On August 10, 2015 Kite Pharma, Inc. (Kite) (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 June 30, 2015 (Press release, Kite Pharma, AUG 10, 2015, View Source [SID:1234507155]).

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"This past quarter has been marked by a number of significant milestones. Most notably, we launched the first Company-sponsored clinical trial of our lead product candidate, KTE-C19," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer. "We also entered into multiple collaborations, and expanded our manufacturing capabilities. In addition, we were very pleased to convene our first investor day on June 23rd, which allowed us to unveil new initiatives and highlight the progress of both our chimeric antigen receptor (CAR) and T cell receptor (TCR) programs."

Highlights of Developments in Second Quarter 2015

Commenced Kite’s Phase 1/2 clinical trial of KTE-C19, an anti-CD19 CAR T-cell therapy, for treatment of refractory, aggressive Non-Hodgkin’s Lymphoma (NHL).

Presented clinical biomarker results at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which demonstrated that conditioning chemotherapy was associated with a significant rise in homeostatic cytokines and chemokines, which could favor expansion, activation, and trafficking of CAR T cells.

Announced our first TCR product candidate, targeting HPV-16 E6, that we plan to advance to a company-sponsored clinical trial.
Entered into an exclusive worldwide collaboration with bluebird bio to advance second generation TCR products to treat HPV-associated cancers.

Partnered with The Leukemia & Lymphoma Society to enhance the development of KTE-C19 in refractory, aggressive NHL and to launch CAR T-cell therapy educational programs.

Completed construction of our clinical supply manufacturing facility in Santa Monica, California.
Began construction on our manufacturing facility in El Segundo, California to support our commercial plans.
Hosted our first Investor Day, which focused on our future research, clinical, and manufacturing plans.

Second Quarter 2015 Financial Results

Cash Position: As of June 30, 2015, Kite had $392.9 million in cash, cash equivalents, and marketable securities, compared to $367.0 million as of December 31, 2014.

Cash Burn: The net increase of $25.9 million in the first half of 2015 was primarily due to $26.7 million in proceeds from the underwriters’ exercise of the over-allotment option from the follow-on public offering and the $60.0 million upfront payment from the Amgen collaboration. This increase was partially offset by cash outflows related to the acquisition of TCF, license obligations, and funding of ongoing operations, including for the advancement of the KTE-C19 program.

Net Loss: GAAP net loss attributable to common stockholders was $20.9 million, or $0.48 per share, for the second quarter of 2015, compared to $17.9 million, or $2.27 per share, for the second quarter of 2014. Non-GAAP net loss attributable to common stockholders for the second quarter of 2015 was $11.5 million, or $0.26 per share. Non-GAAP net loss for the second quarter of 2015 excludes non-cash stock-based compensation expense of $9.4 million. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net loss to non-GAAP net loss.

Revenue: Collaboration revenue was $4.4 million for the second quarter of 2015 compared to $0 for the second quarter of 2014. The increase was primarily comprised of the amortization of deferred revenue related to the $60.0 million upfront payment received from Amgen in the first quarter of 2015.

Total Operating Expenses: Total GAAP operating expenses for the second quarter of 2015 were $26.4 million compared to $11.1 million for the second quarter of 2014.

R&D Expenses: GAAP research and development (R&D) expenses were $16.6 million for the second quarter of 2015, compared to $7.4 million for the second quarter of 2014. The increase of $9.2 million was primarily due to costs associated with the ongoing KTE-C19 Phase 1/2 clinical trial in DLBCL, preparing for the additional trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) later this year, as well as increased personnel expense, including non-cash stock-based compensation, and costs related to growing the Company’s operations in the US and EU.

G&A Expenses: GAAP general and administrative (G&A) expenses were $9.8 million for the second quarter of 2015, compared to $3.7 million for the second quarter of 2014. The increase of $6.1 million was primarily due to increased personnel expense, including non-cash stock-based compensation, and other professional expenses to support growing the Company’s operations, as well as license obligations.

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.