On November 12, 2015 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported financial results for the quarter ended September 30, 2015 (Press release, Kite Pharma, NOV 12, 2015, View Source [SID:1234508221]).

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"Over the past few months, we have achieved many significant corporate and clinical development milestones, including the initiation of two pivotal Phase 2 studies of our lead product candidate, KTE-C19," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "Our ZUMA-1 trial is enrolling patients with aggressive, refractory non-Hodgkin’s lymphoma, while our ZUMA-2 trial is enrolling patients with relapsed or refractory mantle cell lymphoma. We also plan to initiate two additional pivotal studies of KTE-C19 in patients with acute lymphoblastic leukemia prior to the end of this year. We look forward to reporting data from these trials in 2016 with the goal of filing our first Biologics License Application by the end of 2016."

Recent Highlights

Completed the Phase 1 portion of the KTE-C19 study in aggressive, refractory non-Hodgkin’s lymphoma (NHL) and recently opened enrollment in the pivotal Phase 2 (ZUMA-1) multi-center trial to support registration and potential commercial launch of KTE-C19 in 2017.

Initiated the second pivotal Phase 2 KTE-C19 study (ZUMA-2) in patients with relapsed or refractory mantle cell lymphoma (MCL) to support registration in this indication.

Obtained Orphan Drug Designations in the EU for KTE-C19 in leading hematological malignancies including designation for the treatment of primary mediastinal B-cell lymphoma, MCL, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and acute lymphoblastic leukemia (ALL).

Four abstracts were accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, including an abstract on the safety and efficacy data from the Company’s KTE-C19 Phase 1 study in patients with aggressive, refractory NHL.

Expanded our collaboration with the Netherlands Cancer Institute for an exclusive option to license multiple T cell receptor (TCR) gene sequences for the development and commercialization of immunotherapy candidates targeting solid tumors.

Secured an exclusive, worldwide license with the National Institutes of Health to IP related to TCR-based product candidates that target MAGE A3 and A3/A6 antigens.

Secured an exclusive license to Alpine Immune Sciences’ transmembrane immunomodulatory protein (TIP) technology for chimeric antigen receptor and TCR-based products.

Appointed Dr. Franz B. Humer, former Chairman and Chief Executive of Roche Holding Ltd., to our Board of Directors.
Strengthened our Scientific Advisory Board with the addition of Drs. James Allison and Padmanee Sharma, recognized leaders from MD Anderson Cancer Center.

Held the official inauguration for Kite EU, our European headquarters in Amsterdam.
Completed construction of our clinical supply manufacturing facility in Santa Monica.

Third Quarter 2015 Financial Results

Cash Position: As of September 30, 2015, Kite had $368.6 million in cash, cash equivalents, and marketable securities, compared to $367.0 million as of December 31, 2014.

Cash Burn: Cash burn was $24.3 million for the third quarter of 2015, compared to $8.0 million for the third quarter of 2014. This increase was primarily due to the ramp up of our operations supporting the KTE-C19 program, including costs to build out our clinical manufacturing and commercial manufacturing facilities.

Net Loss: GAAP net loss attributable to common stockholders was $27.4 million, or $0.63 per share, for the third quarter of 2015, compared to $9.1 million, or $0.24 per share, for the third quarter of 2014. Non-GAAP net loss attributable to common stockholders for the third quarter of 2015 was $16.6 million, or $0.38 per share. Non-GAAP net loss for the third quarter of 2015 excludes non-cash stock-based compensation expense of $10.8 million for the third quarter of 2015. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net loss to non-GAAP net loss.

Revenue: Revenue was $5.1 million for the third quarter of 2015 compared to $0 for the third quarter of 2014. The increase was primarily due to revenue recognized under the Amgen collaboration.

Total Operating Expenses: Total GAAP operating expenses for the third quarter of 2015 were $32.9 million, compared to $9.1 million for the third quarter of 2014.

R&D Expenses: GAAP research and development (R&D) expenses were $21.7 million for the third quarter of 2015, compared to $5.7 million for the third quarter of 2014, an increase of $16.0 million. This increase was primarily attributable to a $9.1 million increase in research and clinical development expenses supporting the advancement of our KTE-C19 studies and our additional development programs, $3.2 million in expenses related to increased personnel and consulting costs, and $3.7 million of non-cash stock-based compensation expense.

G&A Expenses: GAAP general and administrative (G&A) expenses were $11.1 million for the third quarter of 2015, compared to $3.4 million for the third quarter of 2014, an increase of $7.7 million. This increase was primarily attributable to a $3.0 million increase in personnel related expenses, $0.9 million for license obligations, and $3.8 million of non-cash stock-based compensation.

2015 Financial Guidance: Kite’s guidance remains unchanged. Kite expects to burn between $100 million and $125 million in cash for the full year 2015, which includes both operating expenses and capital expenditures. This guidance does not include cash inflows or outflows for business development activities.