety, efficacy, and biomarker data were generally consistent with previously published data from the National Cancer Institute (NCI).
Initiated three additional pivotal multi-center studies of KTE-C19 for the treatment of relapsed/refractory mantle cell lymphoma (MCL), adult relapsed/refractory acute lymphoblastic leukemia (ALL), and pediatric relapsed/refractory ALL.
Received Breakthrough Therapy Designation for KTE-C19 for the treatment of patients with refractory DLBCL, PMBCL, and TFL.
Secured Orphan Drug Designations in the EU for KTE-C19 for all of Kite’s hematological indications.
Completed Kite’s clinical manufacturing facility that is manufacturing KTE-C19 and that will manufacture future product candidates.
Completed construction of Kite’s commercial manufacturing facility, which is on track for qualification and validation later this year.
Acquisition and Strategic Collaborations
Established European operations with the acquisition of T-Cell Factory, now known as Kite Pharma EU. Through this acquisition, Kite also gained the proprietary TCR-GENErator discovery platform developed by Ton Schumacher, Ph.D., Chief Scientific Officer of Kite Pharma EU.
Expanded clinical and research partnership with the NCI including:
An enhanced Cooperative Research and Development Agreement (CRADA) with the NCI’s Surgery Branch to advance multiple CAR and TCR programs led by Steven Rosenberg, M.D., Ph.D.
A separate CRADA with the NCI’s Experimental Transplantation and Immunology Branch to advance the development of a fully human anti-CD19 CAR product candidate. James Kochenderfer, M.D. is leading the Phase 1 study.
Expanded agreement with the Netherlands Cancer Institute for the exclusive option to license multiple TCR gene sequences for the development and commercialization of immunotherapy candidates targeting solid tumors.
Entered into a research and license agreement with Leiden University Medical Center in the Netherlands to identify and develop TCR product candidates targeting solid tumors that are associated with the human papillomavirus (HPV) type 16 infection.
Partnered with Amgen to develop and commercialize the next generation of novel CAR T cell immunotherapies.
Entered into a collaboration with bluebird bio to advance second-generation TCR cell therapy products to treat HPV-associated cancers.
Secured an exclusive license to Alpine Immune Sciences’ transmembrane immunomodulatory protein (TIPTM) technology for eACT-based products.
Corporate Milestones
Strengthened the organization with the addition of more than 100 new hires across all functions.
Formed Kite’s integrated commercial leadership team, led by Shawn Tomasello, Kite’s Chief Commercial Officer.
Appointed Dr. Franz B. Humer, former Chairman and Chief Executive of Roche Holding Ltd., to Kite’s Board of Directors.
Strengthened Kite’s Scientific Advisory Board with the addition of James Allison, Ph.D. and Padmanee Sharma, M.D., Ph.D., recognized immunotherapy leaders from MD Anderson Cancer Center.
Raised $272.6 million in net proceeds from a public offering in December 2015.
2016 Goals
Announce interim Phase 2 pivotal data from the ZUMA-1 study for the first 50 patients with 90-day follow-up in the second half of 2016.
Submit the KTE-C19 registration filing to the U.S. Food and Drug Administration (FDA) based on interim data from ZUMA-1 study by the end of 2016.
Expand KTE-C19 clinical program to Europe in preparation for a European registration filing in 2017.
Complete the qualification and validation testing of the commercial manufacturing facility in anticipation of pre-approval inspection by the FDA.
Initiate a second series of KTE-C19 studies for additional indications and earlier lines of therapy in DLBCL patients.
Present longer term follow-up KTE-C19 data in patients with refractory aggressive DLBCL from the Phase 1 portion of ZUMA-1.
File investigational new drug (IND) application with the FDA for a TCR product candidate that targets a MAGE antigen expressed on solid tumors.
Advance the Kite-Amgen collaboration resulting in the filing of an IND application with the FDA for a next generation CAR T cell immunotherapy candidate, the first of multiple INDs expected to originate from the collaboration.
Fourth Quarter and Full Year 2015 Financial Results
Revenue was $4.9 million for the fourth quarter of 2015 compared to $0 for the fourth quarter of 2014, and $17.3 million for the full year of 2015, compared to $0 for the full year of 2014. The increase was primarily due to revenue recognized under the Kite-Amgen collaboration.
Research and development expenses were $28.8 million for the fourth quarter of 2015, compared to $7.9 million for the fourth quarter of 2014, and $76.4 million for the full year of 2015 compared to $23.1 million in 2014. The full-year increase of $53.3 million was primarily attributable to a $31.5 million increase in research and development and manufacturing expenses supporting the advancement of KTE-C19 and other programs, $11.8 million in expenses related to increased personnel and consulting costs, and $10.0 million of non-cash stock-based compensation expense.
General and administrative expenses were $14.1 million for the fourth quarter of 2015, compared to $5.4 million for the fourth quarter of 2014, and $44.2 million for the full year of 2015, compared to $13.6 million in 2014. The full-year increase of $30.6 million was primarily attributable to an $8.2 million increase in personnel related expenses, $7.8 million for public company expenses and license obligations, and $14.6 million of non-cash stock-based compensation.
Net loss attributable to common stockholders was $38.2 million, or $0.85 per share, for the fourth quarter of 2015, compared to $13.0 million, or $0.33 per share, for the fourth quarter of 2014. For the full year of 2015, the net loss was $101.7 million, or $2.33 per share, compared to $43.7 million, or $1.91 per share, in 2014.
Non-GAAP net loss attributable to common stockholders for the fourth quarter of 2015 was $24.5 million, or $0.54 per share, which excludes non-cash stock-based compensation expense of $13.8 million for the fourth quarter of 2015. Non-GAAP net loss attributable to common stockholders for the full year of 2015 was $61.0 million, or $1.40 per share, which excludes non-cash stock-based compensation expense of $40.7 million for the full year of 2015.
As of December 31, 2015, Kite had $614.7 million in cash, cash equivalents, and marketable securities, compared to $367.0 million as of December 31, 2014.
Kite expects the full year 2016 net cash burn to be $235 to $250 million dollars, which includes approximately $20 million in capital expenditures, but excludes any inflows or outflows from business development activities. The estimated full year 2016 net cash burn is primarily driven by an estimated net loss of $295 to $310 million, which includes an estimated $80 million of non-cash stock-based compensation expense.